Overview of efficacy of fenbufen in rheumatoid arthritis and osteoarthritis.

Fenbufen (Cinopal) has been evaluated extensively in 155 clinical trials, including 102 in rheumatoid arthritis and 53 in osteoarthritis. Forty-nine of these trials involving 12 protocols have been identified as pivotal. All 12 protocols (six rheumatoid arthritis and six osteoarthritis) were double-blind and controlled, with the duration of treatment ranging from four weeks to one year, and included sufficient patient populations to detect important differences in efficacy between fenbufen and the reference agents. Evaluation of the efficacy results was based on the standard parameters commonly measured for rheumatoid arthritis and osteoarthritis. The primary evaluation point was the end of four weeks of therapy. Results of the 49 studies employing the 12 pivotal protocols, demonstrated that fenbufen, given in divided daily doses of 600 to 1,000 mg, provided significant anti-inflammatory effects. These effects were superior to placebo and comparable to those attained with full therapeutic doses of aspirin, indomethacin, phenylbutazone, and ozyphenbutazone. Long-term trials provided important information as to the relative effectiveness and tolerance of fenbufen in the management of patients with rheumatoid arthritis and osteoarthritis. The proportion of fenbufen-treated patients able to continue long-term therapy was substantially greater than the proportion of aspirin-, indomethacin-, or placebo-treated patients. Results from these trials indicate that fenbufen provides a more favorable ratio of benefit to risk than either aspirin or indomethacin.