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

Research output: Contribution to journalArticle

7 Citations (Scopus)

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. Trial registration: 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).

Original languageEnglish
Article number337
JournalBMC Musculoskeletal Disorders
Volume18
Issue number1
DOIs
Publication statusPublished - 2017 Aug 4

Fingerprint

Transdermal Patch
Musculoskeletal Pain
Buprenorphine
Chronic Pain
Pain
Sleep
Least-Squares Analysis
Opioid Analgesics
Therapeutics
Philippines
Myalgia
Arthralgia
Hong Kong
Korea
Low Back Pain

All Science Journal Classification (ASJC) codes

  • Rheumatology
  • Orthopedics and Sports Medicine

Cite this

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. / Effectiveness and tolerability of transdermal buprenorphine patches : A multicenter, prospective, open-label study in Asian patients with moderate to severe chronic musculoskeletal pain. In: BMC Musculoskeletal Disorders. 2017 ; Vol. 18, No. 1.
@article{a5b5e6c25d59443fba7d3c421b760495,
title = "Effectiveness and tolerability of transdermal buprenorphine patches: A multicenter, prospective, open-label study in Asian patients with moderate to severe chronic musculoskeletal pain",
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. Trial registration: 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).",
author = "Yoon, {Do Heum} and Bin, {Seong Il} and Chan, {Simon Kin Cheong} and Chung, {Chun Kee} and Yong In and Hyoungmin Kim and Lichauco, {Juan Javier} and Mok, {Chi Chiu} and Moon, {Young Wan} and Ng, {Tony Kwun Tung} and Penserga, {Ester Gonzales} and Shin, {Dong Ah} and Dora You and Hanlim Moon",
year = "2017",
month = "8",
day = "4",
doi = "10.1186/s12891-017-1664-4",
language = "English",
volume = "18",
journal = "BMC Musculoskeletal Disorders",
issn = "1471-2474",
publisher = "BioMed Central",
number = "1",

}

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

In: BMC Musculoskeletal Disorders, Vol. 18, No. 1, 337, 04.08.2017.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Effectiveness and tolerability of transdermal buprenorphine patches

T2 - A multicenter, prospective, open-label study in Asian patients with moderate to severe chronic musculoskeletal pain

AU - Yoon, Do Heum

AU - Bin, Seong Il

AU - Chan, Simon Kin Cheong

AU - Chung, Chun Kee

AU - In, Yong

AU - Kim, Hyoungmin

AU - Lichauco, Juan Javier

AU - Mok, Chi Chiu

AU - Moon, Young Wan

AU - Ng, Tony Kwun Tung

AU - Penserga, Ester Gonzales

AU - Shin, Dong Ah

AU - You, Dora

AU - Moon, Hanlim

PY - 2017/8/4

Y1 - 2017/8/4

N2 - 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. Trial registration: 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).

AB - 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. Trial registration: 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).

UR - http://www.scopus.com/inward/record.url?scp=85026796770&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85026796770&partnerID=8YFLogxK

U2 - 10.1186/s12891-017-1664-4

DO - 10.1186/s12891-017-1664-4

M3 - Article

C2 - 28778219

AN - SCOPUS:85026796770

VL - 18

JO - BMC Musculoskeletal Disorders

JF - BMC Musculoskeletal Disorders

SN - 1471-2474

IS - 1

M1 - 337

ER -