title: Comparisons of tolerability findings in international clinical trials.
abstract: 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.
mesh_terms: D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D001241:Aspirin / Q000627:therapeutic use; D002319:Cardiovascular System / Q000187:drug effects; D002986:Clinical Trials as Topic; D004008:Diclofenac / Q000009:adverse effects / Q000627:therapeutic use*; D004361:Drug Tolerance; D005500:Follow-Up Studies; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006403:Hematologic Tests; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use; D007213:Indomethacin / Q000627:therapeutic use; D007391:International Cooperation; D009288:Naproxen / Q000627:therapeutic use; D010648:Phenylacetates / Q000627:therapeutic use*; D013997:Time Factors
chemical_list: D010648:Phenylacetates; D004008:Diclofenac; D009288:Naproxen; D001241:Aspirin; D007052:Ibuprofen; D007213:Indomethacin