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A Randomized, Controlled, Clinical Trial of Etoricoxib in the Treatment of Rheumatoid Arthritis
ALAN K. MATSUMOTO, AGUSTIN MELIAN, DAVID R. MANDEL, HARRIS H. McILWAIN, DAVID BORENSTEIN, PENG LIANG ZHAO, CHRISTOPHER R. LINES, BARRY J. GERTZ, SEAN CURTIS, and the Etoricoxib Rheumatoid Arthritis Study Group
ABSTRACT. Methods. A double blind, randomized, placebo and active comparator controlled, 12 week study conducted at 88 US sites. Eligible patients were chronic nonsteroidal antiinflammatory drug (NSAID) users with clinical worsening of RA upon withdrawal of prestudy NSAID. Patients received either placebo, etoricoxib 90 mg once daily, or naproxen 500 mg twice daily (2:2:1 allocation ratio). Primary efficacy measures: patient and investigator global assessments of disease activity and direct assessment of arthritis by counts of tender and swollen joints. Key secondary measures: patient global assessment of pain, the Stanford Health Assessment Questionnaire, and the percentage of patients both completing the study and meeting the ACR20 criteria. Tolerability was assessed by tabulation of adverse events and routine laboratory evaluations. Results. In all, 816 patients were randomized (placebo = 323, etoricoxib = 323, naproxen = 170), and 448 completed 12 weeks of treatment (placebo = 122, etoricoxib = 230, naproxen = 96). Compared with patients receiving placebo, patients receiving etoricoxib and naproxen showed significant improvements in all efficacy endpoints (p < 0.01). Compared with patients receiving naproxen, patients receiving etoricoxib demonstrated significant improvements (p < 0.05) on all primary endpoints and most other endpoints including ACR20 criteria. The percentage of patients who achieved an ACR20 response and who completed the study was 21%, 53%, and 39% in the placebo, etoricoxib and naproxen groups, respectively. Etoricoxib and naproxen were both generally well tolerated. Conclusion. In this study, etoricoxib 90 mg once daily was more effective than either placebo or naproxen 500 mg twice daily for treating patients with RA over 12 weeks. Etoricoxib 90 mg was generally well tolerated in patients with RA. (J Rheumatol 2002:29:1623-30) Key Indexing Terms:
RHEUMATOID ARTHRITIS
From the Johns Hopkins Medical Institutions, Baltimore, Maryland; Merck Research Laboratories, Rahway, New Jersey; Hillcrest and Geauga Hospital, Mayfield Village, Ohio; Tampa Medical Group, Tampa, Florida; Arthritis and Rheumatism Associates, Washington, DC, USA. Funded by Merck Research Laboratories. A.K. Matsumoto, MD, Johns Hopkins Medical Institutions; A. Melian, MD, Merck Research Laboratories; D.R. Mandel, MD, Hillcrest and Geauga Hospital; H.H. McIlwain, MD, Tampa Medical Group; D. Borenstein, MD, Arthritis and Rheumatism Associates; P.L. Zhao, PhD; C.R. Lines, PhD; B.J. Gertz, MD; S. Curtis, MD, Merck Research Laboratories; and the Etoricoxib Rheumatoid Arthritis Study Group. Address reprint requests to Dr. A.K. Matsumoto, Arthritis and Rheumatism Associates, 2730 University Blvd. West, Suite 310, Wheaton, MD 20902. Submitted December 17, 2001; revision accepted March 20, 2002. |