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Long-term effect of mavacamten in obstructive hypertrophic cardiomyopathy.
Garcia-Pavia, Pablo; Oreziak, Artur; Masri, Ahmad; Barriales-Villa, Roberto; Abraham, Theodore P; Owens, Anjali T; Jensen, Morten K; Wojakowski, Wojciech; Seidler, Tim; Hagege, Albert; Lakdawala, Neal K; Wang, Andrew; Wheeler, Matthew T; Choudhury, Lubna; Balaratnam, Ganesh; Shah, Ashish; Fox, Shawna; Hegde, Sheila M; Olivotto, Iacopo.
Afiliación
  • Garcia-Pavia P; Hospital Universitario Puerta de Hierro Majadahonda, IDIPHISA, CIBERCV, Madrid, Spain.
  • Oreziak A; Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.
  • Masri A; Universidad Francisco de Vitoria (UFV), Pozuelo de Alarcon, Spain.
  • Barriales-Villa R; National Institute of Cardiology, Warsaw, Poland.
  • Abraham TP; Oregon Health & Science University, Portland, OR, USA.
  • Owens AT; Complexo Hospitalario Universitario A Coruña, INIBIC, CIBERCV (ISCIII), A Coruña, Spain.
  • Jensen MK; University of California San Francisco, San Francisco, CA, USA.
  • Wojakowski W; University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA.
  • Seidler T; Aarhus University Hospital, Aarhus, Denmark.
  • Hagege A; Medical University of Silesia, Katowice, Poland.
  • Lakdawala NK; University of Göttingen, Göttingen, Germany.
  • Wang A; Kerckhoff Clinic, Bad Nauheim, Germany.
  • Wheeler MT; AP-HP, Hôpital Européen Georges Pompidou, Paris, France.
  • Choudhury L; Brigham and Women's Hospital, Boston, MA, USA.
  • Balaratnam G; Duke University Hospital, Durham, NC, USA.
  • Shah A; Stanford University School of Medicine, Stanford, CA, USA.
  • Fox S; Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.
  • Hegde SM; Bristol Myers Squibb, Princeton, NJ, USA.
  • Olivotto I; Bristol Myers Squibb, Princeton, NJ, USA.
Eur Heart J ; 2024 Sep 01.
Article en En | MEDLINE | ID: mdl-39217450
ABSTRACT
BACKGROUND AND

AIMS:

Long-term safety and efficacy of mavacamten in patients with obstructive hypertrophic cardiomyopathy (HCM) are unknown. MAVA-LTE (NCT03723655) is an ongoing, 5-year, open-label extension study designed to evaluate the long-term effects of mavacamten.

METHODS:

Participants from EXPLORER-HCM (NCT03470545) could enrol in MAVA-LTE upon study completion.

RESULTS:

At the latest data cut-off, 211 (91.3%) of 231 patients originally enrolled in MAVA-LTE still received mavacamten. Median (range) time on study was 166.1 (6.0-228.1) weeks; 185 (80.1%) and 99 (42.9%) patients had completed the week 156 and 180 visits, respectively. Sustained reductions from baseline to week 180 occurred in left ventricular outflow tract gradients (mean [standard deviation] resting, -40.3 [32.7] mmHg; Valsalva, -55.3 [33.7] mmHg), NT-proBNP (median [interquartile range] -562 [-1162.5, -209] ng/L), and EQ-5D-5L score (mean [standard deviation] 0.09 [0.17]). Mean left ventricular ejection fraction (LVEF) decreased from 73.9% (baseline) to 66.6% (week 24) and 63.9% (week 180). At week 180, 74 (77.9%) of 95 patients improved by at least one New York Heart Association class from baseline. Over 739 patient-years exposure, 20 patients (8.7%; exposure-adjusted incidence 2.77/100 patient-years) experienced 22 transient reductions in LVEF to <50% resulting in temporary treatment interruption (all recovered LVEF of ≥50%). Five (2.2%) patients died (all considered unrelated to mavacamten).

CONCLUSIONS:

Long-term mavacamten treatment resulted in sustained improvements in cardiac function and symptoms in patients with obstructive HCM, with no new safety concerns identified. Transient, reversible reductions in LVEF were observed in a small proportion of patients during long-term follow-up.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Eur Heart J Año: 2024 Tipo del documento: Article País de afiliación: España Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Eur Heart J Año: 2024 Tipo del documento: Article País de afiliación: España Pais de publicación: Reino Unido