Lourdes Vicent1, Ana Ayesta2, Alberto Esteban-Fernández3, Manuel Gómez-Bueno4, Javier De-Juan5, Pablo Díez-Villanueva6, Ángel Manuel Iniesta7, Antonio Rojas-González6, Ramón Bover-Freire3, Diego Iglesias8, Marcos García-Aguado3, Jesús A Perea-Egido9, Manuel Martínez-Sellés10,11. 1. Servicio de Cardiología, Hospital Universitario Gregorio Marañón, CIBERCV, Madrid, Spain. 2. Servicio de Cardiología, Hospital Universitario Central de Asturias, Oviedo, Spain. 3. Servicio de Cardiología, Hospital Universitario Clínico de San Carlos, Madrid, Spain. 4. Servicio de Cardiología, Hospital Universitario Puerta de Hierro, Madrid, Spain. 5. Servicio de Cardiología, Hospital Universitario Doce de Octubre, Madrid, Spain. 6. Servicio de Cardiología, Hospital Universitario La Princesa, Madrid, Spain. 7. Servicio de Cardiología, Hospital Universitario La Paz, Madrid, Spain. 8. Servicio de Cardiología, Hospital Infanta Sofía, Madrid, Spain. 9. Servicio de Cardiología, Hospital de Getafe, Madrid, Spain. 10. Servicio de Cardiología, Hospital Universitario Gregorio Marañón, CIBERCV, Madrid, Spain, mmselles@secardiologia.es. 11. Universidad Complutense, Universidad Europea, Madrid, Spain, mmselles@secardiologia.es.
Abstract
BACKGROUND: Women are underrepresented in sacubitril/valsartan (SV) clinical trials. The aim of this study was to assess sex-specific differences in efficacy, tolerability, and safety of SV in real-world heart failure with reduced ejection fraction (HFrEF) patients. METHODS: A prospective registry in 10 centers including all patients who started SV during the last 6 months was analyzed in this study. RESULTS: A total of 427 patients were included, 126 (29.5%) were women. There were no substantial differences in HFrEF treatment before SV initiation, although fewer women than men carried an implantable cardioverter defibrillator (57 [45.2%] vs. 173 [58.1%], p = 0.02). SV starting dose was 24/26 mg b.i.d. in 206 patients (48.2%), 49/51 mg b.i.d. in 184 (43.1%), and 97/103 mg b.i.d. in 34 (8.2%), without relevant differences associated to sex. There were no losses during a mean follow-up of 7.0 ± 0.1 months. The proportion of patients who discontinued the drug (16 [12.7%] women vs. 33 [11.0%] men, p = 0.66) or presented SV-related adverse effects (31 [24.6%] women vs. 79 [26.5%] men, p = 0.72) was also similar in both sexes. However, female sex was an independent predictor of functional class improvement in the multivariate analysis (odds ratio 2.33, 95% confidence interval: 1.24-4.38, p = 0.04). CONCLUSIONS: SV in women with HFrEF has a similar tolerability as in men. Females seem to have a more frequent functional class improvement than males.
BACKGROUND:Women are underrepresented in sacubitril/valsartan (SV) clinical trials. The aim of this study was to assess sex-specific differences in efficacy, tolerability, and safety of SV in real-world heart failure with reduced ejection fraction (HFrEF) patients. METHODS: A prospective registry in 10 centers including all patients who started SV during the last 6 months was analyzed in this study. RESULTS: A total of 427 patients were included, 126 (29.5%) were women. There were no substantial differences in HFrEF treatment before SV initiation, although fewer women than men carried an implantable cardioverter defibrillator (57 [45.2%] vs. 173 [58.1%], p = 0.02). SV starting dose was 24/26 mg b.i.d. in 206 patients (48.2%), 49/51 mg b.i.d. in 184 (43.1%), and 97/103 mg b.i.d. in 34 (8.2%), without relevant differences associated to sex. There were no losses during a mean follow-up of 7.0 ± 0.1 months. The proportion of patients who discontinued the drug (16 [12.7%] women vs. 33 [11.0%] men, p = 0.66) or presented SV-related adverse effects (31 [24.6%] women vs. 79 [26.5%] men, p = 0.72) was also similar in both sexes. However, female sex was an independent predictor of functional class improvement in the multivariate analysis (odds ratio 2.33, 95% confidence interval: 1.24-4.38, p = 0.04). CONCLUSIONS:SV in women with HFrEF has a similar tolerability as in men. Females seem to have a more frequent functional class improvement than males.