Badreldin Hisham A, Aldosari Nasser, Alnashwan Lama, Almutairi Taif, Yousif Nada, Alsulaiman Khalid, Aljuhani Ohoud, Hafiz Awatif, Alshaya Omar
King Abdullah International Medical Research Center, Department of Pharmacy Practice, College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, Riyadh 11481, Saudi Arabia.
Department of Pharmacy Practice, Faculty of Pharmacy, King Abdulaziz University, Jeddah 21589, Saudi Arabia.
J Cardiovasc Dev Dis. 2022 Feb 10;9(2):54. doi: 10.3390/jcdd9020054.
Early research on neprilysin inhibition showed that sacubitril/valsartan, a combination of the valsartan and the neprilysin inhibitor sacubitril, was superior to enalapril in patients with heart failure with reduced ejection fraction (HFrEF) in the PARADIGM-HF study in 2014. Therefore, for patients with HFrEF, worldwide recommendations have been reformed to include sacubitril/valsartan. In addition, sacubitril/valsartan has been investigated in other cardiovascular disease states, such as patients with heart failure and preserved ejection fraction (HFpEF) and following myocardial infarction (MI) events. In February 2021, the FDA expanded the indication use of sacubitril/valsartan to include the HFpEF patient population based on the results of the PARAGON-HF trial. However, randomized clinical trials post-MI did not show promising results. Sacubitril/valsartan is currently being investigated in many other cardiovascular and non-cardiovascular conditions. This review aims to shed light and summarize the ongoing sacubitril/valsartan registered studies on the United States National Library of Medicine clinical trials registry.
早期关于中性肽链内切酶抑制作用的研究表明，在2014年的PARADIGM-HF研究中，缬沙坦与中性肽链内切酶抑制剂沙库巴曲的组合药物沙库巴曲缬沙坦，在射血分数降低的心力衰竭（HFrEF）患者中优于依那普利。因此，对于HFrEF患者，全球范围内的治疗建议已进行修订，将沙库巴曲缬沙坦纳入其中。此外，沙库巴曲缬沙坦已在其他心血管疾病状态中进行了研究，例如射血分数保留的心力衰竭（HFpEF）患者以及心肌梗死（MI）事件后患者。2021年2月，基于PARAGON-HF试验的结果，美国食品药品监督管理局（FDA）扩大了沙库巴曲缬沙坦的适应症范围，将HFpEF患者群体纳入其中。然而，心肌梗死后的随机临床试验并未显示出理想的结果。目前，沙库巴曲缬沙坦正在许多其他心血管和非心血管疾病中进行研究。本综述旨在阐明并总结美国国立医学图书馆临床试验注册库中正在进行的沙库巴曲缬沙坦注册研究。
