Abstract 4369597: Real-World Safety Profile of Mavacamten in Adults With Hypertrophic Cardiomyopathy: Insights From the FAERS Database

Background: Mavacamten, a novel cardiac myosin inhibitor, has emerged as a targeted therapy for obstructive hypertrophic cardiomyopathy (HCM). While clinical trials have demonstrated its efficacy, real-world post-marketing surveillance is essential to characterize its safety profile. This study analyzes adverse events (AEs) reported in the FDA Adverse Event Reporting System (FAERS) for adult patients receiving mavacamten. Methods: A retrospective analysis of the FAERS database was conducted to identify AE reports linked to mavacamten use. Events were classified as serious or non-serious. Organ system involvement was categorized into cardiovascular (CVS), gastrointestinal (GI), central nervous system (CNS), respiratory, musculoskeletal, renal/urinaryn (RUS), and general categories. Frequency tables and bar charts summarized the distribution of events. Logistic regression analyses (univariate and multivariate) were performed to assess odds ratios (ORs) for serious AEs within each system. Results: Of 2,192 reports, 823 (37.5%) were classified as serious. Most events occurred in females (60.3%) with a mean age of 66.4 ± 13.4 years. Cardiovascular events were reported in 29.7% of cases, with 70.8% of them being serious coded. General adverse events (40.7%), GI (9.9%), CNS (22.0%), and respiratory (20.7%) events were also prevalent. Multivariate logistic regression identified serious cardiovascular AEs (AOR 8.73), renal/urinary events (AOR 1.93), GI events (AOR 1.53), and general events (AOR 1.34) as significant predictors of SAEs. Notably, falls (AOR 5.37) and hypotension (AOR 3.52) were independently associated with increased odds of SAEs. Death was reported in 2.3% of cases. Conclusion: Post-marketing surveillance of mavacamten reveals a substantial proportion of serious AEs, predominantly cardiovascular and systemic. These findings highlight the importance of careful monitoring, particularly for hypotension, renal dysfunction, and falls, in patients treated with mavacamten. Further longitudinal studies are warranted to define risk profiles better and mitigate adverse outcomes in real-world settings.