Efficacy of esomeprazole (20 mg once daily) for reducing the risk of gastroduodenal ulcers associated with continuous use of low-dose aspirin
Date
2008
Authors
Yeomans N.
Lanas A.
Labenz J.
Van Zanten S.V.
Van Rensburg C.
Racz I.
Tchernev K.
Karamanolis D.
Roda E.
Hawkey C.
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
OBJECTIVES: Low-dose aspirin is standard treatment for prevention of cardiovascular events in at-risk patients. However, long-term administration of low-dose aspirin is associated with a greater risk of adverse events, including gastroduodenal ulcers. This study determined the efficacy of esomeprazole for reducing the risk of gastric and/or duodenal ulcers and dyspeptic symptoms in patients receiving continuous, low-dose aspirin therapy. METHODS: Patients aged ≥60 yr, without baseline gastroduodenal ulcer at endoscopy, who were receiving aspirin 75-325 mg once daily, were randomized to esomeprazole 20 mg once daily or placebo for 26 wk. The presence of endoscopic gastric and/or duodenal ulcers and esophageal lesions was assessed at weeks 8 and 26. Upper gastrointestinal symptoms were assessed at weeks 8, 16, and 26. RESULTS: The intention-to-treat population comprised 991 patients (esomeprazole, N = 493; placebo, N = 498). Twenty-seven patients (5.4%) in the placebo group developed a gastric or duodenal ulcer during 26 weeks' treatment compared with eight patients (1.6%) in the esomeprazole group (life-table estimates: 6.2% vs 1.8%; P = 0.0007). At 26 wk, the cumulative proportion of patients with erosive esophagitis was significantly lower for esomeprazole versus placebo (4.4% and 18.3%, respectively; P < 0.0001). At 26 wk, esomeprazole-treated patients were more likely to experience resolution of heartburn, acid regurgitation, and epigastric pain (P < 0.05). CONCLUSIONS: Esomeprazole 20 mg once daily reduces the risk of developing gastric and/or duodenal ulcers and symptoms associated with the continuous use of low-dose aspirin in patients aged ≥60 yr without preexisting gastroduodenal ulcers. © 2008 by Am. Coll. of Gastroenterology.
Description
Keywords
acetylsalicylic acid, esomeprazole, placebo, adult, aged, article, clinical trial, controlled clinical trial, controlled study, double blind procedure, drug efficacy, drug withdrawal, duodenum ulcer, epigastric pain, female, food regurgitation, gastroduodenal ulcer, gastrointestinal hemorrhage, heart disease, heart infarction, heartburn, high risk patient, human, low drug dose, major clinical study, male, multicenter study, priority journal, randomized controlled trial, reflux esophagitis, risk reduction, stomach ulcer, stroke, unspecified side effect, Aged, Anti-Inflammatory Agents, Non-Steroidal, Aspirin, Dose-Response Relationship, Drug, Double-Blind Method, Endoscopy, Gastrointestinal, Enzyme Inhibitors, Female, Follow-Up Studies, Humans, Incidence, Male, Omeprazole, Peptic Ulcer, Retrospective Studies, Risk Factors, Treatment Outcome, World Health
Citation
American Journal of Gastroenterology
103
10
103
10