A pharmacovigilance study of association between proton pump inhibitor and dementia event based on FDA adverse event reporting system data

Sci Rep. 2021 May 21;11(1):10709. doi: 10.1038/s41598-021-90108-7.

Abstract

Proton pump inhibitor (PPI) was widely used around the world. Studies suggested conflicting results between PPI treatment and dementia event. This study examined the association between six PPI agents and dementia event by mining the US FDA Adverse Event Reporting System (FAERS) database from 2004 to 2020. We employed proportional reporting ratio (PRR) and information element (IC) methods to detect the signals of dementia relevant to PPI. We also analyzed characteristics of PPI and positive control reports, compared dementia event between long- and short-duration of PPI treatment. Finally, we identified 2396 dementia cases with PPI treatment. We did not detect significant signal between PPI and dementia event: PRR = 0.98, 95%CI 0.94 to 1.02, IC = -0.03, 95%CI - 0.17 to 0.10, even in gastroesophageal reflux disease cases: PRR = 0.65, 95%CI 0.59 to 0.72, IC = -0.62, 95%CI - 0.97 to - 0.27. No significant differences of dementia event were detected between long- and short- duration groups, the OR (95%CI) of the 3 years, 5 years and 10 years comparison were 0.70 (0.48 to 1.02), 0.72 (0.45 to 1.15) and 1.65 (0.75 to 3.63), respectively. Based on the current FAERS data mining, we discovered no association between PPI use and dementia event, even in long-term PPI therapy case.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adverse Drug Reaction Reporting Systems
  • Data Mining
  • Databases, Factual
  • Dementia / diagnosis
  • Dementia / epidemiology*
  • Dementia / etiology*
  • Disease Susceptibility
  • Drug-Related Side Effects and Adverse Reactions / epidemiology*
  • Drug-Related Side Effects and Adverse Reactions / etiology*
  • Humans
  • Male
  • Pharmacovigilance
  • Protein Interaction Mapping
  • Proton Pump Inhibitors / adverse effects
  • Proton Pump Inhibitors / pharmacology*
  • Public Health Surveillance
  • United States / epidemiology
  • United States Food and Drug Administration

Substances

  • Proton Pump Inhibitors