2014年9月15日讯 /生物谷BIOON/ --安进（Amgen）近日在拉斯维加斯举行的美国心力衰竭协会（HFSA）第18届年度科学会议上公布了心衰药物ivabradine（伊伐布雷定）III期SHIFT研究的新分析数据。

SHIFT研究是迄今为止规模最大的一项关于慢性心力衰竭发病率和死亡率的干预研究，涉及37个国家超过6500例慢性心衰（HF）患者，该研究表明，在常规治疗基础上加入减慢心率的特效药伊伐布雷定能显著降低心力衰竭死亡和住院的风险。

此次公布的SHIFT研究的一项事后分析（post-doc analysis）证实，低收缩压（SBP）与慢性心衰预后不良相关，而ivabradine能够降低低收缩压患者群体心衰恶化心血管死亡或住院复合终点，而安全性在横跨3个SBP组相似。

ivabradine是一种口服、特异性If电流阻滞剂，是首个纯粹的降心率因子、首个选择性特异性If抑制剂，选择性作用于窦房结，ivabradine可显著减慢窦性心律，与其他负性频率药物（如β-阻滞剂及钙离子拮抗剂）不同，ivabradine对心内传导、心肌收缩力或心室复极化无影响。目前，ivabradine正在接受FDA的审查。此前，FDA已授予ivabradine快车道地位和优先审查资格。

慢性心脏衰竭（HF）是一种严重的心脏疾病，尽管当前有治疗药物，但仍可导致很高的再住院率，同时预后很差。ivabradine是过去20年来心血管疾病治疗中最显著的进展之一，如果获批，ivabradine有望提供远高于当前临床治疗标准的重大改善。

ivabradine（伊伐布雷定）由法国制药商施维雅（Servier）开发，商品名为Procoralan，该药于2005年获欧盟批准用于稳定型心绞痛（stable angina）的对症治疗，并于2012年获欧盟批准用于伴有心率过快的慢性心脏衰竭（HF）患者的治疗。

安进于2013年与Servier达成合作，获得了ivabradine在美国的商业化权利。全球范围内，约有2600万心衰竭患者，美国约有510万患者。预测表明，到2030年，心脏衰竭患者数将比2013年增加15%。尽管目前该病有可用的药物，但预后很差。（生物谷Bioon.com）

本文系生物谷原创编译整理，欢迎转载！转载请注明来源并附原文链接。谢谢！

英文原文：Analysis From SHIFT Study Shows Ivabradine Reduced Cardiovascular Death or Hospitalization for Worsening Heart Failure Independent of Baseline Blood Pressure With Similar Safety Profile Across Groups

THOUSAND OAKS, Calif., Sept. 14, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced data from the Phase 3 SHIFT (Systolic Heart failure treatment with the If inhibitor ivabradine Trial) study evaluating ivabradine in patients with chronic heart failure (HF) were presented at the 18th Annual Scientific Meeting of the Heart Failure Society of America (HFSA) in Las Vegas. A post-hoc analysis from the SHIFT study confirmed low systolic blood pressure (SBP) is associated with poor outcomes in chronic HF, and that ivabradine reduced the primary composite endpoint of cardiovascular death or hospitalization for worsening HF in this subgroup with low baseline SBP. Safety was similar across the three SBP groups. Results were published in the July 2014 issue of the European Journal of Heart Failure.1

Ivabradine is an oral drug that inhibits the If current ("funny" current) in the sinoatrial node, the body's cardiac pacemaker.2 It works to slow the heart rate without negative effects on myocardial contractility or ventricular repolarization.2 

"Despite standard of care, chronic heart failure remains a disabling condition with a poor prognosis for patients at risk for hospitalization," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Analyses from the pivotal SHIFT study complement the main trial findings that form the basis of our U.S. submission package for ivabradine. We recently received a priority review designation for ivabradine from the FDA and are working with the agency to potentially bring this important treatment option to certain patients with chronic heart failure in the U.S. as soon as possible."