tapentadol and Opioid-Related-Disorders

Opioid-related harm remains a serious public health issue in Australia, where there is a strong focus on judicious use of opioids to optimize postoperative patient outcomes. The risks associated with preoperative opioid use (worsened postoperative pain, surgical outcomes, increased length of stay and financial costs) must be balanced with the risks of sub-optimal post-surgical pain management (development of chronic pain, persistent postsurgical opioid use and opioid dependence). In addition to significantly lower rates of gastrointestinal adverse effects (nausea, vomiting, constipation), tapendatol (vs oxycodone) is less likely to cause excessive sedation and opioid-induced ventilatory impairment, may be associated with less withdrawal symptoms of mild to moderate intensity and significantly lower odds of 3-month persistent postoperative opioid use in certain patient populations. Studies included in this review were phase III/meta-analyses, referenced in Australian clinical guidelines and/or published ≤5 years), except for cost-effectiveness analyses, where all known, relevant published analyses were included.. Patient harms from medicines related to morphine, which is part of a group of pain-relieving drugs called opioids, is a serious public health issue in Australia, as such, there is a strong focus on the cautious use of these medicines. Using opioids before surgery is associated with risks such as worse pain after surgery and longer hospital stays, however, when pain after surgery is not managed sufficiently, this can result in long-term pain and therefore the need to use these medicines for longer than recommended. Tapentadol is an opioid that has less stomach/gut side effects, causes less sleepiness, is less likely to cause serious breathing impairment, may have less symptoms when stopping the medication and less chance of long-term (more than 3 months) use compared with a more commonly used opioid (oxycodone).

Topics: Analgesics, Opioid; Australia; Chronic Pain; Humans; Opioid-Related Disorders; Pain, Postoperative; Phenols; Tapentadol

Opioids are among the most effective and potent analgesics currently available. Their utility in the management of pain associated with cancer, acute injury, or surgery is well recognized. However, extending the application of opioids to the management of chronic non-cancer pain has met with considerable resistance. This resistance is due in part to concerns related to gastrointestinal and central nervous system-related adverse events as well as issues pertaining to regulatory affairs, the development of tolerance, incorrect drug usage, and addiction. This review focuses on the incidence of opioid-related side effects and the patient and physician barriers to opioid therapy for chronic non-cancer pain. Tapentadol, a centrally acting analgesic with two mechanisms of action, micro-opioid agonism and norepinephrine reuptake inhibition, may be considered to be a partial solution to some of these issues.. MEDLINE was searched for English-language articles from 1950 to February 2010 using the terms chronic non-cancer pain and opioids together and in combination with undertreatment, adherence, and compliance.. The majority of patients treated with traditional opioids experience gastrointestinal- or central nervous system-related adverse events, most commonly constipation, nausea, and somnolence. These side effects often lead to discontinuation of opioid therapy. Concerns about side effects, analgesic tolerance, dependence, and addiction limit the use of opioids for the management of chronic pain. Treatment with tapentadol appears to provide several advantages of an analgesic with a more favorable side-effect profile than the classic micro-opioid receptor agonist oxycodone (especially related to gastrointestinal tolerability).. The pervasiveness of opioid-associated side effects and concerns related to tolerance, dependence, and addiction present potential barriers to the approval and use of opioids for the management of chronic non-cancer pain. The lower incidence of opioid-associated adverse events and possibly fewer withdrawal symptoms, combined with a satisfactory analgesic profile associated with tapentadol, suggest its potential utility for the management of chronic non-cancer pain. This review will focus on the incidence of opioid-related side effects and barriers to opioid therapy that are available as English-language articles in the MEDLINE index, and as such, it is a representative but not an exhaustive review of the current literature.

Topics: Analgesics, Opioid; Chronic Disease; Drug Tolerance; Drug-Related Side Effects and Adverse Reactions; Humans; Neoplasms; Opioid-Related Disorders; Pain; Phenols; Severity of Illness Index; Tapentadol

To examine whether tamper-resistant formulations (TRFs) of tapentadol hydrochloride extended-release (ER) 50 mg (TAP50) and tapentadol hydrochloride 250 mg (TAP250) could be converted into forms amenable to intranasal (study 1) or intravenous abuse (study 2).. Randomized, repeated-measures study designs were employed. A non-TRF of OxyContin® 40 mg (OXY40) served as a positive control. No drug was taken in either study.. The studies took place in an out-patient setting in New York, NY.. Twenty-five experienced, healthy ER oxycodone abusers participated in each study.. The primary outcome for study 1 was the percentage of participants who indicated that they would snort the tampered tablets, while the primary outcome for study 2 was the percentage yield of active drug in solution. Other descriptive variables, such as time spent manipulating the tablets, were also examined to characterize tampering behaviors more clearly.. Tampered TRF tablets were less desirable than the tampered OXY40 tablets. Few individuals were willing to snort the TRF particles (TAP50: 24%, TAP250: 16%; OXY40: 100% P < 0.001). There was less drug extracted from the TAP50 tablet than from the OXY40 tablet (3.52 versus 37.02%, P = 0.008), and no samples from the TAP250 tablets contained analyzable solutions of the drug. It took participants longer to tamper with the TAPs (study 1: TAP50 versus OXY40, P < 0.01; TAP250 versus OXY40, P < 0.01; study 2: TAP250 versus OXY40, P < 0.05).. Tamper-resistant formulations of taptentadol (pain relief) tablets do not appear to be well-liked by individuals who tamper regularly with extended-release oxycodone tablets. Employing tamper-resistant technology may be a promising approach towards reducing the abuse potential of tapentadol extended-release.

Topics: Adult; Analgesics, Opioid; Chemistry, Pharmaceutical; Drug Packaging; Female; Humans; Male; Middle Aged; Opioid-Related Disorders; Oxycodone; Particle Size; Patient Satisfaction; Phenols; Prescription Drug Misuse; Prescription Fees; Tablets; Tapentadol; Treatment Outcome; Young Adult

Opioid harm can vary by opioid type. This observational study examined the effect of opioid type (oxycodone vs. tapentadol) on rates of persistent postoperative opioid use ('persistence'). We linked hospital and community pharmacy data for surgical patients who were dispensed discharge opioids between 1 January 2016 and 30 September 2021. Patients were grouped by opioid experience ('opioid-naive' having received no opioids in the 3 months before discharge) and formulation of discharge opioid (immediate release only or modified release ± immediate release). Mixed-effects logistic regression models predicted persistence (continued use of any opioid at 90 days after discharge), controlling for key persistence risk factors. Of the 122,836 patients, 2.31% opioid-naive and 27.24% opioid-experienced patients met the criteria for persistence. For opioid-naive patients receiving immediate release opioids, there was no significant effect of opioid type. Tapentadol modified release was associated with significantly lower odds of persistence compared with oxycodone modified release, OR (95%CI) 0.81 (0.69-0.94) for opioid-naive patients and 0.81 (0.71-0.93) for opioid-experienced patients. Among patients who underwent orthopaedic surgery (n = 19,832), regardless of opioid experience or opioid formulation, the odds of persistence were significantly lower for those who received tapentadol compared with oxycodone. This was one of the largest and most extensive studies of persistent postoperative opioid use, and the first that specifically examined persistence with tapentadol. There appeared to be lower odds of persistence for tapentadol compared with oxycodone among key subgroups, including patients prescribed modified release opioids and those undergoing orthopaedic surgery.

Topics: Analgesics, Opioid; Humans; Opioid-Related Disorders; Oxycodone; Patient Discharge; Phenols; Retrospective Studies; Tapentadol

Each year, an estimated two million Australians commence opioids, with 50 000 developing longer-term (persistent) opioid use. An estimated 3%-10% of opioid-naïve patients prescribed opioids following surgery develop persistent opioid use. This study will compare rates of persistent opioid use between two commonly used postoperative opioids, oxycodone and tapentadol, to understand if initial postoperative opioid type is important in determining longer-term outcomes.. A retrospective data linkage study that analyses administrative data from hospital and community pharmacies. Data will be obtained from at least four pharmacies that service large hospitals with comparable supplies of oxycodone and tapentadol. The study will include at least 6000 patients who have been dispensed a supply of oxycodone or tapentadol to take home following their discharge from a surgical ward. The primary outcome measure will be persistent opioid use at 3 months postdischarge for opioid naïve people who receive either immediate release tapentadol or immediate release oxycodone. Hierarchical logistic regression models will be used to predict persistent opioid use, controlling for covariates including comorbidities.. Ethics approval has been obtained through the Monash University Human Research Ethics Committee (29977). We will present project findings in a peer-reviewed journal article, in accordance with the REporting of studies Conducted using Observational Routinely-collected health Data statement.

Topics: Aftercare; Analgesics, Opioid; Australia; Humans; Observational Studies as Topic; Opioid-Related Disorders; Oxycodone; Patient Discharge; Retrospective Studies; Tapentadol

Topics: Analgesics, Opioid; Humans; Opioid-Related Disorders; Seizures; Tapentadol

Tapentadol is a molecule incorporating mu opioid receptor agonism and norepinephrine reuptake inhibition to provide analgesia, with the potential for a lower incidence of gastrointestinal side effects than full mu opioid agonists. Postmarketing surveillance of tapentadol as an active pharmaceutical ingredient has consistently revealed low levels of abuse and diversion.. The purpose of the present study was to further characterize the abuse liability of tapentadol extended-release (ER) by evaluating the prevalence of past 30-day tapentadol ER abuse and reported routes of administration as compared with ER opioids with Food and Drug Administration (FDA) abuse-deterrent labeling ("ADF opioids") and ER opioids without FDA abuse-deterrent labeling ("non-ADF opioids").. Data were collected from January 2014 through December 2017 from 776 centers located in 43 states throughout the United States using the Addiction Severity Index-Multimedia Version (ASI-MV), an instrument that is integral to the National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO, Inflexxion, an IBH Company, Costa Mesa, CA, USA).. Tapentadol ER had lower rates of past 30-day abuse than ADF ER and non-ADF ER opioid comparators, both at a population level and when adjusted for drug utilization. Tapentadol ER was primarily abused orally, although it was also abused through alternate routes of administration. Cumulative rates of tapentadol ER abuse by alternative routes of administration were lower than both ADF and non-ADF ER opioid comparators, although large confidence intervals resulting from the small sample size of reported tapentadol ER use limit firm conclusions.. In summary, tapentadol ER was found to have lower rates of both past 30-day abuse and use via alternate routes of administration, specifically snorting and smoking, than ADF and non-ADF ER comparators.

Topics: Analgesics, Opioid; Delayed-Action Preparations; Humans; Multimedia; Opioid-Related Disorders; Prevalence; Tapentadol; United States

A sustained-release formulation (SRF) of tapentadol has been marketed in Australia since February 2013. This study examined tapentadol SRF extra-medical use, attractiveness for extra-medical use, and associated harms in Australia.. This post-marketing study comprises analyses of Australian community sales data (2011-2017) for eleven pharmaceutical opioids (prescription and over-the-counter codeine disaggregated); calls to three poisons information centres (covering five of the eight jurisdictions in Australia) related to pharmaceutical opioids and coded by the centres as 'misuse' or 'abuse' (2011-2017); and interviews with people who inject drugs (n = 888) recruited as part of the Illicit Drug Reporting System (IDRS) from all Australian capital cities (2017).. Population-level availability of tapentadol SRF increased from market launch, comprising the sixth largest market share of all opioid unit sales, and third greatest share in oral morphine equivalent milligrams sold, in December 2017. Lifetime tapentadol SRF use among the IDRS sample (n = 888) was low (1.5%; 95%CI 0.9-2.5), with few reporting past-6 month non-prescribed use or injection. Non-fatal overdose following tapentadol use was self-reported by less than 1% (95%CI 0.1-0.8). Between 2013-2017, 1.1% (n = 25) of pharmaceutical opioid 'misuse/abuse' calls were related to tapentadol, and predominantly the SRF.. Increasing utilisation of tapentadol sustained-release formulation was observed, along with indications of extra-medical use and harms associated with use, although on a smaller scale relative to other opioids. These findings need to be interpreted in the context of the low level of exposure to tapentadol sustained-release formulation among the sentinel population of people who inject drugs.

Topics: Adult; Australia; Delayed-Action Preparations; Drug Overdose; Drug Utilization; Female; Humans; Male; Opioid-Related Disorders; Product Surveillance, Postmarketing; Self Medication; Substance Abuse, Intravenous; Tapentadol; Young Adult

Topics: Adult; Analgesics, Opioid; Buprenorphine, Naloxone Drug Combination; Humans; Internet; Male; Opioid-Related Disorders; Tapentadol

Tapentadol is a synthetic opioid analgesic available in India since 2011. International evidence suggests a low risk of abuse and diversion. Our study aims to question this perception in Indian context.. We report the trend and profile of Tapentadol abuse cases that were treated at a tertiary level addiction treatment centre in southern India. We also describe the ease of repurposing oral tablets of Tapentadol into an injection. At the national level, we have examined the temporal and spatial trends of online interest in Tapentadol and compared it with a non-opioid drug Ilaprazole and an opioid drug Tramadol using Google Trends. We have used the National Drug Use Survey 2019 to illustrate the regional data.. 23 cases of Tapentadol abuse sought treatment between 01/01/2011 and 30/08/2019. In last one year, the number of cases has more than doubled. A majority (N = 19, 83 %) of cases had intravenous Tapentadol abuse, needle sharing and 60 % were diagnosed with Hepatitis C. Tapentadol is attracting new users (N = 13, 56.5 %) as well as replacing other opioids (N = 10, 43.5 %) amongst drug users. Tapentadol has received more online interest than Ilaprazole. Temporal and spatial trends of online interest in Tapentadol parallel Tramadol. States with high prevalence of opioid users have shown high online interest in both opioid drugs.. Tapentadol is being widely abused, and urgent regulatory measures are required.

Topics: Adult; Analgesics, Opioid; Comorbidity; Hepatitis C; Humans; India; Information Seeking Behavior; Internet; Male; Mental Disorders; Opioid-Related Disorders; Patient Acceptance of Health Care; Substance Abuse, Intravenous; Substance-Related Disorders; Tapentadol; Urban Population; Young Adult

Topics: Adult; Analgesics, Opioid; Humans; Male; Opioid-Related Disorders; Receptors, Opioid, mu; Tapentadol; Young Adult

Tapentadol, a Schedule II opioid with a combination of µ-opioid activity and norepinephrine reuptake inhibition, is used for the management of moderate to severe acute and chronic pain. Its dual mechanism of action is thought to reduce opioid-related side effects that can complicate pain management. Since approval, tapentadol has been tracked across multiple outcomes suggesting abuse liability, and a pattern of relatively low, although not absent, abuse liability has been found. This retrospective cohort study further details the abuse liability of tapentadol as an active pharmaceutical ingredient (API) when immediate-release as well as extended-release formulations were on the market together (fourth quarter of 2011 to second quarter of 2016). Tapentadol (API) was compared with tramadol, hydrocodone, morphine, oxycodone, hydromorphone, and oxymorphone across Poison Center, Drug Diversion, and Treatment Center Programs Combined data streams from the Researched Abuse, Diversion and Addiction-Related Surveillance system. Findings suggest the public health burden related to tapentadol to date is low, but present. Event rates of abuse per population-level denominators were significantly lower than all other opioids examined. However, when adjusted for drug availability, event rates of abuse were lower than most Schedule II opioids studied, but were not the lowest. Disentangling these 2 sets of findings further by examining various opioid formulations, such as extended-release and the role of abuse-deterrent formulations, is warranted.. This article presents the results from an examination of tapentadol API across the Researched Abuse, Diversion and Addiction-Related Surveillance System: a broad and carefully designed postmarketing mosaic. Data to date from Poison Center, Drug Diversion, and Treatment Centers combined suggest a low, but present public health burden related to tapentadol.

Topics: Analgesics, Opioid; Chronic Pain; Female; Humans; Male; Opioid-Related Disorders; Oxycodone; Retrospective Studies; Substance-Related Disorders; Tapentadol

It has been argued that tapentadol may pharmacologically have lower abuse potential than other pharmaceutical opioids currently available. However, there has been no comprehensive triangulation of data regarding use and harms associated with this formulation. A sustained-release formulation (SRF) of tapentadol (Palexia) was released in Australia in 2011 and listed for public subsidy in 2013. We summarise here the methods of a postmarketing study which will measure postintroduction: (1) population level availability, (2) extramedical use and diversion, (3) attractiveness for extramedical use and (4) associated harms, of tapentadol compared against other pharmaceutical opioids.. We evaluated key sources on pharmaceutical use and harms in Australia. This review indicateddata from four sources that disaggregate pharmaceutical opioid formulations and capture tapentadol SRF could be triangulated. These data sources comprised: (1) national pharmaceutical opioid community sales data from 2011 to 2017, (2) national pharmaceutical opioid poisonings reported to Poison Information Centres (PICs) from 2011 to 2017, (3) number of vendors on online marketplaces listing pharmaceutical opioids for sale and (4) data on pharmaceutical opioid extramedical use, attractiveness and harms from interviews with people who regularly inject drugs in Australia.. Ethics approval is not required for use of pharmaceutical sales data. Ethics approval has been obtained for use of national pharmaceutical opioid poisonings reported to PICs (LNR/16/SCHN/44) and for use of online marketplace data and interview data from people who inject drugs (HC12086). Key findings will be published mid-2018 in a peer-reviewed academic journal, and presented at various conferences and professional meetings.

Topics: Analgesics, Opioid; Australia; Commerce; Delayed-Action Preparations; Humans; Opioid-Related Disorders; Phenols; Prescription Drug Diversion; Product Surveillance, Postmarketing; Research Design; Tapentadol

Tapentadol is a centrally acting synthetic analgesic which is prescribed for the treatment of a range of chronic pain conditions. Its use in treating various pain conditions is increasing and, as with other opioids, it has the potential to be abused. We describe a three-stage incorporation of tapentadol into validated screening and quantitative methods through: (i) addition of retention time/mass spectral data to a database, (ii) qualitative validation and (iii) quantitative validation. This represents an efficient and flexible approach to the incorporation of new compounds of interest to existing screening methods. Tapentadol was analyzed in blood and serum samples using alkaline liquid-liquid extraction with identification and quantitation by liquid chromatography/time-of-flight mass spectrometry. In a series of six post-mortem cases where tapentadol was detected but was not a primary causative factor in death, blood concentrations ranged from 0.01 to 1.0 mg/L. In two cases where tapentadol was a significant contributor to death, post-mortem blood concentrations were 1.7 and 3.9 mg/L. In one of these fatal cases, ante-mortem blood and serum were also analyzed. The tapentadol concentration in the post-mortem blood was 30% higher than in the ante-mortem blood after a post-mortem interval of 13 days, indicating some potential for post-mortem redistribution. The measured ante-mortem blood:serum ratio was 1.7, and is the first such ratio to be reported. Other drugs were detected in almost all cases, with the majority being prescription analgesics, sedatives and antidepressants. The number of cases in which tapentadol has been detected has increased in recent years, highlighting the importance of screening for this drug in forensic toxicological laboratories.

Topics: Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Autopsy; Cause of Death; Chromatography, Liquid; Female; Forensic Toxicology; Humans; Liquid-Liquid Extraction; Male; Mass Spectrometry; Middle Aged; Opioid-Related Disorders; Reproducibility of Results; Substance Abuse Detection; Tapentadol

Topics: Acute Pain; Adult; Chronic Pain; Drug Tolerance; Early Medical Intervention; Humans; Male; Morphine; Morphine Derivatives; Neural Inhibition; Oligopeptides; Opioid-Related Disorders; Pain Management; Peptides, Cyclic; Phenols; Receptors, Opioid, mu; Spinal Cord Stimulation; Tapentadol; Tramadol; Young Adult

Abuse of prescription opioid pain relievers continues to be a serious public health concern. In contrast to opioids such as oxycodone or morphine, tapentadol, a prescription analgesic, has two mechanisms of action: μ-opioid receptor agonism and norepinephrine reuptake inhibition. As a result of differences in its receptor pharmacology, there may be differences in its abuse profile. As an initial step toward testing this hypothesis, we present a postmarketing examination of tapentadol's abuse liability relative to comparators.. A sentinel sample of 113,914 individuals assessed for substance abuse treatment as part of the NAVIPPRO ASI-MV(®) surveillance system at 624 facilities in 38 states from January 2011 to September 2012 was examined for prevalence and prescription-adjusted prevalence of past 30-day abuse of tapentadol as a compound and its immediate-release (IR) and extended-release (ER) formulations with oxymorphone, hydromorphone, hydrocodone, morphine, fentanyl, oxycodone, tramadol, and buprenorphine as comparators.. Tapentadol abuse was reported significantly less often (P < 0.001) than all comparator compounds. Tapentadol IR abuse prevalence was significantly lower than all comparators except fentanyl IR, which had the next lowest unadjusted abuse prevalence. Prevalence of tapentadol ER abuse was lower than comparators except hydromorphone ER. Low prescription-adjusted estimates were observed for tapentadol as a compound as well as its IR and ER formulations, which were among the lowest observed and the lowest of the Schedule II comparators. Prescription-adjusted risk for tapentadol ER was less than comparators except hydromorphone ER (P = 0.06).. Tapentadol abuse was seen infrequently in this study and, on a prescription basis, was less likely to be abused than most of the examined Schedule II analgesics.

Topics: Adolescent; Adult; Analgesics, Opioid; Female; Humans; Male; Middle Aged; Opioid-Related Disorders; Phenols; Prevalence; Product Surveillance, Postmarketing; Tapentadol; Young Adult

Research on substance abusers in treatment suggests that tapentadol, a prescription analgesic, may have relatively low abuse potential. Messages posted by recreational drug abusers on online forums were examined for amount of discussion and endorsement for abuse of tapentadol and comparator drugs.. Internet messages posted between January 1, 2011 and September 30, 2012 on seven drug-abuse web forums were evaluated. Proportions of posts and unique authors discussing tapentadol were compared with eight comparator compounds. Postcontent was coded to compare endorsement for abuse of tapentadol with two comparators, one drug with high desirability for abuse and one with low desirability for abuse.. A total of 1,940,121 messages posted during the study period were copied from selected web forums. The proportion of all posts discussing tapentadol (proportion = 0.0003) was significantly lower than any of the comparator compounds (range of odds ratios from 16.6 to 104.3; P < 0.001). The proportion of unique authors was also lower. Posts coded for endorsement (N =  2,117) yielded an endorsement ratio (Ero) of 2.14 for tapentadol, which was significantly lower than the highly desirable for abuse oxymorphone (ERo = 5.08; P = 0.0011) and was as low as tramadol (ERo = 1.66), which has a long-established profile of low abuse and desirability for abuse.. Recreational abusers posting on web forums appear to be less interested in abusing tapentadol when compared with other, selected prescription analgesics based on the amount of discussion (i.e., fewer posts and authors mentioning tapentadol). Endorsement of the product for abuse was also low.

Topics: Analgesics, Opioid; Humans; Opioid-Related Disorders; Phenols; Social Media; Tapentadol

Tapentadol (Nucynta) is indicated for the treatment of moderate to severe pain in adults. Tapentadol's mechanism of action consists of acting as an agonist on the μ-opioid receptor and by inhibiting the reuptake of norepinephrine. There are no published reports on the toxicity of tapentadol in pediatric patients. The goals of this study are to describe the incidence, medical outcomes, clinical effects, and treatment secondary to tapentadol exposure.. This retrospective observational study used data from the National Poison Data System. Inclusion criteria were exposure to tapentadol from November 1, 2008 to December 31, 2013; age 0 to 17 years; single ingestion; and followed to a known outcome.. There were 104 patients who met the inclusion criteria. Eighty patients were aged ≤ 6, 2-year-olds the most common age group (60.6%). There were 52 male and 52 female patients. Of the 104 patients, 93 had unintentional exposures. No deaths were reported. Sixty-two of the patients had no effect, 34 had minor effects, 6 had moderate and 2 had major effects. Thirty patients reported drowsiness and lethargy. Other effects reported included nausea, vomiting, miosis, tachycardia, respiratory depression, dizziness/vertigo, coma, dyspnea, pallor, vomiting, edema, hives/welts, slurred speech, pruritus, and hallucinations/delusions. Fifty-three patients were reported to have no medical intervention.. This is the first study examining the toxic effects of tapentadol in a pediatric population. Although a majority of the patients in this review developed no effect from their exposure, two had life-threatening events. The most common effects reported were opioidlike.

Topics: Accidents, Home; Adolescent; Child; Child, Preschool; Dose-Response Relationship, Drug; Drug Overdose; Female; Humans; Infant; Infant, Newborn; Male; Medication Errors; Opioid-Related Disorders; Phenols; Receptors, Opioid, mu; Retrospective Studies; Suicide, Attempted; Tapentadol

There is general agreement about the need to perform a screening test to assess the risk of opioid misuse prior to starting a long-term opioid treatment for chronic noncancer pain. The evidence supporting the effectiveness of opioid long-term treatment is weak, and no predictors of its usefulness have been assessed.. The aim of this study was to assess the effect on pain and quality of life of chronic opioid treatment, and detect the possible predictors of its effectiveness.. This observational, prospective study was conducted in 2 Italian Pain Relief Units on 77 patients affected by intractable chronic pain. Patients were submitted to psycho-logical tests, investigating the individual pain experience, risk of opioid misuse, mood states, quality of life, and personality characteristics prior to starting treatment and at 2,4, and 6-month follow-up.. Both maximum and habitual pain, as measured with VAS, underwent a statistically significant reduction at 2, 4, and 6-month follow-up. In multivariate analysis, lower scores in the Pain Medication Questionnaire (PMQ) were predictive of a major reduction in maximum VAS (P = 0.005). Both low PMQ and MMPI-cynicism scores were predictive of habitual VAS decrease (P = 0.012 and P = 0.028, respectively).. The results indicate that pain relief significantly improved over a 6-month period of opioid treatment, together with quality of life. The outcome was better in patients with a pretreatment low risk of opioid misuse, low scores in the Cynicism scale of MMPI-2, and no aberrant drug behaviors at follow-up. Therefore, a psychological screening and support is crucial for a good outcome of opioid therapy for chronic noncancer pain patients.

Topics: Adult; Aged; Analgesics, Opioid; Buprenorphine; Chronic Pain; Female; Fentanyl; Humans; Hydromorphone; Longitudinal Studies; Male; Middle Aged; Multivariate Analysis; Opioid-Related Disorders; Oxycodone; Pain Clinics; Pain Measurement; Personality; Phenols; Prospective Studies; Quality of Life; Surveys and Questionnaires; Tapentadol; Treatment Outcome

Topics: Adult; Aged, 80 and over; Analgesics, Opioid; Chromatography, Gas; Chromatography, Liquid; False Positive Reactions; Female; Humans; Hydrocodone; Immunoenzyme Techniques; Male; Methadone; Middle Aged; Morphine; Opioid-Related Disorders; Oxycodone; Phenols; Predictive Value of Tests; Reproducibility of Results; Substance Abuse Detection; Tandem Mass Spectrometry; Tapentadol; Urinalysis

This study compared the risks of opioid shopping behavior and opioid abuse between tapentadol immediate release and oxycodone immediate release and, to validate the definition of shopping, examined the association between opioid shopping and opioid abuse further.. This retrospective cohort study using linked dispensing and diagnosis databases followed opioid-naive patients for development of shopping behavior and/or opioid abuse during 1 year after initial exposure to tapentadol or oxycodone. Shopping was defined by having overlapping opioid prescriptions from >1 prescriber filled at ≥3 pharmacies; abuse by having International Classification of Diseases, 9th revision diagnoses reflecting opioid abuse, addiction, or dependence. To determine their association, we cross-tabulated shopping and opioid abuse and calculated odds ratios. Risks of developing each outcome were estimated using logistic regression.. Among 277,401 participants initiating opioid use with tapentadol (39,524) or oxycodone (237,877), 0.6% developed shopping behavior, 0.75% developed abuse. Higher proportions of patients in the oxycodone group developed shopping behavior and abuse than in the tapentadol group (shopping: adjusted odds ratio [95% confidence interval], 0.45 [0.36-0.55]; abuse: 0.44 [0.37-0.54]). Shopping behavior and abuse were associated; of those with shopping behavior, 6.5% had abuse. Age (18 to 64 y), sex (male), prior benzodiazepine use, paying cash, and history (mood disorders, abuse of nonopioid medications, and back pain) were risk factors for developing either outcome.. Shopping behavior and abuse measure complementary, but associated, constructs, which further validates the current definition of shopping. The risk of developing either is lower among patients who initiate opioid use with tapentadol than those who initiate opioid use with oxycodone.

Topics: Adult; Aged; Analgesics, Opioid; Cohort Studies; Databases, Factual; Drug Prescriptions; Drug-Seeking Behavior; Female; Humans; Male; Middle Aged; Opioid-Related Disorders; Oxycodone; Phenols; Sex Factors; Tapentadol; United States

Tapentadol may have a lower abuse risk than other opioids because it has a relatively low affinity for the mu-opioid receptor. The aim of this retrospective cohort study was to compare the risk of opioid abuse between tapentadol immediate release (IR) and oxycodone IR using 2 claims databases (Optum and MarketScan). Subjects with no recent opioid use exposed to tapentadol IR or oxycodone IR in 2010 were followed for 1 year. The outcome was the proportion of subjects who developed opioid abuse, defined as subjects with International Classification of Diseases, 9th revision, codes for opioid abuse, addiction, or dependence. The relative odds of abuse were estimated using a logistic regression model with propensity-score stratification. The estimates from the 2 databases were pooled using a random effects model. There were 13,814 subjects in Optum (11,378 exposed to oxycodone, 2,436 exposed to tapentadol) and 25,553 in MarketScan (21,728 exposed to oxycodone, 3,825 exposed to tapentadol). The risk of abuse was higher in the oxycodone group than in the tapentadol group in each database. The pooled adjusted estimate for the odds of abuse was 65% lower with tapentadol than with oxycodone (odds ratio = .35, 95% confidence interval = .21-.58). The risk of receiving an abuse diagnosis with tapentadol was lower than the risk with oxycodone. Continued monitoring is warranted because opioid desirability can change over time.. This study compared the risk of receiving an opioid abuse diagnosis between tapentadol and oxycodone in 2 U.S. claims databases. The risk of receiving an abuse diagnosis was lower with tapentadol during the year of follow-up. Opioid prescribers and patients must be aware of the risk of abuse associated with all opioids.

Topics: Adult; Aged; Analgesics, Opioid; Cohort Studies; Databases, Factual; Dose-Response Relationship, Drug; Female; Follow-Up Studies; Humans; International Classification of Diseases; Male; Middle Aged; Odds Ratio; Opioid-Related Disorders; Oxycodone; Pain; Phenols; Propensity Score; Retrospective Studies; Risk; Sample Size; Tapentadol

Obtaining opioids from multiple prescribers, known as doctor shopping, is 1 example of opioid abuse and diversion. The dual mechanism of action of tapentadol could make tapentadol less likely to be abused than other opioids. The aim of this retrospective cohort study was to compare the risk of shopping behavior between tapentadol immediate release (IR) and oxycodone IR. Subjects exposed to tapentadol or oxycodone with no recent opioid use were included and followed for 1 year. The primary outcome was the proportion of subjects who developed shopping behavior defined as subjects who had opioid prescriptions written by >1 prescriber with ≥1 day of overlap filled at ≥3 pharmacies. The opioids involved in the shopping episodes were assessed. A total of 112,821 subjects were exposed to oxycodone and 42,940 to tapentadol. Shopping behavior was seen in .8% of the subjects in the oxycodone group and in .2% of the subjects in the tapentadol group, for an adjusted odds ratio of 3.5 (95% confidence interval, 2.8 to 4.4). In the oxycodone group, 28.0% of the shopping events involved exclusively oxycodone, whereas in the tapentadol group, .6% of the shopping events involved exclusively tapentadol. Results suggest that the risk of shopping behavior is substantially lower with tapentadol than with oxycodone.. The risk of opioid doctor shopping, ie, obtaining opioid prescriptions from multiple prescribers, is lower with tapentadol than with oxycodone.

Topics: Analgesics, Opioid; Cohort Studies; Databases, Factual; Drug Prescriptions; Female; Humans; Longitudinal Studies; Male; Middle Aged; Opioid-Related Disorders; Oxycodone; Phenols; Physicians; Retrospective Studies; Risk Assessment; Tapentadol; Treatment Outcome