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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

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Authors
Yoon, Do Heum; Bin, Seong-Il; Chan, Simon Kin-Cheong; Chung, Chun Kee; In, Yong; Kim, Hyoungmin; Lichauco, Juan Javier; Mok, Chi Chiu; Moon, Young-Wan; Ng, Tony Kwun-Tung; Penserga, Ester Gonzales; Shin, Dong Ah; You, Dora; Moon, Hanlim
Issue Date
2017-08-04
Publisher
BioMed Central
Citation
BMC Musculoskeletal Disorders, 18(1):337
Keywords
Transdermal buprenorphineAsianChronic non-malignant painMusculoskeletalPain scoreQuality of lifeSleep qualityEffectivenessTolerability
Description
AEs: Adverse events; BS-11: Box Scale-11; CIs: Confidence intervals; EAPC: European Association for Palliative Care; EQ VAS: EQ-5D visual analogue scale; EQ-5D-3 L questionnaire: EuroQol Group 5-Dimension SelfReport Questionnaire-3 Level Version Survey; GSQA: Global Sleep Quality Assessment Scale; ITT: Intent-to-treat; LS: Least squares; NICE: National Institute for Health and Care Excellence; NSAIDs: Nonsteroidal antiinflammatory drugs; PP: Per-protocol; SD: Standard deviation; TDB: Transdermal buprenorphine; TEAEs: Treatment-emergent adverse events
Abstract
Abstract

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.
ISSN
1471-2474
Language
English
URI
http://hdl.handle.net/10371/138288
DOI
https://doi.org/10.1186/s12891-017-1664-4
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College of Medicine/School of Medicine (의과대학/대학원)Neurosurgery (신경외과학전공)Journal Papers (저널논문_신경외과학전공)
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