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Rofecoxib, a New Cyclooxygenase 2 Inhibitor, Shows Sustained Efficacy, Comparable With Other Nonsteroidal Anti-inflammatory Drugs
A 6-Week and a 1-Year Trial in Patients With Osteoarthritis
Kenneth Saag, MD, MSc;
Desiree van der Heijde, MD;
Chester Fisher, MD;
Adil Samara, MD;
Lisa DeTora, PhD;
James Bolognese, MS;
Rhoda Sperling, MD;
Brian Daniels, MD;
for the Osteoarthritis Studies Group
Arch Fam Med. 2000;9:1124-1134.
Introduction Rofecoxib, a cyclooxygenase 2 inhibitor (sometimes known as a specific cyclooxygenase 2 inhibitor or Coxib), is used in osteoarthritis (OA). Published information indicates rofecoxib's improved gastrointestinal safety profile over nonselective nonsteroidal anti-inflammatory agents (NSAIDs).
Objective To evaluate the efficacy and safety of rofecoxib in treating OA in 2 studies.
Methods Two randomized, double-blind, parallel-group studies in patients with OA of the knee or hip were conducted using identical entry criteria and end points. A 6-week placebo-controlled trial in 736 patients compared 12.5 and 25 mg of rofecoxib once daily with 800 mg of ibuprofen 3 times daily, and a 1-year study compared 12.5 and 25 mg of rofecoxib once daily with 50 mg of diclofenac 3 times daily in 693 patients.
Results Rofecoxib, at 12.5 and 25 mg, demonstrated efficacy clinically comparable with ibuprofen, assessed by 3 primary end points according to predefined comparability criteria. Both rofecoxib doses and ibuprofen provided significantly greater efficacy than placebo on all primary end points at 6 weeks. Both rofecoxib doses and diclofenac showed similar efficacy over 1 year. All treatments were well tolerated.
Conclusions Rofecoxib is effective in treating OA with once-daily dosing for 6 weeks and 1 year. Rofecoxib was generally safe and well-tolerated in OA patients for 6 weeks and 1 year.
From the Division of Clinical Immunology and Rheumatology, University of Alabama, Birmingham (Dr Saag); the Department of Rheumatology, Maastricht University Hospital, Maastricht, the Netherlands (Dr van der Heijde); the Tidewater Physicians Multispecialty Group, Newport News, Va (Dr Fisher); the Department of Rheumatology, Hospital das Clinicas-UNICAMP, Campinas, Sao Paulo, Brazil (Dr Samara); and the Merck Research Laboratories, Merck & Co, Rahway, NJ (Drs DeTora, Sperling, and Daniels and Mr Bolognese). Drs Saag, van der Heijde, and Samara have received honoraria and served as consultants to Merck & Co Inc.
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