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PLoS One. 2015 Jun 10;10(6):e0124653. doi: 10.1371/journal.pone.0124653. eCollection 2015.

Proton Pump Inhibitor Usage and the Risk of Myocardial Infarction in the General Population.

Author information

1
Stanford Center for Biomedical Informatics Research, Stanford University, Stanford, CA, United States of America.
2
Department of Cardiovascular Sciences, Houston Methodist Research Institute, Houston, TX, United States of America.
3
Practice Fusion, Inc., San Francisco, CA, United States of America.
4
Divisions of Cardiovascular Medicine and Vascular Surgery, Stanford University, Stanford, CA, United States of America.

Abstract

BACKGROUND AND AIMS:

Proton pump inhibitors (PPIs) have been associated with adverse clinical outcomes amongst clopidogrel users after an acute coronary syndrome. Recent pre-clinical results suggest that this risk might extend to subjects without any prior history of cardiovascular disease. We explore this potential risk in the general population via data-mining approaches.

METHODS:

Using a novel approach for mining clinical data for pharmacovigilance, we queried over 16 million clinical documents on 2.9 million individuals to examine whether PPI usage was associated with cardiovascular risk in the general population.

RESULTS:

In multiple data sources, we found gastroesophageal reflux disease (GERD) patients exposed to PPIs to have a 1.16 fold increased association (95% CI 1.09-1.24) with myocardial infarction (MI). Survival analysis in a prospective cohort found a two-fold (HR = 2.00; 95% CI 1.07-3.78; P = 0.031) increase in association with cardiovascular mortality. We found that this association exists regardless of clopidogrel use. We also found that H2 blockers, an alternate treatment for GERD, were not associated with increased cardiovascular risk; had they been in place, such pharmacovigilance algorithms could have flagged this risk as early as the year 2000.

CONCLUSIONS:

Consistent with our pre-clinical findings that PPIs may adversely impact vascular function, our data-mining study supports the association of PPI exposure with risk for MI in the general population. These data provide an example of how a combination of experimental studies and data-mining approaches can be applied to prioritize drug safety signals for further investigation.

PMID:
26061035
PMCID:
PMC4462578
DOI:
10.1371/journal.pone.0124653
[Indexed for MEDLINE]
Free PMC Article
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