Dr. Rubin has served as a consultant to, and has received honoraria from, Merck, Pfizer, Wyeth, Amgen, Abbott, and Lilly; has served as a consultant to Aventis; has received honoraria from Procter and Gamble; and has received research grants from Merck, Novartis, Pfizer, Centocor, Genentech, Procter and Gamble, and TAP.
Efficacy and safety profile of treatment with etoricoxib 120 mg once daily compared with indomethacin 50 mg three times daily in acute gout: A randomized controlled trial
Article first published online: 5 FEB 2004
Copyright © 2004 by the American College of Rheumatology
Arthritis & Rheumatism
Volume 50, Issue 2, pages 598–606, February 2004
How to Cite
Rubin, B. R., Burton, R., Navarra, S., Antigua, J., Londoño, J., Pryhuber, K. G., Lund, M., Chen, E., Najarian, D. K., Petruschke, R. A., Ozturk, Z. E. and Geba, G. P. (2004), Efficacy and safety profile of treatment with etoricoxib 120 mg once daily compared with indomethacin 50 mg three times daily in acute gout: A randomized controlled trial. Arthritis & Rheumatism, 50: 598–606. doi: 10.1002/art.20007
- Issue published online: 5 FEB 2004
- Article first published online: 5 FEB 2004
- Manuscript Accepted: 13 OCT 2003
- Manuscript Received: 21 JUL 2003
- Merck & Company, Inc.
To evaluate the efficacy and safety of etoricoxib and indomethacin in the treatment of patients with acute gout.
A randomized, double-blind, active-comparator study was conducted at 42 sites. A total of 189 men and women (≥18 years of age) who were experiencing an acute attack (≤48 hours) of clinically diagnosed gout were treated for 8 days with etoricoxib, 120 mg/day (n = 103), or indomethacin, 50 mg 3 times a day (n = 86). The primary efficacy end point was the patient's assessment of pain in the study joint (0–4-point Likert scale) over days 2–5. Safety was assessed by adverse experiences (AEs) occurring during the trial.
Etoricoxib demonstrated clinical efficacy comparable to that of indomethacin in terms of the patient's assessment of pain in the study joint. The difference in the mean change from baseline over days 2–5 was –0.08 (95% confidence interval –0.29, 0.13) (P = 0.46), which fell within the prespecified comparability bounds of –0.5 to 0.5. Secondary end points over the 8-day study, including the onset of efficacy, reduction in signs of inflammation, and patient's and investigator's global assessments of response to therapy, confirmed the comparable efficacy of the two treatments. The etoricoxib-treated patients had a numerically lower incidence of AEs (43.7%) than did the indomethacin-treated patients (57.0%) and a significantly lower incidence of drug-related AEs (16.5% versus 37.2%; P < 0.05).
Etoricoxib at a dosage of 120 mg once daily was confirmed to be an effective treatment for acute gout. Etoricoxib was comparable in efficacy to indomethacin at a dosage of 50 mg 3 times daily, and it was generally safe and well tolerated.