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Risk assessment of venetoclax-associated adverse events: a meta-analysis approach

Tung-Lung Wu1, Chao-Kun Chen2, Chien-Ming Chao3

  • 1Division of General Surgery, Department of Surgery, St. Martin De Porres Hospital, Chiayi City, Taiwan.

Expert Opinion on Drug Safety
|January 20, 2025
PubMed
Abstract

Insights

This meta-analysis shows that venetoclax increases risks for neutropenia, diarrhea, and cardiovascular events. However, it does not significantly increase the risk of tumor lysis syndrome (TLS).

Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Medicine

Background:

  • Venetoclax is an oral B-cell lymphoma-2 (BCL-2) inhibitor with potential in cancer therapy.
  • The safety profile of venetoclax requires thorough evaluation due to its emerging use.

Purpose of the Study:

  • To conduct a meta-analysis evaluating the safety of venetoclax.
  • To identify and quantify adverse events associated with venetoclax treatment.

Main Methods:

  • A systematic literature search was performed across PubMed, Embase, Cochrane, and ClinicalTrials.gov up to August 2023.
  • Nine studies meeting predefined inclusion criteria were analyzed using a random effects model.
  • Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated for various adverse events.

Main Results:

  • Venetoclax use was associated with a significantly increased risk of neutropenia (RR=1.427, 95% CI=1.118-1.822).
  • Increased risks were also observed for diarrhea (RR=1.889, 95% CI=1.388-2.570) and cardiovascular events (RR=1.726, 95% CI=1.088-2.737).
  • The risk of tumor lysis syndrome (TLS) was not significantly increased with venetoclax (RR=1.478, 95% CI=0.504-4.337).

Conclusions:

  • Venetoclax is linked to higher risks of hematological, gastrointestinal, and cardiac adverse events.
  • Clinical monitoring for these side effects is crucial, particularly in patients with pre-existing conditions.
  • Further research is warranted to comprehensively understand the safety profile of venetoclax.
Keywords:
BCL-2Venetoclaxadverse eventshematologistsafety

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