A pharmacovigilance study of the association between proton pump inhibitors and tumor adverse events based on the FDA adverse event reporting system database
2024

Study on Proton Pump Inhibitors and Tumor Risks

Sample size: 3133 publication 10 minutes Evidence: moderate

Author Information

Author(s): Zhang Ya-Jun, Duan Dan-Dan, Tian Qian-Yu, Wang Cai-E, Wei Shu-Xun

Primary Institution: The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology

Hypothesis

This study aims to comprehensively analyze the relationship between proton pump inhibitors (PPIs) and tumor adverse events (TAEs).

Conclusion

TAEs constitute a small but significant fraction of PPI-related adverse events, highlighting the need for cautious long-term use of PPIs.

Supporting Evidence

  • 3,133 tumor adverse events were identified, representing 2.36% of all PPI-related adverse events.
  • The most common TAEs were gastric cancer (19.05%) and malignant neoplasm (7.23%).
  • Disproportionality analysis revealed ten significant TAEs associated with PPIs.
  • TAEs were less likely to occur in elderly patients, with odds ratios indicating lower risk.
  • 29.70% of TAEs resulted in a fatality.

Takeaway

Proton pump inhibitors, which help with stomach problems, might cause tumors if used for a long time, so doctors need to be careful when prescribing them.

Methodology

The study analyzed PPI adverse reaction reports from the FDA Adverse Event Reporting System (FAERS) database from 2004 to 2024, focusing on disproportionality analysis using Reporting Odds Ratio (ROR).

Potential Biases

Potential underreporting of adverse events in elderly patients and lack of data on confounding factors.

Limitations

The majority of data originates from the United States, and the database does not provide information on other risk factors such as diet or smoking.

Participant Demographics

Median age of participants reporting TAEs was 59 years, with a majority being male.

Statistical Information

P-Value

p<0.001

Confidence Interval

[0.87, 0.95]

Statistical Significance

p<0.001

Digital Object Identifier (DOI)

10.3389/fphar.2024.1524903

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