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

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Expert Opinion on Drug Safety Pub Date : 2025-01-26 DOI:10.1080/14740338.2025.2449987
Tung-Lung Wu, Chao-Kun Chen, Chien-Ming Chao, Ya-Ting Hsu, Sheng-Yen Hsiao, Teng-Song Weng
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Abstract

Introduction: 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.

Methods: 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).

Results: 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).

Conclusions: 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.

Protocol registration: https://inplasy.com/ identifier is INPLASY2023110041.

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venetoclax相关不良事件的风险评估:荟萃分析方法。
Venetoclax是一种口服b细胞淋巴瘤-2 (BCL-2)抑制剂,在癌症治疗中显示出希望,但安全性尚不清楚。本荟萃分析评估了venetoclax的安全性,重点关注不良事件。方法:从PubMed、Embase、Cochrane数据库和ClinicalTrials.gov检索截至2023年8月的数据。根据特定的纳入和排除标准纳入了9项研究。采用随机效应模型计算风险比(rr)和95%置信区间(ci)。结果:meta分析包括9项研究。Venetoclax与中性粒细胞减少(RR = 1.427, 95% CI = 1.118 ~ 1.822)、腹泻(RR = 1.889, 95% CI = 1.388 ~ 2.570)和心血管事件(RR = 1.726, 95% CI = 1.088 ~ 2.737)的风险增加相关。然而,与比较组相比,venetoclax组肿瘤溶解综合征(TLS)的风险并未增加(RR = 1.478, 95% CI = 0.504 ~ 4.337)。结论:Venetoclax增加血液学、胃肠道和心脏不良事件的风险。临床医生应该监测这些副作用,特别是对已有疾病的患者。需要进一步的研究来充分了解venetoclax的安全性。协议注册:https://inplasy.com/标识符为INPLASY2023110041。
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来源期刊
CiteScore
5.90
自引率
3.20%
发文量
97
审稿时长
6-12 weeks
期刊介绍: Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
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