• J Rheumatol · Jun 2005

    Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial

    Efficacy of rofecoxib, celecoxib, and acetaminophen in patients with osteoarthritis of the knee. A combined analysis of the VACT studies.

    • Thomas J Schnitzer, Arthur L Weaver, Adam B Polis, Richard A Petruschke, Gregory P Geba, and VACT-1 and VACT-2 (Protocols 106 and 150) Study Groups.
    • Northwestern University Feinberg School of Medicine, Chicago, Illinois 60611, USA. tjs@northwestern.edu
    • J Rheumatol. 2005 Jun 1;32(6):1093-105.

    ObjectiveTo compare efficacy among 1578 patients with osteoarthritis randomized to take acetaminophen 4000 mg (n=269), celecoxib 200 mg (n=523), rofecoxib 12.5 mg (n=259), or rofecoxib 25 mg (n=527) in a double blind trial [Vioxx, Acetaminophen, Celecoxib Trial (VACT2)]. Results were also pooled with the similarly designed VACT1 trial.MethodsPatients evaluated over Days 1 to 6 and 6 weeks with Patient Global Assessment of Response to Therapy (PGART) and Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index.ResultsFor VACT2, median time to good or excellent PGART response was 6, 5, 4, and 3 days for acetaminophen, celecoxib, rofecoxib 12.5 mg, and rofecoxib 25 mg (COX-2 inhibitors vs acetaminophen, pConclusionRofecoxib and celecoxib provided superior efficacy to acetaminophen. There was a more rapid and greater response with rofecoxib 25 mg than celecoxib 200 mg. Rofecoxib 12.5 mg demonstrated greater efficacy than celecoxib 200 mg over the first 6 days, and was similar over 6 weeks. All study medications were generally well tolerated.

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