Yang Jinghua, Zhao Cong, Yang Lan, Yang Yonggang, Wang Nina, Gao Ang, Wang Xian
Dongzhimen Hospital, Beijing University of Chinese Medicine, Hai Yun Cang on the 5th Zip, Dongcheng District, Beijing, 100007, China.
Baoding First Central Hospital, Baoding, China.
Am J Cardiovasc Drugs. 2025 Jun 28. doi: 10.1007/s40256-025-00734-z.
Ivabradine, a selective I current inhibitor, is widely prescribed for heart failure and chronic angina; however, its post-marketing safety profile across diverse clinical contexts remains underexplored.
This study analyzed ivabradine-associated adverse events (AEs) using the US Food and Drug Administration Adverse Event Reporting System, with a focus on overall patterns and indication-specific subgroups.
We reviewed reports from the US Food and Drug Administration Adverse Event Reporting System from quarter 2, 2015, to quarter 2, 2024, and conducted a disproportionality analysis using four methods: reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and empirical Bayesian geometric mean. We stratified AEs by clinical indications (tachycardia, heart failure, coronary artery disease) and prioritized them using a semi-quantitative scoring system and important or designated medical event criteria as defined by the European Medicines Agency.
A total of 2733 ivabradine-related AE reports were identified, involving 24 system organ classes. Cardiac disorders (n = 1045) and eye disorders (n = 352) were most frequent, with bradycardia, arrhythmias, and photopsia being the leading events. Subgroup analyses revealed distinct AE profiles: sinus tachycardia and supraventricular tachycardia in the tachycardia subgroup; blurred vision and angina in coronary artery disease; and severe AEs-such as dyspnea, prolonged QT interval, and ventricular fibrillation-primarily in heart failure. One rare but notable designated medical event, transient blindness (n = 3), was also identified.
Ivabradine shows an overall favorable safety profile. Most AEs appear related to underlying disease or comedications rather than intrinsic drug toxicity. These findings support indication-specific monitoring to enhance clinical safety and pharmacovigilance.
伊伐布雷定是一种选择性I电流抑制剂，广泛用于治疗心力衰竭和慢性心绞痛；然而，其在不同临床环境下的上市后安全性仍未得到充分研究。
本研究使用美国食品药品监督管理局不良事件报告系统分析伊伐布雷定相关不良事件（AE），重点关注总体模式和特定适应症亚组。
我们回顾了2015年第二季度至2024年第二季度美国食品药品监督管理局不良事件报告系统的报告，并使用四种方法进行不成比例分析：报告比值比、比例报告比值、贝叶斯置信传播神经网络和经验贝叶斯几何均值。我们根据临床适应症（心动过速、心力衰竭、冠状动脉疾病）对不良事件进行分层，并使用半定量评分系统以及欧洲药品管理局定义的重要或指定医疗事件标准对其进行优先级排序。
共识别出2733份与伊伐布雷定相关的不良事件报告，涉及24个系统器官类别。心脏疾病（n = 1045）和眼部疾病（n = 352）最为常见，心动过缓、心律失常和闪光幻视为主要事件。亚组分析显示了不同的不良事件特征：心动过速亚组中的窦性心动过速和室上性心动过速；冠状动脉疾病中的视力模糊和心绞痛；以及主要在心力衰竭中的严重不良事件，如呼吸困难、QT间期延长和心室颤动。还识别出一种罕见但值得注意的指定医疗事件，即短暂性失明（n = 3）。
伊伐布雷定总体安全性良好。大多数不良事件似乎与基础疾病或合并用药有关，而非药物本身毒性。这些发现支持进行特定适应症监测，以提高临床安全性和药物警戒。
