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Should Buprenorphine Be Administered to Patients With Opioid Withdrawal in the Emergency Department?

Tue, 11/07/2017 - 8:09am
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Should Buprenorphine Be Administered to Patients With Opioid Withdrawal in the Emergency Department?

Ann Emerg Med. 2017 Nov 03;:

Authors: Love JS, Perrone J, Nelson LS

PMID: 29103795 [PubMed - as supplied by publisher]

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A physiologically-based pharmacokinetic modeling approach to predict drug-drug interactions of buprenorphine after subcutaneous administration of CAM2038 with perpetrators of CYP3A4.

Mon, 11/06/2017 - 6:09am

A physiologically-based pharmacokinetic modeling approach to predict drug-drug interactions of buprenorphine after subcutaneous administration of CAM2038 with perpetrators of CYP3A4.

J Pharm Sci. 2017 Nov 01;:

Authors: Liu T, Gobburu JVS

Abstract
CAM2038, FluidCrystral (FC) injection depot, is an extended release formulation of buprenorphine given subcutaneously every 1 week (Q1W) or every 4 weeks (Q4W). The purpose of this research is to predict the magnitude of drug-drug interaction (DDI) after coadministration of a strong CYP3A4 inducer or inhibitor using physiologically based pharmacokinetic (PBPK) modeling. A PBPK model was developed for CAM2038 based on the previously published buprenorphine PBPK model after intravenous (IV) and sublingual (SL) administration and the PK profiles after SC administration of CAM2038 from two Phase I clinical trials. The strong CYP3A4 inhibitor ketoconazole was predicted to increase the buprenorphine exposure by 35% for the Q1W and 34% for Q4W formulation, respectively. Also, the strong CYP3A4 inducer rifampin was predicted to decrease the buprenorphine exposure by 26% for both the Q1W and Q4W formulation. The results provided insight into the potential DDI effect for CAM2038 and suggested a lack of clinically meaningful DDI when CAM2038 is co-administered with CYP3A4 inhibitor or inducer. Therefore, no dose adjustment is required when CAM2038 is co-administered with CYP3A4 perpetrators.

PMID: 29102550 [PubMed - as supplied by publisher]

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Willingness to receive intravenous buprenorphine treatment in opioid-dependent people refractory to oral opioid maintenance treatment: results from a community-based survey in France.

Sat, 11/04/2017 - 6:39am
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Willingness to receive intravenous buprenorphine treatment in opioid-dependent people refractory to oral opioid maintenance treatment: results from a community-based survey in France.

Subst Abuse Treat Prev Policy. 2017 Nov 02;12(1):46

Authors: Roux P, Rojas Castro D, Ndiaye K, Briand Madrid L, Laporte V, Mora M, Maradan G, Morel S, Spire B, Carrieri P

Abstract
BACKGROUND: Injectable opioids are an interesting option for people who inject drugs (PWID) that do not respond to oral Opioid Maintenance Treatment (OMT). To date, intravenous (IV) buprenorphine - a safer drug than full-opioid agonists in terms of overdose risk - has never been tested in a clinical trial on opioid dependence. We designed a survey to better understand the profile of PWID eligible for IV buprenorphine, and their willingness to receive it.
METHODS: This cross-sectional community-based national survey was conducted through face-to-face interviews (in low-threshold and addiction care services) and online questionnaires (on https://psychoactif.org and other websites). Among the 557 participants, we selected those who were eligible for IV buprenorphine treatment (history of oral OMT, regular opioid injection) (n = 371). We used regression models to study factors associated with willingness to receive IV buprenorphine treatment among those with data on willingness (n = 353). In those who were willing (n = 294), we subsequently studied their willingness to receive daily supervised IV buprenorphine treatment.
RESULTS: Among the selected 353 participants, 59% mainly injected buprenorphine, 15% heroin, 16% morphine sulfate and 10% other opioids. Eighty-three percent of the sample reported willingness to receive IV buprenorphine treatment. Factors associated with willingness were: more than 5 injection-related complications, regular buprenorphine injection, no lifetime overdose, and completion of the questionnaire online. Factors associated with unwillingness to receive daily supervised treatment were younger age (OR[IC95%]=1.04[1.01; 1.07]) and stable housing (OR[IC95%]=0.61[0.37;1.01]) while regular heroin injectors were more willing to receive daily supervision (OR[IC95%]=2.94 [1.42; 6.10]).
CONCLUSIONS: PWID were very willing to receive intravenous buprenorphine as a treatment, especially those with multiple injection-related complications. In addition, our findings show that IV buprenorphine may be less acceptable to PWID who inject morphine sulfate. Young PWID and those with stable housing were unwilling to receive IV buprenorphine if daily supervision were required. This preliminary study provides useful information for the development of a clinical trial on IV buprenorphine treatment.

PMID: 29096661 [PubMed - in process]

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Prescribing patterns of buprenorphine waivered physicians.

Fri, 11/03/2017 - 7:54am

Prescribing patterns of buprenorphine waivered physicians.

Drug Alcohol Depend. 2017 Oct 18;181:213-218

Authors: Thomas CP, Doyle E, Kreiner PW, Jones CM, Dubenitz J, Horan A, Stein BD

Abstract
BACKGROUND: DATA 2000 enabled physicians with approved training to be waivered to prescribe buprenorphine for the treatment of opioid use disorders (OUD) for a limited number of patients. A rule change in 2016 increased the patient limit for certain buprenorphine waivered physicians from 100 to 275. This study examines the prescribing patterns of buprenorphine prescribers by waiver limit status (30- or 100-patient limit).
METHODS: Prescription Monitoring Program (PMP) data from Ohio, California, and Maine were used to identify prescriptions for buprenorphine for OUD from January 2010 to April 2015. Analysis of prescribing patterns by prescriber waiver status included monthly patient censuses and treatment episode duration by state, year, and the frequency with which prescribers were near their respective patient limits.
RESULTS: In the three states, 8638 physicians initiated 468,148 buprenorphine episodes. The adjusted mean monthly patient census was 42.9 for 100-patient waivered prescribers, 13.6 patients for 30-patient waivered prescribers, and 7.6 patients for prescribers unassociated with a waiver. Half (48.5%) of episodes were associated with 100-patient waivered prescribers, 26.9% with 30-patient waivered prescribers, and 24.4% with non-waivered prescribers. 30-patient waivered physicians were more likely to have no buprenorphine treatment episodes in a given month than 100-patient waivered prescribers.
CONCLUSIONS: Most buprenorphine prescribers practice well under their current patient limit and have numerous months with no patient episodes. For the few high prescribers, increasing the maximum patient limit beyond 100 has the potential to improve access but alone may not have widespread impact unless integrated into complementary approaches toward increasing prescriber capacity.

PMID: 29096292 [PubMed - as supplied by publisher]

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Opioid Use Disorders, Medication-Assisted Treatment, and the Role of the Laboratory.

Fri, 11/03/2017 - 7:54am

Opioid Use Disorders, Medication-Assisted Treatment, and the Role of the Laboratory.

Lab Med. 2017 Oct 31;:

Authors: Bertholf RL, Reisfield GM

Abstract
Urine drug testing is an essential component in the evaluation and management of individuals with opioid use disorders, including those on buprenorphine or methadone maintenance therapies. Notwithstanding its centrality in adherence monitoring, studies have shown that clinicians have important knowledge deficiencies regarding the ordering and interpretation of drug tests. In this review, we discuss the scope and frequency of testing, the advantages and disadvantages of immunoassay- (presumptive) and liquid chromatograph-mass spectrometry- (definitive) based techniques, indications for definitive testing, medical necessity, and other considerations. Optimal use of urine drug testing depends on collaboration between clinicians and laboratory scientists.

PMID: 29096016 [PubMed - as supplied by publisher]

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Pattern and prevalence of substance use and dependence in the Union Territory of Chandigarh: Results of a rapid assessment survey.

Wed, 11/01/2017 - 7:24am

Pattern and prevalence of substance use and dependence in the Union Territory of Chandigarh: Results of a rapid assessment survey.

Indian J Psychiatry. 2017 Jul-Sep;59(3):284-292

Authors: Avasthi A, Basu D, Subodh BN, Gupta PK, Malhotra N, Rani P, Sharma S

Abstract
BACKGROUND: Substance misuse is a matter of major public health concern in India. House-to-house survey, though an appealing method to generate population-level estimates, has limitations for estimating prevalence rates of use of illicit and rare substances.
MATERIALS AND METHODS: In this rapid assessment survey (RAS), respondent-driven sampling was used to recruit substance-using individuals from the field. Size of the substance-using population was estimated using the "benchmark-multiplier" method. This figure was then projected to the entire population of the Union Territory (U.T) of Chandigarh. Focused group discussions were used to study the perceptions and views of the substance users regarding various aspects of substance use.
RESULTS: Prevalence of any substance dependence in the U.T of Chandigarh was estimated to be 4.65%. Dependence rates on opioids, cannabinoids, and sedative hypnotics were found to be 1.53%, 0.52%, and 0.015%, respectively. Prevalence of injectable opioids was calculated to be 0.91%. Injectable buprenorphine was the most commonly used opioid, followed by bhukhi/doda/opium and heroin. A huge gap was found between the prevalence rates of substance-using population and those seeking treatment.
CONCLUSION: RAS can be a useful method to determine the prevalence of illicit and rare substances. Our survey shows that the use of substance including that of opioids is highly prevalent in the U.T of Chandigarh. The findings of this survey can have implications for policymaking.

PMID: 29085086 [PubMed - in process]

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Adverse events associated with medium- and long-term use of opioids for chronic non-cancer pain: an overview of Cochrane Reviews.

Tue, 10/31/2017 - 8:39am

Adverse events associated with medium- and long-term use of opioids for chronic non-cancer pain: an overview of Cochrane Reviews.

Cochrane Database Syst Rev. 2017 Oct 30;10:CD012509

Authors: Els C, Jackson TD, Kunyk D, Lappi VG, Sonnenberg B, Hagtvedt R, Sharma S, Kolahdooz F, Straube S

Abstract
BACKGROUND: Chronic pain is common and can be challenging to manage. Despite increased utilisation of opioids, the safety and efficacy of long-term use of these compounds for chronic non-cancer pain (CNCP) remains controversial. This overview of Cochrane Reviews complements the overview entitled 'High-dose opioids for chronic non-cancer pain: an overview of Cochrane Reviews'.
OBJECTIVES: To provide an overview of the occurrence and nature of adverse events associated with any opioid agent (any dose, frequency, or route of administration) used on a medium- or long-term basis for the treatment of CNCP in adults.
METHODS: We searched the Cochrane Database of Systematic Reviews (the Cochrane Library) Issue 3, 2017 on 8 March 2017 to identify all Cochrane Reviews of studies of medium- or long-term opioid use (2 weeks or more) for CNCP in adults aged 18 and over. We assessed the quality of the reviews using the AMSTAR criteria (Assessing the Methodological Quality of Systematic Reviews) as adapted for Cochrane Overviews. We assessed the quality of the evidence for the outcomes using the GRADE framework.
MAIN RESULTS: We included a total of 16 reviews in our overview, of which 14 presented unique quantitative data. These 14 Cochrane Reviews investigated 14 different opioid agents that were administered for time periods of two weeks or longer. The longest study was 13 months in duration, with most in the 6- to 16-week range. The quality of the included reviews was high using AMSTAR criteria, with 11 reviews meeting all 10 criteria, and 5 of the reviews meeting 9 out of 10, not scoring a point for either duplicate study selection and data extraction, or searching for articles irrespective of language and publication type. The quality of the evidence for the generic adverse event outcomes according to GRADE ranged from very low to moderate, with risk of bias and imprecision being identified for the following generic adverse event outcomes: any adverse event, any serious adverse event, and withdrawals due to adverse events. A GRADE assessment of the quality of the evidence for specific adverse events led to a downgrading to very low- to moderate-quality evidence due to risk of bias, indirectness, and imprecision.We calculated the equivalent milligrams of morphine per 24 hours for each opioid studied (buprenorphine, codeine, dextropropoxyphene, dihydrocodeine, fentanyl, hydromorphone, levorphanol, methadone, morphine, oxycodone, oxymorphone, tapentadol, tilidine, and tramadol). In the 14 Cochrane Reviews providing unique quantitative data, there were 61 studies with a total of 18,679 randomised participants; 12 of these studies had a cross-over design with two to four arms and a total of 796 participants. Based on the 14 selected Cochrane Reviews, there was a significantly increased risk of experiencing any adverse event with opioids compared to placebo (risk ratio (RR) 1.42, 95% confidence interval (CI) 1.22 to 1.66) as well as with opioids compared to a non-opioid active pharmacological comparator, with a similar risk ratio (RR 1.21, 95% CI 1.10 to 1.33). There was also a significantly increased risk of experiencing a serious adverse event with opioids compared to placebo (RR 2.75, 95% CI 2.06 to 3.67). Furthermore, we found significantly increased risk ratios with opioids compared to placebo for a number of specific adverse events: constipation, dizziness, drowsiness, fatigue, hot flushes, increased sweating, nausea, pruritus, and vomiting.There was no data on any of the following prespecified adverse events of interest in any of the included reviews in this overview of Cochrane Reviews: addiction, cognitive dysfunction, depressive symptoms or mood disturbances, hypogonadism or other endocrine dysfunction, respiratory depression, sexual dysfunction, and sleep apnoea or sleep-disordered breathing. We found no data for adverse events analysed by sex or ethnicity.
AUTHORS' CONCLUSIONS: A number of adverse events, including serious adverse events, are associated with the medium- and long-term use of opioids for CNCP. The absolute event rate for any adverse event with opioids in trials using a placebo as comparison was 78%, with an absolute event rate of 7.5% for any serious adverse event. Based on the adverse events identified, clinically relevant benefit would need to be clearly demonstrated before long-term use could be considered in people with CNCP in clinical practice. A number of adverse events that we would have expected to occur with opioid use were not reported in the included Cochrane Reviews. Going forward, we recommend more rigorous identification and reporting of all adverse events in randomised controlled trials and systematic reviews on opioid therapy. The absence of data for many adverse events represents a serious limitation of the evidence on opioids. We also recommend extending study follow-up, as a latency of onset may exist for some adverse events.

PMID: 29084357 [PubMed - as supplied by publisher]

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StatPearls

Tue, 10/31/2017 - 8:39am

StatPearls

Book. 2017 06

Authors:

Abstract
Buprenorphine is a synthetic opioid used for the treatment of pain and opioid addiction that first was developed in the late 1960s. It a synthetic analogue of thebaine, which is an alkaloid compound derived from the poppy flower. It is a schedule III drug, which means that it has some potential for moderate or low physical dependence or high psychological dependence.


PMID: 29083570

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Expanding Treatment Opportunities for Hospitalized Patients with Opioid Use Disorders.

Fri, 10/27/2017 - 4:54pm
Related Articles

Expanding Treatment Opportunities for Hospitalized Patients with Opioid Use Disorders.

J Hosp Med. 2017 Oct 18;:E1-E3

Authors: Winetsky D, Weinrieb RM, Perrone J

Abstract
The prevalence of opioid use disorders (OUDs) is rising across the United States. Patients with OUDs are often hospitalized for medical conditions other than addiction, such as infection, injury, or pregnancy. These hospital admissions provide an opportunity for healthcare providers to initiate opioid agonist therapy with methadone or buprenorphine. Randomized trials have demonstrated the superior effectiveness of this treatment strategy, but its adoption by hospital providers has been slow. A number of barriers have impeded its implementation, including misperceptions about the regulation of opioid prescribing, limited resources for the transition to community- based treatment, and a lack of familiarity among clinicians about the appropriate initiation and dose adjustment of these opioid agonists for maintenance therapy. We discuss changes in policy and practice to expand opportunities to engage patients with OUDs in opioid agonist treatment during their inpatient hospitalizations.

PMID: 29073311 [PubMed - as supplied by publisher]

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Opioid Addiction in Pregnancy: Does Depression Negatively Impact Adherence With Prenatal Care?

Fri, 10/27/2017 - 4:54pm
Related Articles

Opioid Addiction in Pregnancy: Does Depression Negatively Impact Adherence With Prenatal Care?

J Addict Med. 2017 Oct 24;:

Authors: Hensley L, Sulo S, Kozmic S, Parilla BV

Abstract
OBJECTIVE: We aimed to evaluate whether depression in pregnancy in women with opioid dependency negatively impacts adherence with prenatal care.
METHODS: This was a retrospective chart analysis of opioid-dependent pregnant women over a 6-year period at 2 large referral and tertiary care centers. The primary outcome was adherence with prenatal care based on the concurrent diagnosis of depression. Adherence was assessed by looking at the number of observed versus expected prenatal visits. Secondary outcomes included neonatal intensive care unit (NICU) stay, and incidence and severity of neonatal abstinence syndrome (NAS).
RESULTS: A total of 74 patient charts were reviewed. 45/74 (60.8%) of the opioid-dependent pregnant patients were either diagnosed with depression (n = 41), anxiety (n = 2), or scored >10 on the Edinburgh Prenatal Depression Scale (n = 1). Patients with a diagnosis of depression were significantly less adherent with prenatal care; 80% adherent (73% vs 93%; P = 0.03), 90% adherent (62% vs 93%; P = 0.003). A higher number of patients in the depression group had an infant treated for withdrawal (62% vs 38%; P = 0.041), and had longer NICU stays (27% vs 21%; P = 0.018). Analysis of the whole cohort of opioid dependent gravidas revealed Buprenorphine maintenance therapy had the lowest mean NAS score 6.5 ± 4.4, compared with methadone maintenance 10.6 ± 3.6, and no maintenance therapy 9.4 ± 4.0 (P = 0.008).
CONCLUSION: Depression negatively impacts adherence with prenatal care and was significantly associated with a higher incidence of neonatal withdrawal and longer NICU stays. Buprenorphine therapy had the lowest incidence and severity of NAS when compared with methadone and no maintenance therapy.

PMID: 29068826 [PubMed - as supplied by publisher]

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Predictors of heroin abstinence in opiate substitution therapy in heroin-only users and dual users of heroin and crack.

Wed, 10/25/2017 - 6:39am

Predictors of heroin abstinence in opiate substitution therapy in heroin-only users and dual users of heroin and crack.

Addict Behav. 2017 Oct 18;77:210-216

Authors: Heidebrecht F, MacLeod MB, Dawkins L

Abstract
AIMS: To analyse predictors of heroin abstinence in opiate substitution therapy (OST) based on frequency of crack use and its interactions with other predictors in a clinical non-experimental setting.
DESIGN: Retrospective study.
SETTING: A community drug service in London, UK.
PARTICIPANTS: 325 clients starting OST between 2010 and 2014 (197 methadone and 128 buprenorphine).
MEASUREMENTS: Logistic regression models (a general model and separate models for methadone and buprenorphine) assessed demographic and clinical data as predictors of heroin abstinence at one year after treatment start (or at the date of transfer to another service).
FINDINGS: For the general model participants choosing methadone were more likely to use heroin at follow up (OR=2.36, 95% CI: 1.40-3.17) as were daily crack users on methadone (OR=2.62, 95% CI: 0.96-7.16). For the methadone model only daily crack use predicted heroin use at follow up (OR=2.62, 95% CI: 0.96-7.16). For buprenorphine, higher amounts of baseline heroin use, lower buprenorphine dose and daily drinking predicted heroin use at follow up (OR=0.85, 95% CI: 0.75-0.95; OR=1.31, 95% CI: 1.06-1.60 and OR=6.04, 95% CI: 1.26-28.92). Both use of cannabis and depression increased likelihood of heroin abstinence for clients not using crack compared to occasional (OR=6.68, 95% CI: 0.37-119.59; OR=106.31, 95% CI: 3.41-3313.30) and daily (OR=57.49 (95% CI: 2.37-1396.46; OR=170.99 (95% CI: 4.61-6339.47) users.
CONCLUSIONS: Most of the predictors in the general model were found significant only in the buprenorphine but not in the methadone model, suggesting that a general model has little predictive value. Crack use was a significant predictor of heroin abstinence at follow up in all models, however for buprenorphine only when depression or cannabis use was present. Further research is needed to assess effective treatment approaches for the growing population of dual users.

PMID: 29065377 [PubMed - as supplied by publisher]

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Why is buprenorphine coformulated with naloxone?

Wed, 10/25/2017 - 6:39am

Why is buprenorphine coformulated with naloxone?

JAAPA. 2017 Nov;30(11):44-45

Authors: Urnoski E

Abstract
Combination buprenorphine-naloxone is a cornerstone of outpatient treatment for substance use disorder, and is more widely accessible in primary care. Because oral buprenorphine has been diverted and abused for its euphoric properties, a combination formulation was developed and will trigger withdrawal symptoms if injected IV.

PMID: 29064938 [PubMed - in process]

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[ACUTE PAIN MANAGEMENT IN PATIENT ON OPIOID SUBSTITUTION THERAPY WITH METHADONE OR BUPRENORPHINE].

Wed, 10/25/2017 - 6:39am

[ACUTE PAIN MANAGEMENT IN PATIENT ON OPIOID SUBSTITUTION THERAPY WITH METHADONE OR BUPRENORPHINE].

Acta Med Croatica. 2016 09;70(3):173-8

Authors: Adam VN, Matolić M, Stojčić EG, Mršić V, Rašić Ž

Abstract
The result of the increase in drug abuse is a growing number of patients receiving methadone or buprenorphine substitution therapy. Physicians are increasingly confronted with patients on substitution therapy at the time when they are developing acute pain conditions or when they need surgery. Although pain has sensory qualities, it is a very personal and complex experience. The intensity and duration of pain are influenced by numerous factors. Poorly controlled pain leads to unnecessary suffering of the patients with the possibility of permanent changes in behavior and reduced quality of life. Efficacious pain treatment is considered a basic right of every patient. Because of the complex mechanisms of the emergence and transmission of pain and the emotional components that are involved in the experience of pain, appropriate pain relief in patients on substitution therapy is a major challenge for both the physicians and the patients. The article gives an overview of issues related to the treatment of acute pain and perioperative treatment in patients on substitution therapy with methadone and buprenorphine. The article highlights the wrong common misconception about pain treatment in these patients, which also are the most common cause of their inadequate treatment.

PMID: 29064208 [PubMed - as supplied by publisher]

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Efficacy and Safety of Transdermal Buprenorphine versus Oral Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after Spinal Surgery.

Tue, 10/24/2017 - 7:54am
Related Articles

Efficacy and Safety of Transdermal Buprenorphine versus Oral Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after Spinal Surgery.

Pain Res Manag. 2017;2017:2071494

Authors: Lee JH, Kim JH, Kim JH, Kim HS, Min WK, Park YS, Lee KY, Lee JH

Abstract
PURPOSE: Control of persistent pain following spinal surgery is an unmet clinical need. This study compared the efficacy and safety of buprenorphine transdermal system (BTDS) to oral tramadol/acetaminophen (TA) in Korean patients with persistent, moderate pain following spinal surgery.
METHODS: Open-label, interventional, randomized multicenter study. Adults with persistent postoperative pain (Numeric Rating Scale [NRS] ≥ 4 at 14-90 days postsurgery) were enrolled. Patients received once-weekly BTDS (n = 47; 5 μg/h titrated to 20 μg/h) or twice-daily TA (n = 40; tramadol 37.5 mg/acetaminophen 325 mg, one tablet titrated to 4 tablets) for 6 weeks. The study compared pain reduction with BTDS versus TA at week 6. Quality of life (QoL), treatment satisfaction, medication compliance, and adverse events (AEs) were assessed.
FINDINGS: At week 6, both groups reported significant pain reduction (mean NRS change: BTDS -2.02; TA -2.76, both P < 0.0001) and improved QoL (mean EQ-5D index change: BTDS 0.10; TA 0.19, both P < 0.05). The BTDS group achieved better medication compliance (97.8% versus 91.0%). Incidence of AEs (26.1% versus 20.0%) and adverse drug reactions (20.3% versus 16.9%) were comparable between groups.
IMPLICATIONS: For patients with persistent pain following spinal surgery, BTDS is an alternative to TA for reducing pain and supports medication compliance. This trial is registered with Clinicaltrials.gov: NCT01983111.

PMID: 29056859 [PubMed - in process]

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