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.
This is a preview of subscription content, log in to check access.
Buy single article
Instant access to the full article PDF.
Price includes VAT for USA
Herlitz J, Tóth PP, Næsdal J. Low-dose aspirin therapy for cardiovascular prevention: quantification and consequences of poor compliance or discontinuation. Am J Cardiovasc Drugs 2010; 10(2): 125–41
Bhatt DL, Scheiman J, Abraham NS, et al. ACCF/ACG/AHA 2008 Expert Consensus Document on reducing the gastrointestinal risks of antiplatelet therapy and NSAID use: a report of the American College of Cardiology Foundation Task Force on clinical expert consensus documents. Circulation 2008 Oct; 118(18): 1894–909
Lanas A, Scheiman J. Low-dose aspirin and upper gastrointestinal damage: epidemiology, prevention and treatment. Curr Med Res Opin 2007 Jan; 23(1): 163–73
Berger JS, Lala A, Krantz MJ, et al. Aspirin for the prevention of cardiovascular events in patients without clinical cardiovascular disease: a meta-analysis of randomized trials. Am Heart J 2011; 162(1): 115–24.e2
Sussman JB, Vijan S, Choi H, et al. Individual and population benefits of daily aspirin therapy: a proposal for personalizing national guidelines. Circ Cardiovasc Qual Outcomes 2011 May; 4(3): 268–75
Kent DM, Shah ND. Personalizing evidence-based primary prevention with aspirin: individualized risks and patient preference. Circ Cardiovasc Qual Outcomes 2011 May; 4(3): 260–2
Moberg C, Næsdal J, Svedberg LE, et al. Impact of gastrointestinal problems on adherence to low-dose acetyl-salicylic acid: a quantitative study in patients with cardiovascular risk. Patient 2011; 4(2): 103–13
Pratt S, Thompson VJ, Elkin EP, et al. The impact of upper gastrointestinal symptoms on nonadherence to, and discontinuation of, low-dose acetylsalicylic acid in patients with cardiovascular risk. Am J Cardiovasc Drugs 2010; 10(5): 281–8
Biondi-Zoccai GGL, Lotrionte M, Agostoni P, et al. A systematic review and meta-analysis on the hazards of discontinuing or not adhering to aspirin among 50,279 patients at risk for coronary artery disease. Eur Heart J 2006 Nov; 27(22): 2667–74
García Rodríguez LA, Cea Soriano L, Hill C, et al. Increased risk of stroke after discontinuation of acetylsalicylic acid: a UK primary care study. Neurology 2011 Feb 22; 76(8): 740–6
García Rodríguez LA, Cea Soriano L, Martin-Merino E, et al. Discontinuation of low dose aspirin and risk of myocardial infarction: case-control study in UK primary care. BMJ 2011; 343: d4094
Abraham NS, Hlatky MA, Antman EM, et al. ACCF/ACG/AHA 2010 Expert Consensus Document on the concomitant use of proton pump inhibitors and thieno-pyridines: a focused update of the ACCF/ACG/AHA 2008 Expert Consensus Document on reducing the gastrointestinal risks of antiplatelet therapy and NSAID use: a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents. Circulation 2010 Dec 14; 122(24): 2619–33
Hamm CW, Bassand J-P, Agewall S, et al. ESC guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J 2011 Dec; 31(23): 2915–57
Cea-Soriano L, Johansson S, García Rodríguez L, et al. Prescription of antiplatelet and gastroprotective medications after an acute coronary episode: does a history of peptic ulcer disease make any difference? [abstract no. UEGW11-3767]. Gut 2011; 60Suppl. 3: A265
Sörstadius E, Herlitz J, Nauclér E, et al. Prescription rates and adherence to proton pump inhibitor therapy among patients who require low-dose acetylsalicylic acid for cardiovascular prevention [abstract no. PG119]. Value Health 2010; 13(7): A372
Axanum® (acetylsalicylic acid/esomeprazole): EU Summary of Product Characteristics. AstraZeneca, 2011
Scott LJ, Dunn CJ, Mallarkey G, et al. Esomeprazole: a review of its use in the management of acid-related disorders. Drugs 2002; 62(10): 1503–38
Reilly IAG, FitzGerald GA. Aspirin in cardiovascular disease. Drugs 1988 Feb; 35(2): 154–76
McKeage K, Blick SK, Croxtall JD, et al. Esomeprazole: a review of its use in the management of gastric acid-related diseases in adults. Drugs 2008; 68(11): 1571–607
Morrison D, Nagy P, Schettler J, et al. Evaluation of the pharmacodynamics of acetylsalicylic acid 81 mg with or without esomeprazole 20 mg in healthy volunteers [abstract no. OP412]. Gut 2011; 60Suppl. 3: A93
Niazi M, Andersson T, Nauclér E, et al. Evaluation of the pharmacokinetic interaction between esomeprazole (40 mg) and acetylsalicylic acid (325 mg) in healthy volunteers. Int J Clin Pharmacol Ther 2009 Sep; 47(9): 564–9
Niazi M, Andersson T, Nauclér E, et al. Evaluation of bio-equivalence between a single-capsule formulation of esomeprazole 40 mg and acetylsalicylic acid 325 mg and the monotherapies given separately in healthy volunteers. Int J Clin Pharmacol Ther 2011 Feb; 49(2): 169–76
Yeomans N, Lanas A, Labenz J, et al. Efficacy of esomeprazole (20 mg once daily) for reducing the risk of gastroduodenal ulcers associated with continuous use of low-dose aspirin. Am J Gastroenterol 2008 Oct; 103(10): 2465–73
Scheiman JM, Devereaux PJ, Herlitz J, et al. Prevention of peptic ulcers with esomeprazole in patients at risk of ulcer development treated with low-dose acetylsalicylic acid: a randomised, controlled trial (OBERON). Heart 2011 May; 97(10): 797–802
Yeomans ND, Næsdal J. Systematic review: ulcer definition in NSAID ulcer prevention trials. Aliment Pharmacol Ther 2008 Mar 15; 27(6): 465–72
Scheiman J, Agewall S, Svedberg LE, et al. Prevention of peptic ulcers with once-daily esomeprazole 20 mg and 40 mg in low-dose acetylsalicylic acid users at gastrointestinal risk: outcome analysis by cardiovascular risk (OBERON) [abstract no. 1909]. Eur Heart J 2011; 32Suppl. 1: 323
AstraZeneca. A randomized, double-blind, parallel-group, multicentre, phase III study to assess the effect of esomeprazole 20 and 40 mg od versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid (ASA) (OBERON trial) [AstraZeneca study number D961FC00003]. Clinical study report synopsis [online]. Available from URL: http://www.astrazenecaclinicaltrials.com/_mshost800325/content/clinical-trials/resources/pdf/8611150 [Accessed 2012 Jan 16]
Scheiman J, Herlitz J, Agewall S, et al. Esomeprazole 20 mg and 40 mg for 26 weeks reduces the frequency of upper GI symptoms in patients taking low-dose acetylsalicylic acid (ASA) for cardiovascular prevention: the OBERON trial [abstract no. 3982]. Eur Heart J 2010 Sep; 31Suppl. 1: 674
Scheiman J, Herlitz J, Agewall S, et al. Frequency and severity of dyspeptic symptoms among patients taking low-dose acetylsalicylic acid for cardiovascular prevention: the OBERON trial [abstract no. P1157]. Gut 2010; 59Suppl. III: A339
Scheiman J, Lanas A, Veldhuyzen van Zanten S., et al. The effect of baseline erosion status on esomeprazole-mediated prevention of peptic ulcer in patients treated with low-dose acetylsalicylic acid at increased gastrointestinal risk: sub-analysis of the OBERON trial [abstract no. MO1210]. Gastroenterology 2011; 140 (5 Suppl. 1): S–584
AstraZeneca. A randomized double-blind placebo-controlled study to assess the prevention of low-dose acetylsalicylic acid (ASA) associated gastroduodenal lesions and upper gastrointestinal symptoms in patients taking esomeprazole 20mg once daily (od) for 26 weeks (ASTERIX trial) [AstraZeneca study number D9617C00011]. Clinical study report synopsis [online]. Available from URL: http://www.astrazenecaclinicaltrials.com/_mshost800325/content/clinical-trials/resources/pdf/8611103 [Accessed 2012 Jan 16]
AstraZeneca. Association between low dose acetylsalicylic acid (ASA) and proton pump inhibitors and risk of acute myocardial infarction or coronary heart disease death [ClinicalTrials.gov identifier NCT01360073]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://clinicaltrials.gov/ct2/show/NCT01360073 [Accessed 2012 Jan 16]
AstraZeneca. Association between low dose acetylsalicylic acid (ASA) and proton pump inhibitors and risk of acute myocardial infarction or coronary death [ClinicalTrials.gov identifier NCT01360047]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://clinicaltrials.gov/ct2/show/NCT01360047 [Accessed 2012 Jan 16]
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.
About this article
Cite this article
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
- Peptic Ulcer
- Duodenal Ulcer
- Reflux Disease Questionnaire