Double-blind multicentre, between patients comparison of indoprofen and indomethacin in rheumatoid arthritis patients under basic steroid treatment.

The study was aimed at comparing effectiveness, safety and possible steroid sparing effects of indoprofen (800 mg/day) and indomethacin (100 mg/day), in patients with classical or definite rheumatoid arthritis, in active phase, receiving basic steroid treatment at a fixed, not reducible dosage. Treatments were given in double-blind condition, for 1,3 or 6 months, and 97 patients were evaluated. A significant improvement of baseline conditions was obtained with both drugs in all variables considered for evaluation of effectiveness. The initial steroid dosage could be reduced 72% in the indoprofen group and 53% in the indomethacin group; 50% of the patients receiving indoprofen and 22.4% of those receiving indomethacin stopped steroid intake during the trial. Adverse reactions, considered drug related, were observed in 6.7% of patients in the indoprofen group and 34.1% of those given indomethacin.