Twelve-week study of etodolac, aspirin, and placebo in patients with rheumatoid arthritis.

Etodolac, aspirin, and placebo were evaluated for efficacy and safety in 20 patients with adult-onset active rheumatoid arthritis who entered a 12-week, double-blind, parallel-group study divided into drug titration and maintenance periods and preceded by a two-week washout period. During the maintenance period the mean daily doses of etodolac and aspirin were 319 mg and 4,701 mg, respectively. At the end of the study, patients treated with etodolac showed significant improvement from baseline values in seven of ten clinical variables, namely, painful joints, swollen joints, articular index, pain intensity, morning stiffness, and investigator's and patient's overall assessments. In patients treated with aspirin, only pain intensity was lessened significantly; in those treated with placebo, only pain intensity lessened significantly and only the patient's overall assessment improved significantly. No serious side effects were noted in patients treated with etodolac. Three patients treated with aspirin were withdrawn from the study because of adverse reactions--two experienced gastrointestinal side effects and one had elevated liver enzyme levels.