Nuechterlein Kaitlin, AlTurki Ahmed, Ni Jiayi, Martínez-Sellés Manuel, Martens Pieter, Russo Vincenzo, Backelin Charlotte Nordberg, Huynh Thao
Division of Cardiology, Department of Medicine, McGill Health University Center, Montreal, Quebec, Canada.
Cardiology Department, Hospital General Universitario Gregorio Marañón, CIBER-CV, Universidad Europea, Universidad Complutense, Madrid, Spain.
CJC Open. 2021 Sep 15;3(12 Suppl):S202-S208. doi: 10.1016/j.cjco.2021.09.009. eCollection 2021 Dec.
Sacubitril/valsartan (SV) is a novel and effective therapy for heart failure with reduced ejection fraction (HFrEF). Despite several sex-specific particularities that may influence drug effects, there has been no prior study evaluating the safety of SV in women with HFrEF in the "real-world."
We performed a literature search to identify observational studies evaluating SV. We contacted all authors to obtain sex-specific data on major adverse outcomes. We compared all-cause and cardiovascular (CV) deaths, heart failure hospitalizations, hyperkalemia, and hypotension in men and women.
We identified five cohort studies enrolling 8,981 patients; 6,092 men (67.8%) and 2,889 women (32.2%). The mean age was 67 years in both sexes. The rates for all-cause mortality, CV mortality, heart failure hospitalizations, hypotension, and hyperkalemia were similar between women and men. Although the unadjusted aggregate rates of all-cause and CV mortalities were numerically higher in men than in women, these differences did not reach statistical differences.
Our meta-analysis showed similar rates of major adverse events in men and women with HFrEF treated with SV. Larger observational studies with longer duration and a higher number of women are needed to confirm the long-term safety of SV in women in the clinical practice.
沙库巴曲缬沙坦（SV）是一种治疗射血分数降低的心力衰竭（HFrEF）的新型有效疗法。尽管存在一些可能影响药物疗效的性别特异性特点，但此前尚无在“现实世界”中评估SV对HFrEF女性患者安全性的研究。
我们进行了文献检索，以确定评估SV的观察性研究。我们联系了所有作者，以获取主要不良结局的性别特异性数据。我们比较了男性和女性的全因死亡、心血管（CV）死亡、心力衰竭住院、高钾血症和低血压情况。
我们确定了五项队列研究，共纳入8981例患者；其中男性6092例（67.8%），女性2889例（32.2%）。两性的平均年龄均为67岁。女性和男性在全因死亡率、CV死亡率、心力衰竭住院率、低血压和高钾血症发生率方面相似。尽管未调整的全因死亡率和CV死亡率总体发生率在数值上男性高于女性，但这些差异未达到统计学差异。
我们的荟萃分析表明，接受SV治疗的HFrEF男性和女性患者发生主要不良事件的发生率相似。需要开展持续时间更长、纳入女性数量更多的更大规模观察性研究，以证实SV在临床实践中对女性的长期安全性。
