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ARTICLE: STOMACH

Proton pump inhibitors and cardiovascular adverse
events: a meta-analysis of randomized controlled trials
Mosholder, Andrew D. MD, MPH1; Hada, Manila PhD, MPH2; Leishear, Kira PhD1
Author Information
1Division of Epidemiology 1, U.S. Food and Drug Administration Center for Drug Evaluation andResearch, Silver Spring MD
2Formerly with Division of Epidemiology 1, U.S. Food and Drug Administration Center for Drug

Evaluation and Research, Silver Spring MD.
The American Journal of Gastroenterology ():10.14309/ajg.0000000000003058, August 27, 2024.
| DOI: 10.14309/ajg.0000000000003058
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Abstract
Introduction:
Some observational studies suggest a cardiovascular risk from proton pump inhibitor (PPI)
treatment, but observational data may be subject to bias. We conducted a meta-analysis ofrandomized controlled trial data on cardiovascular events during PPI treatment.

Methods:
Manufacturers of PPIs provided data from their PPI clinical trial programs. We included
randomized trials with at least 100 subjects, treatment duration >30 days, and a non-PPI
comparator (active or placebo). We obtained person-time of exposure per trial, to calculate
summary incidence rate ratios (primary analysis) and incident rate differences (secondaryanalysis). Our primary composite outcome was major adverse cardiovascular events-plus(MACE+), which included nonfatal myocardial infarction, nonfatal stroke, fatal cardiovascularadverse events, hospitalization for unstable angina, or coronary revascularization; events wereadjudicated blindly.

Results:
Cardiovascular outcomes were infrequent in randomized trials of PPIs and our primary analysis
found no overall association (summary incident rate ratio, MACE+ events, PPI:placebo, 0.72 (95%confidence interval [CI] 0.42-1.26). There was some heterogeneity by indication category, and by
the incidence rate difference metric, gastroesophageal reflux disorder (GERD) trials had 1.04 (95%CI 0.58, 1.50) excess MACE+ events per 100 person-years of treatment versus placebo.
Comparisons to active controls generally showed positive incidence rate differences with PPI
treatment.

Discussion:
Overall, we found no association of cardiovascular events with PPI treatment. Cardiovascular
events appeared more frequent with PPI treatment in GERD trials, but results from this subgroupshould be interpreted with the limitations of the analysis in mind, including sparse outcome counts
and lack of individual patient data.
© 2024 by The American College of Gastroenterology

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