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Extended-Release Tapentadol Effective for Osteoarthritis Knee Pain With Fewer Treatment Withdrawals Than Oxycodone: Presented at EULAR By Jill Stein COPENHAGEN -- June 11, 2009 -- Tapentadol extended release (ER) 100 to 250 mg BID is an effective treatment for moderate to severe chronic osteoarthritis (OA) knee pain, according to results from a phase 3 study presented here at the 10th Annual Congress of the European League Against Rheumatism (EULAR). In addition, fewer patients treated with tapentadol needed to interrupt therapy because of treatment-emergent adverse events (TEAEs) than patients treated with oxycodone controlled release (CR). Kathleen Kelly, MD, Johnson and Johnson Pharmaceutical Research and Development, LLC, Raritan, New Jersey, and colleagues examined the analgesic efficacy, safety, and therapy interruptions resulting from treatment with tapentadol ER for moderate to severe chronic OA knee pain. All patients had pain for at least 3 months because of OA of the knee (American College of Rheumatology criteria), with a functional capacity class of 1 to 3 and an average pain score during the last 3 days before randomisation of at least 5 on an 11-point numeric rating scale (NRS), where 0 indicated no pain and 10 referred to the worst pain imaginable. A total of 1,023 patients were given controlled, adjustable doses of tapentadol ER, oxycodone HCl CR, or placebo BID for 15 weeks. After titration for 3 weeks, patients were given therapeutic doses of tapentadol ER 100 to 250 mg, oxycodone CR 20 to 50 mg, or placebo BID during a 12-week maintenance period. Primary efficacy endpoints were change in mean pain intensity (0-10 NRS) over the maintenance period and at week 12. Reduced mean pain intensity scores were lower for both endpoints with tapentadol ER versus placebo (least-squares mean difference [LSMD] -0.7; P < .001). Mean pain intensity scores for oxycodone CR were significantly decreased only over the maintenance period (LSMD -0.3; P = .049). The study also found that 87.4% of oxycodone CR-treated patients reported at least 1 TEAE, versus 75.9% of patients on tapentadol ER and 61.1% on placebo. TEAEs were primarily gastrointestinal and led to 42.7%, 19.2%, and 6.5% discontinuations in the oxycodone CR, tapentadol ER, and placebo groups, respectively. “Overall, the results show that tapentadol ER is associated with an improved tolerability profile compared with oxycodone CR, which may result in improved treatment compliance, thus providing more consistent and improved pain relief for patients with moderate to severe chronic OA pain,” said Dr. Kelly. Funding for this study was provided by Immunex Corp. [Presentation title: Similar Analgesic Effect and Improved Tolerability of Tapentadol Extended Release (ER) Versus Oxycodone Controlled Release (CR) for Treatment of Chronic Osteoarthritis (OA) Knee Pain: Results From a Randomized, Double-Blind, Phase 3 Trial. Abstract THU0336] E-mail this page to a friend or colleague! To print, use this version