Data_Sheet_1_Efficacy and safety of sacubitril/valsartan on heart failure with preserved ejection fraction: A meta-analysis of randomized controlled trials.docx

AimsThe efficacy and safety of sacubitril/valsartan for patients with heart failure with preserved ejection fraction (HFpEF) are controversial. Hence, the primary objective of the study was to evaluate the efficacy and safety of sacubitril/valsartan treatment for patients with HFpEF.
Methods and resultsWe used the PubMed, Embase, and Web of Science databases to search for randomized controlled trials of sacubitril–valsartan in patients with HFpEF. Three studies, involving a total of 7,663 patients, were eligible for inclusion. Sacubitril–valsartan reduced the risk of hospitalization for heart failure (HF) [odds ratio (OR): 0.78; 95% CI: 0.70–0.88; p < 0.0001] and the incidence of worsening renal function [risk ratio (RR): 0.79, p = 0.002] among patients with HFpEF in the three trials, but there was no significant reduction in all-cause mortality (0.99, 95% CI: 0.84–1.15; p = 0.86) or cardiovascular mortality (0.95, 95% CI: 0.78–1.15; p = 0.16). Moreover, sacubitril/valsartan was associated with an increased risk of symptomatic hypotension (RR: 1.44; p < 0.00001) and angioedema (RR: 2.66; p < 0.04); there was no difference for decreasing the incidence of hyperkalemia (RR: 0.89; p = 0.11).
ConclusionCompared with valsartan or individualized medical therapy (IMT), sacubitril/valsartan significantly decreased the risk of hospitalization for HF and reduced the incidence of renal dysfunction.

【研究目的】目前沙库巴曲缬沙坦（sacubitril/valsartan）用于射血分数保留型心力衰竭（heart failure with preserved ejection fraction, HFpEF）患者的疗效与安全性尚存争议，因此本研究的核心目的为评估沙库巴曲缬沙坦治疗HFpEF患者的疗效及安全性。【方法与结果】我们通过PubMed、Embase及Web of Science数据库检索沙库巴曲缬沙坦治疗HFpEF患者的随机对照试验，最终纳入符合纳入标准的研究共3项，涉及患者总计7663例。三项试验结果显示，沙库巴曲缬沙坦可降低HFpEF患者因心力衰竭（heart failure, HF）住院的风险[比值比（odds ratio, OR）：0.78；95%置信区间（95% CI）：0.70~0.88；p < 0.0001]，同时可降低肾功能恶化的发生率[风险比（risk ratio, RR）：0.79，p = 0.002]；但全因死亡率（0.99，95%CI：0.84~1.15；p = 0.86）与心血管死亡率（0.95，95%CI：0.78~1.15；p = 0.16）均无显著降低。此外，沙库巴曲缬沙坦会增加症状性低血压的发生风险（RR：1.44；p < 0.00001）及血管性水肿的发生风险（RR：2.66，p < 0.04）；而高钾血症的发生率无显著变化（RR：0.89，p = 0.11）。【结论】与缬沙坦或个体化药物治疗（individualized medical therapy, IMT）相比，沙库巴曲缬沙坦可显著降低HF患者的住院风险，并减少肾功能不全的发生。