PMID- 38403712
OWN - NLM
STAT- Publisher
LR  - 20240225
IS  - 1432-0584 (Electronic)
IS  - 0939-5555 (Linking)
DP  - 2024 Feb 26
TI  - Venetoclax adverse event monitoring: a safety meta-analysis of randomized 
      controlled trials and a retrospective evaluation of the FAERS.
LID - 10.1007/s00277-024-05676-1 [doi]
AB  - Concerns persist about venetoclax's long-term safety in larger populations, with 
      limited evidence of infrequent and delayed adverse events (AEs). The study 
      integrated safety data on venetoclax in leukemia patients from randomized 
      controlled trials (RCTs) and FDA adverse event monitoring system (FAERS). We 
      systematically reviewed RCTs reporting safety outcomes of venetoclax in adult 
      leukemia patients of any gender, either monotherapy or in combination, applying 
      advanced search on databases like PubMed, EMBASE, and ClinicalTrial.gov. The 
      quality assessment was done using the Cochrane Risk of Bias Tool. We utilized a 
      random effect meta-analysis to calculate risk ratio (RR) with 95% confidence 
      intervals (CI). The Open Vigil 2.1 MedDRAv24 was used to search the FAERS 
      database, with data available until September 2023. The disproportionality was 
      calculated using the proportional reporting ratio and the reporting odds ratio. 
      The study protocol for meta-analysis was registered with PROSPERO; 
      CRD42022378006. For the safety meta-analysis, seven RCTs with available AEs were 
      examined. A total of 942 AEs were found associated with the venetoclax group; 79% 
      of them were in grade three or above. Venetoclax significantly increased the risk 
      of neutropenia grade three or above (RR = 1.34, 95% CI: 1.10-1.64, p: 0.0033) 
      compared with the control group. In FAERS, 26,436 patients were reported with AEs 
      associated with venetoclax. Significant signal scores were observed in 
      hematological, cardiac, vascular, and gastrointestinal disorders. 11 out of 30 
      generated signals, failed to meet the signal criteria upon refinement. The 
      current study updated and improved the safety profile of venetoclax in the 
      post-marketing period, assisting in risk evaluation and mitigation for the best 
      possible patient health care.
CI  - (c) 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, 
      part of Springer Nature.
FAU - Kt, Muhammed Favas
AU  - Kt MF
AD  - Department of Pharmacy Practice, National Institute of Pharmaceutical Education 
      and Research (NIPER), SAS Nagar (Mohali), Punjab, India.
FAU - Semwal, Maneesh
AU  - Semwal M
AD  - Department of Pharmacy Practice, National Institute of Pharmaceutical Education 
      and Research (NIPER), SAS Nagar (Mohali), Punjab, India.
FAU - Yoosuf, Beema T
AU  - Yoosuf BT
AD  - Department of Pharmacy Practice, National Institute of Pharmaceutical Education 
      and Research (NIPER), SAS Nagar (Mohali), Punjab, India.
FAU - Lad, Deepesh
AU  - Lad D
AD  - Leukemia/BMT Program of British Columbia, Division of Hematology, Department of 
      Medicine, University of British Columbia, Vancouver, BC, Canada.
FAU - Bansal, Dipika
AU  - Bansal D
AUID- ORCID: 0000-0003-4520-3293
AD  - Department of Pharmacy Practice, National Institute of Pharmaceutical Education 
      and Research (NIPER), SAS Nagar (Mohali), Punjab, India. 
      dipikabansal079@gmail.com.
LA  - eng
PT  - Journal Article
DEP - 20240226
PL  - Germany
TA  - Ann Hematol
JT  - Annals of hematology
JID - 9107334
SB  - IM
OTO - NOTNLM
OT  - Adverse events
OT  - Leukemia
OT  - Pharmacovigilance
OT  - Safety
OT  - Venetoclax
EDAT- 2024/02/26 00:42
MHDA- 2024/02/26 00:42
CRDT- 2024/02/25 23:37
PHST- 2023/11/14 00:00 [received]
PHST- 2024/02/18 00:00 [accepted]
PHST- 2024/02/26 00:42 [medline]
PHST- 2024/02/26 00:42 [pubmed]
PHST- 2024/02/25 23:37 [entrez]
AID - 10.1007/s00277-024-05676-1 [pii]
AID - 10.1007/s00277-024-05676-1 [doi]
PST - aheadofprint
SO  - Ann Hematol. 2024 Feb 26. doi: 10.1007/s00277-024-05676-1.