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© 1992 British Society for Rheumatology

research-article

THE GASTRODUODENAL SAFETY AND EFFICACY OF THE FIXED COMBINATION OF DICLOFENAC AND MISOPROSTOL IN THE TREATMENT OF OSTEOARTHRITIS

W. BOLTEN*, J. A. MELO GOMESt{dagger}, H. STEAD{ddagger} and G. S. GEIS{ddagger}

*Rheumaklinik Bad Rappenau Germany
{dagger}Hospital Militar Principal, Lisbon Portugal
{ddagger}Searle Research and Development Skokie, IL, USA

Correspondence to: Correspondence to G. S. Geis, Senior Director, Clinical Research, Searle Research & Development, 4901 Searle Parkway, Skokie, IL 60077, USA.

A double-blind, randomized, parallel group study was conducted to compare the gastroduodenal safety and antiarthritic efficacy of a fixed combination of diclofenac 50 mg and misoprostol 200 tg with that of a combination of diclofenac 50 mg and placebo in patients with osteoarthritis. Three hundred and sixty-one patients with no significant gastroduodenal lesions were enrolled and received study medication two or three times daily for 4 weeks. Post-treatment endoscopic examination of the gastroduodenal mucosa revealed ulcers in 4% of patients in the diclofenac/placebo group compared with none in the diclofenacimisoprostol group (P=0.015). There were no clinically or statistically significant differences between the two treatment groups in formal assessments of osteoarthritis after either 2 or 4 weeks. It was concluded that diclofenadmisoprostol was associated with significantly less gastroduodenal damage than diclofenac, whilst being as effec tive as diclofenac alone in the treatment of osteoarthritis.

KEY WORDS: Gastroduodenal safety, Diclofenac, Misoprostol, NSAIDs, Osteoarthritis, Ulcers


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