Li Bo, Zhao Yunhe, Yin Bo, Helian Mengfei, Wang Xinmei, Chen Feng, Zhang Hongxia, Sun Hui, Meng Bin, An Fengshuang
Department of Cardiology, Central Hospital of Zibo, Zibo, 255036, PR China.
Department of Pathology, Central Hospital of Zibo, Zibo, 255036, PR China.
Oncotarget. 2017 May 31;8(47):83323-83333. doi: 10.18632/oncotarget.18312. eCollection 2017 Oct 10.
The combined neprilysin/rennin-angiotensin system inhibitor sacubitril/valsartan (LCZ696) has shown its superiority over ACEI/ARB therapy. In view of the existing concern of its adverse effects, we aimed to provide evidence of the safety of the new drug.
A total of 6 randomized trials with 11,821 subjects were included in this analysis. No significant differences were found in any adverse effects between LCZ696 and ACEI/ARB or placebo groups. LCZ696 significantly decreased the risks of serious adverse events and death compared with ACEI/ARB. LCZ696 also significantly decrease the risk of discontinuation of treatment for any adverse event no matter compared with ACEI/ARB or a placebo. LCZ696 significantly increased the risk of angioedema and dizziness, while it decreased the risk of renal dysfunction and bronchitis. There was no difference for hypotension, hyperkalemia, cough, upper respiratory tract inflammation, diarrhoea, back pain, nasopharyngitis, headache and influenza between the LCZ696 group and the ACEI/ARB group.
A meta-analysis of eligible studies that used LCZ696 in heart failure and hypertension was performed. Embase, PubMed and the Cochrane Library were searched for randomized controlled trials (RCTs) with data on any adverse effects, serious adverse events, discontinuation of treatment for any adverse event, death, angioedema, hypotension, hyperkalemia, and other adverse effects to perform this meta-analysis.
In addition to the beneficial effect of LCZ696 on end point events, the available evidences showed that LCZ696 was associated with less drug-risks than a placebo and ACEI/ARB.
新型脑啡肽酶/肾素-血管紧张素系统抑制剂沙库巴曲缬沙坦（LCZ696）已显示出优于ACEI/ARB疗法的效果。鉴于目前对其不良反应的担忧，我们旨在提供该新药安全性的证据。
本分析纳入了6项随机试验，共11821名受试者。LCZ696组与ACEI/ARB组或安慰剂组在任何不良反应方面均未发现显著差异。与ACEI/ARB相比，LCZ696显著降低了严重不良事件和死亡风险。无论与ACEI/ARB还是安慰剂相比，LCZ696也显著降低了因任何不良事件而停药的风险。LCZ696显著增加了血管性水肿和头晕的风险，同时降低了肾功能不全和支气管炎的风险。LCZ696组与ACEI/ARB组在低血压、高钾血症、咳嗽、上呼吸道炎症、腹泻、背痛、鼻咽炎、头痛和流感方面无差异。
对在心力衰竭和高血压中使用LCZ696的合格研究进行荟萃分析。检索了Embase、PubMed和Cochrane图书馆，以获取有关任何不良反应、严重不良事件、因任何不良事件停药、死亡、血管性水肿、低血压、高钾血症及其他不良反应数据的随机对照试验（RCT），以进行此项荟萃分析。
除了LCZ696对终点事件的有益作用外，现有证据表明，与安慰剂和ACEI/ARB相比，LCZ696的药物风险更低。
