@article {Kivitz:May 2004:0002-8614:666, author = "Kivitz, Alan J.", author = "Greenwald, Maria W.", author = "Cohen, Stanley B.", author = "Polis, Adam B.", author = "Najarian, Daryl K.", author = "Dixon, Mary E.", author = "Moidel, Robert A.", author = "Green, Jerry A.", author = "Baraf, Herbert S. B.", author = "Petruschke, Richard A.", author = "Matsumoto, Alan K.", author = "Geba, Gregory P.", title = "Efficacy and Safety of Rofecoxib 12.5mg Versus Nabumetone 1,000mg in Patients with Osteoarthritis of the Knee: A Randomized Controlled Trial", journal = "Journal of the American Geriatrics Society", volume = "52", year = "May 2004", 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 1,000 mg daily. Both therapies were generally well tolerated.", pages = "666-674(9)", url = "http://www.ingentaconnect.com/content/bsc/jgs/2004/00000052/00000005/art00002" doi = "doi:10.1111/j.1532-5415.2004.52201.x" }