Mascolo Annamaria, Di Napoli Raffaella, Balzano Nunzia, D'Alessio Elena, Izzo Imma, Rossi Francesco, Paolisso Giuseppe, Capuano Annalisa, Sportiello Liberata
Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Napoli, Italy.
Department of Experimental Medicine-Section of Pharmacology "L. Donatelli", University of Campania "Luigi Vanvitelli", Napoli, Italy.
Front Pharmacol. 2023 Aug 16;14:1229304. doi: 10.3389/fphar.2023.1229304. eCollection 2023.
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. 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. 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 ( = 1,454; 63.47%) and male ( = 1,497; 65.34%). Most cases were serious ( = 2,131; 93.02%). The most reported events were: atrial fibrillation ( = 913; 31.31%) and haemorrhage ( = 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). 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.
伊布替尼是一种布鲁顿酪氨酸激酶（BTK）抑制剂，已被批准用于治疗慢性淋巴细胞白血病（CLL）。本研究旨在探讨伊布替尼与奥妥珠单抗相比的心脏安全性。对2014年1月1日至2022年9月30日从欧洲药物警戒数据库（EudraVigilance）检索到的数据进行了一项回顾性药物警戒研究。以比较伊布替尼、奥妥珠单抗以及两者联合使用时心血管事件的报告频率。共检索到2291例心血管病例，其中1965例与伊布替尼有关，312例与奥妥珠单抗有关，14例与联合使用有关。大多数病例涉及年龄≥65岁的患者（n = 1454；63.47%）且为男性（n = 1497；65.34%）。大多数病例为严重病例（n = 2131；93.02%）。报告最多的事件为：心房颤动（n = 913；31.31%）和出血（n = 201；6.89%）。与奥妥珠单抗（报告比值比，3.22；95%置信区间，2.89 - 3.60）或联合使用（报告比值比，1.77；95%置信区间，1.11 - 2.83）相比，伊布替尼的心血管事件报告频率更高。与联合使用相比，奥妥珠单抗的报告频率较低（报告比值比，0.55；95%置信区间，0.34 - 0.88）。发现与奥妥珠单抗相比，接受伊布替尼治疗的患者心血管事件报告频率更高。需要进一步研究以更好地探索伊布替尼的安全性。
