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Acetylsalicylic Acid/Esomeprazole Fixed-Dose Combination

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Abstract

The fixed-dose acetylsalicylic acid (ASA)/esomeprazole capsule combines the cardiovascular (CV) protective effects of low-dose ASA with the gastroprotective effects of the proton pump inhibitor esomeprazole. It is approved for use as a convenient once-daily regimen in the prevention of CV and cerebrovascular events in patients requiring continuous low-dose ASA who are at risk of developing gastric and/or duodenal (peptic) ulcers.

In two large, 26-week, randomized, double-blind, multinational, phase III trials (ASTERIX and OBERON) in patients who were receiving low-dose ASA for the prevention of CV events and who had an increased risk of ulcer development, the incidence of endoscopy-proven peptic ulcers (primary end-point) was significantly lower with the addition of esomeprazole 20mg/day versus placebo.

Moreover, patient-reported dyspeptic symptoms (epigastric pain and epigastric burning) were reported in significantly fewer patients in the low-dose ASA plus esomeprazole group than in the low-dose ASA plus placebo group.

Low-dose ASA plus esomeprazole treatment was generally well tolerated, with a similar adverse event profile to that seen with low-dose ASA plus placebo.

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Acknowledgements and Disclosures

The manuscript was reviewed by: A.F.G. Cicero, Internal Medicine, Aging and Kidney Disease Department, S. Orsola-Malpighi University Hospital, Bologna, Italy; E. Resciniti, Division of Cardiology, University of Modena and Reggio Emilia, Modena, Italy; J.M. Scheiman, Division of Gastroenterology, Department of Internal Medicine, University of Michigan Medical Center, Ann Arbor, MI, USA.

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the authors on the basis of scientific and editorial merit.

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Correspondence to Celeste B. Burness.

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Burness, C.B., Scott, L.J. Acetylsalicylic Acid/Esomeprazole Fixed-Dose Combination. Drugs Aging 29, 233–242 (2012). https://doi.org/10.2165/11208610-000000000-00000

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Keywords

  • Clopidogrel
  • Peptic Ulcer
  • Duodenal Ulcer
  • Esomeprazole
  • Reflux Disease Questionnaire