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| |  Buprenorphine Transdermal System Effective, Safe for Patients With Moderate to Severe Lower Back Pain: Presented at APS By Kristina Rebelo SAN DIEGO -- May 14, 2009 -- Buprenorphine transdermal system 20 mcg/hour (BTDS 20) significantly reduces average pain scores over the course of 24 hours in patients with moderate to severe low back pain, according to the study presented here at the 28th Annual Scientific Meeting of the American Pain Society (APS). Researchers demonstrated the analgesic efficacy of BTDS 20 treatment compared with BTDS 5 (buprenorphine, 5 mcg/hour) for the treatment of chronic low back pain in patients requiring continuous treatment with opioid medications. Deborah Steiner, MD, Purdue Pharma, Stamford, Connecticut, and colleagues conducted a multicentre, randomised, double-blind, double-dummy, active-comparator, parallel-group study that employed an enrichment design where BTDS 20 was compared with those treated with BTDS 5 (P < .001). Results of the study were presented on May 8. Patients (n = 660) had moderate to severe low back pain for a minimum of 3 months and had been receiving opioid analgesics at doses between 30 and 80 mg of morphine sulfate or the equivalent at least 4 days per week for at least 30 days prior to the first visit. The predominant pain type was musculoskeletal (91%). Using a repeated measures analysis, all patients accepted into the study were assessed at weeks 4, 8, and 12. Patients who demonstrated analgesic benefit and tolerability with BTDS 20 in the run-in period were randomised to receive BTDS 20 every 7 days, BTDS 5 every 7 days, or immediate-release oxycodone capsules 40 mg daily (10 mg every 6 hours), and matching placebos in the 12-week, double-blind phase. An analysis of the primary efficacy variable "average pain over the last 24 hours" scores collected at double-blind weeks 4, 8, and 12 resulted in significant treatment differences for BTDS 20 versus BTDS 5 (P < .001) and for immediate-release oxycodone capsules versus BTDS 5 (P < .001). There were 3 secondary variables that were analysed utilising a step-wise gate-keeping approach for multiple comparisons. The subjects that were randomised to BTDS 20 reported significantly less sleep disturbance (P < .001) and decreased use of supplemental analgesic medication (P = .006) versus BTDS 5. Clinical laboratory tests and vital signs did not reveal any apparent safety concerns. The incidence of adverse events (AEs) observed for BTDS 20 and the immediate-release oxycodone was comparable, both in terms of the types of events and the most frequently reported AEs. For secondary endpoints, immediate-release oxycodone did not differ significantly from BTDS 5. Patients demonstrated a 30% improvement in pain with BTDS 20 (49%), immediate-release oxycodone (55%), and BTDS 5 (35%). BTDS delivered a consistent dose of buprenorphine with limited fluctuation over a 7-day period. Peak concentration is sustained with repeat dosing. Funding for this study was provided by Purdue Pharma L.P. [Presentation title: The Efficacy and Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain: A Double-Blind Study. Abstract 226]
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