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Around-the-Clock, Controlled-Release Oxycodone Therapy for Osteoarthritis-Related Pain
Placebo-Controlled Trial and Long-term Evaluation
Sanford H. Roth, MD;
Roy M. Fleischmann, MD;
Francis X. Burch, MD;
Frederick Dietz, MD;
Barry Bockow, MD;
Ronald J. Rapoport, MD;
Joel Rutstein, MD;
Peter G. Lacouture, PhD
Arch Intern Med. 2000;160:853-860.
Background Although opioid analgesics have well-defined efficacy and safety in treatment of chronic cancer pain, further research is needed to define their role in treatment of chronic noncancer pain.
Objective To evaluate the effects of controlled-release oxycodone (OxyContin tablets) treatment on pain and function and its safety vs placebo and in long-term use in patients with moderate to severe osteoarthritis pain.
Methods One hundred thirty-three patients experiencing persistent osteoarthritis-related pain for at least 1 month were randomized to double-blind treatment with placebo (n = 45) or 10 mg (n = 44) or 20 mg (n = 44) of controlled-release oxycodone every 12 hours for 14 days. One hundred six patients enrolled in an open-label, 6-month extension trial; treatment for an additional 12 months was optional.
Results Use of controlled-release oxycodone, 20 mg, was superior (P<.05) to placebo in reducing pain intensity and the interference of pain with mood, sleep, and enjoyment of life. During long-term treatment, the mean dose remained stable at approximately 40 mg/d after titration, and pain intensity was stable. Fifty-eight patients completed 6 months of treatment, 41 completed 12 months, and 15 completed 18 months. Common opioid side effects were reported, several of which decreased in duration as therapy continued.
Conclusions Around-the-clock controlled-release oxycodone therapy seemed to be effective and safe for patients with chronic, moderate to severe, osteoarthritis-related pain. Effective analgesia was accompanied by a reduction in the interference of pain with mood, sleep, and enjoyment of life. Analgesia was maintained during long-term treatment, and the daily dose remained stable after titration. Typical opioid side effects were reported during short- and long-term therapy.
From Arthritis Center Ltd, Phoenix, Ariz (Dr Roth); Rheumatology Associates, Metroplex Clinical Research Center, Dallas, Tex (Dr Fleischmann); Rockford Clinic, Rockford, Ill (Dr Dietz); Truesdale Clinic, Fall River, Mass (Dr Rapoport); Arthritis Diagnostic and Treatment Center, San Antonio, Tex (Dr Rutstein); and Purdue Pharma LP, Norwalk, Conn (Dr Lacouture). Dr Burch is in private practice in San Antonio, and Dr Bockow is in private practice in Seattle, Wash. Dr Roth is now with ArthroCare, Arthritis Care & Research, PC, Phoenix. Dr Lacouture is employed by Purdue Pharma LP, the manufacturer of controlled-release oxycodone tablets (OxyContin tablets).
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