Abstract | OBJECTIVES: 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.
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Authors | Alan J Kivitz, Maria W Greenwald, Stanley B Cohen, Adam B Polis, Daryl K Najarian, Mary E Dixon, Robert A Moidel, Jerry A Green, Herbert S B Baraf, Richard A Petruschke, Alan K Matsumoto, Gregory P Geba, Protocol 085 Study Investigators |
Journal | Journal of the American Geriatrics Society
(J Am Geriatr Soc)
Vol. 52
Issue 5
Pg. 666-74
(May 2004)
ISSN: 0002-8614 [Print] United States |
PMID | 15086644
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Butanones
- Cyclooxygenase Inhibitors
- Lactones
- Placebos
- Sulfones
- rofecoxib
- Nabumetone
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Anti-Inflammatory Agents, Non-Steroidal
(administration & dosage, adverse effects, therapeutic use)
- Butanones
(administration & dosage, therapeutic use)
- Cyclooxygenase Inhibitors
(administration & dosage, adverse effects, therapeutic use)
- Data Interpretation, Statistical
- Double-Blind Method
- Female
- Humans
- Lactones
(administration & dosage, adverse effects, therapeutic use)
- Male
- Middle Aged
- Nabumetone
- Osteoarthritis, Knee
(diagnosis, drug therapy)
- Placebos
- Safety
- Sulfones
- Time Factors
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