诺华重组人松弛素III期AHF研究取得积极数据 发布时间：2012-9-27 来源：药品资讯网信息中心诺华(Novartis)今天宣布，有关实验性药物RLX030(serelaxin)的一项III期临床试验(RELAX-AHF)取得了积极数据，试验中RLX030降低了急性心脏衰竭(AHF)患者的全因死亡率(all-cause mortality)。在这项为期6个月的RELAX-AHF研究中，RLX030减少了AHF患者的死亡人数。该项研究有2个主要终点，利用了不同的评分方法(scales)来衡量呼吸困难的缓解，只有1个终点达到了统计学显着差异。研究中RLX030的耐受性良好。相对于其他大多数心血管疾病来说，AHF具有较高的死亡率。呼吸困难，或气短，是AHF患者最常见的症状。织梦内容管理系统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。该项研究的数据，将提交至2012年11月在洛杉矶举行的美国心脏协会(AHA)大会上。诺华将很快启动与全球监管机构就该项III期试验的结果进行讨论。内容来自dedecms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。织梦内容管理系统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。
Results from Novartis Phase III study show that RLX030 reduced deaths in patients with acute heart failure * Reuters is not responsible for the content in this press release. Mon Sep 24, 2012 1:16am EDT Novartis International AG / Results from Novartis Phase III study show that RLX030 reduced deaths in patients with acute heart failure . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement. RELAX-AHF study met one of its two primary endpoints in reducing dyspnea or shortness of breath, and showed RLX030 (serelaxin) was well tolerated[1] Six-month study shows that investigational RLX030 reduced all-cause mortality in patients with acute heart failure (AHF)[1] Results of single Phase III clinical trial to be discussed with health authorities worldwide RELAX-AHF data will be presented at American Heart Association congress in November Basel, September 24, 2012 - Phase III study results show that investigational RLX030 (serelaxin) reduced all-cause mortality in patients with acute heart failure (AHF)[1]. The six-month RELAX-AHF study shows that RLX030 reduces the number of deaths in patients with this disease, which has a higher mortality rate than most other cardiovascular diseases[2]. The study had two primary endpoints using different scales to measure reduction in dyspnea, only one of which reached statistical significance[1]. Dyspnea, or shortness of breath, is the most common symptom of AHF[3]. RLX030 was well tolerated in the study[1]. RELAX-AHF was a Phase III clinical trial to investigate the efficacy and safety of RLX030 for the treatment of AHF. It was a randomized, double-blind, placebo-controlled study involving 1,161 patients in 11 countries[1]. In the study, RLX030 was given on admission to the hospital in the form of an intravenous infusion for up to 48 hours in addition to loop diuretics and other medicines and was compared to placebo on top of standard of care treatment for AHF[4],[5]. The study will be presented at the American Heart Association (AHA) congress in Los Angeles in November, 2012. Novartis will initiate discussions of the results of this single Phase III study with health authorities worldwide shortly. Heart failure is a disease in which the heart is unable to supply enough blood to meet the body's needs[6],[7]. Around half of all patients die within five years of diagnosis[8], particularly as a result of acute episodes in which their symptoms suddenly become worse and urgent hospital treatment is needed[6]. Acute heart failure (AHF) places an enormous burden on healthcare systems and accounts for around two million hospitalizations each year in the EU and US[9]. RLX030 is the first in a new class of medicines and is a recombinant form of the human hormone relaxin-2 which occurs naturally in both men and women[10]. In women, levels of relaxin-2 rise to support important physiological changes during pregnancy[10]. Serelaxin acts by relaxing the blood vessels, leading to reduced stress on the heart and kidneys in both men and women[11].
References
1. Novartis Pharma AG. Data on file.
2. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart Disease and Stroke Statistics - 2011 Update. A Report From the American Heart Association. Circulation. 2011;123:e18-e209.
3. Goldberg RJ, Spencer FA, Szklo-Coxe M, et al. Symptom presentation in patients hospitalized with acute heart failure. Clin Cardiol. 2010;33:e73-80.
4. Clinicaltrials.gov: Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure (RELAX-AHF). http://clinicaltrials.gov/ct2/show/NCT00520806; Accessed September 2012.
5. Ponikowski P, Metra M, Teerlink JR, et al. Design of the RELAXin in Acute Heart Failure Study. Am Heart J. 2012;163:149-55.
6. McMurray JJV, Adamopoulos S, Anker SD, et al. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012;33:1787-1847.
7. Hunt SA, Abraham WT, Chin MH, et al. 2009 Focused Update Incorporated Into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2009;53:e1-90.
8. Roger VL, Lloyd-Jones DM, Benjamin EJ, et al. Heart disease and stroke statistics - 2012 update: a report from the American Heart Association. Circulation. 2012;125:e2-e220.
9. Opportunity Assessment for Relaxin in Acute Heart Failure, Decision Resources. Oct 2010.
10 Dschietzig T, Bartsch C, Baumann G, et al. Relaxin - a pleiotropic hormone and its emerging role for experimental and clinical therapeutics. Pharmacol Therap. 2006;112:38-56.
11. Conrad KP. Unveiling the vasodilatory actions and mechanisms of relaxin. Hypertension. 2010;56:2-9.
No comments:
Post a Comment