buprenorphine and Musculoskeletal-Pain

We examined the effectiveness and tolerability of transdermal buprenorphine (TDB) treatment in real-world setting in Asian patients with musculoskeletal pain.. This was an open-label study conducted in Hong Kong, Korea, and the Philippines between June 2013 and April 2015. Eligible patients fulfilled the following criteria: 18 to 80 years of age; clinical diagnosis of osteoarthritis, rheumatoid arthritis, low back pain, or joint/muscle pain; chronic non-malignant pain of moderate to severe intensity (Box-Scale-11 [BS-11] pain score ≥ 4), not adequately controlled with non-opioid analgesics and requiring an opioid for adequate analgesia; and no prior history of opioid treatment. Patients started with a 5 μg/h buprenorphine patch and were titrated as necessary to a maximum of 40 μg/h over a 6-week period to achieve optimal pain control. Patients continued treatment with the titrated dose for 11 weeks. The primary efficacy endpoint was the change in BS-11 pain scores. Other endpoints included patients' sleep quality and quality of life as assessed by the 8-item Global Sleep Quality Assessment Scale (GSQA) questionnaire and the EuroQol Group 5-Dimension Self-Report Questionnaire-3 Level version (EQ-5D-3 L), respectively. Tolerability was assessed by collecting adverse events.. A total of 114 eligible patients were included in the analysis. The mean BS-11 score at baseline was 6.2 (SD 1.6). Following initiation of TDB, there was a statistically significant improvement in BS-11 score from baseline to visit 3 (least squares [LS] mean change: -2.27 [95% CI -2.66 to -1.87]), which was maintained till the end of the study (visit 7) (LS mean change: -2.64 [95% -3.05 to -2.23]) (p < 0.0001 for both). The proportion of patients who rated sleep quality as 'good' increased from 14.0% at baseline to 26.9% at visit 6. By visit 6, the mean EQ VAS score increased by 7.7 units (SD 17.9). There were also significant improvements in patients' levels of functioning for all EQ-5D-3 L dimensions from baseline at visit 6 (p < 0.05 for all). Seventy-eight percent of patients reported TEAEs and 22.8% of patients discontinued due to TEAEs. TEAEs were generally mild to moderate in intensity (96.5%).. TDB provides effective pain relief with an acceptable tolerability profile over the 11-week treatment period in Asian patients with chronic musculoskeletal pain. More studies are needed to examine the long-term efficacy and safety of TBD treatment in this patient population.. ClinicalTrials.gov NCT01961271 . Registered 7 October 2013 (retrospectively registered; first patient was enrolled on 28 June 2013 and last patient last visit date was 26 Apr 2015).

Topics: Administration, Cutaneous; Adult; Aged; Analgesics, Opioid; Buprenorphine; Chronic Pain; Female; Hong Kong; Humans; Male; Middle Aged; Musculoskeletal Pain; Pain Management; Pain Measurement; Philippines; Prospective Studies; Quality of Life; Republic of Korea; Surveys and Questionnaires; Transdermal Patch; Treatment Outcome

The aim of this noninferiority study was to investigate clinical effectiveness and safety of buprenorphine transdermal system (BTDS) in patients with moderate to severe musculoskeletal pain inadequately controlled with nonsteroidal anti-inflammatory drugs, compared with sustained-release tramadol tablets.. Eligible patients were randomized (1:1) to receive low-dose 7-day BTDS (5, 10, and 20 μg/h, maximum dosage of 20 μg/h) or sustained-release tramadol tablets (100 mg, maximum dosage of 400 mg/d) over an 8-week double-blind treatment period (3-week titration, 5-week maintenance). The primary endpoint was the difference in the visual analogue scale (VAS) pain scores from baseline to treatment completion. Noninferiority was assumed if the treatment difference on the VAS scale was within ±1.5 cm, this threshold indicating a clinically meaningful result. ClinicalTrials.gov identifier: NCT01476774.. Two hundred eighty patients were randomized to BTDS (n=141) or to tramadol (n=139). Both treatments were associated with a significant reduction in pain by the end of the treatment. The least squares mean difference of the change from baseline in VAS scores between the BTDS and tramadol groups were 0.45 (95% confidence interval, -0.02 to 0.91), which was within the ±1.5 cm predefined threshold, indicating that the effectiveness of BTDS was not inferior to the effectiveness of sustained-release tramadol tablets. The incidence of adverse events was comparable between the 2 treatment groups.. Our results suggest that BTDS is a good therapeutic option for patients experiencing chronic musculoskeletal pain of moderate to severe intensity that is insufficiently controlled by nonsteroidal anti-inflammatory drugs.

Topics: Administration, Cutaneous; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Buprenorphine; China; Delayed-Action Preparations; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Least-Squares Analysis; Male; Medication Adherence; Middle Aged; Musculoskeletal Pain; Pain Measurement; Tramadol; Treatment Outcome

Topics: Administration, Cutaneous; Administration, Oral; Analgesics, Opioid; Buprenorphine; Drug Therapy, Combination; Humans; Lung Neoplasms; Methadone; Middle Aged; Morphine; Musculoskeletal Pain; Neuralgia; Palliative Care