IngentaConnect Efficacy and Safety of Rofecoxib 12.5mg Versus Nabumetone 1,000mg...

Authors: Kivitz, Alan J.¹; Greenwald, Maria W.¹; Cohen, Stanley B.²; Polis, Adam B.³; Najarian, Daryl K.³; Dixon, Mary E.³; Moidel, Robert A.⁴; Green, Jerry A.; Baraf, Herbert S. B.⁵; Petruschke, Richard A.³; Matsumoto, Alan K.³; Geba, Gregory P.³

Source: Journal of the American Geriatrics Society, Volume 52, Number 5, May 2004 , pp. 666-674(9)

Publisher: Blackwell Publishing

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.

Keywords: osteoarthritis; NSAIDs; antiinflammatory agents; rofecoxib; nabumetone

Document Type: Research article

DOI: 10.1111/j.1532-5415.2004.52201.x

Affiliations: 1: Altoona Center for Clinical Research, Duncansville, Pennsylvania; 2: Metroplex Clinical Research Center, Dallas, Texas; 3: Merck & Co., Inc., U.S. Human Health, West Point, Pennsylvania; 4: Rheumatology Associates, Sellersville, Pennsylvania; 5: Yale University Medical Center, New Haven, Connecticut;

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