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Area of Science:

  • Pharmacovigilance
  • Cardiovascular Safety
  • Gastrointestinal Pharmacology

Background:

  • Concerns exist regarding cardiovascular (CV) adverse events linked to prokinetic agents that stimulate gastrointestinal (GI) motility.
  • Understanding the CV risk profile of prokinetics is crucial for patient safety.

Purpose of the Study:

  • To investigate the association between prokinetic drug use and an elevated risk of cardiovascular events.
  • To quantify the CV risk associated with different classes and durations of prokinetic exposure.

Main Methods:

  • A self-controlled case series (SCCS) study was conducted using South Korean National Health Claims Database data from 2004-2019.
  • 15,621 participants experiencing CV events (myocardial infarction, stroke) and prokinetic exposure were analyzed.
  • Incidence rate ratios (IRR) compared CV event rates during risk periods (prokinetic use) versus control periods (no prokinetic use).

Main Results:

  • Prokinetic use was associated with a 56% increased risk of CV events (IRR 1.56).
  • The highest CV risk was observed within the first 7 days of prokinetic initiation (IRR 2.29), diminishing after 15 days (IRR 1.03).
  • Central dopamine D2 receptor antagonists showed the highest risk (IRR 2.14), followed by peripheral D2 antagonists (IRR 1.37) and 5-HT4 agonists (IRR 1.29).

Conclusions:

  • Prokinetic drug use is linked to a significant increase in cardiovascular adverse events.
  • The risk is most pronounced in the early phase of treatment and varies by prokinetic class, particularly with central D2 receptor antagonists.