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Clinical therapeutics · Oct 2004
Randomized Controlled Trial Multicenter Study Clinical TrialUlcer recurrence in high-risk patients receiving nonsteroidalanti-inflammatory drugs plus low-dose aspirin: results of a post HOC subanalysis.
- Jay L Goldstein, Bidan Huang, Fouad Amer, and Nikos G Christopoulos.
- Department of Medicine, University of Illinois at Chicago, 840 South Wood Street (m/c 787), Room 1020, 10th Floor, Chicago, IL 60612, USA. jlgoldst@uic.edu
- Clin Ther. 2004 Oct 1; 26 (10): 1637-43.
BackgroundConcomitant aspirin use is a risk factor for nonsteroidal anti-inflammatory drug (NSAID)-associated upper gastrointestinal toxicity. In high-risk individuals, such as those with a history of NSAID-related gastric ulcer bleeding, gastroprotective therapy with a proton pump inhibitor has been reported to reduce the risk of recurrent aspirin-associated gastroduodenal ulcer bleeding.ObjectiveThis analysis compared the efficacy of misoprostol, lansoprazole, and placebo in reducing the risk of gastric or duodenal ulcer recurrence in patients taking NSAIDs and low-dose aspirin.MethodsThis post hoc subanalysis was based on a previous multicenter, prospective, randomized, double-blind, placebo-controlled, 12-week study in patients who had a history of gastric ulcer, were Helicobacter pylori negative, required chronic NSAID therapy, and were free of gastric or duodenal ulcer on baseline endoscopy. The study treatments were misoprostol 200 microg QID or lansoprazole 15 or 30 mg OD. The subanalysis included data from patients in the intent-to-treat cohort who took aspirin at an amount
ResultsOf 535 intent-to-treat patients from the primary study, 70 (40 men, 30 women; mean [SD] age, 64.7 [10.0] years; age range, 40-83 years) met the criteria for inclusion in the subanalysis. The proportions of patients who were free of gastric ulcers at the end of 12 weeks were 96% in the misoprostol group, 93% in the lansoprazole 15-mg group, 100% in the lansoprazole 30-mg group, and 35% in the placebo group (P ConclusionsIn this subgroup analysis in patients at high risk for recurrence of gastric ulcer, use of cotherapy with misoprostol 200 microg QID or lansoprazole 15 or 30 mg OD significantly lowered the risk for gastric ulcer recurrence. Notes
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