Efficacy and Safety of the Seven-Day Buprenorphine Transdermal System in Opioid- Naïve Patients with Moderate to Severe Chronic Low Back Pain: An Enriched,

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Presentation transcript:

Efficacy and Safety of the Seven-Day Buprenorphine Transdermal System in Opioid- Naïve Patients with Moderate to Severe Chronic Low Back Pain: An Enriched, Randomized, Double-Blind, Placebo-Controlled Study Deborah J. Steiner, MD, Steve Sitar, MD, Warren Wen, PhD, Gosford Sawyerr, MA, Catherine Munera, PhD, Steven R. Ripa, MD, Craig Landau, MD Journal of Pain and Symptom Management Volume 42, Issue 6, Pages 903-917 (December 2011) DOI: 10.1016/j.jpainsymman.2011.04.006 Copyright © 2011 U.S. Cancer Pain Relief Committee Terms and Conditions

Fig. 1 Study design. Journal of Pain and Symptom Management 2011 42, 903-917DOI: (10.1016/j.jpainsymman.2011.04.006) Copyright © 2011 U.S. Cancer Pain Relief Committee Terms and Conditions

Fig. 2 Patient disposition. aThree patients did not receive study drug and thus were not included in the safety population. bTwo randomized patients had no safety data during the double-blind phase and thus were excluded from the randomized safety population: one patient from the BTDS treatment group was lost to follow-up, and one patient from the placebo TDS group withdrew because of “patient’s choice.” Journal of Pain and Symptom Management 2011 42, 903-917DOI: (10.1016/j.jpainsymman.2011.04.006) Copyright © 2011 U.S. Cancer Pain Relief Committee Terms and Conditions

Fig. 3 Percent reduction/improvement in pain intensity. More patients in the BTDS treatment group had a ≥30% and a ≥50% improvement compared with patients in the placebo TDS group, regardless of imputation method. When analyzed using hybrid imputation (see Statistical Analysis and Table 1), the results were statistically significant. Analyses of ≥30% reduction/improvement were per protocol, and analyses of ≥50% reduction/improvement were post hoc. (a) Percent reduction/improvement in pain intensity (discontinuations included as nonresponders). (b) Percent reduction/improvement in pain intensity (Week 12 scores for discontinuations were calculated using hybrid imputation). Journal of Pain and Symptom Management 2011 42, 903-917DOI: (10.1016/j.jpainsymman.2011.04.006) Copyright © 2011 U.S. Cancer Pain Relief Committee Terms and Conditions