Efficacy and Safety of Rofecoxib 12.5 mg Versus Nabumetone 1,000 mg in Patients with Osteoarthritis of the Knee: A Randomized Controlled Trial

Autor: Jerry Green, Richard A. Petruschke, Robert A. Moidel, Alan K. Matsumoto, Daryl K. Najarian, Alan Kivitz, Mary E. Dixon, Stanley Cohen, Adam B. Polis, Gregory P. Geba, Herbert S. B. Baraf, Maria Greenwald
Rok vydání: 2004
Předmět:
Zdroj: Journal of the American Geriatrics Society. 52:666-674
ISSN: 1532-5415
0002-8614
DOI: 10.1111/j.1532-5415.2004.52201.x
Popis: 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 5 days, P
Databáze: OpenAIRE