Short-term study of indoprofen in comparison with placebo and indomethacin in rheumatoid arthritis.

The results of a multicentre, double-blind trial are reported, where the effectiveness and safety of indoprofen (IP) were compared with indomethacin (IM) and placebo (PL), in patients with rheumatoid arthritis. After an initial "wash-out" period (3 days), each patient was given each of the three treatments for one week, in randomized sequence. The total dose of indoprofen (tablets) was 800 mg/die and that of indomethacin (capsules) 200 mg/die, in 4 daily doses after the main meals. The evaluation of effectiveness on a cumulative group of 102 cases from 18 centres showed statistically significant differences in favour of both active drugs compared to placebo, based on a series of objectives and subjective criteria. There was no significant difference between IP and IM, but on factorial analysis of correspondences, IP showed a greater difference from placebo. The patient's judgments also suggested that IP (800 mg/die) was slightly more effective than IM (100 mg/die). Adverse reactions were observed in 8.9% of the patients on IM treatment, 3.9% on IP and in 39% on PL. Laboratory variables showed no significant changes in the course of treatment.