A Real‑World Pharmacovigilance Study of FDA Adverse Event Reporting System (FAERS) for Mavacamten
Zeynep Yukselen1, Arvind Kumar Venkataramana Raju1, Pramukh Arun Kumar1
1Department of Internal Medicine, Saint Vincent Hospital, Worcester, MA, USA.
Background:
Mavacamten is a first-in-class cardiac myosin inhibitor approved by the US Food and Drug Administration (FDA) for symptomatic obstructive hypertrophic cardiomyopathy (HCM). This pharmacovigilance study aimed to assess mavacamten-related adverse drug reactions (ADRs) in the real world as reported in the FDA Adverse Event Reporting System (FAERS).
Methods:
We conducted disproportionality analyses with four signal detection algorithms-reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network, and the multi-item gamma Poisson shrinker to identify mavacamten-related ADRs.
Results:
Out of 4,500,131 reports from the FAERS database, 1004 mavacamten-related ADRs were identified from 1 January 2022 to 30 September 2023. A total of 26 significant disproportionality preferred terms (PTs) conforming to the four signal detection algorithms were noted. Some of the statistically significant cardiac ADRs at PT level include decreased ejection fraction (EF) [ROR 33.60 (95% confidence interval, CI 21.79-51.82), PRR 32.86 (χ2 615.96), information component (IC) 5.03, IC025 4.61, empirical Bayesian geometric mean (EBGM) 32.77, EBGM05 21.25], cardiac failure [ROR 9.39 (95% CI 6.49-13.60), PRR 9.13 (χ2 202.42), IC 3.19, IC025 2.83, EBGM 9.12, EBGM05 6.30], and atrial fibrillation [ROR 16.63 (95% CI 12.72-21.75), PRR 15.66 (χ2 769.93), IC 3.97, IC025 3.71, EBGM 15.64, EBGM05 11.96].
Conclusions:
The results of our study were consistent with the safety data of clinical trials, including reduced ejection fraction, atrial fibrillation, dyspnea, and syncope. We also found potential new and unexpected ADR signals, such as urinary tract infection, gout, and peripheral edema.
Insights
This study analyzed real-world data on mavacamten, a cardiac myosin inhibitor, identifying adverse drug reactions. Findings confirmed known side effects like decreased ejection fraction and revealed potential new signals.
Area of Science:
- Pharmacovigilance
- Cardiology
- Drug Safety
Background:
- Mavacamten is an FDA-approved cardiac myosin inhibitor for symptomatic obstructive hypertrophic cardiomyopathy (HCM).
- Real-world safety data is crucial for understanding drug-related adverse events.
- This study focuses on mavacamten-related adverse drug reactions (ADRs) reported in the FDA Adverse Event Reporting System (FAERS).
Purpose of the Study:
- To assess mavacamten-related ADRs in a real-world setting.
- To identify potential safety signals using disproportionality analyses.
- To compare real-world findings with existing clinical trial data.
Main Methods:
- Utilized the FAERS database, analyzing 4,500,131 reports.
- Employed four signal detection algorithms: ROR, PRR, BCNN, and PGBS.
- Identified 26 significant disproportionality preferred terms (PTs) for mavacamten-related ADRs.
Main Results:
- 1004 mavacamten-related ADRs were identified between January 2022 and September 2023.
- Statistically significant cardiac ADRs included decreased ejection fraction (EF), cardiac failure, and atrial fibrillation.
- Specific metrics like ROR and PRR quantified the disproportionality for these ADRs.
Conclusions:
- Real-world findings align with clinical trial safety data for mavacamten.
- Confirmed ADRs include reduced ejection fraction, atrial fibrillation, dyspnea, and syncope.
- Identified potential novel ADR signals: urinary tract infection, gout, and peripheral edema.
More Related Videos
07:02A Computerized Test Battery to Study Pharmacodynamic Effects on the Central Nervous System of Cholinergic Drugs in Early Phase Drug Development
Published on: February 11, 2019
08:33Author Spotlight: Methodologies and Advancements of Chronic Pain Management Research
Published on: January 5, 2024
Related Concept Videos
01:19Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
01:25Drug Regulation
01:11Clinical Trials: Overview
01:20Desensitization and Tachyphylaxis