Gastrointestinal Safety Assessment of GLP-1 Receptor Agonists in the US: A Real-World Adverse Events Analysis from the FAERS Database
2024

Gastrointestinal Safety of GLP-1 Receptor Agonists

Sample size: 16568 publication 10 minutes Evidence: high

Author Information

Author(s): Osei Samuel Prince, Akomaning Edwin, Florut Teodora Francesca, Sodhi Mohit, Lacy Brian E., Aldhaleei Wafa A., Bhagavathula Akshaya Srikanth

Primary Institution: North Dakota State University

Hypothesis

What are the gastrointestinal adverse events associated with GLP-1 receptor agonists in the US?

Conclusion

GLP-1 receptor agonists, especially semaglutide and exenatide, are significantly linked to gastrointestinal adverse events like nausea, vomiting, and pancreatitis.

Supporting Evidence

  • From 2007 to 2023, 187,757 adverse events were reported with GLP-1 receptor agonists.
  • Semaglutide was linked to higher odds of nausea, vomiting, and delayed gastric emptying.
  • Exenatide was associated with pancreatitis and death.
  • Hospitalization was the most commonly reported adverse outcome at 20.3%.

Takeaway

This study looked at how certain diabetes medications can cause stomach problems. It found that some of these medications can make people feel sick or have other serious issues.

Methodology

This was a retrospective pharmacovigilance study using the US FDA FAERS database from 2007 to 2023, analyzing gastrointestinal adverse events related to GLP-1 receptor agonists.

Potential Biases

Potential underreporting of minor side effects and skewed representation towards serious outcomes.

Limitations

The study is limited by its retrospective nature and reliance on self-reported data, which may lead to misclassification of outcomes.

Participant Demographics

Median age was 61 years, with 62.5% female and 61.8% aged 18-64.

Statistical Information

P-Value

0.001

Confidence Interval

95% CI: 0.46, 0.69

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.3390/diagnostics14242829

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