Comparison of benefit-to-risk ratios of aspirin and fenoprofen: controlled multicentre study in rheumatoid arthritis.

The benefit-to-risk ratios of fenoprofen (2.4 gm/day) and aspirin (3.9 gm/day) were compared in a randomized, double-blind, 26-week parallel study involving 216 patients. Criteria for inclusion, exclusion, subjective, and objective evaluations were based on the PMA-FDA Nonsteroidal Anti-Inflammatory Drug Clinical Testing Guidelines. Thirty-four of 109 aspirin-treated patients and 23 of 107 patients on fenoprofen dropped out of the study. Both fenoprofen and aspirin brought about improvement in most efficacy parameters measured, but fenoprofen was superior to aspirin (p less than 0.05) in reduction of swollen joints, grip strength, activity index, and patients' preference of medication. The number and frequency of complaints and the incidence of abnormal SGOT levels, were greater with aspirin than with fenoprofen. The study suggests that fenoprofen has a better benefit-to-risk ratio than aspirin, when given in equally effective doses.