buprenorphine and Chronic-Disease

Opioid use disorder (OUD) is a chronic disorder in which a person loses control over the use of opioids, develops a compulsive behavior, and defends the use despite knowing the negative consequences. There are numerous treatments for OUD, including buprenorphine. Since it is displacing a full agonist opioid, precipitated withdrawal can occur with standard inductions involving buprenorphine.. Case reports have noted success with a low-dose initiation of buprenorphine, which is different from typical protocols, relatively limited by adverse effects when patients were recently administered full agonists. A cohort investigation studied the use of a transdermal patch as part of the protocol, which was fairly well tolerated. While ongoing research is being conducted on this topic, recent case studies and smaller cohort studies have demonstrated the feasibility of a trial to treat OUD with low-dose initiation of buprenorphine.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Disease; Humans; Opiate Substitution Treatment; Opioid-Related Disorders

Opioid use disorder is highly prevalent and can be fatal. At least 2.1 million Americans 12 years and older had opioid use disorder in 2016, and approximately 47,000 Americans died from opioid overdoses in 2017. Opioid use disorder is a chronic relapsing condition, the treatment of which falls within the scope of practice of family physicians. With appropriate medication-assisted treatment, patients are more likely to enter full recovery. Methadone and buprenorphine are opioid agonists that reduce mortality, opioid use, and HIV and hepatitis C virus transmission while increasing treatment retention. Intramuscular naltrexone is not as well studied and is harder to initiate than opioid agonists because of the need to abstain for approximately one week before the first dose. However, among those who start naltrexone, it can reduce opioid use and craving. Choosing the correct medication for a given patient depends on patient preference, local availability of opioid treatment programs, anticipated effectiveness, and adverse effects. Discontinuation of pharmacotherapy increases the risk of relapse; therefore, patients should be encouraged to continue treatment indefinitely. Many patients with opioid use disorder are treated in primary care, where effective addiction treatment can be provided. Family physicians are ideally positioned to diagnose opioid use disorder, provide evidence-based treatment with buprenorphine or naltrexone, refer patients for methadone as appropriate, and lead the response to the current opioid crisis.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Disease; Evidence-Based Medicine; Female; Humans; Male; Mass Screening; Methadone; Naltrexone; Narcotic Antagonists; Opiate Substitution Treatment; Opioid-Related Disorders; Pregnancy

Clinical studies demonstrate that buprenorphine is a pharmacologic agent that can be used for the treatment of various types of painful conditions. This study investigated the efficacy of 5 different types of buprenorphine formulations in the chronic pain population. The literature was reviewed on PubMed/MEDLINE, EMBASE, Cochrane Database, clinicaltrials.gov, and PROSPERO that dated from inception until June 30, 2017. Using the population, intervention, comparator, and outcomes method, 25 randomized controlled trials were reviewed involving 5 buprenorphine formulations in patients with chronic pain: intravenous buprenorphine, sublingual buprenorphine, sublingual buprenorphine/naloxone, buccal buprenorphine, and transdermal buprenorphine, with comparators consisting of opioid analgesics or placebo. Of the 25 studies reviewed, a total of 14 studies demonstrated clinically significant benefit with buprenorphine in the management of chronic pain: 1 study out of 6 sublingual and intravenous buprenorphine, the only sublingual buprenorphine/naloxone study, 2 out of 3 studies of buccal buprenorphine, and 10 out of 15 studies for transdermal buprenorphine showed significant reduction in pain against a comparator. No serious adverse effects were reported in any of the studies. We conclude that a transdermal buprenorphine formulation is an effective analgesic in patients with chronic pain, while buccal buprenorphine is also a promising formulation based on the limited number of studies.

Topics: Administration, Buccal; Administration, Cutaneous; Administration, Sublingual; Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Chronic Disease; Chronic Pain; Clinical Trials as Topic; Humans; Methadone; Neoplasms; Pain Management; Pain Measurement; Risk; Treatment Outcome

Opioid addiction rates are at a national high, with significant morbidity and mortality. In women, rates have been steadily increasing to be at par with addiction rates in men. Women tend to have quicker addiction and shorter duration to adverse outcomes. Treatment of women has the best outcomes when it is gender-specific, trauma-informed, connected with access to psychiatric services, and integrated into the medical home. Improved outcomes can be achieved with coordinated systems of care based on the harm-reduction model, with integration of medication-assisted therapy in a patient-centered medical home.

Topics: Buprenorphine; Chronic Disease; Female; Humans; Naloxone; Narcotic Antagonists; Opiate Substitution Treatment; Opioid-Related Disorders; Primary Health Care; Risk Factors; Women's Health

Topics: Analgesics, Opioid; Buprenorphine; Chronic Disease; Humans; Opioid-Related Disorders; Pain; Pain Management

To examine and analyse recent published research on the impact and management of drug use and related disorders in primary care settings. Emerging trends in drug use and the development of new treatment approaches are making new demands on the primary care sector.. Most recent publications relate to descriptions of the drugs used and their impact on mental health. The use of cannabis and newer stimulants and 'legal highs' tends to coexist with opiate use, and their physical and mental health sequelae often overlap. Several studies address methadone and buprenorphine prescribing, its efficacy and limitations, and organizational issues in delivery of treatment. Other areas identified in this review are pain control, adverse consequences of drug use including morbidity from infections associated with drug taking and death due to overdose, and longer-term outcomes. Several publications cover management of chronic conditions in an ageing population of drug users with multiple health problems, and others examine the trend toward community instead of specialist care.. A picture is presented of extensive use of psychoactive substances in many communities. This ranges from club drug taking and low level cannabis use to more invasive and self-harming drug taking resulting from the use of opiates and stimulants. Treatment services are challenged with the need to change.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Disease; Disease Management; Family Practice; Humans; Illicit Drugs; Methadone; Primary Health Care; Substance-Related Disorders

This article reviews the pharmacology, therapeutic efficacy and tolerability profile of the 7-day lower-dose (5, 10 and 20 μg/h) buprenorphine transdermal patch (BuTrans®, Norspan®) in the management of chronic non-malignant pain, with a focus on European labelling for the drug. Buprenorphine is a semi-synthetic opioid analgesic that acts primarily as a partial agonist at the mu opioid receptor. The transdermal formulation provides continuous delivery of buprenorphine, resulting in relatively consistent plasma drug concentrations throughout the 7-day dosing interval. The analgesic efficacy of transdermal buprenorphine in patients with osteoarthritis of the hip and/or knee has been demonstrated in several randomized controlled trials, which have shown the formulation to be equivalent to sublingual buprenorphine, noninferior to prolonged-release tramadol tablets, noninferior to codeine plus paracetamol (acetaminophen) combination tablets (when transdermal buprenorphine was used together with regularly scheduled oral paracetamol) and generally superior to a matching transdermal placebo patch. Transdermal buprenorphine was significantly more effective than placebo in reducing chronic low back pain of at least moderate severity in two randomized, double-blind, crossover trials. Other clinical trials, including a randomized, double-blind, maintenance-of-analgesia study, have also demonstrated the analgesic efficacy of transdermal buprenorphine in patients with chronic non-malignant pain of various causes. In general, serious adverse events with transdermal buprenorphine are similar to those for other opioid analgesics. Transdermal buprenorphine has a ceiling effect for respiratory depression, and the main risk is when it is combined with other CNS depressants. The most frequently reported adverse events with transdermal buprenorphine are headache, dizziness, somnolence, constipation, dry mouth, nausea, vomiting, pruritus, erythema, application site pruritus and application site reactions. Transdermal buprenorphine was better tolerated than sublingual buprenorphine in a 7-week, randomized, double-blind trial in patients with osteoarthritis pain. Nevertheless, as with other opioids, persistence with transdermal buprenorphine therapy is difficult for many patients because of adverse events or other reasons. Thus, transdermal buprenorphine has generally demonstrated good efficacy and tolerability in clinical trials in chronic non-malignant pain, providing effective

Topics: Analgesics, Opioid; Buprenorphine; Chronic Disease; Dose-Response Relationship, Drug; Humans; Pain; Pain Measurement; Randomized Controlled Trials as Topic; Time Factors; Transdermal Patch; Treatment Outcome

Several decades ago, the analgesic properties of buprenorphine were discovered. Its approval for the use as an agent for the treatment of opioid abuse has led to increasing numbers of patients presenting for surgery on buprenorphine. This article describes the challenges, advantages, and disadvantages of the use of buprenorphine as an analgesic for postoperative pain in patients with and without preoperative maintenance therapy.

Topics: Acute Disease; Analgesics, Opioid; Buprenorphine; Chronic Disease; Humans; Pain, Postoperative; Receptors, Opioid

Opioids have been regarded for millennia as among the most effective drugs for the treatment of pain. Their use in the management of acute severe pain and chronic pain related to advanced medical illness is considered the standard of care in most of the world. In contrast, the long-term administration of an opioid for the treatment of chronic noncancer pain continues to be controversial. Concerns related to effectiveness, safety, and abuse liability have evolved over decades, sometimes driving a more restrictive perspective and sometimes leading to a greater willingness to endorse this treatment. The past several decades in the United States have been characterized by attitudes that have shifted repeatedly in response to clinical and epidemiological observations, and events in the legal and regulatory communities. The interface between the legitimate medical use of opioids to provide analgesia and the phenomena associated with abuse and addiction continues to challenge the clinical community, leading to uncertainty about the appropriate role of these drugs in the treatment of pain. This narrative review briefly describes the neurobiology of opioids and then focuses on the complex issues at this interface between analgesia and abuse, including terminology, clinical challenges, and the potential for new agents, such as buprenorphine, to influence practice.

Topics: Analgesics, Opioid; Animals; Buprenorphine; Chronic Disease; Drug Tolerance; History, Ancient; Humans; Narcotic Antagonists; Nervous System; Opioid-Related Disorders; Pain; Substance Withdrawal Syndrome

Chronic pain in the elderly is a significant problem. Pharmacokinetic and metabolic changes associated with increased age makes the elderly vulnerable to side effects and overdosing associated with analgesic agents. Therefore the management of chronic cancer pain and chronic nonmalignant pain in this growing population is an ongoing challenge. New routes of administration have opened up new treatment options to meet this challenge. The transdermal buprenorphine matrix allows for slow release of buprenorphine and damage does not produce dose dumping. In addition the long-acting analgesic property and relative safety profile makes it a suitable choice for the treatment of chronic pain in the elderly. Its safe use in the presence of renal failure makes it an attractive choice for older individuals. Recent scientific studies have shown no evidence of a ceiling dose of analgesia in man but only a ceiling effect for respiratory depression, increasing its safety profile. It appears that transdermal buprenorphine can be used in clinical practice safely and efficaciously for treating chronic pain in the elderly.

Topics: Administration, Cutaneous; Age Factors; Aged; Analgesics, Opioid; Buprenorphine; Chronic Disease; Delayed-Action Preparations; Humans; Pain; Pain Measurement; Treatment Outcome

Our understanding of the pathophysiologic mechanisms of chronic pain progresses; the complexity of the problem justifies our need for new molecules and new ways of administration that will help to further optimise and better individualize our pharmacologic therapies. Whereas acute pain can be considered an alarm signal, chronic pain constitutes, per se, a syndrome that requires a meticulous selection of the analgesic drug(s). Since pain is permanent, the continuous administration of the analgesic is recommended rather than an on demand administration. Transdermic modes of administration are of value for the treatment of chronic pain because they allow a progressive delivery of the active compound together with the maintenance of stable plasma levels of the drug. Buprenorphine is a semi-synthetic opioid that is available in the sublingual, injectable, or transdermic forms. The matrix patch of buprenorphine represents a major asset for the treatment of chronic pain, whether it be cancerous in origin, or not. Its efficacy and safety have been clearly demonstrated in randomised double blind trials as well as in post-marketing surveillance observations. Buprenorphine, administered as a transdermal therapeutic system, induces a dose-related pain relief, whatever the nature of the pain and the age of the patient. Buprenorphine also exerts an analgesic action on neuropathic pain. It differs from other opioids by its affinity as a partial agonist on mu and kappa receptors, and as a complete agonist of ORL-1 receptors. Therefore, transdermal buprenorphine will be useful to all physicians having to control severe pain by powerful opioids.

Topics: Administration, Cutaneous; Analgesics, Opioid; Buprenorphine; Chronic Disease; Humans; Pain

Sublingual buphrenorphine is a unique opioid medication based on its pharmacokinetics and pharmacodynamic properties. It may be used "on label" as an alternative choice to methadone for the treatment of opioid addiction or "off-label" for the treatment of both acute and chronic pain. Because of high mu receptor affinity and resultant blockade, it has been suggested that this might interfere with the management of moderate to severe pain in patients on opioid agonist treatment. The following article will offer strategies and approaches to address some of these real and perceived challenges.

Topics: Acute Disease; Administration, Sublingual; Adult; Analgesics, Opioid; Buprenorphine; Chronic Disease; Drug Synergism; Female; Humans; Male; Middle Aged; Opioid-Related Disorders; Pain, Intractable; Receptors, Opioid

The transdermal matrix patch formulation of buprenorphine has been shown to be effective in managing moderate-to-severe cancer pain and severe pain unresponsive to nonopioid analgesics. Clinical trials have revealed that it is possible to switch from weak opioids or low doses of step III opioids to transdermal buprenorphine without any problems. With buprenorphine patches, the sublingual buprenorphine intake was dose-dependently reduced and was superior to placebo in this respect. The proportion of responders increased with the buprenorphine dose, and a higher proportion of patients receiving buprenorphine patches reported uninterrupted sleep for longer than 6 h compared with those receiving placebo. In a long-term, open, follow-up study in which the mean duration of treatment was 7.5 months, analgesia was rated as at least satisfactory by 90% of patients. Almost 60% of patients could manage their pain with one patch alone or with one additional sublingual tablet a day during the whole period of treatment, indicating a low incidence of tolerance development. The buprenorphine transdermal patch was assessed as user friendly by 94.6% of patients. In a postmarketing surveillance study, pain relief with transdermal buprenorphine was rated as good or very good by 70% of the responders. Postmarketing surveillance studies have shown that transdermal buprenorphine is also effective in the management of nociceptive and neuropathic pain, which some studies have shown to be relatively insensitive to mu-opioid analgesics, such as morphine. Transdermal buprenorphine was well tolerated. Most adverse events were either local reactions to the patch that generally subsided within 24 h or systemic events typical of treatment with opioid analgesics, such as nausea, vomiting and constipation.

Topics: Administration, Cutaneous; Buprenorphine; Chronic Disease; Humans; Pain; Pain Measurement

Topics: Buprenorphine; Chronic Disease; Hemodynamics; Humans; Intraoperative Period; Pain; Pain Measurement; Receptors, Opioid; Respiration

The mixed agonist-antagonist analgesics do not have a major role in the treatment of chronic pain. Pentazocine, the first and most widely used of this group of drugs has two major limitations: by mouth it is not a strong analgesic, but is closer in efficacy to the peripherally acting drugs aspirin and paracetamol than the weak opioids; and its use is associated with psychotomimetic side effects in 10-20 percent of patients. The weak opioid analgesics codeine and dextropropoxyphene are more effective and better tolerated than pentazocine. Buprenorphine is the most useful of the agonist-antagonists in chronic pain patients. It is potent, long-acting (6-9 h) and effective when given sublingually. However, it has a limited effective dose range and produces the same side effects as morphine-like drugs, possibly more frequently at equianalgesic doses. It may be used in the treatment of cancer pain, or in patients with chronic arthritides or other forms of chronic non-cancer pain who require a potent conventional analgesic, as an alternative to the weak opioids or to morphine in low doses. Nalbuphine and butorphanol are only available for parenteral administration which means that their usefulness in the treatment of chronic pain is limited. Meptazinol is restricted by its manufacturers to 'short term' treatment and there is little information on its use in chronic pain patients.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Disease; Humans; Narcotic Antagonists; Pain

First study to assess any compensatory increase in use of non-opioid illicit substances and alcohol in opioid dependent patients randomized to treatment with extended-release naltrexone (XR-NTX) or buprenorphine-naloxone (BP-NLX) and in longer term treatment with extended-release naltrexone.. A multicenter, outpatient, open-label randomized clinical trial where patients received intramuscular extended-release naltrexone hydrochloride, 380 mg/month, or daily sublingual buprenorphine-naloxone 8-24/2-6 mg for 12 weeks, and an option to continue with extended-release naltrexone for an additional 36 week follow-up. The study was conducted at five urban addiction clinics and detoxification units in Norway between November 2012, and July 2016.. Among the 143 patients, 106 men and 37 women, there were no significant differences between those randomized to XR-NTX or BP-NLX in the risk of first relapse to alcohol (HR 1.31; 0.68-2.53), amphetamines (HR 0.88; 0.43-1.80), benzodiazepines (HR 1.24; 0.74-2.09) or cannabis (HR 1.55; 0.83-2.89). Also in the 36-week (12-48 weeks) follow-up period we found no significant differences between patients continuing with XR-NTX compared to those switching to XR-NTX after the randomized period in risk of first relapse to any non-opioid substance. In both study periods, the mean time in the study were longer among those relapsing to non-opioid addictive substances than those who did not. There was no significant association between first relapse to illicit opioids and first relapse to non-opioid addictive substances.. There was no increase in the risk of relapse to non-opioid addictive substances neither in short term nor longer-term treatment with extended-release naltrexone. Trial registrationclinicaltrials.gov Identifier: NCT01717963.

Topics: Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Chronic Disease; Delayed-Action Preparations; Female; Humans; Injections, Intramuscular; Male; Naltrexone; Narcotic Antagonists; Opioid-Related Disorders; Recurrence

While research suggests primary prescription opioid (PO) abusers may exhibit less severe demographic and drug use characteristics than primary heroin abusers, less is known about whether a lifetime history of heroin use confers greater severity among PO abusers.. In this secondary analysis, we examined demographic and drug use characteristics as a function of lifetime heroin use among 89 PO-dependent adults screened for a trial evaluating the relative efficacy of buprenorphine taper durations. Exploratory analyses also examined contribution of lifetime heroin use to treatment response among a subset of participants who received a uniform set of study procedures.. Baseline characteristics were compared between participants reporting lifetime heroin use ≥5 (H(+); n=41) vs. <5 (H(-); n=48) times. Treatment response (i.e., illicit opioid abstinence and treatment retention at end of study) was examined in the subset of H(+) and H(-) participants randomized to receive the 4-week taper condition (N=22).. H(+) participants were significantly older and more likely to be male. They reported longer durations of illicit opioid use, greater alcohol-related problems, more past-month cocaine use, greater lifetime IV drug use, and greater lifetime use of cigarettes, amphetamines and hallucinogens. H(+) participants also had lower scores on the Positive Symptom Distress and Depression subscales of the Brief Symptom Inventory. Finally, there was a trend toward poorer treatment outcomes among H(+) participants.. A lifetime history of heroin use may be associated with elevated drug severity and unique treatment needs among treatment-seeking PO abusers.

Topics: Adult; Behavior Therapy; Buprenorphine; Chronic Disease; Double-Blind Method; Drug Therapy, Combination; Female; Heroin Dependence; Humans; Male; Naltrexone; Narcotics; Opiate Substitution Treatment; Opioid-Related Disorders; Prescription Drug Misuse

Buprenorphine and fentanyl transdermal patches are used widely for the management of persistent malignant and nonmalignant pain. Buprenorphine and fentanyl transdermal patches, both potent opioids, are considered to be equally efficacious in managing persistent pain. Various retrospective studies comparing dosage changes of buprenorphine and fentanyl patches in persistent pain patients have been completed; however, no long-term prospective, randomized, clinical study has compared the effectiveness of these patches. The objective of the present study was to satisfy this need.. This study aims to compare prospectively the long-term efficacy, acceptability, and side effects of both of these patches in patients with persistent pain. This study would examine the feasibility and lay the groundwork for a larger, multicenter study where such efficacy and safety outcomes of the two medications can be adequately assessed.. The participants were 46 adults (range 22-80 years.) with nonmalignant persistent pain (mean = 11 years), predominantly with lower back pain. Data were obtained monthly for 12 months. Participants recruited were opioid-naïve patients, having pain for the greater part of the day and night, and appropriate for treatment with transdermal patches. After initial assessment, participants were randomly allocated to either buprenorphine or fentanyl patch treatment. Participants were then titrated to optimal doses of medication. Patients with adverse effects or unsatisfactory pain relief were treated alternatively and discontinued from the study.. Nearly one-third of all patients, 41% (8 of 22) of the transdermal buprenorphine (TDB) group and 37.5% (8 of 24) of the transdermal fentanyl (TDF) group stopped treatment due to unacceptable side effects or inadequate pain relief. The remaining participants showed a similar trend in the improvement of pain intensity, physical activity, sleep, and mood throughout the study. Significant relief in the intensity of pain was achieved for the initial 6 months and the effects stabilized in the remainder of the study in both groups. There were no significant group differences over time. However, a higher equipotent dose of fentanyl was required for comparable pain relief. Compared with TDF group, the TDB group initially experienced relatively less side effects. However, a greater number of buprenorphine users suffered from local skin reactions. Buprenorphine users had significant improvement in mood. Thirty-one percent (5 of 16) of the buprenorphine group and 57% (8 of 14) of the fentanyl users needed additional pain relief medications by the end of 3 months. By the end of 12 months, a significant number 78% (7 of 9) of buprenorphine users but comparatively fewer 44% (4 of 9) of the fentanyl group used rescue medicines. Both had more doctor visits in the latter half of the study.. Thirty percent of the total number of patients discontinued treatment because of side effects or unsatisfactory pain relief. For those continuing treatment, clinical improvements were seen in the initial 6 months in both groups. Fifty percent of the TDB and 43% of TDF groups had significant relief in 3 months, which persisted up to 6 months. Only 11% and 13% of patients, respectively, had sustained relief after 6 months. Twenty percent more patients in the TDB group benefited significantly in symptoms of depression from TDB compared with the TDF group. Interestingly, switching of patches seemed to increase acceptability by preventing adverse effects and tolerance. Confirmation of these effects should be studied in future with a multicenter study and larger sample.

Topics: Administration, Cutaneous; Adult; Analgesics, Opioid; Buprenorphine; Chronic Disease; Chronic Pain; Feasibility Studies; Female; Fentanyl; Humans; Longitudinal Studies; Male; Neoplasms; Pain Measurement; Prospective Studies; Transdermal Patch; Treatment Outcome

Chronic pain increases with age, and in the elderly, comorbidities and polypharmacotherapy make the choice of treatment for pharmacological pain control a complex matter.. We conducted a multicenter, prospective, observational study to evaluate the efficacy and safety of the buprenorphine transdermal delivery system (TDS) in elderly patients with chronic noncancer pain. The aim was to assess the cognitive and behavioral status of patients during treatment.. The study included 93 patients (69 women and 24 men); the mean age was 79.7 years, and in most cases, the pain was due to osteoarthritis. Almost three-quarters (74.2%) of the patients had suffered pain for more than 12 months. The treatment was buprenorphine TDS, starting from a dose of 17.5 μg/h. Outcomes were assessed using the Mini-Mental State Examination (MMSE), the 17-item Hamilton Depression scale (HAM-D 17), the Neuropsychiatric Inventory, the Barthel Index, the Short-Form Health Survey (SF-12), a verbal numeric rating scale, and the Cumulative Illness Rating Scale (CIRS).. Buprenorphine treatment was associated with a decrease in pain severity without negative effects on the central nervous system. On the HAM-D scale, there were reductions in both the psychological and somatic scores. On the MMSE, values at the beginning and end of the study were comparable. Evaluation by SF-12 showed improvements in physical and mental status. CIRS values at baseline and at the end of the study were superimposable, indirectly confirming the tolerability and safety profile of the drug.. Our experience confirms the analgesic activity and safety of buprenorphine TDS in the elderly. There was an improvement in mood and a partial resumption of activities, with no influence on cognitive and behavioral ability.

Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Analgesics, Opioid; Behavior; Buprenorphine; Chronic Disease; Cognition; Female; Health Surveys; Humans; Male; Neuropsychological Tests; Osteoarthritis; Pain; Prospective Studies

Despite the fact that buprenorphine is effective, well tolerated and due to its pharmacological profile a very safe drug, the impact of long-term buprenorphine substitution therapy on complex psychomotor and cognitive function predicting driving ability is not yet clear. Therefore, a prospective comparison between patients receiving sublingual buprenorphine and a control group of untreated, healthy volunteers was performed.. Treated and untreated subjects were matched for age and sex, with three control subjects selected for every buprenorphine patient. Patients using unreported drugs were included in the intention-to-treat (ITT) analysis; the remaining patients were analysed as the per-protocol (PP) group. The test battery comprised the assessment of: performance during stress, visual orientation, concentration, attention, vigilance and reaction time. The primary endpoint was defined as the sum of the relevant scores of the tests after z-transformation of the individual scores.. 30 patients with sublingual buprenorphine treatment (7.7±3.9 mg per day) were matched to 90 controls. 19 patients were excluded from the PP-analysis because of additional unreported drug intake. Significant non-inferiority could be demonstrated for the PP-group (p<0.05) as well as for the ITT-group (p<0.001).. Patients receiving a stable dose of sublingual buprenorphine showed no significant impairment of complex psychomotor or cognitive performance as compared to healthy controls. However intake of illicit drugs as well as the lack of social reliability are major problems in this specific patients group. Despite of the absence of a relevant impact of the drug on driving ability, those patients do not seem to be qualified for getting their driving license.

Topics: Adult; Attention; Automobile Driving; Buprenorphine; Chronic Disease; Cognition; Control Groups; Female; Humans; Male; Middle Aged; Narcotic Antagonists; Opioid-Related Disorders; Prospective Studies; Psychomotor Performance; Reaction Time; Time Factors; Visual Perception

The objective of this study was to evaluate the benefit of a seven-day buprenorphine transdermal patch for patients with chronic musculoskeletal pain previously receiving long-term treatment with ibuprofen or diclofenac alone. Data of a subgroup of 703 patients were analysed which were part of a multicenter observational study with 3,295 patients. These patients had previously received ibuprofen or diclofenac and were characterized by older age,the presence of gastrointestinal, cardiovascular, and renal risk factors and the existence of chronic musculoskeletal pain. The switch to the seven-day buprenorphine patch resulted in a clinically significant decrease of the mean pain intensity at rest during the day from 5.3 to 2.9, on physical effort during the day from 7.1 to 3.3, and at night from 4.9 to 1.9 at the end of the study (11-point NRS scale, p

Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Buprenorphine; Chronic Disease; Diclofenac; Drug Administration Schedule; Drug Substitution; Female; Humans; Ibuprofen; Long-Term Care; Male; Middle Aged; Pain; Pain Measurement; Prospective Studies

Musculoskeletal pathologies are among the most frequent causes of long-term non-oncological severe pain and consequent physical impairment. Aims of pharmacological and physical therapy are to reduce pain, promote functional recovery and improve overall quality of life. Pharmacological therapy may include the use of opioids.. To evaluate the efficacy and tolerability of transdermal buprenorphine (TDS) in the long-term management of non-oncological, chronic, moderate-to-severe musculoskeletal pain.. An open-label, prospective, single-centre, 6-month study.. A 'real world' outpatient setting.. Adult patients with chronic moderate-to-severe musculoskeletal pain were enrolled consecutively.. Patients initially received buprenorphine TDS 11.7 microg/h (one-third of 35 microg/h patch) every 72 hours. If required, patients could be up-titrated to 17.5 microg/h (one-half of 35 microg/h patch), 23.4 microg/h (two-thirds of 35 microg/h patch) or 35 microg/h. Concomitant antiemetics were allowed.. The primary endpoint was percentage mean reduction in static and dynamic pain visual analogue scale (VAS) scores at study end (10 being worst pain, 0 being no pain). Quality of life and tolerability were also assessed.. We enrolled 146 patients aged 41-94 years; their baseline mean +/- SD static and dynamic pain VAS scores were 6.87 +/- 1.89 and 7.70 +/- 1.74, respectively. Buprenorphine TDS initial dosages were 11.7 microg/h (n = 139), 17.5 microg/h (n = 4), 23.4 microg/h (n = 1) and 35 microg/h (n = 2). At 6 months, 89 patients were under treatment; 11% (n = 10) were receiving 11.7 microg/h, 30% (n = 27) 17.5 microg/h, 6% (n = 5) 23.4 microg/h and 53% (n = 47) 35 microg/h. Patients achieved a nonsignificant reduction in pain at rest and in movement; mean +/- SD static and dynamic pain VAS scores decreased to 1.56 +/- 2.05 and 3.54 +/- 2.02, respectively. The quality of life improved as shown by significant (p < 0.01) increases from baseline in all items relating to physical and mental health on the Short-Form 36 health survey. Patients experienced recovery of daily and social activities according to the significant (p < 0.01) increase in Karnofsky Performance Status sub-item scores. Twenty-three patients discontinued treatment because of adverse events, which were mainly gastrointestinal or CNS-related.. Low-dose buprenorphine TDS had good analgesic efficacy, and quality of life improved as early as 1 month after treatment initiation. Our results suggest that buprenorphine TDS is a well tolerated long-term analgesic for patients experiencing chronic musculoskeletal pain of moderate-to-severe intensity.

Topics: Administration, Cutaneous; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Disease; Female; Humans; Italy; Male; Middle Aged; Musculoskeletal Diseases; Pain; Prospective Studies; Quality of Life; Severity of Illness Index; Time Factors; Treatment Outcome

Buprenorphine is a mixed-activity, partial mu-opioid agonist. Its lipid solubility makes it well suited for transdermal administration.. This study assessed the efficacy and safety profile of a 7-day buprenorphine transdermal system (BTDS) in adult (age >18 years) patients with moderate to severe chronic low back pain previously treated with > or =1 tablet daily of an opioid analgesic.. This was a randomized, double-blind, placebo-controlled crossover study, followed by an open-label extension phase. After a 2- to 7-day washout of previous opioid therapy, eligible patients were randomized to receive BTDS 10 microg/h or matching placebo patches. The dose was titrated weekly using 10- and 20-microg/h patches (maximum, 40 microg/h) based on efficacy and tolerability. After 4 weeks, patients crossed over to the alternative treatment for another 4 weeks. Patients who completed the double-blind study were eligible to enter the 6-month open-label phase. Rescue analgesia was provided as acetaminophen 325 mg to be taken as 1 or 2 tablets every 4 to 6 hours as needed. The primary outcome assessments were daily pain intensity, measured on a 100-mm visual analog scale (VAS), from no pain to excruciating pain, and a 5-point ordinal scale, from 0 = none to 4 = excruciating. Secondary outcome assessments included the Pain and Sleep Questionnaire (100-mm VAS, from never to always), Pain Disability Index (ordinal scale, from 0 = no disability to 11 = total disability), Quebec Back Pain Disability Scale (categorical scale, from 0 = no difficulty to 5 = unable to do), and the 36-item Short Form Health Survey (SF-36). Patients and investigators assessed overall treatment effectiveness at the end of each phase; they assessed treatment preference at the end of double-blind treatment. After implementation of a precautionary amendment, the QTc interval was measured 3 to 4 days after randomization and after any dose adjustment. All assessments performed during the double-blind phase were also performed every 2 months during the open-label extension. Adverse events were collected by non-directed questioning throughout the study.. Of 78 randomized patients, 52 (66.7%) completed at least 2 consecutive weeks of treatment in each study phase without major protocol violations (per-protocol [PP] population: 32 women, 20 men; mean [SD] age, 51.3 [11.4] years; mean weight, 85.5 [19.5] kg; 94% white, 4% black, 2% other). The mean (SD) dose of study medication during the last week of treatment was 29.8 (12.1) microg/h for BTDS and 32.9 (10.7) microg/h for placebo (P = NS). During the last week of treatment, BTDS was associated with significantly lower mean (SD) pain intensity scores compared with placebo on both the VAS (45.3 [21.3] vs 53.1 [24.3] mm, respectively; P = 0.022) and the 5-point ordinal scale (1.9 [0.7] vs 2.2 [0.8]; P = 0.044). The overall Pain and Sleep score was significantly lower with BTDS than with placebo (177.6 [125.5] vs 232.9 [131.9]; P = 0.027). There were no treatment differences on the Pain Disability Index, Quebec Back Pain Disability Scale, or SF-36; however, BTDS was associated with significant improvements compared with placebo on 2 individual Quebec Back Pain Disability Scale items (get out of bed: P = 0.042; sit in a chair for several hours: P = 0.022). Of the 48 patients/physicians in the PP population who rated the effectiveness of treatment, 64.6% of patients (n = 31) rated BTDS moderately or highly effective, as did 62.5% of investigators (n = 30). Among the 50 patients in the PP population who answered the preference question, 66.0% of patients (n = 33) preferred the phase in which they received BTDS and 24.0% (n = 12) preferred the phase in which they received placebo (P = 0.001), with the remainder having no preference; among investigators, 60.0% (n = 30) and 28.0% (n = 14) preferred the BTDS and placebo phases, respectively (P = 0.008), with the remainder having no preference. The mean placebo-adjusted change from baseline in the QTc interval ranged from -0.8 to +3.8 milliseconds (P = NS). BTDS treatment was associated with a significantly higher frequency of nausea (P < 0.001), dizziness (P < 0.001), vomiting (P = 0.008), somnolence (P = 0.020), and dry mouth (P = 0.003), but not constipation. Of the 49 patients completing 8 weeks of double-blind treatment, 40 (81.6%) entered the 6-month, open-label extension study and 27 completed it. Improvements in pain scores achieved during the double-blind phase were maintained in these patients.. In the 8-week, double-blind portion of this study, BTDS 10 to 40 microg/h was effective compared with placebo in the management of chronic, moderate to severe low back pain in patients who had previously received opioids. The improvements in pain scores were sustained throughout the 6-month, open-label extension. (Current Controlled Trials identification number: ISRCTN 06013881).

Topics: Administration, Cutaneous; Adult; Aged; Analgesics, Opioid; Buprenorphine; Chronic Disease; Cross-Over Studies; Double-Blind Method; Electrocardiography; Female; Humans; Low Back Pain; Male; Middle Aged

This study compared the efficacy and safety of low-dose 7-day buprenorphine patches and prolonged-release tramadol tablets in patients with chronic, moderate to severe osteoarthritis (OA) pain of the hip and/or knee.. Eligible patients were adults with a clinical and radiologic diagnosis of OA of the hip and/or knee and moderate to severe pain, as confirmed by a mean Box Scale 11 (BS-11) score >or=4 while using paracetamol 4000 mg/d for pain during the screening week. Patients were randomized in a 1:1 ratio to receive either low-dose 7-day buprenorphine patches (patch strengths of 5, 10, and 20 microg/h, with a maximum dosage of 20 microg/h) or twice-daily prolonged-release tramadol tablets (tablet strengths of 75, 100, 150, and 200 mg, with a maximum dosage of 400 mg/d) over a 12-week open-label treatment period. Supplementary paracetamol was available as rescue medication throughout the study. The primary end point was the difference in BS-11 scores from baseline to the completion of treatment. Noninferiority was assumed if the treatment difference on the BS-11 scale was -1.5 boxes, indicating a clinically meaningful result. Secondary efficacy variables were rescue medication use, sleep disturbance and quality of sleep, and patients' and investigators' global assessments of pain relief. In addition, patient preference was assessed at the completion visit by asking patients whether, given equal pain relief, they would prefer basic treatment for OA pain with a patch applied once weekly or a tablet taken twice daily. Exploratory variables included investigators' assessments of patients' pain, stiffness, and ability to perform daily activities (Western Ontario and McMaster Universities Osteoarthritis Index); patients' quality of life (EuroQol EQ-5D health states index and EuroQol visual analog scale); and abuse and diversion of study drug.. One hundred thirty-four patients (69 receiving 7-day buprenorphine patches and 65 receiving tramadol tablets) were randomized and received >or=1 dose of study medication. A respective 98.6% and 100% of the 2 treatment groups were white, with mean (SD) ages of 64.4 (11.1) and 64.2 (9.3) years. Both treatments were associated with a clinically meaningful reduction in pain from baseline to study completion. The least squares mean change from baseline in BS-11 scores in the 7-day buprenorphine patch and tramadol tablet groups was -2.26 (95% CI, -2.76 to -1.76) and -2.09 (95% CI, -2.61 to -1.58). The efficacy of 7-day buprenorphine patches was noninferior to that of prolonged-release tramadol tablets. The incidence of adverse events (AEs) was comparable in the 2 treatment groups: 226 AEs were reported in 61 patients (88.4%) in the 7-day buprenorphine patch group, and 152 AEs were reported in 51 patients (78.5%) in the tramadol group. Ten patients (14.5%) in the 7-day buprenorphine patch group and 19 (29.2%) in the tramadol tablet group withdrew from the study due to AEs. The most common AEs in the 7-day buprenorphine patch group were nausea (30.4%), constipation (18.8%), and dizziness (15.9%); the most common AEs in the tramadol tablet group were nausea (24.6%), fatigue (18.5%), and pain (12.3%). Most patients (47/67 [70.1%] in the 7-day buprenorphine patch group and 43/61 [70.5%] in the tramadol tablet group) reported that they would prefer a 7-day patch to a twice-daily tablet for future pain treatment.. In these patients with chronic, moderate to severe OA pain of the hip and/or knee, 7-day low-dose buprenorphine patches were an effective and well-tolerated analgesic. The buprenorphine patches were noninferior to prolonged-release tramadol tablets. European Union Drug Regulating Authorities Clinical Trials number: 2006-003233-32.

Topics: Acetaminophen; Administration, Cutaneous; Administration, Oral; Adult; Aged; Aged, 80 and over; Analgesics, Non-Narcotic; Analgesics, Opioid; Buprenorphine; Chronic Disease; Delayed-Action Preparations; Drug Administration Schedule; Humans; Middle Aged; Osteoarthritis, Hip; Osteoarthritis, Knee; Pain; Pain Measurement; Patient Satisfaction; Radiography; Sleep; Sweden; Tablets; Time Factors; Tramadol; Treatment Outcome

Due to tolerance development and adverse side effects, chronic pain patients frequently need to be switched to alternative opioid therapy. To assess the efficacy and tolerability of an alternative transdermally applied (TDS) opioid in patients with chronic cancer pain receiving insufficient analgesia using their present treatment.. A total of 32 patients received alternative opioid therapy, 16 were switched from buprenorphine to fentanyl and 16 were switched from fentanyl to buprenorphine. The dosage used was 50% of that indicated in equipotency conversion tables. Pain relief was assessed at weekly intervals for the next 3 weeks. Pain relief as assessed by VAS, PPI, and PRI significantly improved (p < 0.0001) in all patients at all 3 follow up visits. After 3 weeks of treatment, the reduction in the mean VAS, PPI, and PRI scores in the fentanyl and buprenorphine groups was 68, 77, 74, and 69, 79, and 62%, respectively. Over the same time period the use of oral morphine as rescue medication was reduced from 27.5 +/- 20.5 (mean +/- SD) to 3.75 +/- 8.06, and 33.8 +/- 18.9 to 3.75 +/- 10.9 mg/day in the fentanyl and buprenorphine groups, respectively. There was no significant difference in either pain relief or rescue medication use between the two patient groups The number of patient with adverse events fell during the study. After the third week of the treatment the number of patients with constipation was reduced from 11 to 5, and 10 to 4 patients in the fentanyl and buprenorphine groups, respectively. There was a similar reduction in the incidence of nausea and vomiting. No sedation was seen in any patient after one week of treatment.. Opioid switching at 50% of the calculated equianalgesic dose produced a significant reduction in pain levels and rescue medication. The incidence of side effects decreased and no new side effects were noted. Further studies are required to provide individualized treatment for patients according to their different types of cancer.

Topics: Adult; Aged; Analgesia; Analgesics, Opioid; Buprenorphine; Chronic Disease; Female; Fentanyl; Humans; Male; Middle Aged; Neoplasms; Pain; Palliative Care

Patients with osteoarthritis often suffer from chronic pain. If pain treatment with NSAIDS and coxibes is no longer indicated, a constant and user friendly opioid analgesia can be achieved with a low dose buprenorphine patch being applicated using an interval of 7 days. The use of this matrix patch was evaluated in a multicenter observational study on 4263 patients in clinical practice. During treatment a significant decrease of mean pain intensity on a 11-point scale could be observed from 6.9 points before using the patch to 2.9 points at the end of observation. Further effects were a decrease of additional analgetic medication and an improvement of aspects of life quality, e.g. mobility and quality of sleep. Only in 4.5% of the patients adverse effects were observed, reflecting the expected range of adverse effects of opioids. Thus it could be demonstrated that the use of the transdermal patch is an effective, user friendly and safe way of chronic pain relief for osteoarthritis patients.

Topics: Administration, Cutaneous; Administration, Sublingual; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Disease; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Osteoarthritis, Hip; Osteoarthritis, Knee; Pain Measurement; Prospective Studies

The injection of low dose buprenorphine to the sympathetic ganglia, termed "GLOA", Ganglionide Local Opioid Analgesia, is used to treat chronic pain in several European centres. It is not known whether the clinically observed GLOA effect in chronic pain syndromes is due to a specific effect of buprenorphine at the ganglia. We assessed whether GLOA, plus intramuscular saline, was more efficacious than the reverse, saline injection to the stellate plus intramuscular buprenorphine, termed SSB.. We devised a randomized, double-blinded, controlled crossover trial to treat patients with chronic upper body pain syndromes. Patients first received either GLOA or SSB. Pain was assessed using pain diaries both before injection and over the first 8h and 6days afterwards, and was expressed as relative pain intensity post versus pre-injection pain.. The median relative pain intensity after injections did not differ between GLOA and SSB. Four patients reported a low, <50%, relative pain level over the first 8h after SSB only. Four patients did not complete the trial and were excluded. One patient with cardiomyopathy became acutely diaphoretic and fatigued after GLOA, his vital signs however remained stable.. We failed to show a superiority of GLOA over SSB. Our results suggest it unlikely that the clinically observed effect after a single GLOA injection is due to a specific action of buprenorphine at the stellate ganglion. The efficacy of GLOA is hereby questioned. The use of GLOA in patients with cardiomyopathy should be cautioned.. ISRCTN59287260; http://www.controlled-trials.com/

Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Autonomic Nerve Block; Buprenorphine; Chronic Disease; Cross-Over Studies; Double-Blind Method; Facial Pain; Female; Humans; Injections; Injections, Intramuscular; Male; Middle Aged; Neck Pain; Pain Measurement; Shoulder Pain; Stellate Ganglion; Sympathetic Fibers, Postganglionic

A number of subjects aged over 65 suffer from some kind of chronic pain. The constant growth of this demographic group makes research of new and efficacious treatment strategies necessary. Transdermal buprenorphine has shown to be a safe and efficacious pharmacotherapy for patients with moderate to severe chronic pain in clinical trials. This paper provides the outcome of this drug in routine clinical practice.. A prospective, uncontrolled observational study that included a 3-month follow-up of patients starting transdermal buprenorphine was performed. Information was collected systematically on pain relief, quality of life (EuroQol-5D questionnaire), comfort of patch use and adverse events. Missing data were imputed by the <>.. Out of 1,188 patients with known age, 564 were under 65, 337 were between 65 and 75, and 287 were over 75 years. Within these respective age groups, 63.9%, 66.3% and 67.7% of patients showed <> or <> pain relief; 60.4%, 60.7% and 65.2% showed improvement of sleep quality; and the mean increases of the score of the EuroQol-5D visual analogue scale were 16.0 mm, 15.8 mm and 16.8 mm. Drug-related adverse events were reported in 39.6%, 35.4% and 31.9% of patients, respectively.. This study performed in the routine-care setting supports the findings from previous randomised controlled clinical trials of transdermal buprenorphine.

Topics: Administration, Cutaneous; Aged; Analgesics, Opioid; Buprenorphine; Chronic Disease; Female; Humans; Male; Middle Aged; Pain; Prospective Studies

Opioid rotation is increasingly becoming an option to improve pain management especially in long-term treatment. Because of insufficient analgesia and intolerable side effects, a total of 42 patients (23 male, 19 female; mean age 64.1 years) suffering from severe musculoskeletal (64%), cancer (21%) or neuropathic (19%) pain were converted from high-dose morphine (120 to >240 mg/day) to transdermal buprenorphine. The dose of buprenorphine necessary for conversion (at least 52.5 microg/h) was titrated individually by the treating physician. No conversion recommendations were given and the treating physician used his or her own judgment for dose adjustment. Pain relief, overall satisfaction and quality of sleep (very good, good, satisfactory, poor, or very poor), and the incidence and severity of adverse drug reactions over a period of at least 10 weeks and up to 1 year was assessed. Following rotation, patients experiencing good/very good pain relief increased from 5% to 76% (P < 0.001). Only 5% reported insufficient relief. Relief was achieved with buprenorphine alone in 77.4%, while 17% needed an additional opioid for breakthrough pain. Sleep quality (good/very good) increased from 14% to 74% (P < 0.005). Adverse effects were reported in 11.9%, mostly because of local irritation, did not result in termination of therapy. Neither tolerance nor refractory effect following rotation from morphine to buprenorphine was noted. Conversion tables with a fixed conversion ratio are of limited value in patients treated with high-dose morphine.

Topics: Administration, Cutaneous; Aged; Analgesics, Opioid; Buprenorphine; Chronic Disease; Clinical Protocols; Dose-Response Relationship, Drug; Drug Tolerance; Female; Humans; Male; Middle Aged; Morphine; Pain; Pain Measurement; Palliative Care; Patient Satisfaction; Product Surveillance, Postmarketing; Prospective Studies; Sleep

This study compared the efficacy and safety profile of buprenorphine transdermal delivery system (BTDS) and placebo in subjects with persistent noncancer-related pain who required opioid analgesics.. This was a multicenter, double-blind, parallel-group study in adult subjects (age >/=18 years) with at least a 2-month history of noncancer-related pain for which they received oral opioid combination agents. The study employed a maintenance-of-analgesia, or randomized-withdrawal, design. During a 7- to 21-day open-label run-in phase, all subjects received BTDS, titrated as needed. Subjects who achieved stable pain control and were able to tolerate BTDS in the run-in phase were randomly assigned to continue BTDS at the dose achieved during the run-in phase or to receive placebo for up to 14 days. Acetaminophen 500-mg tablets were provided as escape (rescue) medication. Subjects completed the study on day 14 or when they met predefined criteria for ineffective treatment: requiring >1 g of acetaminophen as escape medication on any day of the double-blind evaluation phase, requiring a change in study drug dose, having difficulty keeping the patch affixed, or discontinuing because of ineffective treatment without meeting any of the first 3 criteria. The primary efficacy variable was the proportion of subjects with ineffective treatment. Secondary efficacy variables were the time to ineffective treatment; the proportion of subjects who reached ineffective treatment or discontinued for any reason other than ineffective treatment; and the amount of escape medication used. Assessment of the safety profile was based on adverse events and changes in vital signs and physical and laboratory findings.. Five hundred eighty-eight subjects entered the open-label run-in phase, and 267 (129 BTDS, 138 placebo) were subsequently randomized to doubleblind treatment. Demographic characteristics were similar between the double-blind BTDS and placebo groups (61.2% and 63.8% female, respectively; 99.2% and 98.6% white; mean [SD] age, 56.2 [13.3] and 59.2 [11.5] years). In the primary efficacy analysis, the proportion of subjects with ineffective treatment was lower with BTDS than with placebo (51.2% vs 65.0%; 95% CI, 1.09-2.95); the odds of ineffective treatment were 1.79 times greater for placebo relative to BTDS (P = 0.022). In the secondary efficacy analyses, the median time from the first dose of double-blind study drug to ineffective treatment was significantly longer with BTDS than with placebo (median, 10 vs 3 days; P = 0.011). The proportion of subjects who reached ineffective treatment or discontinued for reasons other than ineffective treatment was lower in the BTDS group compared with the placebo group (55.0% vs 67.9%); the odds of ineffective treatment or discontinuation for a reason other than ineffective treatment was 1.76 times greater with placebo compared with BTDS (P = 0.028). The mean amount of escape medication used was significantly lower in the BTDS group than in the placebo group (1.7 vs 2.2 acetaminophen tablets per day; P = 0.015). The most common adverse events in the open-label run-in or double-blind phase occurring at a higher incidence with BTDS than with placebo were pruritus at the patch application site (9.3% vs 5.1%, respectively), headache (3.9% vs 2.2%), and somnolence (2.3% vs 0.7%).. In this population of adult subjects with persistent noncancer-related pain who required opioid therapy, BTDS use was associated with analgesic efficacy and was generally well tolerated. Results of this study were presented in part at the annual meeting of the American Pain Society, March 30-April 2, 2005, Boston, Massachusetts.

Topics: Acetaminophen; Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; Analgesics, Non-Narcotic; Analgesics, Opioid; Buprenorphine; Chronic Disease; Double-Blind Method; Drug Delivery Systems; Female; Humans; Male; Middle Aged; Pain; Treatment Failure

Buprenorphine, a potent opioid analgesic, has been available in parenteral and oral or sublingual(SL) formulations for >25 years. In 2001, the buprenorphine transdermal delivery system (TES) was introduced at 3 release rates (35, 52.5, and 70 microg/h) for the treatment of chronic cancer and noncancer pain.. This study compared the analgesic efficacy and tolerability of buprenorphine TES at a release rate of 35 microg/h with those of buprenorphine SL and placebo in patients with severe or very severe chronic cancer or noncancer pain.. This multicenter, double-blind, placebo-controlled, parallel-group trial was 1 of 3 Phase III studies involved in the clinical development of buprenorphine TDS. It comprised a 6-day open-label run-in phase in which patients received buprenorphine SL 0.8 to 1.6 mg/d as needed and a double-blind phase in which patients were randomized to receive 3 sequential patches containing buprenorphine TES 35 microg/h or placebo, each lasting 72 hours. Rescue analgesia consisting of buprenorphine SL 02-mg tablets was available as needed throughout the double-blind phase. The main outcome measures were (1) the number of buprenorphine SL tablets required in addition to buprenorphine TES during the double-blind phase compared with the placebo group and compared with the buprenorphine SL requirement during the run-in phase, and (2) patients' assessments of pain intensity, pain relief, and duration of sleep uninterrupted by pain in the double-blind phase compared with the run-in phase. Adverse events were documented throughout the study.. One hundred thirty-seven patients were included in the double-blind phase (90 buprenorphine TES, 47 placebo). The buprenorphine TES group included 47 men and 43 women (mean [SD] age, 56.0 [12.1] years), and the placebo group included 23 men and 24 women (mean age, 55.7 [12.9] years). Forty-five patients had cancer-related pain and 92 had noncancer-related pain. The 2 treatment groups were comparable with respect to sex distribution, age, height, and body weight Patients receiving buprenorphine TES significantly reduced their consumption of buprenorphine SL tablets in the double-blind phase compared with patients receiving placebo (reduction of 0.6 [0.4] mg vs 0.4 [0.4] mg; P = 0.03). The relationship between the buprenorphine SL dose in the run-in phase and the number of buprenorphine SL tablets required in the double-blind phase was dose dependent in the active-treatment group only. Patients' assessments of pain intensity and pain relief suggested better analgesia with buprenorphine TES than with placebo, although the differences did not reach statistical significance. The proportion of patients who reported sleeping for >6 hours uninterrupted by pain in the double-blind phase compared with the run-in phase increased by 6.4% in the buprenorphine TDS group (35.6% vs 292%, respectively), compared with a decrease of 5.9% in the placebo group (40.4% vs 463%); no statistical analysis of sleep duration data was performed. Buprenorphine TDS was well tolerated, with adverse events generally similar to those associated with other opioids. The incidence of systemic adverse events in the double-blind phase was similar in the 2 treatment groups (28.9% buprenorphine TDS, 27.6% placebo), with the most common adverse events being nausea, dizziness, and vomiting. After patch removal, skin reactions (mainly mild or moderate pruritus and erythema) were seen in 35.6% of the buprenorphine TDS group and 25.5% of the placebo group.. In the population studied, buprenorphine TDS provided adequate pain relief, as well as improvements in pain intensity and duration of pain-free sleep. It may be considered a therapeutic option for the treatment of moderate to severe chronic pain.

Topics: Administration, Cutaneous; Administration, Sublingual; Analgesics, Opioid; Buprenorphine; Chronic Disease; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Middle Aged; Neoplasms; Pain; Pain Measurement; Tablets

Buprenorphine is a potent opioid analgesic that is available in sublingual and parenteral formulations. A new formulation, buprenorphine transdermal delivery system (TDS), has been developed.. The aim of this study was to compare the analgesic efficacy and tolerability of the 3 available dosages of buprenorphine TDS (35.0, 52.5, and 70.0 microg/h) with placebo.. This was a randomized, double-blind, placebo-controlled, multicenter study. Patients with chronic, severe pain related to cancer or other diseases and inadequately controlled with weak opioids were randomized to receive buprenorphine TDS 35.0, 52.5, or 70.0 microg/h or placebo patch for up to 15 days. A new patch was applied every 72 hours, for a total of 5 patches. All patients were permitted rescue analgesia with sublingual buprenorphine tablets (0.2 mg) as required for breakthrough pain.. A total of 157 patients (86 women, 71 men; mean [SD] age, 58.7 [11.8] years) were initially enrolled in the study. Buprenorphine TDS was associated with significantly higher response rates than was placebo at the 35.0- and 52.5-microg/h dosages (36.6% and 47.5%, respectively, vs 16.2%; P=0.032 and P=0.003, respectively) and a numerically higher response rate at 70.0 microg/h (33.3%), although this difference did not reach statistical significance. Patients treated with buprenorphine TDS experienced a 56.7% reduction in use of sublingual rescue analgesic during the study compared with an 8% reduction with the placebo patch. A total of 43.5% of patients treated with buprenorphine TDS reported good or complete pain relief compared with 32.4% in the placebo group. Pain intensity decreased in a dose-dependent manner with buprenorphine TDS, and the duration of sleep uninterrupted by pain was improved by the end of the study. More than three fourths (78.8%) of patients in the placebo and buprenorphine TDS groups reported at least 1 adverse event (AE) during the study. The most common AEs were central nervous system and gastrointestinal symptoms. The majority of treatment-related AEs were mild or moderate in intensity and were typical of those occurring at the beginning of therapy with a strong opioid.. Buprenorphine TDS was shown to be an effective analgesic against chronic, severe pain in this study population. Patients treated with this new formulation of buprenorphine showed improved duration of sleep and reduced need for additional oral analgesics.

Topics: Administration, Cutaneous; Administration, Sublingual; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Disease; Dosage Forms; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Middle Aged; Neoplasms; Pain; Pain Measurement; Sleep

In many cases, the treatment of neuropathic pain by intrathecal opioids fails to meet expectations. In a trial involving 10 patients, the intrathecal administration of clonidine combined with opioids in the treatment of chronic pain was introduced in our department for the first time. Eight patients with neuropathic pain syndromes were subjected to a continuous intrathecal clonidine application in addition to intrathecal morphine. At an average dose of 44 microg clonidine/day, a 70-100% reduction in pain was achieved. Residual non-neuropathic pain in 4 of 8 patients was successfully treated with clonidine and low doses of opioids. On the basis of the results achieved so far, we recommend that clonidine should be routinely tested for intrathecal drug administration, especially in patients with a prominent neuropathic pain component.

Topics: Adrenergic alpha-Agonists; Adult; Aged; Analgesics; Analgesics, Opioid; Buprenorphine; Chronic Disease; Clonidine; Drug Therapy, Combination; Female; Humans; Infusion Pumps, Implantable; Injections, Spinal; Male; Middle Aged; Morphine; Pain; Pain Measurement

The management of intractable pain in chronic pancreatitis is difficult. A novel method for its relief is described.. Twelve patients were given a mixture of buprenorphine (0.3 mg) and blood (10-15 mL) into the epidural space.. All patients had pain relief lasting up to six months.. Epidural buprenorphine injection is a simple, safe and effective method for pain relief in chronic pancreatitis.

Topics: Adolescent; Adult; Analgesics, Opioid; Buprenorphine; Child; Chronic Disease; Female; Humans; Injections, Epidural; Male; Pain Measurement; Pain, Intractable; Pancreatitis; Time Factors; Treatment Outcome

The time has come to evaluate critically our practice of cancer pain management and the assumptions on which it is based. We owe it to our patients to maximize the quality of their lives and to provide evidence for them that is based on a scientific approach rather than anecdotal experience. From the information available, opioids do have effects on cognitive and psychomotor function, and although many of these effects diminish once the patient is on a stable dose, the evidence suggests that baseline pretreatment levels are not achieved. In addition, the relationship between measurable effects and the performance of everyday tasks such as driving is unclear. The challenge we now face is to continue the improvements in cancer pain control achieved over the last 25 years. The management of the central adverse effects of opioids must be focused on accurate assessment and careful titration of opioids against pain. Adjuvant analgesic drugs and non-drug measures should be used whenever possible, and drugs should be chosen that will not contribute to existing difficulties. The appropriate use of psychostimulants has yet to be established as has the relative benefit of one opioid over another in cancer pain.

Topics: Adult; Amphetamines; Analgesics, Opioid; Buprenorphine; Central Nervous System Stimulants; Chronic Disease; Cocaine; Codeine; Cognition; Dextropropoxyphene; Dopamine Uptake Inhibitors; Humans; Methylphenidate; Morphine; Neoplasms; Pain; Psychomotor Performance; Randomized Controlled Trials as Topic; Reaction Time; Thiazoles

The aim of the present study has been to assess the responsiveness of various types of chronic pain to opioids given i.v. and tested against placebo in a double-blind, randomized fashion. Pain classified as primary nociceptive was effectively alleviated (P greater than 0.001) while neuropathic deafferentation pain was not significantly influenced by morphine or equivalent doses of other opioids. Also 'idiopathic' pain, defined as chronic pain with no or little demonstrable pathology, failed to respond. The results were not related to whether the patients were regular users of narcotic analgesics or not. The outcome of our double-blind opioid test has proved useful to justify a continued, or discontinued, use of narcotic medication in individual patients. It may also support the indication and choice of invasive stimulation procedures (spinal cord or brain). The results of the study illustrate the misconception of chronic pain as an entity and highlight the importance of recognizing different neurobiological mechanisms and differences in responsiveness to analgesic drugs as well as to non-pharmacological modes of treatment. The opioid test has thus become a valuable tool in pain analysis and helpful as a guide for further treatment.

Topics: Analgesics; Buprenorphine; Chronic Disease; Endorphins; Female; Humans; Male; Morphine; Nervous System Diseases; Nociceptors; Pain; Pain Measurement; Pain, Intractable; Palliative Care; Transcutaneous Electric Nerve Stimulation

Topics: Administration, Cutaneous; Analgesics, Opioid; Buprenorphine; Chronic Disease; Chronic Pain; Humans; Opioid-Related Disorders

Topics: Administration, Cutaneous; Analgesics, Opioid; Buprenorphine; Chronic Disease; Chronic Pain; Humans

Opioid use disorder (OUD) continues to present a major public health problem in the United States. Civil commitment for substance use is one mandatory form of treatment for severe opioid use that has become increasingly available in recent years, but empirical data on this approach are lacking. This study examines clinical outcomes of civil commitment in a sample of adults with severe opioid use.. Participants were 121 persons with opioid use who were interviewed at the point of entry into civil commitment, then followed for 12 weeks after their release.. Prior to civil commitment, this sample exhibited serious substance use characteristics (including high rates of illicit opioid use, other substance use, and injection drug use), as well as mental health problems (diagnoses of depression and anxiety disorders). During follow-up, approximately 41 % of the sample reported at least one illicit opioid use day. More than 64 % of the sample reported at least one day of medication for opioid use disorder (MOUD) receipt, and participants were significantly less likely to use illicit opioids on days that they received MOUDs. No participants died during the follow-up period.. In this sample of persons with severe opioid use, clinical outcomes of civil commitment included illicit opioid relapse as well as varying levels of MOUD uptake. Civil commitment may be a viable method for short-term prevention of overdose for a subset of this vulnerable patient population.

Topics: Adult; Analgesics, Opioid; Buprenorphine; Chronic Disease; Drug Overdose; Humans; Opiate Substitution Treatment; Opioid-Related Disorders; Recurrence; United States

While opioid use disorder (OUD) is prevalent, little is known about what patients with OUD in sustained remission think about the chronic disease model of OUD and their perspectives of the cause, course, and ongoing treatment needs of their OUD.. To (1) examine patient perceptions of the chronic disease model of addiction and disease identity and (2) use an explanatory model framework to explore how these perceptions inform ongoing treatment needs and help maintain abstinence.. Qualitative study of a cross-sectional cohort of patients with OUD in long-term sustained remission currently receiving methadone or buprenorphine. Participants completed a single in-depth, semi-structured individual interview.. Twenty adults were recruited from two opioid treatment programs and two office-based opioid treatment programs in Baltimore, MD. Half of the participants were Black, had a median (IQR) age of 46.5 (43-52) years and the median (IQR) time since the last non-prescribed opioid was 12 (8-15) years.. Hybrid deductive-inductive thematic analysis of the transcribed interviews.. Some participants described a chronic OUD disease identity where they continue to live with OUD. Participants who maintain an OUD identity describe inherent traits or predetermination of developing OUD. Maintaining a disease identity helps them remain vigilant against returning to drug use. Others described a post-OUD/survivor identity where they no longer felt they had OUD, but the experience remains. Each perspective informed attitudes about continued treatment with methadone or buprenorphine and strategies to remain in remission.. The identity that people with OUD in sustained remission maintain was the lens through which they viewed other aspects of their OUD including cause and ongoing treatment needs. An alternative, post-OUD/survivorship model emerged or was accepted by participants who did not identify as currently having OUD. Understanding patient perspectives of OUD identity might improve patient-centered care and improve outcomes.

Topics: Adult; Analgesics, Opioid; Buprenorphine; Chronic Disease; Cross-Sectional Studies; Humans; Middle Aged; Opiate Substitution Treatment; Opioid-Related Disorders; Survivors; Survivorship

Approximately 15-40% of people living with HIV develop HIV-associated neurocognitive disorders, HAND, despite successful antiretroviral therapy. There are no therapies to treat these disorders. HIV enters the CNS early after infection, in part by transmigration of infected monocytes. Currently, there is a major opioid epidemic in the United States. Opioid use disorder in the context of HIV infection is important because studies show that opioids exacerbate HIV-mediated neuroinflammation that may contribute to more severe cognitive deficits. Buprenorphine is an opioid derivate commonly prescribed for opiate agonist treatment. We used the EcoHIV mouse model to study the effects of buprenorphine on cognitive impairment and to correlate these with monocyte migration into the CNS. We show that buprenorphine treatment prior to mouse EcoHIV infection prevents the development of cognitive impairment, in part, by decreased accumulation of monocytes in the brain. We propose that buprenorphine has a novel therapeutic benefit of limiting the development of neurocognitive impairment in HIV-infected opioid abusers as well as in nonabusers, in addition to decreasing the use of harmful opioids. Buprenorphine may also be used in combination with HIV prevention strategies such as pre-exposure prophylaxis because of its safety profile.

Topics: AIDS Dementia Complex; Animals; Antigens, Ly; Brain; Buprenorphine; Chronic Disease; Cognitive Dysfunction; Disease Models, Animal; HIV Infections; Inflammation; Male; Mice, Inbred C57BL; Monocytes; Phenotype; Viral Load

Topics: Analgesics, Opioid; Anemia, Sickle Cell; Buprenorphine; Child; Chronic Disease; Chronic Pain; Humans

Although buprenorphine is an evidence-based treatment for opioid use disorder (OUD), it is unknown whether buprenorphine use may affect patients' adherence to treatments for chronic, unrelated conditions.. To quantify the effect of buprenorphine treatment on patient adherence to 5 therapeutic classes: (1) antilipids; (2) antipsychotics; (3) antiepileptics; (4) antidiabetics; and (5) antidepressants.. This was a retrospective cohort study.. We started with 12,719 commercially ensured individuals with a diagnosis of OUD and the buprenorphine initiation between January 2011 and June 2015 using Truven Health's MarketScan data. Individuals using any of the 5 therapeutic classes of interest were included.. Within the 180-day period post buprenorphine initiation, we derived 2 daily indicators: having buprenorphine and having chronic medication on hand for each therapeutic class of interest. We applied logistic regression to assess the association between these 2 daily indicators, adjusting for demographics, morbidity, and baseline adherence.. Across the 5 therapeutic classes, the probability with a given treatment on hand was always higher on days when buprenorphine was on hand. After adjustment for demographics, morbidity, and baseline adherence, buprenorphine was associated with a greater odds of adherence to antilipids [odds ratio (OR), 1.27; 95% confidence interval (CI), 1.04-1.54], antiepileptics (OR, 1.22; CI, 1.10-1.36) and antidepressants (OR, 1.42; CI, 1.32-1.60).. Using buprenorphine to treat OUD may increase adherence to treatments for chronic unrelated conditions, a finding of particular importance given high rates of mental illness and other comorbidities among many individuals with OUD.

Topics: Adult; Analgesics, Opioid; Buprenorphine; Chronic Disease; Female; Humans; Male; Medication Adherence; Middle Aged; Opiate Substitution Treatment; Opioid-Related Disorders; Retrospective Studies

Targeting chemokine signaling pathways is crucial in neuropathy development. In this study, we investigated the influence of chronic administration of maraviroc (CCR5 antagonist) on nociception and opioid effectiveness during neuropathy, which develops as a result of chronic constriction injury (CCI) of the sciatic nerve. To investigate the mechanism of action of maraviroc, we measured the expression of glial cell markers, CCR5 and certain CCR5 ligands (CCL3, CCL4, CCL5, CCL7, CCL11), in the spinal cord and dorsal root ganglia (DRG) of vehicle- and maraviroc-treated, CCI-exposed rats. Our results demonstrate that chronic intrathecal administration of maraviroc diminished neuropathic pain symptoms on day 7 post-CCI. Western blot analysis showed that maraviroc diminished protein level of Iba-1 and GFAP and reversed the up-regulated CCR5 expression observed in spinal cord and DRG after CCI. Additionally, using qRT-PCR, we demonstrated that CCR5 and some of its pronociceptive ligands (CCL3, CCL4, CCL5) increased in the spinal cord after nerve injury, and maraviroc effectively diminished those changes. However, CCL11 spinal expression was undetectable, even after injury. In vitro primary culture studies showed that CCL3, CCL4, CCL5 and CCL7 (but not CCL11) were of microglial and astroglial origin and were up-regulated after LPS stimulation. Our results indicate that maraviroc not only attenuated the development of neuropathic pain symptoms due to significant modulation of neuroimmune interactions but also intensified the analgesic properties of morphine and buprenorphine. In sum, our results suggest the pharmacological modulation of CCR5 by maraviroc as a novel therapeutic approach for co-treatment of patients receiving opioid therapy for neuropathy.

Topics: Analgesics, Opioid; Animals; Astrocytes; Buprenorphine; CCR5 Receptor Antagonists; Cells, Cultured; Chronic Disease; Cyclohexanes; Cytokines; Disease Models, Animal; Drug Synergism; Ganglia, Spinal; Hyperalgesia; Lipopolysaccharides; Male; Maraviroc; Microglia; Morphine; Neuralgia; Rats, Wistar; Sciatic Nerve; Spinal Cord; Triazoles

Opioids provide effective analgesia for moderate-to-severe, chronic pain. Transdermal buprenorphine (TDB) is available in the UK as weekly, lower-dose (5-20 μg/h) patches and twice-weekly, higher dose (35-70 μg/h) patches. This prospective, observational, multicenter study of patients with various chronic pain conditions assessed the safety, perceptions, and discontinuation of treatment with TDB in a real-world, non-interventional setting (ClinicalTrials.gov study ID: NCT01225861).. Patients aged ≥18 years who were already receiving or initiating treatment with TDB were recruited in the UK during routine clinical visits and were followed for 6 visits or 9 months (whichever came first). Self-reported treatment adherence, patient satisfaction, and safety data were collected at each study visit.. Of 465 patients, 272 were already receiving 7-day TDB at the study start (TDB experienced), 146 were TDB naïve, and 47 were prescribed twice-weekly TDB. Most patients were female (72.9 %) and overweight/obese (body mass index ≥25: 75.3 %). The median age was 67 years, and the mean duration of pain was 11.1 years. Arthritis/other musculoskeletal disorders (39.6 %) were the most common causes of pain. Mild adverse events were commonly reported. Skin irritations, which were most frequent in 7-day TDB-experienced patients (45.6 %), rarely resulted in treatment discontinuation (8.8 %). Nearly all patients used TDB in accordance with treatment recommendations. Most patients reported that TDB was 'effective'/'very effective' at relieving pain and were 'satisfied'/'very satisfied' with TDB therapy.. In everyday clinical practice, TDB was well tolerated and patients were satisfied with their therapy. Self-reported adherence to TDB was very high, and adverse events rarely resulted in treatment discontinuation. Opportunities were identified to limit common adverse events associated with TDB.

Topics: Administration, Cutaneous; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Disease; Chronic Pain; Female; Humans; Male; Medication Adherence; Middle Aged; Pain Measurement; Patient Satisfaction; Prospective Studies; United Kingdom

High dose buprenorphine (HDB), commonly known as Subutex(®), is nowadays largely prescribed as a replacement therapy for major opiate dependence. Its sublingual administration allows a decrease in the withdrawal syndrome accompanying opiate abuse cessation. Over the past few decades, epidemiological data on people on replacement therapy have emphasized an increase in the misuse of Subutex(®) and more specifically intravenous injections of HDB. These growing practices pave the way to major physical consequences or even death. Several studies have highlighted the infectious, vascular, venous and arterial (pseudo-aneurysm) complications stemming from this habit. Among the possible vascular complications, we can notice the presence of abscess, venous thrombosis, phlegmons, skin necrosis, cellulite, and profound and superficial thrombophlebitis at injection sites. These can evolve into chronic edemas of the tips and subcutaneous nodules. The Popeye syndrome is one of the possible complications of this misuse. This syndrome is characterized by the swelling of both sides of the forearms and hands. These edemas tend to become persistent and to be paired with tissue changes such as skin thickening. Besides, the increase in the hands volume can occur bilaterally or sometimes in an asymmetrical way, accentuated on the hand of the non-dominant limb. This syndrome does not decrease, or just a little, after the stoppage of injections. It can have a psychological, social, psychopathological and esthetic impact.. In this article, we will focus on the clinical case of a 43-year-old man, who is hospitalized in an addictology unit for massive injections of HDB. This patient suffers from a Popeye syndrome as well as from an alcoholic dependence.. Following the description of psychopathological disorders, our analysis will originate from a clarification relative to the specificities of the practice of intravenous HDB injection to better sharpen the understanding of these misuses in their psychopathological and clinical aspects. We will discuss some proposals for interventions aiming at taking better care of the people suffering from a drug addiction characterized by the injection of HDB replacement therapy.. Adam requested an admission in an addictology ward for treatment of a self-medication by Subutex started 4 years ago. A certain awkwardness can be perceived when he lays his highly damaged and marked hands on the desk. His upper limbs, thus on display, have tripled in volume: this indicates the presence of a Popeye syndrome, consequence of repeated Subutex injections. These observations lead us to question the function and the sense of this injection behavior in the mental economy, as this repeated behavior engages the body specifically. This bruised body, marked with repeated injection holes has become a place of inscription, of representation that shows the impossibility to access other ways of expression. In this sense, taking action is becoming an act of speech. Within this speech, we can notice the existence of a profound state of uneasiness. To put up with the painful feeling of inner emptiness that is calling for a necessary filling, aiming at re-establishing a frail balance, Adam appeals to repeated injections. However, when the tortured body signifies its incapacity to receive an ultimate injection, thus showing its limits and the destruction it is undergoing, it is no longer possible to resort to Subutex injections. As a consequence, Adam came up with the idea of quitting. The withdrawal was initiated by himself and not coupled with medical care. It has led him to feel a gap, beyond the physical uneasiness. Adam has tried to fill in this unbearable feeling of empty body with tobacco, alcohol and food. The body, highly mobilized, translates the presence of a physical conflict where a massive mental anxiety is expressed in a hidden way. During the interview, Adam also addressed the repetitive familial pattern and the transgeneration effects. He seems to be fully aware of these.. Several perspectives can be addressed as part of Adam's treatment and especially cognitive-behavioral therapies as they could prove to be of a certain interest. The aim of this therapy would thus be to assess the motivation for change in order to begin a psychotherapeutic work based on personal adherence to the cessation of this misuse. This could be set up in parallel with an anxiety management work.. A better understanding and an extensive knowledge of the possible complications linked to the misuse of HDB seems necessary to sensitize and better inform people who suffer from high-risk behaviors and also to enable a more adapted care.

Topics: Adult; Alcoholism; Buprenorphine; Chronic Disease; Cognitive Behavioral Therapy; Comorbidity; Conflict, Psychological; Cross-Sectional Studies; Defense Mechanisms; Dose-Response Relationship, Drug; Edema; Forearm; France; Hand Deformities, Acquired; Humans; Male; Opiate Substitution Treatment; Opioid-Related Disorders; Prescription Drug Misuse; Psychopathology; Recurrence; Skin Diseases; Substance Abuse, Intravenous; Syndrome

A 6-year-old, neutered male, domestic shorthair cat was presented with shifting leg lameness and palpable effusion of the carpal and tarsal joints. Blood work, arthrocentesis, and radiographs identified an immune-mediated erosive polyarthritis. The cat was positive for feline syncytia-forming virus, and with his signalment, was diagnosed with feline chronic progressive polyarthritis.

Topics: Amines; Analgesics; Animals; Anti-Inflammatory Agents; Arthritis; Buprenorphine; Cat Diseases; Cats; Chronic Disease; Cyclohexanecarboxylic Acids; Cyclosporine; Gabapentin; gamma-Aminobutyric Acid; Immunosuppressive Agents; Male; Pain; Prednisolone; Retroviridae Infections; Spumavirus

The buprenorphine transdermal delivery system (BTDS) is indicated for reduction of pain in moderate to severe chronic low back pain (CLBP), which can affect patients' ability to perform routine activities of daily living (ADLs). This post hoc analysis of clinical trial data examines the impact of BTDS treatment on CLBP patients' ability to perform ADLs that relate to functioning with low back pain.. Data are drawn from a multicenter, enriched enrollment, randomized, placebo-controlled, double-blind 12-week trial of BTDS for pain control among opioid-naive patients with moderate to severe CLBP. The 23 selected ADLs are those that (1) appear in the Low Back Pain Core Set of the International Classification of Functioning, Disability and Health and (2) link to the content of 3 patient-reported outcome instruments administered during the trial. Logistic regression models estimated the odds ratios (ORs) of BTDS patients' ability to perform each ADL at 12 weeks, controlling for baseline ability, relative to placebo.. The ORs for 10 ADLs related to sleeping, lifting, bending, and working reached multiplicity-adjusted statistical significance and indicated a greater ability to perform ADLs among BTDS users than among the placebo group. These 10 ORs ranged from 1.9 (no physical health-related restrictions on the kind of work performed) to 2.4 (being able to sleep undisturbed by pain).. These results suggest that for patients with moderate to severe CLBP, 12 weeks use of BTDS improves the ability to carry out certain ADLs related to sleeping, lifting, bending, and working.

Topics: Activities of Daily Living; Administration, Cutaneous; Analgesics, Opioid; Buprenorphine; Chronic Disease; Disabled Persons; Double-Blind Method; Female; Humans; International Classification of Diseases; Logistic Models; Low Back Pain; Male; Pain Measurement; Sleep; Treatment Outcome; Walking; Work

Topics: Buprenorphine; Chronic Disease; Criminal Law; Humans; Illicit Drugs; Methadone; Narcotic Antagonists; Opioid-Related Disorders; Social Stigma

Buprenorphine is an effective treatment for opioid dependence that can be provided in a primary care setting. Offering this treatment may also facilitate the identification and treatment of other chronic medical conditions.. We retrospectively reviewed the medical records of 168 patients who presented to a primary care clinic for treatment of opioid dependence and who received a prescription for sublingual buprenorphine within a month of their initial visit.. Of the 168 new patients, 122 (73%) did not report having an established primary care provider at the time of the initial visit. One hundred and twenty-five patients (74%) reported at least one established chronic condition at the initial visit. Of the 215 established diagnoses documented on the initial visit, 146 (68%) were not being actively treated; treatment was initiated for 70 (48%) of these within one year. At least one new chronic medical condition was identified in 47 patients (28%) during the first four months of their care. Treatment was initiated for 39 of the 54 new diagnoses (72%) within the first year.. Offering treatment for opioid dependence with buprenorphine in a primary care practice is associated with the identification and treatment of other chronic medical conditions.

Topics: Adult; Buprenorphine; Chronic Disease; Female; Humans; Insurance Claim Review; Male; Middle Aged; Narcotic Antagonists; Opioid-Related Disorders; Primary Health Care; Retrospective Studies; Socioeconomic Factors

In monitoring a patient with chronic pain who was taking high-dose morphine and oxycodone with weekly urine enzymatic immunoassay (EIA) toxicology testing, the authors noted consistent positives for buprenorphine. The patient was not taking buprenorphine, and gas chromatography/mass spectroscopy (GCMS) testing on multiple samples revealed no buprenorphine, indicating a case of false-positive buprenorphine EIAs in a high-dose opiate case. The authors discontinued oxycodone for a period of time and then discontinued morphine. Urine monitoring with EIAs and GCMS revealed false-positive buprenorphine EIAs, which remained only when the patient was taking morphine. When taking only oxycodone and no morphine, urine samples became buprenorphine negative. When morphine was reintroduced, false-positive buprenorphine results resumed. Medical practitioners should be aware that high-dose morphine (with morphine urine levels turning positive within the 15,000 to 28,000 mg/mL range) may produce false-positive buprenorphine EIAs with standard urine EIA toxicology testing.

Topics: Analgesics, Opioid; Buprenorphine; Chronic Disease; Enzyme Assays; False Positive Reactions; Gas Chromatography-Mass Spectrometry; Humans; Low Back Pain; Male; Middle Aged; Morphine; Oxycodone; Reagent Kits, Diagnostic

Glossopharyngeal neuralgia is a rare condition and the origin is mostly idiopathic. Causes of symptomatic glossopharyngeal neuralgia can be tumors, infarction or trauma. We report the case of a 28-year-old patient who developed glossopharyngeal neuralgia after resection of a glossopharyngeal schwannoma, which is an extremely rare tumor. Treatment consisted of orally administered pregabalin and a series of injections of buprenorphine in the superior cervical ganglion (ganglionic local opioid application/analgesia, GLOA) which led to a substantial decrease in the frequency of pain attacks. This improvement was maintained at 1-year follow-up. This is the first report of development of glossopharyngeal neuralgia after resection of a glossopharyngeal schwannoma.

Topics: Administration, Oral; Adult; Analgesics; Analgesics, Opioid; Autonomic Nerve Block; Buprenorphine; Chronic Disease; Female; gamma-Aminobutyric Acid; Glossopharyngeal Nerve; Glossopharyngeal Nerve Diseases; Humans; Injections; Magnetic Resonance Imaging; Neurilemmoma; Pain Measurement; Pain, Postoperative; Pregabalin; Superior Cervical Ganglion

To evaluate the use of a buprenorphine transdermal patch (Transtec*) in routine clinical practice, including dosage, indications, efficacy and tolerability.. This prospective, open-label, non-comparative, non-interventional, post-marketing study was performed in Poland by 339 investigators in a range of clinical practice settings. Patients with chronic moderate to severe cancer pain, or chronic severe non-cancer pain that was insufficiently controlled by non-opioids, were prescribed buprenorphine transdermal patch 35, 52.5 or 70 μg/hour (changed twice weekly), and followed up for 3 months. Additional analgesia, and adjuvant/supportive treatments were allowed at the discretion of the physician.. The study enrolled 4030 patients, with a mean age of 62.8 years. Most patients had cancer-related pain (80.7%). Non-cancer pain was generally musculoskeletal or neuropathic. A starting dose of 35, 52.5 or 70 μg/hour was used in 73.4%, 21.5%, and 4.8% of patients, respectively. Buprenorphine dose was increased in 44.7% of patients during the observation, generally from 35 to 52.5 μg/hour. Mean pain intensity (using a 100 mm visual analogue scale) decreased by 73.5% from 62.3 mm at baseline to 16.5 mm after 3 months. Most patients rated pain relief as 'very good' (41.4%) or 'good' (44.5%). Sleep quality also improved. 48.1% of patients needed no additional analgesics during buprenorphine treatment. Most patients (96%) rated the buprenorphine transdermal patch as 'very easy' or 'easy' to change. The most common treatment-related reasons for discontinuation were lack of analgesic effect (3.3% of patients) and adverse drug reactions (ADRs, 0.8%). ADRs, all non-serious, occurred in 34 patients (0.8%), most commonly local skin reactions or vomiting. At study end, it was planned to continue treatment with transdermal buprenorphine in 70.1% of patients. The main limitations related to the observational study design, balanced by advantages gained from the 'real life' exploration of transdermal buprenorphine use.. In routine Polish clinical practice, transdermal buprenorphine was effective and generally well-tolerated in patients with chronic moderate to severe cancer pain or chronic severe non-malignant pain insufficiently controlled by non-opioids.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Disease; Female; Humans; Male; Middle Aged; Neoplasms; Pain; Poland; Product Surveillance, Postmarketing; Prospective Studies; Severity of Illness Index; Treatment Outcome; Young Adult

The FDA has approved the partial opioid agonist buprenorphine in a transdermal formulation (Butrans-Purdue) for treatment of moderate to severe chronic pain. Buprenorphine has been available in the US for years in parenteral formulations for pain and in sublingual tablets for opioid dependence. Transdermal buprenorphine has been available in Europe for several years.

Topics: Administration, Cutaneous; Analgesics, Opioid; Buprenorphine; Chronic Disease; Drug Interactions; Humans; Pain; Randomized Controlled Trials as Topic; Receptors, Opioid, mu

Topics: Administration, Cutaneous; Analgesics, Opioid; Buprenorphine; Chronic Disease; Drug Delivery Systems; Humans; Narcotics; Pain; Risk Assessment

Addiction to opioids, or opioid dependence, encompasses the biopsychosocial dysfunction seen in illicit heroin injectors, as well as aberrant behaviours in patients prescribed opioids for chronic nonmalignant pain.. To outline the management of opioid dependence using opioid pharmacotherapy as part of a comprehensive chronic illness management strategy.. The same principles and skills general practitioners employ in chronic illness management underpin the care of patients with opioid dependence. Opioid pharmacotherapy, with the substitution medications methadone and buprenorphine, is an effective management of opioid dependence. Training and regulatory requirements for prescribing opioid pharmacotherapies vary between jurisdictions, but this treatment should be within the scope of most Australian GPs.

Topics: Adult; Analgesics, Opioid; Australia; Buprenorphine; Chronic Disease; Disease Management; Female; General Practice; Humans; Methadone; Opiate Substitution Treatment; Opioid-Related Disorders; Patient Care Planning

The transdermal 7-day buprenorphine matrix patch provides a constant and user-friendly pain management when chronic musculoskeletal pain requires opioids. This analysis of clinical routine data evaluated the benefit of this treatment for patients previously receiving oral long-term treatment with weak opioids alone. Data of 310 patients previously treated with tramadol or tildate/naloxone and part of a multicentre observational study with 3295 patients were analyzed. In 89.7% of the 310 patients oral treatment with weak opioids was replaced by the 7-day buprenorphine patch due to insufficient analgesia. During treatment with the 7-day buprenorphine patch there was a clinically significant decrease of the mean pain intensity at rest during the day from 5.7 to 2.9, on physical effort during the day from 7.3 to 3.8 and at night from 5.2 to 2.3 (11-point NRS scale, p < or = 0.001). In addition, quality of life aspects such as mobility, self-reliance and quality of sleep improved, which are relevant for individual patient satisfaction with pain management. For patients with previous long-term tramadol or tilidate/naloxone treatment the switch to the 7-day buprenorphine matrix patch proved to be effective and safe for the management of chronic pain. The user-friendly 7-day application interval contributes to improving compliance and a reducing exposure to tablets.

Topics: Activities of Daily Living; Administration, Cutaneous; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Disease; Drug Substitution; Female; Germany; Humans; Long-Term Care; Male; Middle Aged; Naloxone; Pain; Pain Measurement; Prospective Studies; Quality of Life; Tilidine; Tramadol

Opioid analgesics are known to impact on the central nervous system (CNS). These CNS side effects, such as dizziness and confusion, have been shown to lead to an increased risk of falling with subsequent fractures in elderly patients being treated with opioids. The risk of experiencing fractures has been shown to be dependent on the substance administered. Therefore, a health economic model was developed to investigate the cost-effectiveness of the most commonly used strong opioids in Germany, focussing on opioid-related fractures. By means of a Markov model, the consequences of hip, spine and forearm fractures due to the prior administration of transdermal (TD) buprenorphine, TD fentanyl, oral oxycodone as well as oral morphine were assessed from the perspectives of the German statutory health insurance (SHI) and the German social security (GSS) system over a time horizon of 6 years. The most frequently prescribed strength/package-size combinations of these opioids were taken into consideration, including generics where available. The results of the present analysis predict that TD buprenorphine is dominant compared to TD fentanyl and oxycodone by showing better effects [life years gained/quality adjusted life years (QALY) gained] at lower cost. From the SHI perspective, the incremental cost-effectiveness ratio (ICER) compared to morphine is 6,801.61 per life year gained, and 7,766.11 per QALY gained. From the GSS perspective, the ICER is 2,496.77 per life year gained and 2,850.83 per QALY gained. The model is robust regarding probabilistic variations of all parameters in the sensitivity analyses. Focussing on fractures due to the prior administration of strong opioids, TD buprenorphine is less costly and more effective than TD fentanyl and oxycodone and represents a cost-effective treatment option versus morphine in patients with chronic pain from both the SHI and GSS perspective in Germany.

Topics: Accidental Falls; Aged; Analgesics, Opioid; Buprenorphine; Chronic Disease; Cost-Benefit Analysis; Fractures, Bone; Germany; Health Services; Humans; Markov Chains; Middle Aged; Models, Economic; Morphine; Oxycodone; Pain; Quality-Adjusted Life Years

Chronic tendinopathy is characterized with longstanding activity-related pain with degenerative tendon injuries. An objective tool to measure painful responses in animal models is essential for the development of effective treatment for tendinopathy. Gait analysis has been developed to monitor the inflammatory pain in small animals. We reported the use of motion analysis to monitor gait changes in a rat model of degenerative tendon injury. Intratendinous injection of collagenase into the left patellar tendon of Sprague Dawley rat was used to induce degenerative tendon injury, while an equal volume of saline was injected in the control groups. Motion analyses with a high speed video camera were performed on all rats at pre-injury, 2, 4, 8, 12 or 16 weeks post injection. In the end-point study, the rats were sacrificed to obtain tendon samples for histological examination after motion analyses. In the follow-up study, repeated motion analyses were performed on another group of collagenase-treated and saline-treated rats. The results showed that rats with injured patellar tendon exhibited altered walking gait as compared to the controls. The change in double stance duration in the collagenase-treated rats was reversible by administration of buprenorphrine (p=0.029), it suggested that the detected gait changes were associated with pain. Comparisons of end-point and follow-up studies revealed the confounding effects of training, which led to higher gait velocities and probably a different adaptive response to tendon pain in the trained rats. The results showed that motion analysis could be used to measure activity-related chronic tendon pain.

Topics: Analgesics, Opioid; Animals; Behavior, Animal; Biomechanical Phenomena; Buprenorphine; Chronic Disease; Collagenases; Disease Models, Animal; Gait; Lameness, Animal; Male; Pain; Pain Measurement; Predictive Value of Tests; Rats; Rats, Sprague-Dawley; Sensitivity and Specificity; Tendon Injuries; Tendons; Video Recording; Walking

Topics: Administration, Topical; Aged; Analgesics, Opioid; Buprenorphine; Cholestasis; Chronic Disease; Drug Combinations; Female; Humans; Injections, Intravenous; Naloxone; Narcotic Antagonists; Neoplasms; Pain; Pain Measurement; Palliative Care; Pruritus; Treatment Outcome

The 7-day, low-dose buprenorphine patch has been available in the United Kingdom since 2005 for the treatment of chronic nonmalignant pain that is unresponsive to nonopioid analgesics. Osteo-arthritis pain, a significant cause of pain and disability in the elderly, is a common reason for prescribing bu-prenorphine patches.. The goals of this study were to investigate utilization and treatment persistence in patients receiving low-dose buprenorphine patches and the expected patterns of treatment 12 months after the initiation of treatment.. This was a retrospective cohort study of patients who were prescribed low-dose buprenorphine patches in general practice in the United Kingdom. Patients in this cohort were matched by age, sex, and practice with comparator cohorts prescribed oral codeine, dihydrocodeine, or tramadol. Data on baseline characteristics, utilization, and adverse events were obtained from the General Practice Research Database, which contains computerized medical records from UK general practice. Treatment persistence was determined based on repeat prescribing within 90 days after the expected end of a prescription; rates of persistence were compared between the buprenorphine and comparator cohorts. Cox proportional hazards regression models were used to compare the incidence of typical opioid adverse effects (constipation, dizziness, and nausea and/or vomiting) between cohorts.. The study cohort included 4968 patients who were prescribed low-dose buprenorphine patches. The majority of patients (64.2%) were aged >65 years, and the most frequently recorded indication for low-dose buprenorphine patches was osteoarthritis (48.7%). Most patients (76.1%) started treatment at the lowest patch strength (5 microg/h). The mean patch strength prescribed over time stabilized at 10 to 12 microg/h. Persistence with low-dose buprenorphine patches over 6 months was significantly higher than with codeine, dihydrocodeine, and tramadol (28.9%, 22.4%, 24.4%, and 23.8%, respectively; P < 0.01). Persistence over 12 months also was significantly higher with low-dose buprenorphine patches compared with the comparators (18.5%, 16.1%, 18.0%, and 17.6%; P < 0.01). After 12 months, the difference in persistence levels between cohorts was not statistically significant. In the Cox proportional hazards regression models, patients using buprenorphine patches had an increased incidence of constipation, dizziness, and nausea and vomiting compared with those who used the comparator opioids (P < 0.05).. Significantly more patients receiving low-dose buprenorphine patches in this study persisted with treatment at 6 and 12 months compared with those receiving other opioid analgesics. Treatment with low-dose buprenorphine patches was most frequently initiated at the lowest patch strength and stabilized at a mean of 10 to 12 microg/h.

Topics: Administration, Cutaneous; Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Disease; Codeine; Cohort Studies; Databases, Factual; Dose-Response Relationship, Drug; Female; Follow-Up Studies; Humans; Male; Medication Adherence; Middle Aged; Pain; Primary Health Care; Proportional Hazards Models; Retrospective Studies; Time Factors; Tramadol; United Kingdom; Young Adult

Topics: Buprenorphine; Chronic Disease; Humans; Narcotics; Opioid-Related Disorders; Secondary Prevention; Treatment Outcome

To obtain information on the efficacy, tolerability and safetyofa transdermal buprenorphine patch (Transtec PRO) in patients with moderate to severe chronic pain. In addition it should be evaluated to what extent the two fixed patch change days per weekare simplifyingthe therapy.. In this prospective multi-center post marketing surveillance study patients with chronic cancer and non-cancer pain were treated with transdermal buprenorphine for up to eight weeks. The evaluation included pain intensity, the dosage of the applied analgesics and additional therapies, the renal function (by serum creatinine) and adverse events.. 3654 patients were treated for a mean of 50.4 days. Using the NRS-11 the mean pain intensity decreased from 6.3 at the time when patients were switched to the transdermal buprenorphine patch to 2.6 at the last treatment evaluation. The matrix patch was safe and well tolerated also in patients with advanced renal insufficiency. Adverse events were reported in 6.7% of the patients. 89.3% of the physicians quoted to prefer transdermal buprenorphine with the two fixed patch change days per week compared to the pre-treatment.. The buprenorphine-containing matrix patch was effective and well tolerated in patients with moderate to severe chronic cancer and noncancer pain. From the physicians view the two fixed patch change days per week facilitate the guidance of therapy. In patients with advanced renal insufficiency a dose adjustment is not necessary.

Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Disease; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Neoplasms; Pain; Product Surveillance, Postmarketing; Prospective Studies

Topics: Analgesics, Opioid; Buprenorphine; Chronic Disease; Humans; Methadone; Opioid-Related Disorders; Pain

Pain still afflicts most cancer patients, mainly in the metastatic phases, and undertreatment is well documented. Transdermal delivery systems (TDS) could potentially have advantages over oral and parental routes, but evidence from comparative trials are scanty. In the framework of a wider initiative, an Outcome Research Study was carried out in Italy in 2006 to evaluate the effects of various analgesic options, particularly TDS Buprenorphine. Despite the limitations due to the observational design, these findings may be useful to clinicians to better judge the value of the drug under evaluation and to help researchers to design further comparative studies.

Topics: Administration, Cutaneous; Analgesics, Opioid; Buprenorphine; Chronic Disease; Dose-Response Relationship, Drug; Female; Humans; Italy; Male; Middle Aged; Neoplasms; Outcome Assessment, Health Care; Pain; Pain Measurement; Palliative Care; Prospective Studies; Quality of Life; Research Design; Surveys and Questionnaires; Treatment Outcome

Opioids produce analgesia via different pain pathways. The aim of these case studies was to address the issue of opioid rotation or switching, raising the important issue of conversion ratios between different compounds and routes of administration.. We present two cases of neuropathic pain and two cases of nociceptive pain with a significant neuropathic component, which were successfully treated with transdermal buprenorphine after the failure of other opioids.. In each case, effective pain relief was produced by a lower dose than the proposed equipotency ratio of 1:75 would indicate, suggesting that a ratio of 1:110 to 1:115 may be more appropriate.

Topics: Administration, Cutaneous; Aged; Analgesics, Opioid; Buprenorphine; Chronic Disease; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Pain

Topics: Adult; Analgesics, Opioid; Buprenorphine; Cerebral Angiography; Cerebrovascular Circulation; Chronic Disease; Dose-Response Relationship, Drug; Female; Heroin Dependence; Humans; Intracranial Hemorrhages; Marijuana Abuse; Tomography, X-Ray Computed; Vasospasm, Intracranial

Topics: Benzazepines; Buprenorphine; Bupropion; Chronic Disease; Financing, Government; Genetic Testing; Harm Reduction; Humans; Marijuana Smoking; Naltrexone; Narcotic Antagonists; Prevalence; Privacy; Quinoxalines; Receptors, Nicotinic; Recurrence; Risk-Taking; Smoking; Smoking Cessation; Smoking Prevention; Social Environment; Substance-Related Disorders; Varenicline

The therapeutic use of opioids has been associated with altered cognition and impaired psychomotor function. Several studies have demonstrated the impact of opioid therapy on psychomotor performance and cognition, but there are no data about the effect of long-term treatment with transdermal buprenorphine on driving ability.. Thirty patients suffering from chronic noncancer pain, who had been treated with stable doses of transdermal buprenorphine, included in a prospective trial and compared with 90 healthy volunteers (matched pairs). A computerized test battery, developed to assess the driving ability of traffic delinquents in Germany, was used. Attention reaction, visual orientation, motor coordination, and vigilance were evaluated. The data from 14 variables were assessed, and for each test, a relevant score was defined. As the primary end-point, the sum score of the three relevant scores was determined. A weaker statistical means to assess the patient's performance is to compare the test results to an age-independent control group. Individuals performing worse than the 16th percentile of this control group are considered to be unable to drive according to German law.. According to tests that predict driving ability, patients receiving transdermal buprenorphine were shown to be noninferior to the control group. Driving ability, as defined as a result above the 16th percentile, did not differ significantly between the patients and the control group.. Long-term use of transdermal buprenorphine for chronic noncancer pain does not impair driving ability, but because of the individual variability of test results, an individual assessment is recommended.

Topics: Administration, Cutaneous; Adult; Aged; Automobile Driving; Buprenorphine; Chronic Disease; Cognition; Female; Humans; Long-Term Care; Male; Middle Aged; Pain; Prospective Studies; Psychomotor Performance; Reaction Time

The present study was designed to study the impact of intermittent hemodialysis on the disposition of the partial agonist buprenorphine and its metabolite norbuprenorphine during therapy with transdermal buprenorphine in chronic pain patients with end-stage kidney disease. Ten patients (mean age 63 years) who had received transdermal buprenorphine for at least 1 week, were asked to provide blood samples immediately before and after hemodialysis. Blood samples were analysed for buprenorphine and its metabolite norbuprenorphine. The median buprenorphine plasma concentrations were found to be 0.16 ng/ml before and 0.23 ng/ml after hemodialysis. A significant correlation between plasma levels and administered doses was observed (Spearman R=0.74; P<0.05). In three patients norbuprenorphine plasma levels were detected. No differences in pain relief before and after hemodialysis were observed. This investigation shows no elevated buprenorphine and norbuprenorphine plasma levels in patients with renal insufficiency receiving transdermal buprenorphine up to 70 microg/h. Furthermore, hemodialysis did not affect buprenorphine plasma levels, leading to stable analgesic effects during the therapy.

Topics: Administration, Cutaneous; Adult; Aged; Analgesics, Opioid; Buprenorphine; Chronic Disease; Female; Humans; Kidney Failure, Chronic; Male; Middle Aged; Pain; Renal Dialysis

Transdermal buprenorphine is available in Europe for the treatment of moderate to severe chronic pain. It has been evaluated at doses of 35, 52.5, and 70 microg/h for the management of moderate to severe chronic cancer and noncancer pain in 3 randomized, double-blind, placebo-controlled trials, each of limited duration (approximately 14 days each). Long-term data are essential to determining the performance of an analgesic in the management of chronic pain.. The purpose of this follow-up study was to obtain data on the efficacy and tolerability of long-term treatment with transdermal buprenorphine in cancer and noncancer patients with chronic persistent pain of moderate to severe intensity.. This was an open-label, uncontrolled, follow-up study in patients from the 3 previous clinical trials who elected to continue treatment with transdermal buprenorphine 35 microg/h and sublingual buprenorphine tablets (0.2 mg) as needed for breakthrough pain. The patch was to be changed every 72 hours throughout the patient's course of pain therapy. At visits every 2 weeks for the first 4 weeks and every 4 weeks for the remainder of study participation, patients evaluated their pain relief retrospectively on a 4-point verbal rating scale. They also rated the ease of patch handling using a 3-point verbal rating scale. Patterns of dose escalation and dose stability were monitored over time. Adherence to therapy was determined based on the number of patients who complied with the dosing schedule. Adverse events were documented by type, intensity, location (systemic or local), and relationship to study medication.. Two hundred thirty-nine patients were included in this follow-up study (120 women, 119 men; 100% white; mean [SD] age, 58 [11.3] years; mean weight, 70.8 [14.7] kg). One hundred thirty-four had cancer-related pain and 105 had pain of noncancerous origin. The mean duration of participation was 7.5 months, and 37 (15.5%) patients participated for >12 months. Maximum study participation was 3.4 years in cancer patients and 5.7 years in noncancer patients. One hundred eighty-eight (78.7%) patients were considered adherent to therapy. The majority (65.9%) of patients managed their pain with the patchalone or took no more than 1 additional sublingual tablet daily for breakthrough pain. At least satisfactory pain relief was reported by 215 (90.0%) patients, and the buprenorphine patch was generally well tolerated. The most common systemic adverse drug reactions were nausea (9.2%), dizziness (4.6%), vomiting (4.2%), constipation (3.8%), and tiredness (2.9%), whereas the most common local adverse drug reactions were erythema (12.1%), pruritus (10.5%), and exanthema (8.8%).. Transdermal buprenorphine was generally well tolerated and effective for the long-term treatment of chronic cancer or noncancer pain in these patients who had previously received buprenorphine in 3 short-term clinical trials.

Topics: Administration, Cutaneous; Administration, Sublingual; Analgesics, Opioid; Buprenorphine; Chronic Disease; Delayed-Action Preparations; Female; Follow-Up Studies; Humans; Male; Middle Aged; Pain

Buprenorphine is a semi-synthetic opioid derived from thebaine. The transdermal formulation of buprenorphine has been available in Belgium for 3 years, during which time the Pain Clinic of the St Elisabeth of Verviers Hospital has gained experience in the use of transdermal buprenorphine for the treatment of moderate-to-severe pain. This paper presents four cases of chronic, non-malignant pain, and one case of chronic cancer pain. By starting patients on low doses and slowly titrating upwards, transdermal buprenorphine matrix patches provided effective analgesia and were well tolerated. Low doses of transdermal buprenorphine were created by cutting the smallest available matrix patch (35 mug/h) into halves or quarters. The initial dose was then gradually titrated upwards to the dose needed for optimum pain relief by the patients. No problems were encountered in switching patients from prior analgesic therapy with other opioids to transdermal buprenorphine.

Topics: Administration, Cutaneous; Adult; Analgesics, Opioid; Buprenorphine; Chronic Disease; Female; Humans; Male; Middle Aged; Pain

We carried out a cost-effectiveness evaluation of transdermal fentanyl compared to three other widely used opioids: transdermal buprenorphine, sustained-release morphine, and controlled-release oxycodone from a third-party-payers perspective. A decision analytic model with data from a structured database search and from panel data and assumptions was used to derive both cost and utility results. Probabilistic sensitivity analysis was performed to ensure the findings. Transdermal fentanyl patients gain more quality adjusted life-days or quality-adjusted life-years per euro. The incremental cost per quality-adjusted life-year is 1,625.65 euro for transdermal fentanyl compared to sustained-release morphine and 1,003.03 euro compared to CO, and it is cost-saving compared to transdermal buprenorphine (-203.38 euro per patient). Transdermal fentanyl is thus cost-effective compared to both sustained-release morphine and CO and dominant compared to transdermal buprenorphine in the treatment of adults with nonmalignant moderate to severe chronic pain.

Topics: Administration, Cutaneous; Analgesics, Opioid; Buprenorphine; Chronic Disease; Cost-Benefit Analysis; Delayed-Action Preparations; Fentanyl; Germany; Health Services; Humans; Morphine; Oxycodone; Pain; Quality-Adjusted Life Years

Buprenorphine is a potent opioid analgesic clinically used to treat moderate to severe pain. The present study assessed its analgesic efficacy in a broad range of rodent models of acute and chronic pain. In the phenylquinone writhing, hot plate, and tail flick mouse models of acute pain, full analgesic efficacy was obtained (ED50 values: 0.0084-0.16 mg/kg i.v.). Full analgesic efficacy was also obtained in yeast- and formalin-induced inflammatory pain (ED50 values: 0.0024-0.025 mg/kg i.v., rats and mice) and in mustard-oil-induced spontaneous pain, referred allodynia, and referred hyperalgesia in mice (ED50 values: 0.018-0.025 mg/kg i.v.). Buprenorphine strongly inhibited mechanical and cold allodynia in mononeuropathic rats, as well as mechanical hyperalgesia and cold allodynia in polyneuropathic rats (ED50 values: 0.055 and 0.036 mg/kg i.v. and 0.129 and 0.038 mg/kg i.p., respectively). It is concluded that buprenorphine shows a broad analgesic profile and offers the opportunity to treat different pain conditions, including neuropathic pain.

Topics: Acute Disease; Analgesics, Opioid; Animals; Buprenorphine; Chronic Disease; Disease Models, Animal; Dose-Response Relationship, Drug; Male; Mice; Pain; Pain Measurement; Rats; Rats, Sprague-Dawley

The equipotency ratio of transdermal (TD) fentanyl to oral morphine has been established as 1:100; for buprenorphine TD, a ratio of 1:75 has been proposed, although this ratio has not been confirmed in clinical studies. Growing evidence from clinical practice, in which much lower doses of buprenorphine are used, suggests that this conversion ratio may be too high.. The aim of this study was to compare calculated equipotent oral morphine doses of fentanyl TD with equipotent oral morphine doses of buprenorphine TD prescribed in clinical practice.. This retrospective study identified patients with cancer and noncancer pain who had received > or =1 prescription for fentanyl TD or buprenorphine TD (the all-patients groups) from the German IMS Disease Analyzer-mediplus database, which contains all relevant data concerning drug prescriptions from 400 practices in Germany. Also identified were subgroups of the all-patients groups who had received long-term treatment with fentanyl TD or buprenorphine TD and were considered to have similar pain intensity, as they had previously received similar analgesic medication (the identical-cohort groups). Mean prescribed daily doses for the all-patients and identical-cohort groups were calculated based on the distribution of prescribed patch strengths. Because patients could have applied >1 patch, mean prescribed daily doses were also calculated based on an assumption of double application when appropriate. Equipotent oral morphine doses were estimated using equipotency ratios of 1:100 for fentanyl TD and 1:75 for buprenorphine TD.. The all-patients groups consisted of 2198 patients with noncancer pain and 2544 patients with cancer pain; the identical-cohort groups consisted of 380 patients with noncancer pain and 496 patients with cancer pain (529 women, 347 men; mean age, 74 years [range, 25-101 years]). Equipotent doses of oral morphine were significantly lower in patients receiving buprenorphine TD compared with those receiving fentanyl TD (P < 0.001). In cancer patients, the equipotent oral morphine doses of fentanyl TD and buprenorphine TD were 130.9 to 138.9 mg and 85.2 to 88.8 mg, respectively; in noncancer patients, the corresponding values were 117.0 to 118.3 mg and 80.2 to 80.9 mg. Based on these results, an equipotency ratio of 1:110 to 1:115 for buprenorphine TD would appear to be more appropriate than the proposed ratio of 1:75.. The fact that this retrospective analysis conducted in identical cohorts showed lower calculated equipotent oral morphine doses in the buprenorphine TD groups compared with the fentanyl TD groups calls into question the proposed 1:75 ratio for conversion of buprenorphine TD to equipotent oral morphine doses. Based on the findings of the present study, an equipotency ratio of 1:110 to 1:115 may be more appropriate. However, confirmative data from prospective randomized clinical trials are needed.

Topics: Administration, Cutaneous; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Disease; Cohort Studies; Female; Fentanyl; Hospitalization; Humans; Male; Middle Aged; Neoplasms; Pain; Referral and Consultation; Retrospective Studies

A new transdermal delivery system (TDS) for the rate-controlled systemic delivery of buprenorphine is available in 3 patch strengths, with release rates of 35, 52.5, and 70 microg/h over 72 hours, delivering daily amounts of 0.8, 1.2, and 1.6 mg, respectively. Randomized, double-blind, placebo-controlled, Phase III clinical trials in >400 patients with severe pain of malignant or nonmalignant origin have shown the analgesic efficacy of buprenorphine TDS.. This study investigated the effectiveness and tolerability of buprenorphine TDS for the relief of chronic pain in routine clinical practice.. This was a multicenter, open-label, uncontrolled, prospective, observational, 3-month follow-up study in patients who were beginning buprenorphine TDS treatment for moderate to severe cancer or noncancer pain that had not responded to nonopioid analgesics. Patches were to be changed every 72 hours. Patients were evaluated at 1 and 3 months after the start of treatment. Those who dropped out were considered treatment failures. Pain relief was assessed on a 5-category verbal rating scale, and quality of life was assessed using the European Quality of Life 5D (EQ-5D) questionnaire. Tolerability was determined based on adverse events recorded during the follow-up period.. The study recruited 1223 patients, most of whom were outpatients. Of the 1212 patients for whom sex data were available, 820 (67.7%) were women. In the 1188 patients with age data, the mean (SD) age was 64.9 (12.9) years. In the 1175 patients with data on the etiology of pain, 82.4% had noncancer pain. Six hundred eighty-eight (56.3%) patients completed the 3-month follow-up period. The median daily amount of buprenorphine TDS received at the beginning of the study was 0.8 mg (corresponding to 35 microg/h). Over the study period, there was a significant increase in the proportion of patients reporting very good or good pain relief (P < 0.001), from 3.6% (43/1205) at baseline to 63.2% (762/1205) after 1 month and 56.8% (685/1205) after 3 months. Quality of life also improved, from a mean (SD) EQ-5D score of 40.6 (20.5) at baseline to 56.8 (23.5) at 3 months (P < 0.001). Five hundred seventeen (42.3%) of the original 1223 patients experienced adverse events; the investigator judged 397 (32.5%) of these events possibly or probably related to study drug. The likelihood of experiencing a drug-related adverse event was greater in noncancer patients than in cancer patients. The most common adverse events were nausea (11.0%), vomiting (9.2%), and constipation (7.8%); the most common local adverse events were pruritus (1.4%), dermatitis (1.3%), and erythema (1.3%).. In the population studied, buprenorphine TDS was effective in alleviating cancer and noncancer pain and was well tolerated overall.

Topics: Administration, Cutaneous; Analgesics, Opioid; Buprenorphine; Chronic Disease; Female; Follow-Up Studies; Humans; Male; Middle Aged; Neoplasms; Pain; Pain Measurement; Quality of Life

The objective of this post-marketing surveillance study was to collect effectiveness and safety data on the labelled use of buprenorphine transdermal patches (Transtec*) under routine clinical conditions.. For this open, observational study, patients with moderate to severe cancer or non-cancer pain requiring treatment with an opioid analgesic were recruited at hospitals, outpatient clinics and general practitioners' practices in Germany. Buprenorphine transdermal patches (35 microg/h, 52.5 microg/h or 70 microg/h) were prescribed at physicians' discretion in accordance with the product's Summary of Product Characteristics (SmPC). Patients assessed their pain relief as 'very good', 'good', 'satisfactory', 'poor' or 'no effect'. Investigators were instructed to report all adverse events throughout the observation period. On completion, effectiveness and tolerability were evaluated for the overall study population, cancer and non-cancer patients, and patients < 70 years and > or = 70 years. Other analyses assessed pain relief with respect to previous opioid treatment and increased patch strength, and in patients who remained on their original dose. The total observation time was 9 months, and the average individual documented treatment time was 60.8 days.. A total of 13,179 patients were evaluated; 3690 (28%) with cancer pain and 9489 (72%) with non-cancer pain. The most frequent diagnoses in non-cancer patients were musculoskeletal disorders (77%) and neuropathy (23%). In the great majority of cases (78%), treatment was started with the 35 microg/h patch. The initial dose needed to be increased subsequently only in about 18% of subjects. Buprenorphine transdermal patches provided effective, sustained and dose-dependent analgesia in patients with cancer and non-cancer pain, irrespective of the patients' age or pain syndromes. Whereas good or very good pain relief was documented only for 6% of the patients with the initial assessment, this percentage increased to 71% at the first follow-up and 80% at the final assessment. Fewer than 5% of subjects discontinued treatment owing to unsatisfactory pain relief. Altogether, adverse events were documented for 2874 patients (22%), whereas a relationship with trans dermal buprenorphine (adverse drug reactions) was assumed for only 10% (2220 adverse drug reactions in 1330 patients). The tolerability profile was as expected for an opioid and did not vary to a relevant extent with either the patient's age or the cause of pain (cancer or non-cancer). No evidence emerged of any previously unknown side effects.. Buprenorphine transdermal patches are well tolerated and effective in the treatment of chronic cancer and non-cancer pain, irrespective of the patients' age. There was no clinically relevant development of tolerance.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Disease; Female; Health Care Surveys; Humans; Male; Middle Aged; Observation; Pain; Product Surveillance, Postmarketing; Treatment Outcome

Topics: Analgesics, Opioid; Buprenorphine; Chronic Disease; Humans; Hyperalgesia; Pain

Patients with moderate to severe pain were treated with buprenorphine patches in one of 3 concentrations: 35 micrograms/h, 52.5 micrograms/h and 70 micrograms/h (= 0.8 mg/d, 1.2 mg/d and 1.6 mg/d respectively). The aim of this review was to assess the efficacy and tolerability of this transdermal system (TDS) in patients with chronic pain. A total of 445 patients were included in 3 double-blinded studies. The dosage titration with buprenorphine patches followed pretreatment with buprenorphine sublingual tablets, higher doses of weak opioids (level 2 substances), low dose morphine (level 3) or other analgesics. Patients with chronic tumour or non-tumour pain were recruited for these studies and treated with buprenorphine patches or placebo for 6 to 15 days. All patients were offered, in addition, buprenorphine sublingual tablets to be taken as required for supplementary pain relief. Pain intensity, analgesia, consumption of buprenorphine sublingual tablets and sleep duration were all assessed. All patients in the double-blinded studies were between the ages of 22 and 88. 249 patients suffered from tumour pain and 196 patients suffered from non-tumour pain. To examine long-term efficacy and tolerability of the transdermal system, treatment was expanded, if the patients were interested in participating in an open-label-study. In all 3 studies, the number of patients with moderate, severe and very severe pain increased in the placebo-patch treated group, while the patients in the buprenorphine transdermal system treated group had a greater incidence of mild or no pain. A further benefit in the buprenorphine transdermal system treated group was evidenced by a great number of patients with a daily sleep duration of more than 6 hours compared to the placebo group--an indicator of greater well-being. The systemic side-effects were typically opioid in nature and rare and usually only mild. Of particular note was the very low incidence of constipation in only 5.3% of cases. Dermatological reactions to the patches were only rarely encountered. The dermatological reactions consisted mainly of erythema and pruritus with a mild to moderate extent. Half the cases of erythema and more than on third of the cases of pruritus were spontaneously reversible. More than half the patients (53.7%) in the double blind studies wished to continued treatment with buprenorphine transdermal system. These results demonstrate that buprenorphine patches achieved a very good analgesic effe

Topics: Administration, Cutaneous; Analgesics, Opioid; Buprenorphine; Chronic Disease; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Humans; Long-Term Care; Neoplasms; Pain; Pain Measurement; Randomized Controlled Trials as Topic; Treatment Outcome

Adequate pain control is vital in the treatment of patients with musculoskeletal disease. These diseases are characterised by a number of pain-induced vicious circles, and satisfactory control of pain acts to disrupt these self-perpetuating processes. Consequently, early mobilisation can be achieved in patients with painful osteoporotic vertebral fractures, low back pain and sciatica, for example. In other cases analgesics may act simply to maintain the mobility of patients and in this way preserve their quality of life. When simple analgesics are not sufficient, the use of opioid-type analgesics is justified. Buprenorphine transdermal therapeutic system (TDS) is a novel formulation of a well-tolerated and highly effective drug for satisfactory pain control that can also be used in patients with chronic non-malignant pain (CNMP) due to musculoskeletal diseases. Three case reports are presented to illustrate the effectiveness of buprenorphine TDS in such patients.

Topics: Administration, Oral; Analgesics, Opioid; Buprenorphine; Chronic Disease; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Middle Aged; Musculoskeletal Diseases; Pain; Pain Measurement; Patient Satisfaction; Severity of Illness Index; Treatment Outcome

The aim of this study was to investigate objective characterisation of gait as a marker of the chronic pain of adjuvant arthritis (AA). Video recorded images of spontaneous rat ambulations were analysed to quantify various temporal and spatial parameters and compare these between the AA and control groups. Changes were also recorded after the administration of a single dose of buprenorphine (15 ?g). Individual temporal parameters were significantly reduced (velocity (P=0.05), stride length (P=0.007), single stance time (P<0.001), swing time (P=0.001)), or increased (dual stance time (P<0.001)) at 10 days in the AA group compared to control. The rear paws showed reduced ground contact and the fore paws an increase in proximal pad and decrease in digit area, although these changes were not all statistically significant. Some of the gait parameters showed significant reversal following administration of buprenorphine (velocity (P<0.001) and stride length (P<0.001) were increased and single stance time (P=0.014) reduced). It is proposed that changes in gait are a marker of AA chronic pain in this model. These behavioural changes were significant at a very early stage (day 10), before the development of physical deformities and increase in paw volume and might permit an earlier detection of pain than other models.

Topics: Analgesics, Opioid; Animals; Area Under Curve; Arthritis, Experimental; Body Weight; Buprenorphine; Chronic Disease; Disease Models, Animal; Female; Freund's Adjuvant; Gait; Hindlimb; Injections, Subcutaneous; Motor Activity; Pain; Pain Measurement; Rats

There is very little research into the problem of chronic pain in dialysed patients, despite the fact that pain is a widely diffused phenomena amongst these patients. This work proposes to evaluate the intensity of pain, supply a scale of levels of intervention, with an indication of the consumption and relative costs of pharmacological therapies.. 37 out of 100 patients undergoing haemodialysis suffer chronic pain. Aetiological research has shown that osteoarticular pain (24 cases), is the most common, peripheral vascular pain (3 cases), is subjectively and indirectly considered to be the most serious form. Nine cases have presented pain of a neuromuscular origin, whilst one case of a neoplastic origin. The degree of personal invalidism shows serious invalidism in 11 cases.. The therapeutic file that forsaw four levels of pharmacological intervention (1st levels: FANS, 2nd level: Codeine+paracetamol, 3rd level: Buprenorphine, 4th level: Morphine for os), accompanied by instrumental and pharmacological support intervention, has proved to be indispensable in confronting the problem. Through pharmacy data, we have noticed a progressive increase over the year in the use of analgesic medicines, of which we can confirm the effectiveness, tolerability, low level of side-effects, at low costs.. In our opinion chronic pain in dialysed patients should not be neglected. The perfection of diagnostic techniques, the discovery of pain-killers with reduced side-effects, the multidisciplinary approach, and reduced costs of treatment, are all valid arguments in favour of an intervention that improves the quality of life of these patients, already so compromised by the nature of the illness itself.

Topics: Acetaminophen; Analgesics; Arthralgia; Buprenorphine; Chronic Disease; Codeine; Disability Evaluation; Drug Costs; Drug Therapy, Combination; Humans; Italy; Morphine; Neuromuscular Diseases; Pain; Pain Measurement; Renal Dialysis; Vascular Diseases

Topics: Aged; Analgesia; Analgesics, Non-Narcotic; Analgesics, Opioid; Buprenorphine; Carbamazepine; Chronic Disease; Female; Ganglia, Parasympathetic; Humans; Injections; Male; Pain Measurement; Retrospective Studies; Superior Cervical Ganglion; Trigeminal Neuralgia

Topics: Analgesics, Opioid; Bile Ducts; Buprenorphine; Chronic Disease; Codeine; Humans; Morphine; Pain; Pancreatitis; Pentazocine; Sphincter of Oddi; Tramadol

Stellate ganglion blockade, typically performed by using palpable osseous landmarks, is an accepted method in the diagnosis and treatment of sympathetically maintained pain and other conditions. The authors present the results of stellate ganglion injection performed with computed tomographic (CT) guidance. Thirteen CT-guided procedures were performed in seven patients. Lidocaine, bupivacaine, and buprenorphine were used to achieve the blockade. Successful blocks were achieved in all 13 cases as evidenced by production of Horner syndrome and ipsilateral hand temperature elevations. The average ipsilateral and contralateral hand temperature changes following the procedure were 7.5 degrees C and 0.5 degrees C. The ipsilateral hand temperature changes and the differences between the ipsilateral and contralateral hand temperature changes exceeded 1.5 degrees C in every case. Five patients preferred the CT-guided procedure over the conventional technique, and two patients noted no substantial difference between the approaches. With the CT-guided technique, a highly effective sympathetic block is achieved with a substantially reduced volume of anesthetic compared with the conventional approach.

Topics: Adult; Autonomic Nerve Block; Bupivacaine; Buprenorphine; Chronic Disease; Female; Humans; Injections; Lidocaine; Male; Middle Aged; Pain Management; Radiography, Interventional; Stellate Ganglion; Tomography, X-Ray Computed

During a trimester time-course, pain and the efficiency of analgesic interventions were carefully analyzed over 4 weeks in 50 consecutive medical oncology patients with chronic cancer pain. Pain self-assessment was performed with help of a semi-verbal linear analogue scale (VAS). During the initial hospital stay a mean reduction in pain intensity of "40-50%" on VAS in (largely insufficiently pretreated) cancer patients was recorded within 3-7 days. Optimizing pain therapy was not accompanied by more prominent side-effects from more potent analgesic measures, which consisted in regular "pain prophylaxis" instead of PRN-orders, more frequent use of analgesics with a central analgesic action, combination of analgesics with antidepressants or neuroleptic agents and diligent use of still available potentially effective causal pain relief from palliative chemo-hormonotherapy, irradiation and supportive surgery. The (most frequent) skeletal pain situations were usually managed effectively by prostaglandin-synthetase inhibitors, and also by liberal use of palliative antitumor therapy. Visceral cancer pain was more effectively controlled by analgesics only (opiates/opioids). Strong emphasis is placed on critical interpretation of VAS pain scores and on concomitant psychosocial issues.

Topics: Adult; Aged; Analgesics; Buprenorphine; Chronic Disease; Female; Humans; Male; Middle Aged; Morphine; Neoplasms; Pain; Pain Measurement; Prospective Studies

Topics: Buprenorphine; Chronic Disease; Humans; Narcotics; Pain

Topics: Adult; Aged; Buprenorphine; Chronic Disease; Evoked Potentials, Somatosensory; Female; Humans; Injections, Intramuscular; Male; Middle Aged; Pain; Time Factors

Fifty-one patients aged over 65 years with chronic pain entered an open study to assess the efficacy and tolerance of low-dose (0.1 mg) sub-lingual buprenorphine administered 3 to 4-times a day over a 14-day period. There was significant improvement in symptoms during the treatment period and the drug was well tolerated, with good compliance. Patients aged over 80 years responded comparatively better than those aged between 65 and 80 years. The incidence of unwanted effects was low and constipation was only reported by 1 patient.

Topics: Administration, Cutaneous; Age Factors; Aged; Aged, 80 and over; Buprenorphine; Chronic Disease; Drug Evaluation; Female; Humans; Male; Mouth Floor; Pain Management

During a 2-year period, 150 patients were treated with epidural opioids for more than 7 days; 89 received morphine and 61 buprenorphine. In 16 cases, medication was changed from morphine to buprenorphine, and in 6 from buprenorphine to morphine. In 19 patients in each group, the disease process was benign. The median daily dose of morphine was 17 mg given by an average of 2.9 injections; the corresponding figures in the buprenorphine group were 1.3 mg and 2.6 injections. The mean duration of treatment was 49 days (7-397) in the morphine group and 53 days (7-262) in the buprenorphine group. Satisfactory pain relief was achieved in 40 (45%) patients who received morphine and 41 (67%) patients given buprenorphine. Altering medication from morphine to buprenorphine improved analgesia in 32% of patients, while the reverse improved pain relief in a further 46% of the patients. Side effects were reported in 46% of patients given morphine and 20% given buprenorphine. Seventy-one patients were treated on an outpatient basis. In these cases, buprenorphine was administered for 89% of the total duration of treatment and morphine chloride for 52%.

Topics: Buprenorphine; Chronic Disease; Epidural Space; Humans; Injections; Morphinans; Morphine; Pain; Retrospective Studies

Topics: Adult; Antidepressive Agents; Buprenorphine; Chronic Disease; Humans; Male; Middle Aged; Morphine; Pain; Pancreatitis; Pyridoxine; Thiamine

Buprenorphine was administered as sublingual tablets to 70 patients suffering from chronic pain of malignant or non-malignant origin. Daily doses ranging from 0.4 mg to 3.2 mg were administered and good analgesia was reported by the majority of patients. The most common unwanted effects were drowsiness/sleepiness, nausea and/or vomiting and sweating which appeared to be dose related but the incidence of dizziness was not related to daily dose. The incidence of all these unwanted effects except drowsiness/sleepiness decreased after the first week's treatment. No buprenorphine related changes in vital signs or laboratory values were observed and no signs of tolerance or physical dependence were seen in the short term period after discontinuation of treatment. A significant positive correlation between buprenorphine plasma concentration and daily dose was observed but there was no correlation between plasma levels and pain relief.

Topics: Administration, Oral; Adult; Aged; Buprenorphine; Chronic Disease; Evaluation Studies as Topic; Female; Humans; Kinetics; Male; Middle Aged; Morphinans; Pain

This case-report of a 78-year old patient, suffering from extreme pain caused by metastatic formation and pathological bone fractures, shows, that the epidural injection of buprenorphine is a good alternative compared to other means of pain-treatment. During almost four days heart rate, blood pressure and breathing frequency, as well as the general reactions of the patient, were observed. Few side effects and little discomfort make the method advisable for patients in poor general condition.

Topics: Aged; Anesthesia, Epidural; Breast Neoplasms; Buprenorphine; Chronic Disease; Epidural Space; Female; Femoral Neck Fractures; Humans; Injections; Morphinans; Neoplasm Metastasis; Pain