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

in Expert opinion on drug safety by Tung-Lung Wu, Chao-Kun Chen, Chien-Ming Chao, Ya-Ting Hsu, Sheng-Yen Hsiao, Teng-Song Weng

TLDR

  • The study found that venetoclax increases the risk of adverse events, including neutropenia, diarrhea, and cardiovascular events, but not tumor lysis syndrome, and recommends monitoring patients for these side effects and further research to improve safety.

Abstract

Venetoclax, an oral B-cell lymphoma-2 (BCL-2) inhibitor, shows promise in cancer treatment but has an unclear safety profile. This meta-analysis evaluates the safety of venetoclax, focusing on adverse events. Data from PubMed, Embase, Cochrane databases, and ClinicalTrials.gov were retrieved up to August 2023. Nine studies were included based on specific inclusion and exclusion criteria. A random effects model was used to calculate risk ratios (RRs) and 95% confidence intervals (CIs). The meta-analysis included nine studies. Venetoclax was associated with increased risks of neutropenia (RR = 1.427, 95% CI = 1.118 to 1.822), diarrhea (RR = 1.889, 95% CI = 1.388 to 2.570), and cardiovascular events (RR = 1.726, 95% CI = 1.088 to 2.737). However, the risk of tumor lysis syndrome (TLS) with venetoclax was not increased compared to the comparators (RR = 1.478, 95% CI = 0.504 to 4.337). Venetoclax increases the risk of hematological, gastrointestinal, and cardiac adverse events. Clinicians should monitor these side effects, especially in patients with preexisting conditions. Further research is needed to fully understand venetoclax's safety profile. https://inplasy.com/ identifier is INPLASY2023110041.

Overview

  • The study aims to evaluate the safety of venetoclax, a B-cell lymphoma-2 inhibitor, by analyzing adverse events from nine included studies.
  • The meta-analysis included articles from PubMed, Embase, Cochrane databases, and ClinicalTrials.gov up to August 2023, and used a random effects model to calculate risk ratios and 95% confidence intervals.
  • The study focuses on the safety of venetoclax and aims to identify the risks of adverse events, particularly hematological, gastrointestinal, and cardiovascular events, as well as tumor lysis syndrome (TLS).

Comparative Analysis & Findings

  • The meta-analysis found that venetoclax was associated with increased risks of neutropenia, diarrhea, and cardiovascular events compared to comparators.
  • The study did not find an increased risk of tumor lysis syndrome (TLS) with venetoclax compared to comparators.
  • The findings suggest that venetoclax increases the risk of hematological, gastrointestinal, and cardiac adverse events, and clinicians should monitor for these side effects, especially in patients with pre-existing conditions.

Implications and Future Directions

  • The study identifies the need for further research to fully understand the safety profile of venetoclax and to identify subgroups of patients who may be more susceptible to adverse events.
  • Clinicians should monitor patients receiving venetoclax for hematological, gastrointestinal, and cardiac adverse events, and consider prophylactic measures for patients with pre-existing conditions.
  • Future research could investigate the optimal dosing and duration of venetoclax treatment to minimize side effects while maximizing therapeutic benefits.
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