Etodolac, aspirin, and placebo in patients with rheumatoid arthritis: a 12-week study.

Etodolac, aspirin, and placebo were evaluated for efficacy and safety in 18 patients with adult-onset, active rheumatoid arthritis. This was a 12-week, double-blind, parallel-group study divided into drug titration and maintenance periods and preceded by a washout period of up to two weeks. The mean daily maintenance doses of etodolac and aspirin were 394 mg and 4,414 mg, respectively. Etodolac was significantly (P less than or equal to 0.05) more effective than placebo in five of ten clinical variables of efficacy: number of painful joints, number of swollen joints, pain intensity, erythrocyte sedimentation rate, and patients' overall assessments. Aspirin was significantly more effective than placebo in only two assessments: number of painful joints and pain intensity. One patient on etodolac, two patients on aspirin, and four patients on placebo had to be withdrawn from the trial because of insufficient therapeutic response. One patient in the placebo group was withdrawn from the study because of a pruritic rash. Mild to moderate gastrointestinal complaints occurred in all three treatment groups: in three patients taking etodolac, three taking aspirin, and two taking placebo.