Cardiovascular adverse events associated with PARP inhibitors for ovarian cancer: a real world study (RWS) with Bayesian disproportional analysis based on the FDA adverse event reporting system (FAERS).

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Cardiovascular adverse events associated with PARP inhibitors for ovarian cancer: a real world study (RWS) with Bayesian disproportional analysis based on the FDA adverse event reporting system (FAERS).

Cardiovascular adverse events associated with PARP inhibitors for ovarian cancer: a real world study (RWS) with Bayesian disproportional analysis based on the FDA adverse event reporting system (FAERS).

アブストラクト	BACKGROUND: To investigate the pharmacovigilance (PV) and make pairwise comparisons on reporting proportion, seriousness, and severity of outcomes of major adverse cardiovascular events (MACE) among poly(ADP-ribose) polymerase-inhibitors (PARPis) in treating ovarian cancer, fallopian tube carcinoma, and primary peritoneal cancer (collectively named EOC) from the US Food and Drug Administration Adverse Event Reporting System (FAERS). RESEARCH DESIGN AND METHODS: Data on adverse cardiovascular events reports related to EOC treatment submitted to FAERS from the first quarter of 2015 to the second quarter of 2023 were harvested. Three PARPis were identified: olaparib, niraparib, and rucaparib. RESULTS: Eventually, a total of 258,596 eligible records were enrolled with 12,331 reports including 5,292 reports of MACE and 7,039 reports of other cardiovascular events. For the primary composite endpoint, a PV signal associated with MACE was detected in niraparib (ROR = 1.12; IC(025) = 0.03), whereas it was not detected in olaparib and rucaparib; For the secondary endpoint, PV signals associated with other cardiovascular events were detected in niraparib (ROR = 1.17;IC(025) = 0.04), but not in olaparib and rucaparib. CONCLUSIONS: For EOC patients, close monitoring of blood pressure, heart rate, and coagulation function should be conducted when selecting niraparib for treatment.
ジャーナル名	Expert opinion on drug safety
Pubmed追加日	2024/8/12
投稿者	Yang, Chenguang; Song, Xuan; Sun, Hongmei; Chen, Xi; Liu, Chengjiang; Chen, Min
組織名	Department of Gynaecology and Obstetrics, Affiliated Xuancheng Hospital of Wannan;Medical College, Xuancheng, Anhui Province, China.;Department of General Medicine, Affiliated Xuancheng Hospital of Wannan Medical;College, Xuancheng, Anhui Province, China.;Department of Epidemiology and Statistics, School of Public Health, Medical;College, Zhejiang University, Zhejiang, China.;Department of General Medicine, Affiliated Anqing First People's Hospital of;Anhui Medical University, Hefei, China.
Pubmed リンク	https://www.ncbi.nlm.nih.gov/pubmed/39132853/