Physicians' Academy for Cardiovascular Education

Sex-specific differences in HFrEF patients using ARNI in real-world setting

Sex Influence on the Efficacy and Safety of Sacubitril/Valsartan

Literature - Vicent L, Ayesta A, Esteban-Fernández A, et al. - Cardiology 2019, 142:73–78, doi: 10.1159/000498984

Introduction and methods

Women are underrepresented in clinical trials [1,2]. There are sex differences in pharmacokinetics, and treatment response, or incidence of adverse events can differ between sexes [3,4]. With respect to CVD, men tend to suffer from CVD earlier in life [5]. For some CVD, women have a worse prognosis than men, which may be due to reduced administration of evidence-based therapies in women [5]. When looking at heart failure {HF), women more often have preserved left ventricular ejection fraction and a higher prevalence of hypertension [6-8]. Furthermore, women have increased survival, but are older and a worse functional class [8].

The PARADIGM-HF trial demonstrated that sacubitril/valsartan reduced mortality and HF hospitalization compared to enalapril [9]. In this trial, 21% of patients were women and a similar percentage of women was enrolled in the TITRATION trial [9,10].

This study examined sex differences in efficacy, tolerability and safety of sacubitril/valsartan in a real-world cohort of HFrEF patients. This prospective registry in 10 centers included all patients starting treatment with sacubitril/valsartan as outpatients during 6 months prior. Mean follow-up was 7 months.

Main results

Sex-specific differences in HFrEF patients using ARNI in real-world setting


In a real-world cohort of HFrEF patients starting sacubitril/valsartan, 29.5% were women. Tolerability and safety were similar in women vs. men. NYHA functional class improvement was greater in women compared with men.


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