Rofecoxib in rheumatoid arthritis: new indication. No better that other NSAIDS

(1) For symptoms of rheumatoid arthritis (pain, joint stiffness), the reference treatment is a nonsteroidal antiinflammatory drug (NSAID) such as diclofenac or ibuprofen. Celecoxib, a coxib NSAID, has no proven advantages over these other NSAIDs. (2) Rofecoxib is the second coxib to be approved in this indication. The clinical evaluation file shows that the optimal daily dose is 25 mg. (3) A comparative trial in more than 8 000 patients, showed that rofecoxib was no more effective than 1 g/day of naproxen. There are no trials comparing rofecoxib with celecoxib, diclofenac or ibuprofen. (4) In clinical trials the overall frequencies of adverse effects and treatment withdrawals for adverse effects were the same for rofecoxib as for other NSAIDs. In one trial, rofecoxib caused fewer gastrointestinal disturbances, particularly serious ones, than naproxen. But rofecoxib caused more gastrointestinal disturbances than placebo. During postmarketing follow up in the United States, a number of deaths due to gastrointestinal complications on rofecoxib were reported. Rofecoxib carries the same renal risk as other NSAIDs. An excess risk of cardiovascular events cannot be ruled out. (5) In practice, the advent of rofecoxib in no way influences the choice of NSAID for symptomatic treatment of rheumatoid arthritis.