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Buprenorphine transdermal system for opioid therapy in patients with chronic low back pain.
Pain Res Manag. 2010 May-Jun; 15(3):169-78.PR

Abstract

OBJECTIVE

The present randomized, double-blinded, crossover study compared the efficacy and safety of a seven-day buprenorphine transdermal system (BTDS) and placebo in patients with low back pain of moderate or greater severity for at least six weeks.

METHODS

Prestudy analgesics were discontinued the evening before random assignment to 5 microg/h BTDS or placebo, with acetaminophen 300 mg/codeine 30 mg, one to two tablets every 4 h to 6 h as needed, for rescue analgesia. The dose was titrated to effect weekly, if tolerated, to 10 microg/h and 20 microg/h BTDS. Each treatment phase was four weeks.

RESULTS

Fifty-three patients (28 men, 25 women, mean [+/- SD] age 54.5+/-12.7 years) were evaluable for efficacy (completed two weeks or more in each phase). Baseline pain was 62.1+/-15.5 mm (100 mm visual analogue scale) and 2.5+/-0.6 (five-point ordinal scale). BTDS resulted in lower mean daily pain scores than in the placebo group (37.6+/-20.7 mm versus 43.6+/-21.2 mm on a visual analogue scale, P=0.0487; and 1.7+/-0.6 versus 2.0+/-0.7 on the ordinal scale, P=0.0358). Most patients titrated to the highest dose of BTDS (59% 20 microg/h, 31% 10 microg/h and 10% 5 microg/h). There were improvements from baseline in pain and disability (Pain Disability Index), Pain and Sleep (visual analogue scale), Quebec Back Pain Disability Scale and Short-Form 36 Health Survey scores for both BTDS and placebo groups, without significant differences between treatments. While there were more opioid-related side effects with BTDS treatment than with placebo, there were no serious adverse events. A total of 82% of patients chose to continue BTDS in a long-term open-label evaluation, in whom improvements in pain intensity, functionality and quality of life were sustained for up to six months without analgesic tolerance.

CONCLUSION

BTDS (5 microg/h to 20 microg/h) represents a new treatment option for initial opioid therapy in patients with chronic low back pain.

Authors+Show Affiliations

Mount Sinai Hospital, Toronto, Ontario, Canada.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20577660

Citation

Gordon, Allan, et al. "Buprenorphine Transdermal System for Opioid Therapy in Patients With Chronic Low Back Pain." Pain Research & Management, vol. 15, no. 3, 2010, pp. 169-78.
Gordon A, Rashiq S, Moulin DE, et al. Buprenorphine transdermal system for opioid therapy in patients with chronic low back pain. Pain Res Manag. 2010;15(3):169-78.
Gordon, A., Rashiq, S., Moulin, D. E., Clark, A. J., Beaulieu, A. D., Eisenhoffer, J., Piraino, P. S., Quigley, P., Harsanyi, Z., & Darke, A. C. (2010). Buprenorphine transdermal system for opioid therapy in patients with chronic low back pain. Pain Research & Management, 15(3), 169-78.
Gordon A, et al. Buprenorphine Transdermal System for Opioid Therapy in Patients With Chronic Low Back Pain. Pain Res Manag. 2010 May-Jun;15(3):169-78. PubMed PMID: 20577660.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Buprenorphine transdermal system for opioid therapy in patients with chronic low back pain. AU - Gordon,Allan, AU - Rashiq,Saifudin, AU - Moulin,Dwight E, AU - Clark,Alexander J, AU - Beaulieu,André D, AU - Eisenhoffer,John, AU - Piraino,Paula S, AU - Quigley,Patricia, AU - Harsanyi,Zoltan, AU - Darke,Andrew C, PY - 2010/6/26/entrez PY - 2010/6/26/pubmed PY - 2010/8/13/medline SP - 169 EP - 78 JF - Pain research & management JO - Pain Res Manag VL - 15 IS - 3 N2 - OBJECTIVE: The present randomized, double-blinded, crossover study compared the efficacy and safety of a seven-day buprenorphine transdermal system (BTDS) and placebo in patients with low back pain of moderate or greater severity for at least six weeks. METHODS: Prestudy analgesics were discontinued the evening before random assignment to 5 microg/h BTDS or placebo, with acetaminophen 300 mg/codeine 30 mg, one to two tablets every 4 h to 6 h as needed, for rescue analgesia. The dose was titrated to effect weekly, if tolerated, to 10 microg/h and 20 microg/h BTDS. Each treatment phase was four weeks. RESULTS: Fifty-three patients (28 men, 25 women, mean [+/- SD] age 54.5+/-12.7 years) were evaluable for efficacy (completed two weeks or more in each phase). Baseline pain was 62.1+/-15.5 mm (100 mm visual analogue scale) and 2.5+/-0.6 (five-point ordinal scale). BTDS resulted in lower mean daily pain scores than in the placebo group (37.6+/-20.7 mm versus 43.6+/-21.2 mm on a visual analogue scale, P=0.0487; and 1.7+/-0.6 versus 2.0+/-0.7 on the ordinal scale, P=0.0358). Most patients titrated to the highest dose of BTDS (59% 20 microg/h, 31% 10 microg/h and 10% 5 microg/h). There were improvements from baseline in pain and disability (Pain Disability Index), Pain and Sleep (visual analogue scale), Quebec Back Pain Disability Scale and Short-Form 36 Health Survey scores for both BTDS and placebo groups, without significant differences between treatments. While there were more opioid-related side effects with BTDS treatment than with placebo, there were no serious adverse events. A total of 82% of patients chose to continue BTDS in a long-term open-label evaluation, in whom improvements in pain intensity, functionality and quality of life were sustained for up to six months without analgesic tolerance. CONCLUSION: BTDS (5 microg/h to 20 microg/h) represents a new treatment option for initial opioid therapy in patients with chronic low back pain. SN - 1203-6765 UR - https://www.unboundmedicine.com/medline/citation/20577660/Buprenorphine_transdermal_system_for_opioid_therapy_in_patients_with_chronic_low_back_pain_ L2 - https://dx.doi.org/10.1155/2010/216725 DB - PRIME DP - Unbound Medicine ER -