Gastroduodenal safety of Nimesulid (Nimesil, Berlin Chemie) in rheumatic patients with history of ulcer

Abstract

Objective. To assess safety of nimesulid in rheumatic pts with history of ulcer or multiple erosions (ME) of stomach and/or duodenal mucosa. Methods. 42 pts with rheumatic diseases aged 22-73 years were included. AH had gastric or duodenal ulcers or ME (n>10) connected with NSAID treatment and confirmed by endoscopy no more than 6 months before the beginning of the study. Pts were included after healing of ulcers and erosions. The pts were randomized to receive Nimesulid 200 mg/day (group 1) or Diclofenac suppositoria 100 mg/day + ranitidine 150 mg/day (group 2). Esophagogastroduodenoscopy was performed before and 12 weeks after the beginning of treatment. Results. Relapse of stomach ulcer was observed in I pts of group 1 (5,6%). Relapse of NSAID-induced ulcers and ME was noted in 6 pts of group 2 (33,3%): in 4 cases stomach ulcers, in 1 case stomach ME, in 1 case duodenal ulcer (p=0,0424). Presence of gastralgias and dyspepsia was noted in 36,8% pts of group 1 and in 20% pts of group 2 (p=0,0539). In 1 pts of group 2 gastralgias were the reason for premature endoscopy. Conclusion. Nimesil (Nimesulid) can be considered as a more safe drug than classical NSAIDs with smaller risk of serious gastroduodenal complications development in rheumatic pts with ulcer history. The results of the study allow to recommend Nimesulid as a drug of choice for treatment of pts with history of NSAID-induced gastropathy.

Keywords

• selective cox-2 inhibitor
• nimesulid
• nsaid-induced gastropathy
• safety of antirheumatic drugs