Double-blind comparison of etodolac and diclofenac in patients with rheumatoid arthritis.

The efficacy and tolerability of etodolac was compared to diclofenac in a multi-centre, double-blind, randomized parallel group study. Fifty-three patients with rheumatoid arthritis received etodolac (400 mg/day) and 55 patients received diclofenac (150 mg/day) for 12 weeks. Thirty-nine etodolac-treated patients and 44 diclofenac-treated patients completed the study. At the final evaluation, etodolac-treated patients showed significant (p < or = 0.05) improvement for all 4 primary assessments (patients' and physicians' global evaluations, number of tender or painful joints, and number of swollen joints) and 6 of 7 secondary assessments, while diclofenac-treated patients showed significant improvement for 3 primary assessments (patients' and physicians' global evaluations and number of tender joints) and 3 secondary assessments. In the physicians' global assessment, improvement at the final evaluation was indicated for 58% of the etodolac-treated patients and 47% of the diclofenac-treated patients. Both etodolac and diclofenac were well tolerated. As expected for non-steroidal anti-inflammatory drugs, gastrointestinal side-effects were the most common, occurring in 12 patients in each group. There were no significant differences between groups in the incidence of any study event. In conclusion, the results of this study indicate that etodolac is well tolerated and effective in the treatment of rheumatoid arthritis, comparable to diclofenac.