Masuda Rikuto, Noguchi Yoshihiro, Yoshimura Tomoaki
Laboratory of Clinical Pharmacy, Gifu Pharmaceutical University, 1-25-4 Daigakunishi, Gifu-Shi, Gifu, 501-1196, Japan.
Cardiovasc Toxicol. 2025 Jun 24. doi: 10.1007/s12012-025-10029-z.
Among the drugs used for insomnia, the use of benzodiazepine and non-benzodiazepine hypnotics is correlated to the occurrence of cardiac arrhythmia. Conversely, melatonin receptor agonists may exert cardioprotective effects. Therefore, in the present study, we investigated the association between the use of melatonin receptor agonists and the occurrence of cardiac arrhythmia using the Food and Drug Administration Adverse Event Reporting System (FAERS). Eligible patients are registered in FAERS. The targeted drugs were melatonin receptor agonists and benzodiazepine receptor agonists (BZRAs). The target disease was cardiac arrhythmia, and data for the disease were extracted from the Medical Dictionary for Regulatory Activities (MedDRA) 27.1; Standardized MedDRA Query (SMQ). The reporting odds ratio (ROR) was calculated in the study. The results showed that melatonin receptor agonists were negatively correlated with all cardiac arrhythmia-related SMQs. The RORs for each SMQ were as follows: "cardiac arrhythmias" (ROR: 0.47, 95%CI: 0.41-0.54), "bradyarrhythmias" (ROR: 0.20, 95%CI: 0.10-0.40), "tachyarrhythmias" (ROR: 0.21, 95%CI: 0.13-0.33), "supraventricular tachyarrhythmias" (ROR: 0.24, 95%CI: 0.14-0.41), "ventricular tachyarrhythmias" (ROR: 0.05, 95%CI: 0.01-0.33), and "TdP" (ROR: 0.32, 95%CI: 0.25-0.41). Conversely, BZRAs were positively correlated with cardiac arrhythmia-related SMQs. Overall, the present results suggest that compared with BZRAs, melatonin receptor agonist usage is weakly associated with cardiac arrhythmia.
在用于失眠的药物中，苯二氮䓬类和非苯二氮䓬类催眠药的使用与心律失常的发生相关。相反，褪黑素受体激动剂可能具有心脏保护作用。因此，在本研究中，我们使用美国食品药品监督管理局不良事件报告系统（FAERS）调查了褪黑素受体激动剂的使用与心律失常发生之间的关联。符合条件的患者已在FAERS中登记。目标药物为褪黑素受体激动剂和苯二氮䓬受体激动剂（BZRAs）。目标疾病是心律失常，该疾病的数据从《药物监管活动医学词典》（MedDRA）27.1；标准化医学术语查询（SMQ）中提取。在研究中计算报告比值比（ROR）。结果显示，褪黑素受体激动剂与所有与心律失常相关的SMQ呈负相关。每个SMQ的ROR如下：“心律失常”（ROR：0.47，95%CI：0.41 - 0.54）、“缓慢性心律失常”（ROR：0.20，95%CI：0.10 - 0.40）、“快速性心律失常”（ROR：0.21，95%CI：0.13 - 0.33）、“室上性快速性心律失常”（ROR：0.24，95%CI：0.14 - 0.41）、“室性快速性心律失常”（ROR：0.05，95%CI：0.01 - 0.33）和“尖端扭转型室速”（ROR：0.32，95%CI：0.25 - 0.41）。相反，BZRAs与心律失常相关的SMQ呈正相关。总体而言，目前的结果表明，与BZRAs相比，褪黑素受体激动剂的使用与心律失常的关联较弱。
