Wang Zhanzhang, Lu Haoyang, Li Yuandan, Huang Shanqing, Zhang Ming, Wen Yuguan, Shang Dewei
The Affiliated Brain Hospital, Guangzhou Medical University, 36 Mingxin Road, Guangzhou, China.
Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Guangzhou Medical University, Guangzhou, China.
Br J Clin Pharmacol. 2024 Oct 29. doi: 10.1111/bcp.16326.
This study aimed to provide a comprehensive view of cardiovascular adverse events (AEs) associated with venlafaxine (VEN) therapy.
Cardiovascular AE reports for patients receiving VEN therapy were retrieved from January 2004 to December 2023 from the FDA Adverse Event Reporting System database. Effects of age, sex and daily VEN dose on the occurrence of different types of cardiovascular AEs and the influence of demographics, VEN dose, comorbidity and co-medication on death in patients with cardiovascular AEs were analysed by multivariate logistic regression analysis.
The study included 16 110 AE reports following VEN treatment (median age: 51 years, females: 69.78%, median VEN daily dose: 100 mg/day). VEN daily dose was associated with increased risks of cardiac arrhythmias, embolic and thrombotic events, torsade de pointes/QT prolongation, ischaemic heart disease, cardiac failure, cardiomyopathy and overall cardiovascular events. The elderly (≥ 75 years), male sex, comorbidity (infections and infestations, cardiac disorders, nervous system disorders) and co-medication (quetiapine and clozapine) were related to death following VEN-associated cardiovascular AEs; however, the risk of cardiovascular death did not increase with regular VEN doses.
Our study confirmed the association of cardiovascular AEs with VEN therapy and revealed the influencing factors for the risk of VEN-related cardiovascular AEs and death due to these events. Based on the obtained evidence, the cardiovascular health of late-elderly patients with complex comorbidity and polytherapy should be closely monitored when they receive VEN therapy. As an exploratory study, prospective studies are needed to validate our findings in the future.
本研究旨在全面了解与文拉法辛（VEN）治疗相关的心血管不良事件（AE）。
从2004年1月至2023年12月的FDA不良事件报告系统数据库中检索接受VEN治疗患者的心血管AE报告。通过多因素逻辑回归分析，分析年龄、性别和VEN日剂量对不同类型心血管AE发生的影响，以及人口统计学、VEN剂量、合并症和联合用药对心血管AE患者死亡的影响。
该研究纳入了16110例VEN治疗后的AE报告（中位年龄：51岁，女性：69.78%，VEN日剂量中位数：100mg/天）。VEN日剂量与心律失常、栓塞和血栓形成事件、尖端扭转型室速/QT间期延长、缺血性心脏病、心力衰竭、心肌病及总体心血管事件风险增加相关。老年人（≥75岁）、男性、合并症（感染和寄生虫病、心脏疾病、神经系统疾病）及联合用药（喹硫平和氯氮平）与VEN相关心血管AE后的死亡有关；然而，心血管死亡风险并未随VEN常规剂量增加。
我们的研究证实了心血管AE与VEN治疗之间的关联，并揭示了VEN相关心血管AE风险及这些事件所致死亡的影响因素。基于所获证据，对于合并复杂疾病且接受多种治疗的高龄患者，在接受VEN治疗时应密切监测其心血管健康。作为一项探索性研究，未来需要前瞻性研究来验证我们的发现。
