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- Title
Efficacy and Safety of Rofecoxib 12.5 mg Versus Nabumetone 1,000 mg in Patients with Osteoarthritis of the Knee: A Randomized Controlled Trial.
- Authors
Kivitz, Alan J.; Greenwald, Maria W.; Cohen, Stanley B.; Polis, Adam B.; Najarian, Daryl K.; Dixon, Mary E.; Moidel, Robert A.; Green, Jerry A.; Baraf, Herbert S. B.; Petruschke, Richard A.; Matsumoto, Alan K.; Geba, Gregory P.
- Abstract
To evaluate the use of starting doses of rofecoxib and nabumetone in patients with osteoarthritis (OA) of the knee. A 6-week, randomized, parallel-group, double-blind, placebo-controlled study. One hundred thirteen outpatient sites in the United States. A total of 1,042 male and female patients aged 40 and older with OA of the knee (>6 months). 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. 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. 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. 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.
- Subjects
UNITED States; OSTEOARTHRITIS; KNEE diseases; ANTI-inflammatory agents; PLACEBOS; DRUG efficacy; DRUG tolerance
- Publication
Journal of the American Geriatrics Society, 2004, Vol 52, Issue 5, p666
- ISSN
0002-8614
- Publication type
Article
- DOI
10.1111/j.1532-5415.2004.52201.x