Objective To determine whether once-daily esomeprazole 40 mg or 20 mg compared with placebo reduces the incidence of peptic ulcers over 26 weeks of treatment in patients taking low-dose acetylsalicylic acid (ASA) and who are at risk for ulcer development.
Design Multinational, randomised, blinded, parallel-group, placebo-controlled trial.
Setting Cardiology, primary care and gastroenterology centres (n=240).
Patients Helicobacter pylori-negative patients taking daily low-dose ASA (75–325 mg), who fulfilled one or more of the following criteria: age ≥18 years with history of uncomplicated peptic ulcer; age ≥60 years with either stable coronary artery disease, upper gastrointestinal symptoms and five or more gastric/duodenal erosions, or low-dose ASA treatment initiated within 1 month of randomisation; or age ≥65 years. All patients were ulcer-free at study entry.
Interventions Once-daily, blinded treatment with esomeprazole 40 mg, 20 mg or placebo for 26 weeks.
Main outcome measures The primary end point was the occurrence of endoscopy-confirmed peptic ulcer over 26 weeks.
Results A total of 2426 patients (52% men; mean age 68 years) were randomised. After 26 weeks, esomeprazole 40 mg and 20 mg significantly reduced the cumulative proportion of patients developing peptic ulcers; 1.5% of esomeprazole 40 mg and 1.1% of esomeprazole 20 mg recipients, compared with 7.4% of placebo recipients, developed peptic ulcers (both p<0.0001 vs placebo). Esomeprazole was generally well tolerated.
Conclusions Acid-suppressive treatment with once-daily esomeprazole 40 mg or 20 mg reduces the occurrence of peptic ulcers in patients at risk for ulcer development who are taking low-dose ASA.
Clinical trial registration number ClinicalTrials.gov identifier: NCT00441727.
- Peptic ulcer
- acetylsalicylic acid
- cardiovascular risk management
- clinical trials
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Funding This study was supported by AstraZeneca, the manufacturer of esomeprazole.
Competing interests JMS—consultant: AstraZeneca, Novartis, Pfizer, Bayer, Takeda, Pozen, NiCox. Speaker's honoraria: AstraZeneca. PJD—AstraZeneca previously supplied the study drug for a large, international, investigator-initiated, Canadian Institutes of Health Research funded randomised, controlled trial (ie, the POISE-1 Trial). JH—no conflicts of interest declared. PHK—speaker for AstraZeneca, Nycomed and Janssen-Cilag. No stocks or shares or direct financial links. AL—adviser to AstraZeneca, Pfizer, Nicox, Bayer. Speaker: AstraZeneca, Pfizer. SVvZ—grant/research support and/or honoraria: Abbott, AstraZeneca, Janssen-Ortho, Nycomed and Takeda. EN, L-ES—employees: AstraZeneca.
Ethics approval This study was conducted with the approval of the relevant local institutional review boards or independent ethics committees of each study centre, according to local regulations.
Provenance and peer review Not commissioned; externally peer reviewed.
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