A Doubleblind Comparison of the Gastroduodenal Safety and Efficacy of Diclofenac and a Fixed Dose Combination of Diclofenac and Misoprostol in the Treatment of Rheumatoid Arthritis

Abstract

Verdickt W, Moran C, Hantzschel H, Fraga AM, Stead H, Geis GS. A Double-blind Comparison of the Gastroduodenal Safety and Efficacy of Diclofenac and a Fixed Dose Combination of Diclofenac and Misoprostol in the Treatment of Rheumatoid Arthritis. Scand J Rheumatol 1992; 21: 85–91.

This double-blind, parallel group study was conducted to evaluate the gastroduodenal safety and antiarthritic efficacy of a fixed combination of diclofenac sodium 50 mg and misoprostol 200 mcg, compared with a combination of diclofenac 50 mg and placebo. Three hundred and thirty-nine patients with rheumatoid arthritis and no significant gastric or duodenal mucosal damage were enrolled and received study medication (diclofenac/misoprostol, 164; diclofenac/placebo, 175) BID or TID for 12 weeks. Post-treatment gastroduodenal endoscopic examinations revealed ulcers in 11% of the diclofenac/placebo group, compared with only 4% of the diclofenac/ misoprostol group (p = 0.034). Four-weekly assessments of arthritic condition revealed no clinically or statistically significant treatment differences. It was concluded that diclofenadmisoprostol caused significantly less gastroduodenal damage than diclofenac, but was as effective as diclofenac alone in the treatment of rheumatoid arthritis.

Key Words:

• diclofenachnisoprostol
• fixed combination
• gastroduodenal ulcer
• rheumatoid arthritis