Butrans® (buprenorphine) Transdermal System and Chronic Low Back Pain

Fort Lauderdale—Patients with moderate-to-severe chronic low back pain who received 12 weeks of treatment with the Butrans^® (buprenorphine) transdermal system had significant improvements in several activities of daily living compared with a placebo group, according to a multicenter, randomized, double-blind, placebo-controlled, phase 3 trial.

Results were presented during a poster session at the AAPM meeting. The poster was titled Butrans^®(buprenorphine) Transdermal System (BTDS) Treatment Reduces Impairment in Activities of Daily Living for Patients with Moderate-to-Severe Chronic Low Back Pain.

The authors noted that patients with moderate-to-severe chronic low back pain may suffer from numerous impairments in activities of daily living, including sleep quality, bending, lifting, standing, and working.

In 2010, the FDA approved the buprenorphine transdermal system for patients with moderate-to-severe chronic pain who require a continuous opioid analgesic. The system delivers 5-, 10-, or 20-mcg per hour of buprenorphine for 7 days. Buprenorphine, a Schedule III controlled substance, is an opioid agonist. In randomized, phase 3 trials, the buprenorphine transdermal system was safe, effective, and well tolerated in patients with moderate-to-severe chronic lower back pain, according to the authors.

This study included opioid-naïve patients who were first enrolled in an open-label run-in period to establish responsiveness and tolerability to the buprenorphine transdermal system. They then entered the 12-week, double-blind phase during which they were randomized to receive the buprenorphine transdermal system or placebo.

The World Health Organization’s International Classification of Functioning, Disability and Health (ICF) includes approximately 15,000 functions necessary for daily life. The ICF features sub-sets of functions relevant for most diseases. The 35 functions for patients with moderate-to-severe chronic lower back pain include sleeping, sitting, standing, lifting, bending, walking, and working.

The activities of daily living in this study were measured using 3 patient-reported instruments: (1) the Short Form Health Survey (36-item measure of health-related quality of life); (2) Medical Outcomes Study Sleep Scale (12-item measure of sleep problems); and (3) Oswestry Disability Index (10-item measure of functional disabilities in lower back pain patients). The authors included 23 activities, which were broken into 4 categories: (1) sleep; (2) sitting/standing/lifting/bending; (3) walking; and (4) work.

For each of the 23 activities, the authors recorded whether patients were able to perform, which was defined as fully or almost fully able to perform or having no or very little impairment. Patients were considered to be unable to perform the activity if they were fully or unable to perform or showed at least some impairment.

Before treatment, the most common impairments were for bending, work limitations due to physical problems, sleep inadequacy, and walking long distances. The least impaired conditions were work limitations due to emotional problems, standing, sleep disturbance due to pain, and walking short distances.

After the 12-week treatment period, patients in the buprenorphine transdermal system group were statistically more likely to perform 10 out of the 23 activities of daily living that were measured compared with the placebo group. The authors added that the improvement from baseline in the percentage of patients able to perform the functions typically favored the patients who received treatment with the buprenorphine transdermal system, as well. They concluded that treatment with the buprenorphine transdermal system was associated with a 2-fold increase in the likelihood of being able to perform daily functions related to sleeping, lifting, bending, and working.

This poster was funded by Purdue Pharma L.P. and QualityMetric.