DICLOFENAC MISOPROSTOL - THE EUROPEAN CLINICAL-EXPERIENCE/

Objective. The fixed combination of diclofenac sodium and misoprostol (Arthrotec(R) is the only nonsteroidal antiinflammatory drug (NSAID) t hat contains a gastroprotective component and is available in 2 formul ations: (1) an enteric coated con of diclofenac sodium 50 mg surrounde d by a mantle of misoprostol 200 mu g, and (2) a 75 mg enteric coated diclofenac core also surrounded by a 200 mu g mantle of misoprostol. T his article reviews the European clinical experience with both formula tions in patients with arthritis. Methods. Three randomized, blinded, multicenter studies, including one in general practice, evaluated the efficacy of combination diclofenac/misoprostol versus diclofenac or ib uprofen in a total of 1824 patients with rheumatoid arthritis (RA) or osteoarthritis (OA). Four additional studies assessed antiarthritic ef ficacy and employed endoscopy to compare the gastroduodenal safety of combined diclofenac50/misoprostol with that of diclofenac, naproxen, p iroxicam, or indomethacin in 1459 patients with RA, OA, or ankylosing spondylitis. The gastroduodenal safety and antiarthritic efficacy of d iclofenac75/misoprostol was compared with that of diclofenac in one en doscopy study involving 514 patients with RA or OA. Results. The effic acy and safety data obtained from these European clinical trials show that both formulations diclofenac50/misoprostol and diclofenac75/misop rostol are effective antiinflammatory drugs, with clinical efficacy eq uivalent to that of diclofenac. Diclofenac50/misoprostol is at least a s effective as naproxen, piroxicam, indomethacin, and ibuprofen. Both formulations of the combination were associated with significantly few er gastroduodenal ulcers compared with diclofenac. In separate studies , the tolerability of diclofenac50/misoprostol las determined by withd rawal rates) was shown to be equivalent to that of diclofenac, naproxe n, piroxicam, and ibuprofen, and the tolerability of diclofenac75/miso prostol was shown to be equivalent to that of diclofenac. The diclofen ac50/misoprostol was associated with fewer decreases in hemoglobin con centration compared with diclofenac in the general practice study as w ell as in hospital patients. Conclusion. Diclofenac50/misoprostol and diclofenac75/misoprostol are effective in treating the signs and sympt oms. of RA and OA and are well tolerated by the majority of patients. Both of these formulations achieve a significant reduction in the inci dence of both gastric and duodenal ulcers compared with other NSAID.