Abstract
This study evaluated the impact of treatment with Buprenorphine Transdermal System
(BTDS) on the health-related quality of life for patients with moderate-to-severe
chronic low back pain (CLBP), and the correspondence between quality of life and pain.
A multicenter, enriched, double-blind (DB), placebo-controlled, randomized trial evaluated
BTDS 10 and 20 μg/hour for treatment of opioid-naïve patients with moderate-to-severe
CLBP. The SF-36v2 survey, which measures 8 domains of quality of life, was administered
at screening and following an open-label run-in period with BTDS and at weeks 4, 8,
and 12 of the DB phase. Post hoc analyses compared SF-36v2 scores between BTDS and
placebo groups during the DB phase. Condition burden was examined through comparisons
with a U.S. general population sample. Correlations examined the correspondence between
quality of life and pain measures. BTDS produced larger improvements than placebo
at 12 weeks in all quality-of-life domains (Ps < .05). Treatment group differences in both physical and mental quality of life
emerged by 4 weeks. Patients' pretreatment quality of life was worse than that in
the general population (Ps < .05); only BTDS treatment eliminated deficits in pain, social functioning, and
role limitations due to emotional health. Improvements in quality of life were moderately
associated with pain reduction. These data suggest that moderate-to-severe CLBP patients
receiving BTDS exhibited better quality of life than patients receiving placebo.
Perspective
This post hoc analysis suggests that patients with moderate-to-severe CLBP treated
with BTDS exhibit better health-related quality of life than those using placebo within
4 weeks of treatment, and were more likely to exhibit clinically meaningful improvements
in quality of life following 12 weeks of treatment.
Key words
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Article info
Publication history
Published online: December 03, 2012
Accepted:
September 22,
2012
Received in revised form:
September 13,
2012
Received:
April 16,
2012
Footnotes
This study was sponsored by Purdue Pharma LP. Drs. Wen, Dain, Lynch, and Ripa are full-time employees of Purdue Pharma LP. Drs. Pergolizzi and Raffa served as paid consultants to Purdue Pharma LP. Drs. Yarlas and Miller are full-time employees of QualityMetric, Inc, which received payment from Purdue Pharma LP to conduct the statistical analyses presented here and to assist in the development of this manuscript.
Identification
Copyright
© 2013 American Pain Society. Published by Elsevier Inc. All rights reserved.
