哪个药物在CLL患者中心血管安全性方面更占优势？ibrutinib与obinutuzumab之争。
Which is the top player for the cardiovascular safety? ibrutinib vs. obinutuzumab in CLL.
发表日期：2023
作者：
Annamaria Mascolo, Raffaella Di Napoli, Nunzia Balzano, Elena D'Alessio, Imma Izzo, Francesco Rossi, Giuseppe Paolisso, Annalisa Capuano, Liberata Sportiello
来源：
Frontiers in Pharmacology
摘要：
引言：伊布替尼（Ibrutinib）是一种布鲁顿酪氨酸激酶（BTK）抑制剂，被授权用于慢性淋巴细胞白血病（CLL）的治疗。本研究旨在比较伊布替尼与奥比努妥珠单抗（obinutuzumab）的心脏安全性。 方法：从2014年1月1日至2022年9月30日期间，对从欧洲药品安全监测数据库（Eudravigilance）中获取的数据进行了一项回顾性药物监测研究。比较了伊布替尼、奥比努妥珠单抗以及两种药物的联合使用中心血管事件的报告频率。 结果：共检索到2,291例心血管事件，其中1,965例与伊布替尼有关，312例与奥比努妥珠单抗有关，14例与两种药物联合使用有关。大多数病例涉及年龄≥65岁的患者（N=1,454；63.47%）和男性（N=1,497；65.34%）。大部分病例属于严重程度（N=2,131；93.02%）。最常报道的事件包括：心房颤动（N=913；31.31%）和出血（N=201；6.89%）。与奥比努妥珠单抗相比，伊布替尼的心血管事件报告频率较高（风险比，3.22；95%置信区间，2.89-3.60），与两种药物联合使用相比也较高（风险比，1.77；95%置信区间，1.11-2.83）。奥比努妥珠单抗与两种药物联合使用相比，报告频率较低（风险比，0.55；95%置信区间，0.34-0.88）。 讨论：本研究发现，与奥比努妥珠单抗相比，患者接受伊布替尼的心血管事件报告频率较高。需要进一步研究来更好地探究伊布替尼的安全性。 版权所有 © 2023 Mascolo, Di Napoli, Balzano, D’Alessio, Izzo, Rossi, Paolisso, Capuano and Sportiello.
Introduction: Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, is authorized for the treatment of chronic lymphocytic leukemia (CLL). This study aims to explore the cardiac safety profile of ibrutinib in comparison with obinutuzumab. Methods: A retrospective pharmacovigilance study was conducted on data retrieved from the European pharmacovigilance database (Eudravigilance) from 1 January 2014 to 30 September 2022. To compare the reporting frequency of cardiovascular events among ibrutinib, obinutuzumab, and the combination of both. Results: A total of 2 291 CV cases were retrieved, of which 1965 were related to ibrutinib, 312 to obinutuzumab, and 14 to the combination. Most cases referred to patients aged ≥65 years (N = 1,454; 63.47%) and male (N = 1,497; 65.34%). Most cases were serious (N = 2,131; 93.02%). The most reported events were: atrial fibrillation (N = 913; 31.31%) and haemorrhage (N = 201; 6.89%). A higher reporting frequency of CV events was found when ibrutinib was compared to obinutuzumab (ROR, 3.22; 95% CI, 2.89-3.60) or combination (ROR, 1.77; 95% CI, 1.11-2.83). A lower reporting was observed when obinutuzumab was compared to combination (ROR, 0.55; 95% CI, 0.34-0.88). Discussion: A higher reporting frequency of CV events in patients exposed to ibrutinib in comparison with obinutuzumab was found. Further studies are needed to better explore the safety of ibrutinib.Copyright © 2023 Mascolo, Di Napoli, Balzano, D’Alessio, Izzo, Rossi, Paolisso, Capuano and Sportiello.