Around-the-clock, controlled-release oxycodone therapy for osteoarthritis-related pain: placebo-controlled trial and long-term evaluation.

Abstract

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, osteo-arthritis-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.

• Authors: S H Roth, R M Fleischmann, F X Burch, F Dietz, B Bockow, R J Rapoport, J Rutstein, P G Lacouture
• Journal: Archives of internal medicine (Arch Intern Med) Vol. 160 Issue 6 Pg. 853-60 (Mar 27 2000) ISSN: 0003-9926 [Print] United States
• PMID: 10737286 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics, Opioid
• Delayed-Action Preparations
• Oxycodone

Topics

• Aged
• Analgesics, Opioid (administration & dosage, adverse effects)
• Delayed-Action Preparations
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Osteoarthritis (complications)
• Oxycodone (administration & dosage, adverse effects)
• Pain (drug therapy, etiology)
• Severity of Illness Index
• Treatment Outcome