Buprenorphine transdermal system compared with placebo reduces interference in functioning for chronic low back pain

Abstract

Objective: This study examines the efficacy of the buprenorphine transdermal system (BTDS) for reducing the interference of pain on physical and emotional functioning associated with chronic low back pain (CLBP). Methods: A post-hoc analysis used data from a randomized, placebo-controlled, double-blind trial of patients with moderate-to-severe CLBP. The Brief Pain Inventory (BPI) measured pain interference at screening, following a run-in period, and during the 12-week double-blind treatment phase. Statistical analyses examined treatment arm differences (BTDS vs placebo) for the following: BPI Interference subscale items and subscale scores at the trial end point (week 12); patterns of change in the Interference subscale scores over time; proportions of patients indicating mild or no interference following treatment; and proportions of patients showing improvement (30%, 50%, 2-point, or 4-point change in score from screening to week 12) for each item and subscale. Results: Mean scores for BPI Interference items and Interference subscale were significantly lower (ie, indicated less interference) for BTDS than for placebo (all P < 0.001). Treatment arm differences in Interference subscale scores emerged within 4 weeks of treatment. The BTDS patients were significantly more likely to indicate mild/no interference on 5 of 7 Interference subscale items following treatment (P < 0.05). For most comparisons, BTDS patients were significantly more likely to show criterion-level improvements in Interference item and subscale scores (P < 0.05 for differences). Discussion: Results indicate the efficacy of BTDS treatment, compared with placebo, for reducing the interference of pain on physical and emotional functioning in patients with moderate-to-severe CLBP. The advantage of BTDS was observed within 4 weeks of treatment, and was maintained throughout the 12-week treatment phase.

Keywords:

• pain interference
• buprenorphine transdermal system
• Butrans
• chronic low back pain
• opioid treatment

Declaration of interest: This study was financially supported by Purdue Pharma, LP. Warren Wen, PhD, Shau Yu Lynch, PhD, Catherine Munera, PhD, and Steven R. Ripa, MD, are full-time employees of Purdue Pharma. Joseph V. Pergolizzi Jr, MD, and Robert Raffa, PhD, served as paid consultants to Purdue Pharma, LP. Aaron Yarlas, PhD, and Kate Miller, PhD, are full-time employees of Optum, which received payment from Purdue Pharma to conduct the statistical analyses presented here and to assist in the development of this manuscript.