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Acid Suppressive Drugs for Peptic Ulcer Disease: Proton Pump Inhibitors01:13

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Interventional Diagnostic Procedure: A Practical Guide for the Assessment of Coronary Vascular Function
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Proton-Pump Inhibitors and Cardiovascular Adverse Events: A Meta-Analysis of Randomized Controlled Trials.

Andrew D Mosholder1, Manila Hada2, Kira Leishear1

  • 1Division of Epidemiology 1, US Food and Drug Administration Center for Drug Evaluation and Research, Silver Spring, Maryland, USA.

The American Journal of Gastroenterology
|August 29, 2024
PubMed
Summary
This summary is machine-generated.

Proton-pump inhibitor (PPI) use showed no increased cardiovascular risk in a meta-analysis of randomized trials. While some gastroesophageal reflux disorder trials suggested a slight increase, overall findings indicate PPIs are safe for heart health.

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Area of Science:

  • Cardiology
  • Pharmacology
  • Clinical Trials

Background:

  • Observational studies suggested potential cardiovascular risks associated with proton-pump inhibitor (PPI) use.
  • Such observational data may be prone to bias, necessitating more robust evidence.

Purpose of the Study:

  • To evaluate the cardiovascular safety of proton-pump inhibitors (PPIs) by analyzing data from randomized controlled trials (RCTs).
  • To determine the association between PPI treatment and major adverse cardiovascular events (MACE+).

Main Methods:

  • A meta-analysis of data from PPI manufacturers' clinical trial programs was conducted.
  • Included RCTs had ≥100 subjects, >30 days duration, and a non-PPI comparator.
  • Primary analysis used incidence rate ratios for MACE+, a composite outcome of cardiovascular events.

Main Results:

  • Overall, no significant association was found between PPI treatment and MACE+ events (summary incidence rate ratio: 0.72).
  • Heterogeneity was observed, with gastroesophageal reflux disorder trials showing a potential excess of 1.04 MACE+ events per 100 person-years.
  • Comparisons with active controls generally indicated positive incidence rate differences with PPIs.

Conclusions:

  • The meta-analysis found no overall association between PPI treatment and cardiovascular events.
  • A potential increase in cardiovascular events in PPI users with gastroesophageal reflux disorder warrants cautious interpretation due to limited data.