Evaluation of the pharmacokinetic interaction between esomeprazole (40 mg) and acetylsalicylic acid (325 mg) in healthy volunteers

Niazi, Mohammad; Andersson, Tommy; Nauclér, Emma; Sundin, M; Næsdal, J

doi:10.5414/cpp47564

Cited by 24 publications

(8 citation statements)

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“…However, in the present study, there were no reports of myocardial infarction in esomeprazole-treated patients (although two events were reported in the placebo group). This mirrors the findings of no myocardial infarctions in esomeprazole recipients in the ASTERIX study, while in OBERON, only one case of myocardial infarction was reported in a patient taking esomeprazole 40 mg. To date, no pharmacokinetic or pharmacodynamic interactions have been observed between low-dose ASA and esomeprazole 29 30. Concern has also been raised recently about the possibility of an increased risk of fracture31 and pneumonia32 with long-term PPI treatment; however, no cases of fracture or pneumonia were reported here with long-term esomeprazole therapy.…”

Section: Discussionmentioning

confidence: 85%

Multinational, double-blind, randomised, placebo-controlled, prospective study of esomeprazole in the prevention of recurrent peptic ulcer in low-dose acetylsalicylic acid users: the LAVENDER study

Sugano

Choi

Lin

et al. 2013

Gut

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Section: Discussionmentioning

confidence: 85%

Multinational, double-blind, randomised, placebo-controlled, prospective study of esomeprazole in the prevention of recurrent peptic ulcer in low-dose acetylsalicylic acid users: the LAVENDER study

Sugano

Choi

Lin

et al. 2013

Gut

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“…Hypothetically, PPIs might affect aspirin bioavailability by raising gastric pH and therefore attenuate the antiplatelet effect of aspirin. Only a few studies tested the latter hypothesis and showed contradictory results . The clinical significance of these hypotheses has recently also been seriously challenged .…”

Section: Discussionmentioning

confidence: 99%

Should patients prescribed long-term low-dose aspirin receive proton pump inhibitors? A systematic review and meta-analysis

et al. 2015

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Background: Several clinical guidelines recommend the use of proton pump inhibitors (PPIs) in patients taking low-dose aspirin but report no or limited supporting data. We conducted a systematic review and meta-analysis to examine the effects of co-administration of PPIs in patients taking low-dose aspirin on the risks of adverse gastrointestinal (GI) and cardiovascular (CV) events, and on patient adherence to aspirin. Methods: We searched PUBMED, EMBASE and Cochrane Central Register of Controlled Trials databases for relevant articles published through November 2013. We included randomised controlled trials (RCTs) and observational studies in patients taking low-dose aspirin with and without PPIs. Risk of bias was assessed using the Cochrane Collaboration's tool (for RCTs) and the Newcastle-Ottawa Scale (for observational studies). Pooled risk ratios (RRs) were computed using a random-effects model. Results: We included 13 studies, of which 12 (2 RCTs and 10 observational studies) reported on GI events, and one (cohort study) on both GI bleeding and CV events. No study reported on adherence to aspirin. Co-administration of PPIs in patients receiving low-dose aspirin was associated with risk reductions of 73% (RR 0.27, 95% CI 0.17-0.42) and 50% (RR 0.50, 95% CI 0.32-0.80) in the occurrence of peptic ulcer and GI bleeding respectively. There was evidence of bias in publications reporting on the GI events. Conclusions: The practice of co-prescribing PPIs in patients taking lowdose aspirin is supported by some data, but the evidence is rather weak. It currently remains unclear whether the benefits of co-administration of PPIs in users of low-dose aspirin outweigh their potential harms. Review criteria• Randomised controlled trials (RCTs) and observational studies in patients receiving lowdose aspirin.• Studies reporting on adverse gastrointestinal or cardiovascular events, or adherence to aspirin.

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“…A pharmacokinetic evaluation was conducted with 55 male and female healthy volunteers (mean age 27.1 years, mean body mass index [BMI] 23 kg/m 2 ) who were randomized in an open 3-way crossover study to receive either uncoated aspirin 325 mg alone, esomeprazole 40 mg alone, or the combination of the two drugs (in separate tablet/capsules) for 5 days separated by at least a 13 day washout period 27. There were no significant pharmacokinetic interactions observed after repeated coadministration.…”

Section: Methodsmentioning

confidence: 99%

Esomeprazole and aspirin fixed combination for the prevention of cardiovascular events

Sylvester¹,

Cheng²,

Mehra³

2013

VHRM

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Low dose aspirin therapy plays a fundamental role in both the primary and secondary prevention of cardiovascular events. Although the evidence using low dose aspirin for secondary prevention is well-established, the decision to use aspirin for primary prevention is based on an evaluation of the patient’s risk of cardiovascular events compared to their risk of adverse events, such as bleeding. In addition to the risk of bleeding associated with long term aspirin administration, upper gastrointestinal side effects, such as dyspepsia often lead to discontinuation of therapy, which places patients at an increased risk for cardiovascular events. One option to mitigate adverse events and increase adherence is the addition of esomeprazole to the medication regimen. This review article provides an evaluation of the literature on the concomitant use of aspirin and esomeprazole available through February 2013. The efficacy, safety, tolerability, cost effectiveness, and patient quality of life of this regimen is discussed. A summary of the pharmacokinetic and pharmacodynamic interactions between aspirin and esomeprazole, as well as other commonly used cardiovascular medications are also reviewed. The addition of esomeprazole to low dose aspirin therapy in patients at high risk of developing gastric ulcers for the prevention of cardiovascular disease, significantly reduced their risk of ulcer development. Pharmacokinetic and pharmacodynamic studies suggested that esomeprazole did not affect the pharmacokinetic parameters or the antiplatelet effects of aspirin. Therefore, for those patients who are at a high risk of developing a gastrointestinal ulcer, the benefit of adding esomeprazole likely outweighs the risks of longer term proton pump inhibitor use, and the combination can be recommended. Administering the two agents separately may also be more economical. On the other hand, for those patients at lower risk of developing a gastrointestinal ulcer, both the additional risk and cost make the inclusion of a proton pump inhibitor unwarranted.

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Evaluation of the pharmacokinetic interaction between esomeprazole (40 mg) and acetylsalicylic acid (325 mg) in healthy volunteers

Cited by 24 publications

References 0 publications

Multinational, double-blind, randomised, placebo-controlled, prospective study of esomeprazole in the prevention of recurrent peptic ulcer in low-dose acetylsalicylic acid users: the LAVENDER study

Multinational, double-blind, randomised, placebo-controlled, prospective study of esomeprazole in the prevention of recurrent peptic ulcer in low-dose acetylsalicylic acid users: the LAVENDER study

Should patients prescribed long-term low-dose aspirin receive proton pump inhibitors? A systematic review and meta-analysis

Esomeprazole and aspirin fixed combination for the prevention of cardiovascular events

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