A new study shows that adults in the United States who are exposed to proton pump inhibitors (PPI) including Dexilant, Nexium, Prevacid, Prilosec, Protonix and AcipHex are at increased risk of myocardial infarction (MI), or heart attack.
Researchers evaluated data collected from more than 16 million clinical documents on 2.9 million patients using the STRIDE database at Stanford University (1.8 million patients) and a Web-based electronic health record system (Practice Fusion Inc. – 1.1 million patients). Scientists evaluated the data for PPI use after an indication for gastroesophageal reflux disease (GERD), followed by an incidence of MI. The team specifically evaluated the drugs dexlansoprazole (Dexilant), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix) and rabeprazole (AcipHex). In addition to the PPIs, researchers also evaluated H2 blockers, according to Healio.
“The current study suggests that the risk of PPIs may extend beyond previously studied high risk individuals,” wrote lead researcher Nigam H. Shah, MBBS, PhD, of the Stanford Center for Biomedical Informatics Research in Stanford, California, and colleagues. They published their findings online June 10 in PLOS One. Cardiovascular Business viewed the report.
Patients who received PPIs were found to have a 1.16-fold increased cardiovascular risk compared with patients who did not receive the drugs. A prospective cohort survival analysis found that PPI doubled the risk of cardiovascular mortality. In their report, the researchers cited data that showed there are an estimated 113 million PPI prescriptions each year, accounting for more than $13 billion in worldwide sales. Approximately 21 million people in the U.S. received a PPI prescription in 2009, according to Cardiovascular Business.
The scientists said in the report that Dexilant, Nexium, Prevacid, Prilosec, Protonix and AcipHex were all associated with increased cardiovascular risk in the general population, including young patients and patients who did not take antiplatelets. According to the researchers, the results suggested PPIs “may promote risk via an unknown mechanism that does not directly involve platelet aggregation,” Cardiovascular Business reported.
The study was limited by the fact that the researchers evaluated observational data, saying that patients taking PPIs may be sicker than the general population and the findings may not be generalizable to other patients. Additionally, the team did not examine over-the-counter (OTC) PPIs and could not determine the dosage of PPIs that patients received, according to Cardiovascular Business.
“We recognize that these findings are hypothesis generating, and a prospective randomized study in the general population (inclusive of both lean and obese individuals) is required before changing clinical practice,” the researchers wrote in the study, obtained by Cardiovascular Business. “However, the number of subjects needed to detect harm among PPI users for MI is considerable, projected to be about 4,000.”