Comparisons of tolerability findings in international clinical trials

This report summarizes tolerability results from over 30 000 patients treated with diclofenac in clinical trials in rheumatic and other indications in 21 countries. Comparative trials indicates that 75-150 mg daily of diclofenac is better tolerated than similar doses of indomethacin and 1.5-5 g daily of aspirin, and at least as well tolerated as 600-1200 mg of ibuprofen and 500 mg daily of naproxen. In general practice populations unwanted effects can be expected in about 18% of patients and will result in discontinuation in about 4%. Gastrointestinal disturbances were the most frequent unwanted effects with diclofenac, occurring in about 8% of patients. Mild CNS effects also occurred infrequently in about 1.5% and dermatological effects in about 1%; cardiovascular effects also occurred in about 1%. As over 80% of unwanted effects and all of the discontinuations for intolerability occurred in the first six months, the tolerability of diclofenac does not decrease with time.