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Effectiveness and tolerability of transdermal buprenorphine patches: a multicenter, prospective, open-label study in Asian patients with moderate to severe chronic musculoskeletal pain

 Do Heum Yoon  ;  Seong-Il Bin  ;  Simon Kin-Cheong Chan  ;  Chun Kee Chung  ;  Yong In  ;  Hyoungmin Kim  ;  Juan Javier Lichauco  ;  Chi Chiu Mok  ;  Young-Wan Moon  ;  Tony Kwun-Tung Ng  ;  Ester Gonzales Penserga  ;  Dong Ah Shin  ;  Dora You  ;  Hanlim Moon 
Journal Title
Issue Date
Administration, Cutaneous ; Adult ; Aged ; Analgesics, Opioid/therapeutic use* ; Buprenorphine/therapeutic use* ; Chronic Pain/drug therapy* ; Female ; Hong Kong ; Humans ; Male ; Middle Aged ; Musculoskeletal Pain/drug therapy* ; Pain Management/methods ; Pain Measurement ; Philippines ; Prospective Studies ; Quality of Life ; Republic of Korea ; Surveys and Questionnaires ; Transdermal Patch/adverse effects* ; Treatment Outcome
Asian ; Chronic non-malignant pain ; Effectiveness ; Musculoskeletal ; Pain score ; Quality of life ; Sleep quality ; Tolerability ; Transdermal buprenorphine
BACKGROUND: We examined the effectiveness and tolerability of transdermal buprenorphine (TDB) treatment in real-world setting in Asian patients with musculoskeletal pain.

METHODS: 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.

RESULTS: 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%).

CONCLUSIONS: 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.
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1. College of Medicine (의과대학) > Dept. of Neurosurgery (신경외과학교실) > 1. Journal Papers
Yonsei Authors
Shin, Dong Ah(신동아) ORCID logo https://orcid.org/0000-0002-5225-4083
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