Safety and efficacy of aficamten in patients with non-obstructive hypertrophic cardiomyopathy: A 36-week analysis from FOREST-HCM.

Autor: Masri A; Oregon Health and Science University, Portland, OR, USA., Barriales-Villa R; Complexo Hospitalario Universitario de A Coruña, A Coruña, Spain., Elliott P; Barts Heart Centre and University College London, London, UK., Nassif ME; Saint Luke's Mid America Heart Institute, Kansas City, MO, USA., Oreziak A; National Institute of Cardiology, Warsaw, Poland., Owens AT; University of Pennsylvania, Philadelphia, PA, USA., Tower-Rader A; Massachusetts General Hospital, Boston, MA, USA., Heitner SB; Cytokinetics Incorporated, South San Francisco, CA, USA., Kupfer S; Cytokinetics Incorporated, South San Francisco, CA, USA., Malik FI; Cytokinetics Incorporated, South San Francisco, CA, USA., Melloni C; Cytokinetics Incorporated, South San Francisco, CA, USA., Meng L; Cytokinetics Incorporated, South San Francisco, CA, USA., Wei J; Cytokinetics Incorporated, South San Francisco, CA, USA., Saberi S; University of Michigan Medical Center, Ann Arbor, MI, USA.
Jazyk: angličtina
Zdroj: European journal of heart failure [Eur J Heart Fail] 2024 Jul 18. Date of Electronic Publication: 2024 Jul 18.
DOI: 10.1002/ejhf.3372
Abstrakt: Aims: The aim of this study was to report safety and efficacy of aficamten in patients with non-obstructive hypertrophic cardiomyopathy (nHCM) over 36 weeks in the ongoing FOREST-HCM trial.
Methods and Results: Patients were started on aficamten 5 mg daily, with doses adjusted in 5-mg increments (5-20 mg) at ≥2-week intervals according to site-read left ventricular ejection fraction (LVEF). Aficamten dose was increased if LVEF ≥55%, maintained if LVEF 50-54%, decreased if LVEF 40-<50%, and temporarily interrupted if LVEF <40%. Safety and efficacy were assessed over 36 weeks. Overall, 34 patients were enrolled (mean age 57.2 ± 15.3 years, 62% female, 41% in New York Heart Association [NYHA] class III). Over 36 weeks, 82.3% achieved 15-20 mg daily dose and there was a modest reduction in LVEF by -4.3% ± 5.2 from 70% ± 6.1 (p < 0.0001). At Week 36, NYHA class improved by ≥1 class in 27 (79.4%) patients. Mean Kansas City Cardiomyopathy Questionnaire clinical summary score improved by 13.8 ± 12.5 points relative to baseline. Median (interquartile range) levels of N-terminal pro-B-type natriuretic peptide were significantly improved from baseline (-665.5 pg/ml [-1244.0, -232.0]; p < 0.0001), while high-sensitivity cardiac troponin I was unchanged (-2.7 ng/L [-11.3, 1.6]; p = 0.25). There were no drug discontinuations due to adverse events. LVEF <50% occurred in 2 (5.9%) patients, one following pulmonary vein isolation and one associated with atrial fibrillation.
Conclusions: Over 36 weeks, aficamten appeared safe and effective in the studied patients with nHCM.
(© 2024 The Author(s). European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
Databáze: MEDLINE
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