Randomised double blind trial of etoricoxib and indometacin in treatment of acute gouty arthritis
BMJ 2002; 324 doi: https://doi.org/10.1136/bmj.324.7352.1488 (Published 22 June 2002) Cite this as: BMJ 2002;324:1488
- H Ralph Schumacher Jr, professor of medicinea,
- Judith A Boice (judith_boice{at}merck.com), senior medical program coordinatorb,
- David I Daikh, assistant professor of medicined,
- Saurabh Mukhopadhyay, senior biometricianc,
- Kerstin Malmstrom, directorb,
- Jennifer Ng, associate directorc,
- Guillermo A Tate, directore,
- Javier Molina, honorary professor of medicinef
- a Division of Rheumatology, University of Pennsylvania School of Medicine and Department of Veterans Affairs Medical Center, Philadelphia, PA 19104, USA
- b Department of Clinical Immunology and Analgesia, Merck Research Laboratories, Rahway, NJ 07065, USA
- c Department of Clinical Biostatistics and Research Data Systems, Merck Research Laboratories
- d Division of Rheumatology, University of California, San Francisco and Department of Veterans Affairs Medical Center, San Francisco, CA 94121, USA
- e Centro de Osteopatias, Reumatologia e Investigaciones Clinicas, 1012 Buenos Aires, Argentina
- f Department of Internal Medicine, Antioquia University, Calle 64 Carrera 51 D, Medellin-Colombia, 1226
- Correspondence to: J A Boice
- Accepted 11 April 2002
Abstract
Objective: To assess the safety and efficacy of etoricoxib, a selective cyclo-oxygenase-2 inhibitor, in comparison with indometacin in the treatment of acute gouty arthritis.
Design: Randomised, double blind, active comparator controlled trial.
Setting: 43 outpatient study centres in 11 countries.
Participants: 142 men and eight women (75 patients per treatment group) aged 18 years or over presenting with clinically diagnosed acute gout within 48 hours of onset.
Interventions: Etoricoxib 120 mg administered orally once daily versus indometacin 50 mg administered orally three times daily, both for 8 days
Main outcome measures: Patients' assessment of pain in the study joint over days 2 to 5 (primary end point); investigators' and patients' global assessments of response to treatment and tenderness of the study joint (key secondary end points).
Results: Etoricoxib showed efficacy comparable to indometacin. Patients' assessment of pain in the study joint (0-4 point Likert scale, “no pain” to “extreme pain”) over days 2 to 5 showed a least squares mean change from baseline of −1.72 (95% confidence interval −1.90 to −1.55) for etoricoxib and −1.83 (−2.01 to −1.65) for indometacin. The difference between treatment groups met prespecified comparability criteria. All other efficacy end points, including those reflecting reduction in inflammation and analgesia, provided corroborative evidence of comparable efficacy. Significant pain relief was evident at the first measurement, 4 hours after the first dose of treatment. Prespecified safety analyses revealed that drug related adverse experiences occurred significantly less frequently with etoricoxib (22.7%) than with indometacin (46.7%) (P=0.003), although overall adverse experience rates were similar between the two treatment groups.
Conclusion: Etoricoxib 120 mg once daily provides rapid and effective treatment for acute gouty arthritis comparable to indometacin 50 mg three times daily. Etoricoxib was generally safe and well tolerated in this study.
Footnotes
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Funding Merck Research Laboratories, Rahway, NJ, USA, provided funding to all participating investigators to cover the costs of patient procedures and evaluations.
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Competing interests HRS is on the Merck arthritis advisory board and has received fees for speaking and organising educational programmes and consultancy fees from Merck Research Laboratories and Pfizer. DID has received fees for speaking and a consultancy fee from Merck Research Laboratories. JAB, SM, KM, and JN are employed by Merck and own shares of Merck common stock.
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An additional box, table, and figure appear on bmj.com
- Accepted 11 April 2002