Abstract
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 1,000mg daily. Both therapies were generally well tolerated.
Original language | English (US) |
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Pages (from-to) | 666-674 |
Number of pages | 9 |
Journal | Journal of the American Geriatrics Society |
Volume | 52 |
Issue number | 5 |
DOIs | |
State | Published - May 2004 |
Externally published | Yes |
Keywords
- Antiinflammatory agents
- NSAIDs
- Nabumetone
- Osteoarthritis
- Rofecoxib
ASJC Scopus subject areas
- Geriatrics and Gerontology