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Efficacy of esomeprazole (20 mg once daily) for reducing the risk of gastroduodenal ulcers associated with continuous use of low-dose aspirin

dc.contributor.authorYeomans N.
dc.contributor.authorLanas A.
dc.contributor.authorLabenz J.
dc.contributor.authorVan Zanten S.V.
dc.contributor.authorVan Rensburg C.
dc.contributor.authorRacz I.
dc.contributor.authorTchernev K.
dc.contributor.authorKaramanolis D.
dc.contributor.authorRoda E.
dc.contributor.authorHawkey C.
dc.contributor.authorNaucler E.
dc.contributor.authorSvedberg L.-E.
dc.date.accessioned2011-05-15T16:15:20Z
dc.date.available2011-05-15T16:15:20Z
dc.date.issued2008
dc.identifier.citationAmerican Journal of Gastroenterology
dc.identifier.citation103
dc.identifier.citation10
dc.identifier.issn00029270
dc.identifier.other10.1111/j.1572-0241.2008.01995.x
dc.identifier.urihttp://hdl.handle.net/10019.1/13295
dc.description.abstractOBJECTIVES: 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.
dc.subjectacetylsalicylic acid
dc.subjectesomeprazole
dc.subjectplacebo
dc.subjectadult
dc.subjectaged
dc.subjectarticle
dc.subjectclinical trial
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectdouble blind procedure
dc.subjectdrug efficacy
dc.subjectdrug withdrawal
dc.subjectduodenum ulcer
dc.subjectepigastric pain
dc.subjectfemale
dc.subjectfood regurgitation
dc.subjectgastroduodenal ulcer
dc.subjectgastrointestinal hemorrhage
dc.subjectheart disease
dc.subjectheart infarction
dc.subjectheartburn
dc.subjecthigh risk patient
dc.subjecthuman
dc.subjectlow drug dose
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectmulticenter study
dc.subjectpriority journal
dc.subjectrandomized controlled trial
dc.subjectreflux esophagitis
dc.subjectrisk reduction
dc.subjectstomach ulcer
dc.subjectstroke
dc.subjectunspecified side effect
dc.subjectAged
dc.subjectAnti-Inflammatory Agents, Non-Steroidal
dc.subjectAspirin
dc.subjectDose-Response Relationship, Drug
dc.subjectDouble-Blind Method
dc.subjectEndoscopy, Gastrointestinal
dc.subjectEnzyme Inhibitors
dc.subjectFemale
dc.subjectFollow-Up Studies
dc.subjectHumans
dc.subjectIncidence
dc.subjectMale
dc.subjectOmeprazole
dc.subjectPeptic Ulcer
dc.subjectRetrospective Studies
dc.subjectRisk Factors
dc.subjectTreatment Outcome
dc.subjectWorld Health
dc.titleEfficacy of esomeprazole (20 mg once daily) for reducing the risk of gastroduodenal ulcers associated with continuous use of low-dose aspirin
dc.typeArticle
dc.description.versionArticle


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