Acetylsalicylic acid/esomeprazole fixed-dose combination

Drugs and Aging

Volumn 29, Issue 3, 2012, Pages 233-242

  Burness, Celeste B ^a   Scott, Lesley J ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

Adis Drug Profiles; Aspirin; Cardiovascular disorders; Elderly; Esomeprazole; Gastrointestinal ulcer

Indexed keywords

ACETYLSALICYLIC ACID; ACETYLSALICYLIC ACID PLUS ESOMEPRAZOLE; ATAZANAVIR; DIGOXIN; ESOMEPRAZOLE; ITRACONAZOLE; KETOCONAZOLE; NELFINAVIR; PLACEBO;

ABDOMINAL PAIN; ARTICLE; BRONCHITIS; CARDIOVASCULAR DISEASE; CONSTIPATION; DIARRHEA; DOSE RESPONSE; DRUG ANTAGONISM; DRUG BLOOD LEVEL; DRUG TOLERABILITY; DUODENUM ULCER; DYSPEPSIA; EPIGASTRIC BURNING; EPIGASTRIC PAIN; FLATULENCE; FOOD REGURGITATION; HEADACHE; HEARTBURN; HUMAN; LIVER DISEASE; LOW DRUG DOSE; MAXIMUM PLASMA CONCENTRATION; NAUSEA AND VOMITING; PEPTIC ULCER; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; RHINOPHARYNGITIS; RISK FACTOR; STOMACH ULCER; UPPER RESPIRATORY TRACT INFECTION;

ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ANTI-ULCER AGENTS; ASPIRIN; CAPSULES; CARDIOVASCULAR DISEASES; DRUG COMBINATIONS; HUMANS; OMEPRAZOLE; PEPTIC ULCER; PLATELET AGGREGATION INHIBITORS; PRODRUGS; PROTON PUMP INHIBITORS;

EID: 84857862510     PISSN: 1170229X     EISSN: 11791969     Source Type: Journal    
DOI: 10.2165/11208610-000000000-00000     Document Type: Article

References (33)

1. 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
2. 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
3. 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
4. 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
5. 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
6. 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
7. Moberg C, Næsdal J, Svedberg LE, et al. Impact of gastrointestinal problems on adherence to low-dose acetylsalicylic acid: A quantitative study in patients with cardiovascular risk. Patient 2011; 4 (2): 103-13
8. 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
9. 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
10. García Rodríguez LA, Cea Soriano L, Hill C, et al. Increased risk of stroke after discontinuation of acetylsalicylic acid: A UKprimary care study.Neurology 2011 Feb 22; 76 (8): 740-6
11. 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
12. Abraham NS, Hlatky MA, Antman EM, et al. ACCF/ACG/AHA 2010 Expert Consensus Document on the concomitant use of proton pump inhibitors and thienopyridines: 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
13. 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
14. 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; 60 Suppl. 3: A265
15. 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
16. Axanum- (acetylsalicylic acid/esomeprazole): EU Summary of Product Characteristics. AstraZeneca, 2011
17. 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
18. Reilly IAG, FitzGerald GA. Aspirin in cardiovascular disease. Drugs 1988 Feb; 35 (2): 154-76
19. 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
20. 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; 60 Suppl. 3: A93
21. 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
22. Niazi M, Andersson T, Nauclér E, et al. Evaluation of bioequivalence 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
23. 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
24. 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
25. Yeomans ND, Næsdal J. Systematic review: Ulcer definition in NSAID ulcer prevention trials. Aliment Pharmacol Ther 2008 Mar 15; 27 (6): 465-72
26. Scheiman J, Agewall S, Svedberg LE, et al. Prevention of peptic ulcers with once-daily esomeprazole 20mg and 40mg in low-dose acetylsalicylic acid users at gastrointestinal risk: Outcome analysis by cardiovascular risk (OBERON) [abstract no. 1909]. Eur Heart J 2011; 32 Suppl. 1: 323
27. 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]
28. 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; 31 Suppl. 1: 674
29. Scheiman J, Herlitz J, Agewall S, et al. Frequency and severity of dyspeptic symptoms among patients taking lowdose acetylsalicylic acid for cardiovascular prevention: The OBERON trial [abstract no. P1157]. Gut 2010; 59 Suppl. III: A339
30. 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-doseacetylsalicylic acid at increased gastrointestinal risk: Subanalysis of the OBERON trial [abstract no. MO1210]. Gastroenterology 2011; 140 (5 Suppl. 1): S-584
31. 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 20 mg 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]
32. 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]
33. 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]