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Sex Influence on the Efficacy and Safety of Sacubitril/Valsartan

机译：对Sacubitril / Valsartan的疗效和安全性的性别影响

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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. (C) 2019 S. Karger AG, Basel
机译：背景：妇女在Sacubitril / Valsartan（SV）的临床试验中是强名的。本研究的目的是评估SV在现实世界心力衰竭中的疗效，耐受性和安全性的性别特异性差异，具有降低的喷射部分（HFREF）患者。方法：在这项研究中分析了10个中心的预期登记中心，包括在过去6个月内开始SV的所有患者进行了分析。结果：共有427名患者，女性是妇女126名（29.5％）。在SV启动前没有大量差异，虽然较少的女性携带植入的心脏除颤器（57 [58.1％]，P = 0.02）。 SV开始剂量为24/26 mg B.I.D.在206名患者中（48.2％），49/51 mg B.I.D。 184年（43.1％）和97/103 mg B.I.D. 34（8.2％），没有与性有关的相关差异。平均随访7.0 +/- 0.1个月内没有损失。停药的患者的比例（16 [12.7％]患者与33 [11.0％]男性，P = 0.66）或呈现患者相关的不良反应（31 [24.6％]女性与79 [26.5％]男性，p = 0.72）在两性也相似。然而，女性是多元分析中功能阶级改善的独立预测因素（差距2.33,95％置信区间：1.24-4.38，P = 0.04）。结论：HFREF妇女的SV具有与男性相似的耐受性。女性似乎具有比男性更频繁的功能阶级改善。 （c）2019年S. Karger AG，巴塞尔

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