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GSK启动急性冠脉综合征药物losmapimod关键III期研究

来源:生物谷 2014-06-06 08:55

2014年6月5日讯 /生物谷BIOON/ --葛兰素史克(GSK)6月5日宣布启动实验性药物losmapimod关键性III期研究(LATITUDE-TIMI 60)。LATITUDE-TIMI 60是一项随机、双盲、安慰剂对照、跨国多中心大型III期研究,预计招募2.55万名患者。研究中,符合条件的急性冠脉综合征(ACS)患者,除接受标准护理外,还将随机接受为期3个月的7.5mg剂量losmapimod(每日口服2次)或安慰剂治疗。研究的主要疗效终点是对裁定的主要不良心血管事件的综合衡量,包括发生首例心血管死亡、心肌梗死或严重复发性缺血需要紧急冠状动脉血管重建的时间。关键次要终点包括心血管死亡和心肌梗死。其他复合次要终点包括心脏衰竭和中风住院。

急性冠状动脉综合征(acute coronary syndromes,ACS)是以冠状动脉粥样硬化斑块破裂(rupture)或侵蚀(erosion),继发完全或不完全闭塞性血栓形成为病理基础的一组临床综合征,包括急性ST段抬高性心肌梗死(STEMI)、急性非ST段抬高性心肌梗死(NSTEMI)和不稳定型心绞痛(UA)。

Losmapimod是一种p38促分裂原活化蛋白(MAP)激酶抑制剂,该激酶在心脏发作期间发生的急性炎症中发挥着重要作用。(生物谷Bioon.com)

英文原文:GSK announces start of phase III cardiovascular outcomes study with losmapimod in patients with acute coronary syndrome

Issued: Thursday 5 June 2014, London UK

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the start of a pivotal phase III study, LATITUDE-TIMI 60, to evaluate the effects of losmapimod in patients presenting with acute coronary syndrome. The global, phase III study will assess whether losmapimod can reduce the risk of a subsequent cardiac event when administered orally twice a day for a period of three months immediately after presentation with an acute coronary syndrome.

Acute coronary syndrome is a term used to describe situations or events, including heart attack, where there is an abrupt reduction of blood flow to the heart through the coronary arteries. Presentation by a patient with acute coronary syndrome is a manifestation of coronary heart disease.

Losmapimod is an inhibitor of p38 mitogen activated protein (MAP) kinase, an enzyme understood to play a central role in the acute inflammation that occurs during a heart attack.

Dr. John Lepore, Senior Vice President of Metabolic Pathways and Cardiovascular R&D at GSK, commented:

“Although changes in diet and lifestyle along with new approaches to treatment have led to improved outcomes for patients with coronary artery disease, patients who suffer a heart attack remain at increased risk of a recurrent heart attack or other vascular event in the ensuing weeks and months.  The start of our losmapimod study is an important step forward in the search for innovative therapies aimed at reducing the recurrence of cardiovascular events.”

About the LATITUDE-TIMI 60 study

LATITUDE-TIMI 60 (LosmApimod To Inhibit p38 MAP kinase as aTherapeUtic target and moDify outcomes after an acute coronary syndrome-Thrombolysis In Myocardial Infarction 60; NCT02145468) is a randomised, double-blind, placebo-controlled, multi-centre study across 39 countries. It is anticipated that a total of 25,500 patients will be enrolled over the study period. Eligible patients presenting with acute coronary syndrome (specifically, a heart attack) will be randomised to receive three months of twice daily oral treatment with either 7.5mg of losmapimod or placebo in addition to standard of care.

The primary efficacy endpoint of the study is the composite measure of adjudicated major adverse cardiovascular events, comprising the time to first occurrence of cardiovascular death, myocardial infarction, or severe recurrent ischemia requiring urgent coronary artery revascularization. The key secondary endpoint of the trial is cardiovascular death and myocardial infarction. Other composite secondary endpoints include those which examine hospitalisation for heart failure and stroke.

The LATITUDE-TIMI 60 study is being conducted in collaboration with the TIMI Study Group, Brigham and Women's Hospital, Boston, Massachusetts.

About losmapimod and p38 MAP kinase

Losmapimod is an anti-inflammatory that works by inhibiting the activity of p38, a mitogen-activated protein kinase, which is a type of enzyme that is associated with the acute inflammation that occurs in the blood vessels during and immediately after an acute coronary syndrome.

For cardiovascular disease, studies have demonstrated several key biological functions of p38 MAP kinase in the coronary vessel wall and in the myocardium, which make p38 MAP kinase inhibition a potentially important therapeutic approach in acute coronary syndrome. Evidence to date suggests that p38 MAP kinase inhibition may potentially attenuate the inflammatory processes in the vascular wall, improve vascular function and prevent subsequent thrombosis, thereby potentially reducing the risk of subsequent plaque rupture and cardiac events.

Losmapimod is designed as a short-term treatment to be administered as quickly as possible after an acute coronary syndrome (specifically, a heart attack) and for a period of 12 weeks thereafter, when the patient is most at risk of a further major cardiovascular event.

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