Sex-specific differences in HFrEF patients using ARNI in real-world setting
Sex Influence on the Efficacy and Safety of Sacubitril/Valsartan
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
- Of 427 patients, 126 (29.5%) were women.
- There was no difference in discontinuation with sacubitril/valsartan between women and men (16 women [12.7%] and 33 men [11.0%]).
- There were no differences in received dose of sacubitril/valsartan (24/26, 49/51 or 97/103 mg) between women vs. men.
- A greater proportion of women improved functional class compared to men (104 women [82.5%] vs. 221 men [73.4%], P=0.047).
- There was no difference in SV-related adverse events (31 women [24.6%] vs. 79 men [26.5%]).
- Female sex was an independent predictor of functional class improvement (OR 2.33, 95%CI:1.24-4.38, P=0.04).
Conclusion
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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