Hernandez Adrian V, Pasupuleti Vinay, Scarpelli Nancy, Malespini Jack, Banach Maciej, Bielecka-Dabrowa Agata M
Department of Pharmacy Practice, University of Connecticut School of Pharmacy, Storrs, CT, USA.
Unidad de Revisiones Sistemáticas y Meta-análisis (URSIGET), Vicerrectorado de Investigación, Universidad San Ignacio de Loyola (USIL), Lima, Peru.
Arch Med Sci. 2023 May 14;19(3):565-576. doi: 10.5114/aoms/159113. eCollection 2023.
Heart failure (HF) is still a major cause of morbidity and mortality all over the world. Aim of the study was to assess the benefits and harms of sacubitril/valsartan (S/V) compared to angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) in patients with HF.
We systematically searched for randomised controlled trials (RCTs) evaluating S/V vs. ACEI or ARB in acute or chronic HF in August 2021. Primary outcomes were HF hospitalisations and cardiovascular (CV) mortality; secondary outcomes included all-cause mortality, biomarkers, and renal function.
We selected 11 RCTs ( = 18766) with 2-48 months follow-up. Five RCTs had ACEIs as control, 5 RCTs had ARBs as control, and one RCT had both ACEI and ARB as control. Compared to ACEI or ARB, S/V reduced HF hospitalisations by 20% (HR = 0.80, 95% CI: 0.68-0.94; 3 RCTs; = 65%; high CoE), CV mortality by 14% (HR = 0.86, 95% CI: 0.73-1.01; 2 RCTs; = 57%; high CoE), and all-cause mortality by 11% (HR = 0.89, 95% CI: 0.78-1.00; 3 RCTs; = 36%; high CoE). S/V reduced NTproBNP (SMD = -0.34, 95% CI: -0.52 to -0.16; 3 RCTs; = 62%) and hs-TNT (ratio of differences = 0.84, 95% CI: 0.79-0.88; 2 RCTs; = 0%), and caused a decline in renal function by 33% (HR = 0.67, 95% CI: 0.39-1.14; 2 RCTs; = 78%; high CoE). S/V increased hypotension (RR = 1.69, 95% CI: 1.33-2.15; 9 RCTs; = 65%; high CoE). Hyperkalaemia and angioedema events were similar. Effects were in the same direction when stratified by type of control (ACEI vs. ARB).
Sacubitril/valsartan had better clinical, intermediate, and renal outcomes in HF in comparison to ACEI or ARB. There was no difference in angioedema and hyperkalaemia events, but there were more hypotension events.
心力衰竭（HF）仍是全球发病和死亡的主要原因。本研究的目的是评估沙库巴曲缬沙坦（S/V）与血管紧张素转换酶抑制剂（ACEI）或血管紧张素受体阻滞剂（ARB）相比，在心力衰竭患者中的获益与危害。
我们于2021年8月系统检索了评估S/V与ACEI或ARB用于急性或慢性心力衰竭的随机对照试验（RCT）。主要结局为因心力衰竭住院和心血管（CV）死亡；次要结局包括全因死亡、生物标志物和肾功能。
我们纳入了11项RCT（n = 18766），随访时间为2至48个月。5项RCT以ACEI作为对照，5项RCT以ARB作为对照，1项RCT同时以ACEI和ARB作为对照。与ACEI或ARB相比，S/V使因心力衰竭住院减少20%（HR = 0.80，95%CI：0.68 - 0.94；3项RCT；n = 65%；证据质量高），心血管死亡减少14%（HR = 0.86，95%CI：0.73 - 1.01；2项RCT；n = 57%；证据质量高），全因死亡减少11%（HR = 0.89，95%CI：0.78 - 1.00；3项RCT；n = 36%；证据质量高）。S/V使N末端B型利钠肽原（NTproBNP）降低（SMD = -0.34，95%CI：-0.52至-0.16；3项RCT；n = 62%），高敏肌钙蛋白T（hs - TNT）降低（差异比值 = 0.84，95%CI：0.79 - 0.88；2项RCT；n = 0%），并使肾功能下降33%（HR = 0.67，95%CI：0.39 - 1.14；2项RCT；n = 78%；证据质量高）。S/V增加低血压的发生（RR = 1.69，95%CI：1.33 - 2.15；9项RCT；n = 65%；证据质量高）。高钾血症和血管性水肿事件相似。按对照类型（ACEI与ARB）分层时，效应方向相同。
与ACEI或ARB相比，沙库巴曲缬沙坦在心力衰竭患者中具有更好的临床、中间和肾脏结局。血管性水肿和高钾血症事件无差异，但低血压事件更多。
