Presented at the 2013 AAPM Annual Meeting « Back

Butrans® (Buprenorphine) Transdermal System (BTDS) Treatment Reduces Impairment in Activities of Daily Living for Patients with Moderate-to-Severe Chronic Low Back Pain

Aaron S. Yarlas, PhD, ayarlas@qualitymetric.com¹, Kate Miller, PhD MPH¹, Warren Wen, PhD², warren.wen@pharma.com, Maribeth B. Kowalski, PharmD MS CPE³, Shau Yu Lynch, PhD², Bradley Dain², Steven R. Ripa, MD², (1) QualityMetric, Inc., Lincoln, Rhode Island, (2) Purdue Pharma LP, Stamford, Connecticut, (3) Purdue Pharma LP, West Union, South Carolina

Introduction: The symptoms of chronic low back pain (CLBP), particularly pain, can interfere with the ability to perform activities of daily living (ADLs) such as sleeping, sitting, bending, lifting, walking, and working. The Buprenorphine Transdermal System (BTDS) decreases pain in patients with moderate-to-severe CLBP. The current objective was to assess the impact of 12 weeks’ BTDS treatment on CLBP patients’ ability to perform ADLs. Materials and Methods: Data were from a multicenter, enriched, double-blind, randomized, IRB-approved trial of adult opioid-naive moderate-to-severe CLBP patients who received BTDS (at 10 or 20 mcg/hour) or placebo. Screening and run-in periods were followed by a 12-week double-blind phase. Patients completed surveys measuring health-related quality of life, activity limitations, and sleep quality. Following World Health Organization guidelines, we identified 23 items capturing activities relevant to this patient population. Logistic regression assessed treatment arm differences in patients’ ability to perform each ADL at endpoint. Results: BTDS users were roughly twice as likely to have no health-related restrictions in amount of time spent working or amount of work accomplished, and more than twice as likely to sleep without pain, fall back asleep after waking, lift objects without pain, and bend without restriction (post-hoc multiplicity-adjusted Ps<0.05). Conclusions: Among CLBP patients, 12 weeks of BTDS treatment, relative to placebo, conferred roughly two-fold, statistically significant differences in the likelihood of being able to perform ADLs related to sleeping, lifting, bending, and working.

Funding: This project was funded by Purdue Pharma LP.