Prevention of peptic ulcers with esomeprazole in patients at risk of ulcer development treated with low-dose acetylsalicylic acid: a randomised, controlled trial (OBERON)

Scheiman, James M.; Devereaux, P. J.; Herlitz, Johan; Katelaris, Peter H.; Lanas, Angel; van Zanten, Sander Veldhuyzen; Naucl?(c)r, Emma; Svedberg, Lars-Erik
March 2011
Heart;Mar2011, Vol. 97 Issue 6, p797
Academic Journal
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.


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