Proton pump inhibitors ( PPIs ) have been associated with adverse clinical outcomes amongst Clopidogrel ( Plavix ) 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.
Researchers have explored this potential risk in the general population via data-mining approaches.
Using a novel approach for mining clinical data for pharmacovigilance, researchers queried over 16 million clinical documents on 2.9 million individuals to examine whether proton pump inhibitor usage was associated with cardiovascular risk in the general population.
In multiple data sources, researchers found gastroesophageal reflux disease ( GERD ) patients exposed to proton pump inhibitors to have a 1.16 fold increased association ( 95% CI 1.09–1.24 ) with myocardial infarction.
Survival analysis in a prospective cohort found a two-fold ( hazard ratio, HR = 2.00; 95% CI 1.07–3.78; P = 0.031 ) increase in association with cardiovascular mortality.
Researchers found that this association exists regardless of Clopidogrel use.
Investigators 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.
In conclusion, consistent with the pre-clinical findings that proton pump inhibitors may adversely impact vascular function, the data-mining study supports the association of proton pump inhibitors exposure with risk for myocardial infarction 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. ( Xagena )
Shah NH et al, PLoS ONE 10(6): e0124653. doi:10.1371/journal.pone.012465323.47 21/06/2015