We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Effectiveness and tolerability of transdermal buprenorphine patches: a multicenter, prospective, open-label study in Asian patients with moderate to severe chronic musculoskeletal pain.
- Authors
Do Heum Yoon; Seong-Il Bin; Simon Kin-Cheong Chan; Chun Kee Chung; Yong In; Hyoungmin Kim; Lichauco, Juan Javier; Chi Chiu Mok; Young-Wan Moon; Tony Kwun-Tung Ng; Gonzales Penserga, Ester; Dong Ah Shin; Dora You; Hanlim Moon; Yoon, Do Heum; Bin, Seong-Il; Chan, Simon Kin-Cheong; Chung, Chun Kee; In, Yong; Kim, Hyoungmin
- Abstract
<bold>Background: </bold>We examined the effectiveness and tolerability of transdermal buprenorphine (TDB) treatment in real-world setting in Asian patients with musculoskeletal pain.<bold>Methods: </bold>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.<bold>Results: </bold>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%).<bold>Conclusions: </bold>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.<bold>Trial Registration: </bold>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).
- Subjects
SOUTH Korea; PHILIPPINES; HONG Kong (China); MUSCULOSKELETAL system abnormalities; BUPRENORPHINE; DIAGNOSIS; OSTEOARTHRITIS; ANALGESICS; OPIOIDS; THERAPEUTIC use of narcotics; PAIN management; CHRONIC pain; CLINICAL trials; COMPARATIVE studies; DRUG administration; LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; QUALITY of life; QUESTIONNAIRES; RESEARCH; TRANSDERMAL medication; EVALUATION research; PAIN measurement; TREATMENT effectiveness
- Publication
BMC Musculoskeletal Disorders, 2017, Vol 18, p1
- ISSN
1471-2474
- Publication type
journal article
- DOI
10.1186/s12891-017-1664-4