ESC 2013：RLX030显著改善急性心力衰竭（AHF）各亚组症状和死亡率

诺华（Novartis）9 月2日在2013年欧洲心脏病学会年会（ESC 2013）上，公布了有关实验性药物RLX030（serelaxin）III期RELAX-AHF研究新的分析数据。数据表明，在横跨急性心力衰竭 （AHF）患者多个亚组中，RLX030持续地改善了患者的症状，并降低了全因死亡率（all-cause mortality）。这些数据同时也发表于《欧洲心脏杂志》（European Heart Journal）。

RLX030被视为诺华研发管线中最重要的一种药物，如果获批，RLX030有望成为20年中用于治疗急性心力衰竭（AHF）的首个突破性药物。

杰富瑞（Jefferies）集团分析师预计，RLX030的年销售峰值将达到15亿美元。

RELAX-AHF是一项随机、双盲、安慰剂对照的III期临床试验，涉及11个国家1161例AHF患者，目的是调查RLX030治疗AHF的疗 效和安全性。在研究中，RLX030通过静脉输液给药并结合袢利尿剂（loop diuretics）和其他药物的治疗，与标准的AHF护理治疗进行对比。

2012年11月公布的III期研究数据表明，与安慰剂相比，RLX030使全因死亡率降低了37%，此次公布的最新数据，进一步展现了RLX030在不同的患者亚群中的表现。

在所有的患者亚组中，RLX030改善了呼吸困难、并降低了死亡率，包括肾功能受损患者亚组、75岁及以上患者亚组、房颤患者亚组。

心脏衰竭是一种疾病，导致心脏不能提供足够的血液来满足身体的需要。该病5年死亡率约为50%，尤其是症状的急性发作，需要紧急住院治疗。相对于其他大多数心血管疾病来说，急性心力衰竭（AHF）具有较高的死亡率，最常见的症状为呼吸困难或气短。

RLX030是一种首创新药，是重组形式的人松弛素-2（relaxin-2），该激素在男性和女性中均自然存在。在女性中，relaxin-2水平的上升用于支持怀孕期间的重要生理变化。Serelaxin通过放松血管发挥作用，从而减少男性和女性心脏、肾脏的压力。

FDA于今年6月授予RLX030突破性疗法认定。目前，该药正在接受世界各地卫生当局的审查，包括FDA和EMA。

英文原文：Novartis heart failure drug effective across patient groups

AMSTERDAM (Reuters) - An experimental drug from Novartis to treat heart failure proved equally effective regardless of the age of patients or whether they had other medical problems, clinical trial results presented on Monday showed.

The drug, serelaxin, which is a form of a human hormone that relaxes blood vessels and eases stress on the heart and other organs, is viewed as an important medicine in the Swiss drugmaker's developmental pipeline.

Analysts at Jefferies expect the drug to generate peak sales of $1.5 billion a year.

Results from a Phase III study last November found it reduced deaths by 37 percent compared with placebo - and the latest data offers further insight by showing how it performed in different patient sub-groups.

The drug led to reduced dyspnea, or breathlessness, and fewer deaths after six months in all patient groups, including those with impaired kidney function, those aged 75 or older, and those with atrial fibrillation, or irregular heartbeats.

The new findings were presented at the European Society of Cardiology congress in Amsterdam, where heart doctors have highlighted the enormous need for new treatments for acute heart failure, in which the heart is unable to pump enough blood.

Some 2 million patients are hospitalized each year in Europe and United States as a result of heart failure, and about half of all patients die within five years of being diagnosed with the condition.

Medical treatment of heart failure has changed little since the 1970s but Novartis hopes serelaxin will soon offer cardiologists a new therapy option.

U.S. regulators in June gave serelaxin "breakthrough therapy" status, potentially fast-tracking its development and approval.

The Novartis drug is currently being assessed by health authorities around the world, including the U.S. Food and Drug Administration and the European Medicines Agency.

Novartis previously disclosed that while serelaxin met one of the study's two primary goals by reducing deaths and relieving dyspnea, it failed to hit a secondary combined objective of lowering cardiovascular death and reducing the need for patients to go back into hospitals.

Researchers view the life-saving benefit as the more important measure, although many still want to see further evidence of the drug's performance given past disappointments in the field

相关研究：
Hernandez-Montfort JA, Arora S, Slawsky MT.Relaxin for treatment of acute heart failure: making the case for treating targeted patient profilesCurr Heart Fail Rep. 2013 Sep;10(3):198-203.

von Haehling S.Recent developments in the treatment of heart failure: highlights from the American Heart Association's Scientific Sessions, Los Angeles, California, 3 - 7 December 2012. Expert Opin Investig Drugs. 2013 Jul;22(7):933-7

Metra M, Cotter G, Davison BA, Felker GM, Filippatos G, Greenberg BH, Ponikowski P, Unemori E, Voors AA, Adams KF Jr, Dorobantu MI, Grinfeld L, Jondeau G, Marmor A, Masip J, Pang PS, Werdan K, Prescott MF, Edwards C, Teichman SL, Trapani A, Bush CA, Saini R, Schumacher C, Severin T, Teerlink JR; RELAX-AHF Investigators.Effect of serelaxin on cardiac, renal, and hepatic biomarkers in the Relaxin in Acute Heart Failure (RELAX-AHF) development program: correlation with outcomes. J Am Coll Cardiol. 2013 Jan 15;61(2):196-206

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Ponikowski P, Metra M, Teerlink JR, Unemori E, Felker GM, Voors AA, Filippatos G, Greenberg B, Teichman SL, Severin T, Mueller-Velten G, Cotter G, Davison BA.Design of the RELAXin in acute heart failure study.Am Heart J. 2012 Feb;163(2):149-55

Voors AA, Davison BA, Felker GM, Ponikowski P, Unemori E, Cotter G, Teerlink JR, Greenberg BH, Filippatos G, Teichman SL, Metra M; Pre-RELAX-AHF study group.Early drop in systolic blood pressure and worsening renal function in acute heart failure: renal results of Pre-RELAX-AHF.Eur J Heart Fail. 2011 Sep;13(9):961-7.