Safety of proteasome inhibitor drugs for the treatment of multiple myeloma post-marketing: a pharmacovigilance investigation based on the FDA adverse event reporting system.

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Safety of proteasome inhibitor drugs for the treatment of multiple myeloma post-marketing: a pharmacovigilance investigation based on the FDA adverse event reporting system.

Safety of proteasome inhibitor drugs for the treatment of multiple myeloma post-marketing: a pharmacovigilance investigation based on the FDA adverse event reporting system.

アブストラクト	BACKGROUND: The use of proteasome inhibitors (PIs), namely Bortezomib and Carfilzomib, revolutionized multiple myeloma (MM) treatment. Understanding their distinct adverse event (AE) profiles aids in tailored treatment plans. RESEARCH DESIGN AND METHODS: We analyzed FDA Adverse Event Reporting System (FAERS) data (Q1 2012-Q4 2023) for Bortezomib and Carfilzomib, utilizing reporting odds ratio (ROR), proportional reporting ratio (PRR), and Bayesian confidence propagation neural network (BCPNN). RESULTS: FAERS yielded 19,720 Bortezomib and 12,252 Carfilzomib AE reports. Males aged 45-65 exhibited higher AE susceptibility. Common AE systems included Infections, Nervous System Disorders, Blood Disorders, General Disorders, Cardiac Disorders, and Renal Disorders. New Bortezomib signals were sepsis and colitis. Carfilzomib exhibited elevated cardiac and renal toxicity but reduced peripheral neuropathy and thrombocytopenia. CONCLUSIONS: FAERS analysis revealed new AE signals (sepsis, colitis) for Bortezomib and highlighted Carfilzomib's heightened cardiac and renal risks compared to Bortezomib. Balancing PIs' benefits and risks is crucial for clinical decision-making.
ジャーナル名	Expert opinion on drug safety
Pubmed追加日	2024/8/19
投稿者	Yu, Dongdong; Cheng, Ting; Liu, Tong; Xu, Wenjun; Liu, Dawei; Dai, Jinzhi; Cai, Shanshan; Guan, Yuxiang; Ye, Ting; Cheng, Xiaoyu
組織名	The First Affiliated Hospital, Anhui University of Chinese Medicine, Hefei City,;Anhui province, China.;Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou;City, Guangdong province, China.;School of Traditional Chinese Medicine, Anhui University of Chinese Medicine,;Hefei City, Anhui province, China.;School of Nursing, Anhui University of Chinese Medicine, Hefei City, Anhui;province, China.;School of Integrated Chinese and Western Medicine, Anhui University of Chinese;Medicine, Hefei City, Anhui province, China.
Pubmed リンク	https://www.ncbi.nlm.nih.gov/pubmed/39157912/