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通过抑制血管紧张素-脑啡肽酶治疗急性失代偿性心力衰竭
Angiotensin–Neprilysin Inhibition in Acute Decompensated Heart Failure


Eric J. Velazquez ... 心脑血管疾病 • 2019.02.07
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摘要


背景

在美国,急性失代偿性心力衰竭每年导致超过100万次住院。对因急性失代偿性心力衰竭住院治疗的患者启动沙库巴曲缬沙坦治疗是否安全有效尚不清楚。

 

方法

我们在美国的129家研究中心纳入了因急性失代偿性心力衰竭住院治疗且射血分数降低的心力衰竭患者。血流动力学稳定后,患者被随机分配接受沙库巴曲缬沙坦(目标剂量,每日2次,每次97 mg沙库巴曲和103 mg缬沙坦)或依那普利(目标剂量,每日2次,每次10 mg)治疗。主要疗效结局为从基线至第4周和第8周的N末端B型钠尿肽前体(NT-proBNP)浓度的时均变化比例。关键安全性结局为肾功能恶化、高钾血症、有症状的低血压和血管性水肿的发生率。

 

结果

在经随机分组的881例患者中,440例被分配接受沙库巴曲缬沙坦治疗,441例被分配接受依那普利治疗。与依那普利组相比,沙库巴曲缬沙坦组NT-proBNP浓度的时均降幅显著较大;在沙库巴曲缬沙坦组和依那普利组中,第4周和第8周时所获得数值的几何均值与基线值的比值分别为0.53和0.75(变化百分比,-46.7% vs. -25.3%;沙库巴曲缬沙坦与依那普利相比,所发生变化的比值,0.71;95%置信区间[CI],0.63~0.81;P<0.001)。沙库巴曲缬沙坦组与依那普利组相比,较大的NT-proBNP浓度降幅早在第1周已经显而易见(所发生变化的比值,0.76;95% CI,0.69~0.85)。两组肾功能恶化、高钾血症、有症状的低血压和血管性水肿的发生率无显著差异。

 

结论

在因急性失代偿性心力衰竭住院治疗且射血分数降低的心力衰竭患者中,与依那普利治疗相比,启动沙库巴曲缬沙坦治疗使NT-proBNP浓度有较大降幅。两组肾功能恶化、高钾血症、有症状的低血压和血管性水肿的发生率无显著差异(由诺华资助;PIONEER-HF在ClinicalTrials.gov注册号为NCT02554890)。





作者信息

Eric J. Velazquez, M.D., David A. Morrow, M.D., M.P.H., Adam D. DeVore, M.D., M.H.S., Carol I. Duffy, D.O., Andrew P. Ambrosy, M.D., Kevin McCague, M.A., Ricardo Rocha, M.D., and Eugene Braunwald, M.D. for the PIONEER-HF Investigators*
From the Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT (E.J.V.); the Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston (D.A.M., E.B.); Duke Clinical Research Institute, Duke University, Durham, NC (A.D.D.); Novartis Pharmaceuticals, East Hanover, NJ (C.I.D., K.M., R.R.); and the Division of Cardiology, Permanente Medical Group, San Francisco, and the Division of Research, Kaiser Permanente Northern California, Oakland — both in California (A.P.A.). Address reprint requests to Dr. Velazquez at Yale University School of Medicine, P.O. Box 208017, New Haven, CT 06520-8017, or at eric.velazquez@yale.edu. *A complete list of the PIONEER-HF investigators is provided in the Supplementary Appendix, available at NEJM.org.

 

参考文献

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2. Report to the Congress: Medicare and the health care delivery system — mandated report: the effects of the Hospital Readmissions Reduction Program. Washington, DC: Medicare Payment Advisory Commission, June 2018 (http://www.medpac.gov/).

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7. McMurray JJV, Packer M, Desai AS, et al. Angiotensin–neprilysin inhibition versus enalapril in heart failure. N Engl J Med 2014;371:993-1004.

8. Ambrosy AP, Mentz RJ, Fiuzat M, et al. The role of angiotensin receptor-neprilysin inhibitors in cardiovascular disease-existing evidence, knowledge gaps, and future directions. Eur J Heart Fail 2018;20:963-972.

9. Velazquez EJ, Morrow DA, DeVore AD, et al. Rationale and design of the comParIson Of sacubitril/valsartaN versus Enalapril on Effect on nt-pRo-bnp in patients stabilized from an acute Heart Failure episode (PIONEER-HF) trial. Am Heart J 2018;198:145-151.

10. Senni M, McMurray JJ, Wachter R, et al. Initiating sacubitril/valsartan (LCZ696) in heart failure: results of TITRATION, a double-blind, randomized comparison of two uptitration regimens. Eur J Heart Fail 2016;18:1193-1202.

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