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Another Database Study Finds that Re-hospitalization for Myocardial Infarction Increased Almost Two-fold with Proton Pump Inhibitor and Clopidogrel Use; But Uncertainty About Interaction Continues
Sarah A. Spinler, PharmD, FCCP, BCPS (AQ Cardiology)
June, 2010
Ref: Stockl KM, et al. Risk of rehospitalization for patients using clopidogrel plus a proton pump inhibitor. Arch Intern Med 2010;170:704-10.
In a recent issue of Archives of Internal Medicine, Stockl et al report on the risk of rehospitalization for myocardial infarction (MI) from January 2004 to December 2006 in patients prescribed clopidogrel with or without a proton pump inhibitor (PPI) through 1 year following discharge for acute coronary syndrome (ACS) using the Prescription Solutions pharmacy-linked medical outcomes claims data from 5 states. Similar to the results of the Medco claims data study presented by Eric Stanek in May 2009 at the Society of Cardiovascular Angiography and Interventions, the authors of this study found that the risk of rehospitalization for MI was increased by almost 2-fold in patients prescribed a PPI with clopidogrel compared to clopidogrel without a PPI. As in the Medco study, prescription of pantoprazole was also associated with worsened outcome. These studies contrast with the recent findings from the Tennessee Medicaid program where use of PPIs plus clopidogrel (including pantoprazole) was not found to increase the risk of reinfarction, PCI or unstable angina. Differences between the current study and the Medco one include the fact that patients with both private insurance and Medicare were included, patients with ACS without percutaneous coronary intervention (PCI) were included, and statistical adjustment using propensity score for baseline differences was used. Like the Medco and Tennessee Medicaid studies, the study by Stockl et al suffers from the limitations that adherence was not assured and no information on concomitant aspirin prescription or adherence was available. In the study by Stockl et al, patients prescribed PPIs had an increased risk of hospitalization for gastrointestinal bleeding while in the Tennessee Medicaid study, patients had a decreased risk of gastrointestinal bleeding hospitalizations. While the authors claim that the study adds to the published literature because of the large subgroup prescribed pantoprazole, 63.8% of the 1033 patients in the clopidogrel-PPI group, 62% of the 7593 patients prescribed PPIs were prescribed pantoprazole in the Tennessee Medicaid study with divergent findings. The Medco study, while similarly large - 1653 of the 6828 patients taking a PPI, remains unpublished. So who are we to believe? In my opinion, we keep doing what we have been doing until an adequately powered, randomize trial can be performed - limiting use of PPIs to patients who truly need them such as those with a history of gastrointestinal bleeding or GERD who have failed H2 blockers. Currently, we have enough database trials with conflicting data that no decisive conclusions can be made.
Additional references:
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Ray WA, et al. Outcomes with concurrent use of clopidogrel and proton pump inhibitors: a cohort study. Ann Intern Med 2010;152:337-45.
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Stanek EJ, Aubert RE, Flockhart DA, et al. A national study of the effect of individual proton pump inhibitors on cardiovascular outcomes in patients treated with clopidogrel following coronary stenting: the clopidogrel Medco outcomes study. Poster Session Presented at: The Society for Cardiovascular Angiography and Interventions. 2009 May 9; Washington DC. https://www.medcoresearch.com/.../SCAI_PPI_Agents_FNL_clinical_brief.pdf. Accessed 2009 Aug 29.
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