Adverse events in mavacamten treatment for hypertrophic cardiomyopathy: a study based on the US FDA Adverse Event Reporting System database
10.3760/cma.j.cn114015-20240620-00473
- VernacularTitle:玛伐凯泰治疗肥厚型心肌病的不良事件：一项基于美国FDA不良事件报告系统数据库的研究
- Author:
Yilong YAN
1
;
Yi'nan ZHANG
1
;
Zhigang ZHAO
1
Author Information
1. 首都医科大学附属北京天坛医院药学部，北京 100070
- Publication Type:Journal Article
- Keywords:
Cardiomyopathy, hypertrophic;
Cardiac myosins inhibitors;
Safety;
Adverse event signal mining;
Mavacamten
- From:
Adverse Drug Reactions Journal
2025;27(4):207-211
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To mine the risk signals of adverse events (AEs) in mavacamten treatment for hypertrophic cardiomyopathy, and provide reference for safe use of the drug in clinic.Methods:AE reports on mavacamten from June 2022 to June 2024 were collected by searching US Food and Drug Administration Adverse Event Reporting System (FAERS) database. AEs were classified and standardized according to the system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities version 26.1. Reporting odds ratio (ROR) method and comprehensive standard method of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) were used to mine the AE risk signals. An AE that simultaneously met the criteria of ≥3 reports, lower limit of the 95% confidence interval ( CI) of ROR>1, PRR ≥2, and χ2 ≥4 was defined as a risk signal. Descriptive statistical analysis on signals was performed. Results:A total of 1 041 AE reports were collected, involving 47 PTs and 12 SOCs. The top 10 risk signals based on the number of AE reports were dyspnea, dizziness, fatigue, atrial fibrillation, cardiac failure, palpitation, nasopharyngitis, chest pain, COVID-19, and weight increased. Except dizziness and heart failure, above AEs were not recorded in the label. The top 10 risks in signal intensity were acquired left ventricle outflow tract obstruction, transvalvular pressure gradient increased, cardiovascular symptom, echocardiogram abnormal, hypervolaemia, left ventricular failure, ejection fraction decreased, coronavirus infection, brain fog, and atrial fibrillation. Except cardiovascular symptom, left ventricular failure, and ejection fraction decreased, above AEs were not recorded in the label.Conclusions:The AE risk signals of mavacamten in the treatment for hypertrophic cardiomyopathy recorded in the label are mainly heart failure and ejection fraction decreased. Clinicians and pharmacists should also be vigilant against risk signals not recorded in the lakel, such as atrial fibrillation, fatigue, nasopharyngitis, coronavirus infection, and brain fog, etc.
