A pharmacovigilance study of association between PPI and Dementia event based on FDA adverse event reporting system data
Proton pump inhibitor (PPI) was commonly used worldwide, to treat peptic ulcer disease (PUD), gastroesophageal reflux disease (GERD), Helicobacter pylori infection, or prevent side effects of glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs). However, PPI agents were also overused by off label indication, excessive dosage and long-term treatment.
With the widespread use of PPI agents, numerous studies concerned the safety of PPI treatment. The association between PPI therapy and dementia event was a hot issue.
TAKE HOME MESSAGE:
Some studies reported PPI use could increase dementia event. More recent studies found no significant association between PPI and dementia.
Adverse event reporting system (AERS) data was an outstanding source for pharmacovigilance analysis and post-marketing drug safety monitoring. The United States Food and Drug Administration (FDA) AERS (FAERS) is one of the biggest databases open to the public
The objective of present study was to detect the association between PPI use and dementia event by comprehensively assessing spontaneous reports submitted to the FAERS database.
The current study investigated the association between six PPI agents and dementia event, compared different time interval of PPI treatment and dementia event. The results indicated no association between dementia event and PPI agents, including esomeprazole, dexlansoprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole.
In summary, the current study revealed no association between six PPI agents and dementia event based on the FAERS data mining. Author’s findings suggested that dementia event might not be considered as a factor in discontinuing PPI treatment.
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Abstract
Objectives: 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.
Method: Authors employed proportional reporting ratio (PRR) and information element (IC) methods to detect the signals of dementia relevant to PPI. Authors also analyzed characteristics of PPI and positive control reports, compared dementia event between long- and short-duration of PPI treatment.
Results: Finally, authors identified 2396 dementia cases with PPI treatment. Authors did not detect significant signal between PPI and dementia event even in gastroesophageal reflux disease cases. No significant differences of dementia event were detected between long- and short- duration groups, of the 3Â years, 5Â years and 10Â years comparison respectively. Â
Conclusions: Based on the current FAERS data mining, authors discovered no association between PPI use and dementia event, even in long-term PPI therapy case.
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