Short-term efficacy and tolerance of tiaprofenic acid ('Surgam') in rheumatoid arthritis and osteoarthritis: multi-centre, placebo-controlled trials

Abstract

Two multi-centre, placebo-controlled, crossover trials of tiaprofenic acid were conducted to an identical design: one in 80 patients suffering from rheumatoid arthritis, the other in 60 patients suffering from osteoarthritis. After a washout period, each patient received 600 mg tiaprofenic acid daily and placebo each for 1 week. The results were similar for both trials. Tiaprofenic acid was more effective than placebo in both rheumatoid arthritis and osteoarthritis and differences in all the assessments of efficacy used were statistically significant. This significance was attained from the first day in rheumatoid arthritis and from the second day in osteoarthritis. Tiaprofenic acid was as well tolerated as placebo. Routine laboratory tests revealed no adverse effects. Possible side-effects, which were predominantly mild and related to the gastro-intestinal system, were reported by 23% patients with tiaprofenic acid and 21% patients with placebo. The 2 patients withdrawn for possible side-effects were both receiving placebo.