buprenorphine and Osteoarthritis

Topics: Administration, Cutaneous; Administration, Oral; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Buprenorphine; Cyclooxygenase 2 Inhibitors; Humans; Naloxone; Osteoarthritis; Pain; Risk Factors; Tilidine; Tramadol

The aim of the study was to evaluate analgesia, adverse effects, and quality of life of elderly patients diagnosed with osteoarthritis during treatment with different initial doses of transdermal buprenorphine. Transdermal buprenorphine was used for 10 days in 60 patients over 64 years old with chronic pain of severe intensity - Numerical Rating Scale (NRS > 5) caused by degenerative changes in joints. All patients were randomly assigned to 3 groups. A starting dose for the treatment was respectively: 8.75 μg/h, 17.5 μg/h or 35 μg/h, in each group. The severity and impact of pain on everyday activities performed by the patients were assessed at baseline and daily for 10 days using the Brief Pain Inventory - Short Form. In order to identify the components of neuropathic pain, except for the symptoms (hyperalgesia and allodynia), the DN4 (Douleur Neuropathique en 4 questionnaire) was used. During buprenorphine treatment a decrease in pain severity was obtained in all groups of patients as well as an improvement in pain interference with general activity, mood, walking ability, relations with other people, sleep and enjoyment of life with no differences between patient groups treated with different initial doses of transdermal buprenorphine. No differences regarding DN4 scores were find between patient groups. Several adverse effects (drowsiness, confusion, vomiting) occurred less frequently in groups of patients treated with lower initial doses (8.75 μg/h and 17.5 μg/h) in comparison to a starting dose of 35 μg/h. We concluded that treatment of elderly patients with chronic pain of severe intensity with transdermal buprenorphine provided effective analgesia and improvement of quality of life with respect to general functioning of patients. Treatment tolerance seemed to be better with lower initial doses of transdermal buprenorphine: 8.75 μg/h and 17.5 μg/h in comparison with the dose of 35 μg/h.

Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Buprenorphine; Chronic Pain; Female; Humans; Male; Osteoarthritis; Quality of Life

The objective of this study was to evaluate continued pain control and tolerability of converting patients from Vicodin (hydrocodone/acetaminophen; HCD/APAP) to the buprenorphine transdermal system (BTDS).. Adult patients with pain from osteoarthritis receiving a stable dosage of HCD/APAP (i.e., 15 - 30 mg hydrocodone/day) were switched to an equivalent or near-equivalent dosage of open-label Vicodin for 7 days. Patients maintaining acceptable analgesia were stratified based on their Vicodin dosage and randomized to receive either titratable BTDS 10 μg/h or fixed-dose BTDS 20 μg/h. The primary efficacy variable was completion of the 14-day double-blind phase. Tolerability was assessed.. A total of 84.3% of patients met the primary end point, completion of the 14-day double-blind phase (167/198 patients, 95% CI 79.3 - 89.4). Adverse events were consistent with those associated with the use of opioid analgesics and transdermal patches.. There was a similar analgesic and tolerability profile when patients treated with Vicodin for osteoarthritis pain were switched to 7-day BTDS treatment.

Topics: Acetaminophen; Administration, Cutaneous; Administration, Oral; Aged; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Arthralgia; Buprenorphine; Double-Blind Method; Drug Combinations; Drug Substitution; Female; Humans; Hydrocodone; Kaplan-Meier Estimate; Male; Middle Aged; Osteoarthritis; Pain Measurement; Time Factors; Transdermal Patch; Treatment Outcome; United States

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

Fifty-six (56) patients scheduled for arthroplasty, received 7-day extended-release buprenorphine transdermal patches (5 µg/h) for five consecutive weeks, starting two weeks prior to the surgery. Simultaneous plasma and cerebrospinal fluid (CSF) samples were collected during spinal anesthesia.. Median buprenorphine plasma and CSF concentrations at steady-state were 54 pg/mL (range 8.6 - 167 pg/mL) and 1.6 pg/mL (0.30 - 7.3 pg/mL), respectively. The median CSF/plasma -ratio was 3% (range 0.35 - 16%). Large between-subject variability was observed in the measured buprenorphine concentrations within the study population.

Topics: Administration, Cutaneous; Analgesics, Opioid; Buprenorphine; Humans; Osteoarthritis; Transdermal Patch

The patients with chronic pain in osteoarthritis often have insufficient pain relief from non-opioids analgesics. Buprenorphine is a promising molecule for symptomatic relief of chronic pain. The marketed parenteral injections and sublingual tablets have short duration of action (half-life = 2.7 h), which is not suitable to manage chronic pain. The purpose of this research was to design buprenorphine-loaded Pluronic F127-reduced graphene oxide transdermal (noninvasive) hydrogel to achieve sustained release of buprenorphine to manage chronic pain in osteoarthritis. Pluronic F127 was used to stabilize the reduced graphene oxide in hydrogel system. The characterization studies including Fourier transform infrared spectroscopy, X-ray diffraction, and Raman spectroscopy confirmed the synthesis of Pluronic F127-reduced graphene oxide from graphite. The transmission electron microscopy image showed flat nanosheets of reduced graphene oxide (rGO). The developed hydrogel showed desirable pH, viscosity, adhesiveness, hardness, and cohesiveness for transdermal application. The

Topics: Buprenorphine; Graphite; Humans; Hydrogels; Osteoarthritis

Osteoarthritis (OA) causes substantial pain and reduced health-related quality of life (HRQL). Although opioid analgesics are commonly used, the relative benefits of different opioids are poorly studied. Transdermal buprenorphine (TDB) offers an alternative to oral opioids for the treatment of moderate-to-severe chronic pain. This observational study of people with OA pain assessed satisfaction, HRQL and medication adherence.. Patients in the UK with self-reported knee and/or hip OA who had been receiving one or more of TDB, co-codamol (an oral paracetamol/codeine combination) and tramadol for at least 1 month completed an online or telephone questionnaire. Medication satisfaction scores, HRQL scores (Short-Form 36 [SF-36]), medication adherence (Morisky Medication Adherence Scale [MMAS™]), adverse events and treatment discontinuations were recorded. Linear and logistic regression models were used to compare the treatment effect of TDB with co-codamol or tramadol.. Overall, 966 patients met the inclusion criteria; 701 were taking only one of the target medications (TDB: 85; co-codamol: 373; tramadol: 243). The largest age group was 50-59 years and 76.0 % of patients were female. The TDB group was younger, with more male patients, therefore the statistical models were adjusted for age and sex. Medication satisfaction scores were significantly higher in the TDB group than the other two groups (TDB vs. co-codamol: 3.56, 95 % confidence interval [CI] 1.90-6.68, p < 0.0001; TDB vs. tramadol: 3.22, 95 % CI 1.67-6.20, p = 0.0005). Physical Component Summary scores for HRQL and mean adherence were also higher in the TDB group, while Mental Component Summary HRQL scores were similar across the three groups.. Patients with knee and/or hip OA pain treated with TDB were more satisfied and more adherent with their medication, and reported higher Physical Component Summary HRQL scores than those treated with co-codamol or tramadol, although demographic differences were observed between groups.

Topics: Acetaminophen; Administration, Cutaneous; Administration, Oral; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Codeine; Drug Combinations; Female; Humans; Male; Medication Adherence; Middle Aged; Osteoarthritis; Pain Measurement; Patient Satisfaction; Prospective Studies; Quality of Life; Severity of Illness Index; Surveys and Questionnaires; Tramadol; United Kingdom

A recent pharmacokinetic study with buprenorphine transdermal patches showed similar systemic exposures of buprenorphine in subjects aged ≥75 and 50-60 years. The current prospective, open-label study aimed to verify this in a clinical setting by evaluating efficacy and safety of buprenorphine patches in patients with chronic osteoarthritis (OA) pain.. Patients with chronic, moderate to severe osteoarthritic pain (hip and/or knee) were enrolled: 50-60 years (younger group, N = 65) and ≥75 years (elderly group, N = 57). After 2 weeks on paracetamol only, patients received buprenorphine patches (5-40 µg/h) for 12 weeks. Paracetamol rescue was provided. Primary endpoint was the Box-Scale-11 (BS-11) score for pain on average over the last week. WOMAC OA Index, EQ-5D, Patients' and Investigators' Global Assessment of Pain Relief, rescue medication use, sleep disturbance and quality of sleep were secondary efficacy endpoints.. Both groups showed a statistically significant (p < 0.0001) and clinically relevant change from baseline to last visit in BS-11 score, with no significant difference between groups. The least squares (LS) mean change from baseline was 2.20 in elderly and 1.87 in younger patients, with an age group difference of 0.33 (95% CI: -0.42, 1.07). Non-inferiority of the elderly versus the younger group was shown. Both age groups showed a significant improvement in WOMAC total score, patients' overall health state (EQ-5D visual analogue scale) and sleep quality, and a significant reduction in rescue use and nights woken due to pain, with no significant differences between groups. Elderly patients tolerated buprenorphine patches at least as well as younger patients.. Efficacy and tolerability of buprenorphine patches was demonstrated in chronic pain patients, regardless of age, supporting the conclusion that no age-related dose adjustment of transdermal buprenorphine is needed. A study limitation is lack of active control but no other opioid was appropriate in elderly patients or this indication.

Topics: Age Factors; Aged; Aged, 80 and over; Analgesics, Opioid; Buprenorphine; Chronic Pain; Female; Humans; Male; Middle Aged; Osteoarthritis; Outcome Assessment, Health Care; Pain Measurement; Prospective Studies; Sleep; Transdermal Patch

Mechanical allodynia during ambulation in osteoarthritis (OA) animal models can be assessed as decreased extent of loading or decreased duration of loading. We propose to measure gait adaptation to pain by both mechanisms with the development of Limb Idleness Index (LII) in a rat model of knee OA.. Rats were assigned to anterior cruciate ligament transection (ACLT), Sham, or Normal group (n = 6). Gait data were collected at pre-injury, 1, 2, 3 and 6 months post-injury. Ratios of target print intensity, anchor print intensity, and swing duration were combined to obtain LII. The association of gait changes with pain was assessed by buprenorphine treatment at 3 and 6 months post-injury. At 6 months, OA-related structural changes in knee joints were examined by μCT and results from histological scoring were correlated with LII.. As compared to pre-injury level (range 0.75-1.20), LII in ACLT group was increased at 6 months post-injury, which was significantly higher than that in Sham and Normal groups (P = 0.024). The increase in LII in ACLT group was effectively reversed by buprenorphine treatment (P = 0.004). ACLT group exhibited a significantly higher maximum Osteoarthritis Research Society International (OARSI) score as compared to Sham (P = 0.005) and Normal (P = 0.006) groups. Significant correlation was found between LII and side-to-side difference in OARSI score (r = 0.893, P < 0.001).. LII presents a good measurement for OA-related knee pain in rat model.

Topics: Adaptation, Physiological; Analgesics, Opioid; Animals; Arthritis, Experimental; Buprenorphine; Extremities; Female; Gait; Movement; Osteoarthritis; Pain; Pain Measurement; Radiography; Rats; Rats, Sprague-Dawley; Stifle; Weight-Bearing

Enrichment strategies which select subjects who appear to respond to the drug have been used in drug studies to demonstrate clinical efficacy. We have used clinical trial simulation techniques to examine factors that are relevant in clinical trial design based on enrichment where poor responders are excluded from the double-blind phase of the study.. Simulations were performed for an analgesic trial design involving an open-dose titration phase (enrichment phase) followed by a double-blind, randomized, placebo-controlled maintenance phase. Enrichment was examined by excluding subjects above a predefined pain score (cutoff) from analysis of efficacy for the maintenance phase. Cutoff pain scores ranging from 4 to 7 on a 0 to 10 categorical scale were examined. A database consisting of chronic pain patients who participated in studies with a new formulation of buprenorphine was used to build the simulation model. Since no data were available for the key model variable "correlation between treatment and placebo response", values of 0.25, 0.5, and 0.75 were used for the simulations.. A correlation between treatment and placebo effect ranging from 0.75 to 0.25 will cause the likelihood of trial success to vary from 50% to 95%. This model also shows that recruitment efficiency will decrease with the use of lower cutoff pain scores.. Prior to using enrichment techniques, investigators must consider the correlation between treatment effect and placebo response to optimize clinical trial design.

Topics: Analgesics, Opioid; Back Pain; Buprenorphine; Clinical Trials as Topic; Humans; Models, Statistical; Osteoarthritis