Comparison of Prevention of NSAID-Induced Gastrointestinal Complications by Rebamipide and Misoprostol: A Randomized, Multicenter, Controlled Trial-STORM STUDY

Abstract

Summary Nonsteroidal anti-inflammatory drugs (NSAIDs) have gastrointestinal side effects such as dyspepsia, peptic ulcer, hemorrhage, and perforation. Misoprostol and PPIs have been used to prevent NSAID-induced gastroduodenal injury. Rebamipide increases gastric mucus and stimulates the production of endogenous prostaglandins. The prophylactic effect of rebamipide on NSAID-induced gastrointestinal complications is unknown. The aim of this study was to compare NSAID-induced gastrointestinal complications in rebamipide-and misoprostol-treated groups. Patients were randomized to two groups and took a conventional NSAID plus rebamipide or misoprostol for 12 weeks. Gastric mucosal damage was evaluated by endoscopy at screening and the end of the study. The prevalences of active gastric ulcer were 7/176 (3.9%) in the rebamipide group and 3/156 (1.9%) in the misoprostol group. The prevalences of peptic ulcer were 8/176 (4.5%) in the rebamipide group and 7/156 (4.4%) in the misoprostol group. The cumulative incidences of peptic ulcer in the high-risk subgroup were 6/151 (4.0%) for rebamipide and 6/154 (3.9%) for misoprostol. In conclusion, rebamipide prevented NSAID-induced peptic ulcer as effectively as misoprostol in patients on long-term NSAID therapy. Rebamipide may be a useful therapeutic option for the prevention of NSAIDinduced gastrointestinal ulcer because of its therapeutic effect and safety.Key Words: rebamipide, misoprostol, NSAID, gastrointestinal tract, clinical trial *To whom correspondence should be addressed. Tel: +82-2-3779-3029Fax: +82-2-3779-1331 E-mail: psheon@catholic.ac.kr Abbreviations: NSAID, nonsteroidal antiinflammatory drug; PPI, proton pump inhibitor; GERD, gastroesophageal reflux disease; H2RA, histamine 2 receptor antagonist; STORM, Study of NSAID-induced GI Toxicity Prevention by Rebamipide and Misoprostol.

Management for non-variceal upper gastrointestinal bleeding in elderly patients: the experience of a tertiary university hospital

“…have been proposed according to cases even with oral antithrombotic drugs alone (23,24). On the other hand, there have been reports that histamine 2 receptor antagonists (H2RA) and certain mucosal protective agents have a preventive effect against NSAIDs ulcers (25,26). On the contrary, PPI has also been reported as a possible exacerbating factor for NSAIDsinduced small intestinal ulcers (27,28).…”

Present status and strategy of NSAIDs-induced small bowel injury

“…A PPI was administered 30 min before indomethacin administration: omeprazole (30, 100 mg/kg), lansoprazole (30, 100 mg/kg), or rabeprazole (30, 100 mg/kg). The following were administered twice-30 min before and 6 h after indomethacin administration: an H 2 receptor antagonist (famotidine (3, 10 mg/kg), cimetidine (100 mg/kg), lafutidine [50] (30 mg/kg), or roxatidine [51] (60, 100, 200 mg/kg)); a mucosal protective agent (teprenone [52] (100, 300 mg/kg), rebamipide [53] (100, 300 mg/kg), irsogladine [54] (1, 10 mg/kg), ecabet sodium [55] (300 mg/kg)); sucralfate (500 mg/kg) or a PG analog (misoprostol (0.1 mg/kg)).…”

Circadian Variations of Gastrointestinal Mucosal Damage Detected with Transnasal Endoscopy in Apparently Healthy Subjects Treated with Low-Dose Aspirin (ASA) for a Short Period

“…In the future, it will be important to investigate the relationship between slight gastric damage over a few days and serious bleeding. Recently, it was reported that rebamipide may have better preventive efficacy for NSAIDinduced GI ulcers than misoprostol 32) . Although PPI is the most commonly used drug for patients with low-dose ASA induced GI complications, the result of our previous study may suggest the possibility of rebamipide as a candidate drug for H.pylori -negative patients.…”