• Kate Miller, Aaron Yarlas, Warren Wen, Bradley Dain, Shau Yu Lynch, Michael J Brennan, and Steven R Ripa.
• QualityMetric, Inc./OptumInsight, 24 Albion Road, Building 400, Lincoln, RI 02865, USA. kmiller@qualitymetric.com
• Expert Opin Pharmacother. 2013 Feb 1;14(3):269-77.

ObjectivesTo evaluate the impact of 12 weeks of treatment with Butrans® (buprenorphine) transdermal system (BTDS) on the health-related quality of life (HRQoL) for patients with chronic low back pain (CLBP), and the maintenance of effects over 52 weeks.Research Design And MethodsA multicenter, enriched, double-blind (DB), randomized trial comparing BTDS 20 μg/h (BTDS 20) against 5 μg/h (BTDS 5) for treatment of opioid-experienced patients with moderate-to-severe CLBP, including a 52-week open-label (OL) extension phase.Main Outcome MeasuresQoL was measured with the SF-36v2 survey before and after an OL run-in period with BTDS 20, three times during the DB phase, and seven times over the extension phase. This post hoc analysis tested for SF-36v2 score differences between treatment groups during the DB phase and maintenance of effects over the extension phase.ResultsAt 12 weeks, BTDS 20 produced larger improvements than BTDS 5 in role limitations due to physical health, bodily pain and overall physical QoL (p < 0.01). Treatment group differences in overall physical QoL were sustained throughout the DB phase. Quality-of-life improvements associated with BTDS 20 persisted through the extension phase.ConclusionsThese data suggest that opioid-experienced moderate-to-severe CLBP patients receiving BTDS 20 exhibited better QoL than patients receiving BTDS 5.

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