Research supported by Merck & Co., Inc.
Efficacy and Safety of Rofecoxib 12.5 mg Versus Nabumetone 1,000 mg in Patients with Osteoarthritis of the Knee: A Randomized Controlled Trial
Article first published online: 14 APR 2004
Journal of the American Geriatrics Society
Volume 52, Issue 5, pages 666–674, May 2004
How to Cite
Kivitz, A. J., Greenwald, M. W., Cohen, S. B., Polis, A. B., Najarian, D. K., Dixon, M. E., Moidel, R. A., Green, J. A., Baraf, H. S. B., Petruschke, R. A., Matsumoto, A. K., Geba, G. P., for the Protocol 085 and study investigators (2004), Efficacy and Safety of Rofecoxib 12.5 mg Versus Nabumetone 1,000 mg in Patients with Osteoarthritis of the Knee: A Randomized Controlled Trial. Journal of the American Geriatrics Society, 52: 666–674. doi: 10.1111/j.1532-5415.2004.52201.x
- Issue published online: 14 APR 2004
- Article first published online: 14 APR 2004
- antiinflammatory agents;
Objectives: To evaluate the use of starting doses of rofecoxib and nabumetone in patients with osteoarthritis (OA) of the knee.
Design: A 6-week, randomized, parallel-group, double-blind, placebo-controlled study.
Setting: One hundred thirteen outpatient sites in the United States.
Participants: A total of 1,042 male and female patients aged 40 and older with OA of the knee (>6 months).
Interventions: Rofecoxib 12.5 mg once a day (n=424), nabumetone 1,000 mg once a day (n=410), or placebo (n=208) for 6 weeks.
Measurements: The primary efficacy endpoint was patient global assessment of response to therapy (PGART) over 6 weeks, which was also specifically evaluated over the first 6 days. The main safety measure was adverse events during the 6 weeks of treatment.
Results: The percentage of patients with a good or excellent response to therapy as assessed using PGART at Week 6 was significantly higher with rofecoxib (55.4%) than nabumetone (47.5%; P=.018) or placebo (26.7%; P<.001 vs rofecoxib or nabumetone). Median time to first report of a good or excellent PGART response was significantly shorter in patients treated with rofecoxib (2 days) than with nabumetone (4 days, P=.002) and placebo (>5 days, P<.001) (nabumetone vs placebo; P=.007). The safety profiles of rofecoxib and nabumetone were generally similar, including gastrointestinal, hypertensive, and renal adverse events.
Conclusion: Rofecoxib 12.5 mg daily demonstrated better efficacy over 6 weeks of treatment and quicker onset of OA efficacy over the first 6 days than nabumetone 1,000 mg daily. Both therapies were generally well tolerated.