Once-Weekly Transdermal Buprenorphine Application Results in Sustained and Consistent Steady-State Plasma Levels

Kapil, Ram P.; Cipriano, Alessandra; Friedman, Kristen; Michels, Gregory; Shet, Manjunath S.; Colucci, Salvatore V.; Apseloff, Glen; Kitzmiller, Joseph P; Harris, Stephen

doi:10.1016/j.jpainsymman.2012.06.014

Cited by 32 publications

(21 citation statements)

References 42 publications

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“…Buprenorphine TDS is absorbed slowly, and it reaches active concentration after ~24 hours and steady state during the first 72 hours in young healthy patients. 35 Although pharmacokinetics have not been investigated in the very old and frail, buprenorphine TDS appears to be absorbed at a similar rate in people aged ≥75 years compared to a younger control group. 29 The largest drop in daytime activity observed in our study (recorded ~24–36 hours after administration) may therefore correspond to the first systemic exposure to buprenorphine.…”

Section: Discussionmentioning

confidence: 99%

Tolerability of buprenorphine transdermal system in nursing home patients with advanced dementia: a randomized, placebo-controlled trial (DEP.PAIN.DEM)

Erdal¹,

Flo²,

Aarsland³

et al. 2018

CIA

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PurposeBuprenorphine transdermal system is increasingly prescribed in people with advanced dementia, but no clinical trial has investigated the safety and factors associated with discontinuation due to adverse events in this population.Patients and methodsOne hundred sixty-two people with advanced dementia and significant depression from 47 nursing homes were included and randomized to active analgesic treatment (acetaminophen/buprenorphine) or identical placebo for 13 weeks. In this secondary analysis, the main outcomes were time to and reasons for discontinuation of buprenorphine due to adverse events. Change in daytime activity as measured by actigraphy was a secondary outcome.ResultsOf the 44 patients who received active buprenorphine 5 µg/hour, 52.3% (n=23) discontinued treatment due to adverse events compared to 13.3% (6 of 45) in the placebo group (p<0.001). Psychiatric and neurological adverse events were the most frequently reported causes of discontinuation (69.6%, n=16). Concomitant use of antidepressants significantly increased the risk of discontinuation (HR 23.2, 95% CI: 2.95–182, p=0.003). Adjusted for age, sex, cognitive function, pain and depression at baseline, active buprenorphine was associated with 24.0 times increased risk of discontinuation (Cox model, 95% CI: 2.45–235, p=0.006). Daytime activity dropped significantly during the second day of active treatment (−21.4%, p=0.005) and decreased by 12.9% during the first week (p=0.053).ConclusionActive buprenorphine had significantly higher risk of discontinuation compared with placebo in people with advanced dementia and depression, mainly due to psychiatric and neurological adverse events. Daytime activity dropped significantly during the first week of treatment. Concomitant use of antidepressants further reduced the tolerability of buprenorphine.

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Section: Discussionmentioning

confidence: 99%

Tolerability of buprenorphine transdermal system in nursing home patients with advanced dementia: a randomized, placebo-controlled trial (DEP.PAIN.DEM)

Erdal¹,

Flo²,

Aarsland³

et al. 2018

CIA

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“… 5 The buprenorphine transdermal delivery system (BTDS; Norspan®; Mundipharma (China) Pharmaceutical Co., Ltd, Beijing, People’s Republic of China) is a type of transdermal patch that contains an analgesic drug (buprenorphine in the case of the BTDS). The BTDS continuously delivers dosages of 5, 7.5, 10, 15, or 20 mg/h of buprenorphine steadily over 7 days, 6 , 7 thereby administering a controlled release of the medication to patients with chronic pain. 8 – 10 Improvements in the health-related quality of life of patients have been demonstrated in post hoc analyses of randomized clinical trials of patients with pain who were treated by the BTDS.…”

Section: Introductionmentioning

confidence: 99%

Perioperative analgesia with a buprenorphine transdermal patch for hallux valgus surgery: a prospective, randomized, controlled study

Wang

et al. 2018

JPR

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PurposeHallux valgus surgery often results in significant postoperative pain. Adequate control of pain is essential for patient satisfaction and improves the outcome of the procedure. This study aimed to investigate the perioperative analgesic effect of a buprenorphine transdermal patch in patients who underwent hallux valgus surgery.Patients and methodsA total of 90 patients were randomly divided into the following three groups based on the perioperative analgesic method: flurbiprofen axetil intravenous injection (Group F), oral celecoxib (Group C), and buprenorphine transdermal delivery system (BTDS) (Group BTDS). The pain status, degree of satisfaction, adverse effects, and administration of tramadol hydrochloride for uncontrolled pain were recorded on the night before surgery, postoperative day 1, postoperative day 2, and postoperative day 3.ResultsThe BTDS could effectively control perioperative pain for patients undergoing hallux valgus surgery. The analgesic effect of the BTDS was better than that of oral celecoxib. In addition, statistically significant differences were not observed in the visual analog scale (VAS) scores, adverse effects, and rescue analgesia between the patients who received the BTDS and the patients who received the flurbiprofen axetil intravenous injection. However, the degree of patient satisfaction of the BTDS group was significantly higher (P<0.05) than that of the other two groups.ConclusionThe BTDS (a preemptive analgesia regimen) could exert an analgesic effect during the perioperative period for patients who had received hallux valgus surgery, and this effect is beneficial for sustaining postoperative physiological and psychological states and promoting functional rehabilitation.

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“…It is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate [11]. BTDS continuously delivers dosages of 5, 7.5, 10, 15, or 20 mcg/h of buprenorphine for 7 days [23,24], as a steady over time, controlled release of the medication to patients in chronic pain [25][26][27][28][29][30][31]. Improvements in health-related quality of life have also been demonstrated in post hoc analyses of randomized clinical trials of patients with pain treated with BTDS [32,33] as well as improvements in sleep quality [34] and reductions in pain interference in functioning [35].…”

Section: Introductionmentioning

confidence: 99%

Comparison of abuse, suspected suicidal intent, and fatalities related to the 7-day buprenorphine transdermal patch versus other opioid analgesics in the National Poison Data System

Coplan

Sessler

Harikrishnan

et al. 2016

Postgraduate Medicine

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Once-Weekly Transdermal Buprenorphine Application Results in Sustained and Consistent Steady-State Plasma Levels

Cited by 32 publications

References 42 publications

Tolerability of buprenorphine transdermal system in nursing home patients with advanced dementia: a randomized, placebo-controlled trial (DEP.PAIN.DEM)

Tolerability of buprenorphine transdermal system in nursing home patients with advanced dementia: a randomized, placebo-controlled trial (DEP.PAIN.DEM)

Perioperative analgesia with a buprenorphine transdermal patch for hallux valgus surgery: a prospective, randomized, controlled study

Comparison of abuse, suspected suicidal intent, and fatalities related to the 7-day buprenorphine transdermal patch versus other opioid analgesics in the National Poison Data System

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