title: Comparison of Prevention of NSAID-Induced Gastrointestinal Complications by Rebamipide and Misoprostol: A Randomized, Multicenter, Controlled Trial-STORM STUDY.
abstract: 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 NSAID-induced gastrointestinal ulcer because of its therapeutic effect and safety.
authors.affiliation: St. Mary’s Hospital, The Catholic University of Korea, Seoul 150-713, Korea.
authors.forename: Soo-Heon
authors.initials: SH
authors.lastname: Park
authors.forename: Chul-Soo
authors.initials: CS
authors.lastname: Cho
authors.forename: Oh-Young
authors.initials: OY
authors.lastname: Lee
authors.forename: Jae-Bum
authors.initials: JB
authors.lastname: Jun
authors.forename: San-Ren
authors.initials: SR
authors.lastname: Lin
authors.forename: Li-Ya
authors.initials: LY
authors.lastname: Zhou
authors.forename: Yao-Zong
authors.initials: YZ
authors.lastname: Yuan
authors.forename: Zhao-Shen
authors.initials: ZS
authors.lastname: Li
authors.forename: Xiao-Hua
authors.initials: XH
authors.lastname: Hou
authors.forename: Hong-Chuan
authors.initials: HC
authors.lastname: Zhao
authors.forename: Udom
authors.initials: U
authors.lastname: Kachintorn
authors.forename: Chomsri
authors.initials: C
authors.lastname: Kositchaiwat
authors.forename: Comson
authors.initials: C
authors.lastname: Lertkupinit