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【drug-news】赛诺菲报告ExTRACT-TIMI 25 和 STEEPLE 一年临床试验结果

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PARIS, September 2 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that one year findings from the landmark ExTRACT-TIMI 25 and STEEPLE studies confirm clear net clinical benefit for patients with acute ST-segment elevation myocardial infarction (STEMI) for Lovenox® vs Unfractionnated Heparin (UFH).

The ExTRACT-TIMI 25 and STEEPLE one year results were presented during hotline sessions at the European Society of Cardiology (ESC) Congress in Vienna, Austria.

ExTRACT-TIMI 25 (Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment, Thrombolysis in Myocardial Infarction -- Study 25) trial showed that in patients with STEMI treated with fibrinolysis, at one year, the primary endpoint of death or nonfatal myocardial infarction remained significantly in favor or enoxaparin vs UFH (15.8% vs 17.0% p-0.01). Net clinical benefit (all cause of death / nonfatal MI / nonfatal disabling stroke) was also significantly in favour of enoxaparin vs UFH through one year of follow up (16.0% vs 17.3% p=0.007).

"This was a very large trial with conclusive results at 30 days. The persistence of significant net clinical benefit a full year after treatment is further evidence of the viability of the strategy of using enoxaparin as adjunctive anticoagulant therapy to fibrinolysis in the STEMI patient population," noted ExTRACT TIMI 25 principal investigator Dr. Elliott Antman, M.D., Senior Investigator TIMI Study Group, Director, Samuel A. Levine Cardiac Unit at Brigham and Women's Hospital, Professor of Medicine, Harvard Medical School, and lead investigator of the ExTRACT-TIMI 25 study.

ExTRACT TIMI 25 was a major randomized clinical trial that supported the worldwide submission and subsequent approval by the FDA and some European countries of the new Lovenox® indication for the treatment of patients with acute ST-segment elevation myocardial infarction (STEMI).

STEEPLE (SafeTy and Efficacy of Enoxaparin in Percutaneous Coronary Intervention Patients) trial one year follow up shows that the composite of all cause death at 1 year and major bleeding was 3.1% for Lovenox® 0.5 mg/kg (p=0.06 vs. UFH), 3.4% for Lovenox® 0.75 mg/kg (p=0.07 vs. UFH), 3.3% for the two Lovenox® arms combined (p=0.03 vs. UFH) and 4.7% for UFH.

There were low and statistically similar 1-year death rates in the enoxaparin groups (0.5mg/kg or 0.75 mg/kg) and UFH during and after elective percutaneous intervention (PCI). In addition to patient risk factors, ischemic events and major bleeding were found to be independent predictors of death at 1 year.

Commenting on the results, Dr. Gilles Montalescot who is Professor of Cardiology at the Institute of Cardiology, Hopital de la Pitie Salpetriere, Institut du Coeur, Paris, France and a member of the STEEPLE steering committee noted, "The significant reduction in major bleeding and similar efficacy compared with UFH confirms Lovenox® is an appropriate anticoagulant for elective PCI."

About Coronary Artery Disease (CAD) and Acute Coronary Syndrome (ACS)

Coronary artery disease (CAD) is the most common type of heart disease globally and is a serious health problem worldwide. CAD causes approximately 17 million deaths per year: the equivalent of one out of every three deaths worldwide. According to the American Heart Association, more than 13 million Americans have a history of CAD and 7.5 million have experienced an acute heart attack.

Acute coronary syndrome (ACS) is an umbrella term used to describe a group of clinical diagnoses caused by narrowing of the coronary arteries and cover any group of clinical symptoms compatible with acute myocardial ischemia, caused by an imbalance between myocardial oxygen supply and demand that results from CAD.

Immediate treatment is required for all ACS. The treatment approach is multifaceted and aims to try and protect the affected heart muscle from further damage, reinstate blood flow through the artery and reduce the heart's demand for oxygen. In the emergency room, the primary goals are to rapidly identify patients with MI (STEMI), exclude alternative causes of chest pain, and stratify patients into low- and high-risk groups and provide appropriate therapy to minimize further damage or ischemia to cardiac muscle.

Restoration of blood to the heart (reperfusion) can be achieved either via the use of certain drugs (fibrinolytics), used to break down blood clots, or mechanically by surgery, i.e. Percutaneous Coronary Intervention (PCI). Pharmacological options for the treatment ACS include the use of antiplatelet agents, to help prevent platelets from sticking together and forming clots, and anticoagulants to prevent blood clotting. Anticoagulants prevent clots from growing and new ones from forming, but they do not dissolve clots.

About Percutaneous Coronary Intervention (PCI)

PCI is a treatment procedure that unblocks coronary arteries that have narrowed due to atherosclerosis or atherothrombosis. The procedure restores coronary arterial flow (or coronary perfusion) in an acutely or sub-acutely occluded artery during acute myocardial infarction or unstable angina. PCI includes balloon angioplasty and implantation of intracoronary stent. The main long-term concern of PCI is re-stenosis. However, the use of coated and drug-eluting stents has been shown to reduce this risk. Primary PCI is defined as intervention in the culprit vessel within 12 hours after the onset of chest pain or other symptoms of acute myocardial infarction, without prior (full or concomitant) thrombolytic or other clot-dissolving therapy. Elective PCI is performed in all other less-urgent cases in patients with coronary artery disease (CAD).

About Clexane® / Lovenox® (enoxaparin)

Lovenox® is a unique chemical entity in a class of antithrombotic agents known as low-molecular weight heparin (LMWH). The no. 1 selling low-molecular weight heparin in the world, Lovenox® is obtained by alkaline degradation of heparin benzyl ester and is about one-third the molecular size of unfractionated heparin. Lovenox® is the most widely studied LMWH, with 20 years of use in the treatment of 185 million patients in 96 countries.

Its clinical applications are linked to its antithrombotic properties. It is used to inhibit clot formation in venous and arterial vessels to prevent potential acute or chronic complications of venous or arterial thrombosis. As with all anticoagulants, the most frequently reported side effect with Lovenox® is bleeding. Clinical indications for Lovenox® may vary from one country to another.
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PARIS, September 2 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that one year findings from the landmark ExTRACT-TIMI 25 and STEEPLE studies confirm clear net clinical benefit for patients with acute ST-segment elevation myocardial infarction (STEMI) for Lovenox® vs Unfractionnated Heparin (UFH).
巴黎，九月二日/新华美通/--赛诺菲今天宣布，通过具有里程碑意义的 ExTRACT-TIMI 25 和STEEPLE 的为期一年的研究，有力的证实了对于急性ST段抬高型心肌梗塞（STEMI），Lovenox®比未分馏肝素（UFH）具有明显临床疗效。

The ExTRACT-TIMI 25 and STEEPLE one year results were presented during hotline sessions at the European Society of Cardiology (ESC) Congress in Vienna, Austria.
为期一年的ExTRACT-TIMI 25和STEEPLE 研究结果的发布之际，正值欧洲心脏病学会会议在维也纳，澳大利亚如火如荼的进行。

ExTRACT-TIMI 25 (Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment, Thrombolysis in Myocardial Infarction -- Study 25) trial showed that in patients with STEMI treated with fibrinolysis, at one year, the primary endpoint of death or nonfatal myocardial infarction remained significantly in favor or enoxaparin vs UFH (15.8% vs 17.0% p-0.01). Net clinical benefit (all cause of death / nonfatal MI / nonfatal disabling stroke) was also significantly in favour of enoxaparin vs UFH through one year of follow up (16.0% vs 17.3% p=0.007).
ExTRACT-TIMI 25 （在急性心肌梗塞，心肌梗死溶栓中使用依诺肝素和血栓溶解再灌注—研究25）试验证明，在一年中，用纤维组蛋白溶解来治疗抬高型心梗患者，主要终点死亡或者非致命性心肌梗死指标依然是依诺肝素优于 UFH (15.8%比17.0% p-0.01)。通过一年的随访发现，净临床效果（全部死因/非致命性MI/非致命性中风）也是依诺肝素优于 UFH (16.0% 比 17.3% p=0.007)。

"This was a very large trial with conclusive results at 30 days. The persistence of significant net clinical benefit a full year after treatment is further evidence of the viability of the strategy of using enoxaparin as adjunctive anticoagulant therapy to fibrinolysis in the STEMI patient population," noted ExTRACT TIMI 25 principal investigator Dr. Elliott Antman, M.D., Senior Investigator TIMI Study Group, Director, Samuel A. Levine Cardiac Unit at Brigham and Women's Hospital, Professor of Medicine, Harvard Medical School, and lead investigator of the ExTRACT-TIMI 25 study.
“三十天得出这个明确的结论是项很大的试验。全年治疗后，持续的明显净临床疗效进一步证明，在抬高型心梗患者人群中，使用依诺肝素作为辅助抗凝剂来治疗纤维蛋白溶解的方法是可行的，” ExTRACT TIMI 25 原理的研究者埃利奥特波博士是TIMI 研究小组高级研究员，塞缪午.路易威的布里格姆和妇女医院主任，哈佛大学医学院医学教授，由他领导ExTRACT-TIMI 25 小组的研究。

ExTRACT TIMI 25 was a major randomized clinical trial that supported the worldwide submission and subsequent approval by the FDA and some European countries of the newLovenox® indication for the treatment of patients with acute ST-segment elevation myocardial infarction (STEMI).
ExTRACT TIMI 25 是一个可以支持全球数据提交的重大随机对照临床试验，随后新 Lovenox®用于急性ST段抬高型心肌梗死患者的适应症也得到FDA和一些欧洲国家的批准。

STEEPLE (SafeTy and Efficacy of Enoxaparin in Percutaneous Coronary Intervention Patients) trial one year follow up shows that the composite of all cause death at 1 year and major bleeding was 3.1% for Lovenox? 0.5 mg/kg (p=0.06 vs. UFH), 3.4% for Lovenox? 0.75 mg/kg (p=0.07 vs. UFH), 3.3% for the two Lovenox? arms combined (p=0.03 vs. UFH) and 4.7% for UFH.
随后一年的STEEPLE（依诺肝素在经皮冠状动脉介入治疗中的安全性和有效性）试验结果显示，一年中的所有死亡和出血原因的综合因素，对于 Lovenox® 0.5 mg/kg (p=0.06 vs. UFH) 是3.1%，Lovenox® 0.75 mg/kg (p=0.07 vs. UFH)是3.4%，两种Lovenox®组合为 3.3% (p=0.03 vs. UFH)而UFH为4.7% 。

There were low and statistically similar 1-year death rates in the enoxaparin groups (0.5mg/kg or 0.75 mg/kg) and UFH during and after elective percutaneous intervention (PCI). In addition to patient risk factors, ischemic events and major bleeding were found to be independent predictors of death at 1 year.
在选择性经皮冠脉介入治疗（PCI） 期间及之后，依诺肝素组和UFH（0.5mg/kg 或 0.75 mg/kg）中，一年的死亡率很低且统计学相似。此外，还发现，一年内包括缺血性事件和严重出血患者的危险因素和死亡无关。

Commenting on the results, Dr. Gilles Montalescot who is Professor of Cardiology at the Institute of Cardiology, Hopital de la Pitie Salpetriere, Institut du Coeur, Paris, France and a member of the STEEPLE steering committee noted, "The significant reduction in major bleeding and similar efficacy compared with UFH confirms Lovenox® is an appropriate anticoagulant for elective PCI."
法国巴黎心脏研究所，圣皮尔斯医院心脏研究所的吉尔斯.蒙特斯科特教授对该结果评论到，“大面积出血的显著减少及与UFH相类似的疗效说明，Lovenox®对于选择性PCI治疗来说是种合适的抗凝剂”

About Coronary Artery Disease (CAD) and Acute Coronary Syndrome (ACS)
关于冠心病（CAD）和急性冠脉综合症（ACS）

Coronary artery disease (CAD) is the most common type of heart disease globally and is a serious health problem worldwide. CAD causes approximately 17 million deaths per year: the equivalent of one out of every three deaths worldwide. According to the American Heart Association, more than 13 million Americans have a history of CAD and 7.5 million have experienced an acute heart attack.
就全球来说，CAD是种最常见的心脏病，也是全球性的健康难题。CAD每年大约导致1700万人死亡：相当于全世界每3例死亡中就有1例为CAD导致的死亡。根据美国心脏协会的统计，超过1300万美国人有CAD史并且有750万人曾遭受心脏病发作。

Acute coronary syndrome (ACS) is an umbrella term used to describe a group of clinical diagnoses caused by narrowing of the coronary arteries and cover any group of clinical symptoms compatible with acute myocardial ischemia, caused by an imbalance between myocardial oxygen supply and demand that results from CAD.
急性冠状综合症（ACS）可用雨伞一词表示，它描述了一组涵盖了任何符合急性心肌缺血临床症状且由冠状动脉狭窄导致的临床诊断，这种急性心肌缺血是由于CAD而导致心肌氧供需不平衡。

Immediate treatment is required for all ACS. The treatment approach is multifaceted and aims to try and protect the affected heart muscle from further damage, reinstate blood flow through the artery and reduce the heart's demand for oxygen. In the emergency room, the primary goals are to rapidly identify patients with MI (STEMI), exclude alternative causes of chest pain, and stratify patients into low- and high-risk groups and provide appropriate therapy to minimize further damage or ischemia to cardiac muscle.
所有的急性冠脉综合症（ACS） 都需要即时治疗。治疗是全方面的，目的是尽量保护受损心脏肌内免受进一步损伤，恢复通过动脉的血流并减少心脏的需氧量。在急诊室，首要的任务是快速鉴别患者是否为MI(STEMI),排除其它原因导致的胸痛，并将病人分层为低风险和高风险群体，提供合适的治疗使缺血心肌的损伤降到最低。

Restoration of blood to the heart (reperfusion) can be achieved either via the use of certain drugs (fibrinolytics), used to break down blood clots, or mechanically by surgery, i.e. Percutaneous Coronary Intervention (PCI). Pharmacological options for the treatment ACS include the use of antiplatelet agents, to help prevent platelets from sticking together and forming clots, and anticoagulants to prevent blood clotting. Anticoagulants prevent clots from growing and new ones from forming, but they do not dissolve clots.
恢复血液向心脏的流动（灌流），要么通过一种过去用于破碎血液凝块的药物（溶纤物），要么通过手术实现，例如经皮冠状动脉介入治疗（PCI）。通过药理方法来治疗ACS包括使用抗血小板试剂，它可以防止血小板粘在一起而形成血块。抗凝剂的作用是阻止血块的生长和新血块的生成，但是它们并不溶解血块。

About Percutaneous Coronary Intervention (PCI)
关于经皮冠状动脉介入治疗（PCI）

PCI is a treatment procedure that unblocks coronary arteries that have narrowed due to atherosclerosis or atherothrombosis. The procedure restores coronary arterial flow (or coronary perfusion) in an acutely or sub-acutely occluded artery during acute myocardial infarction or unstable angina. PCI includes balloon angioplasty and implantation of intracoronary stent. The main long-term concern of PCI is re-stenosis. However, the use of coated and drug-eluting stents has been shown to reduce this risk. Primary PCI is defined as intervention in the culprit vessel within 12 hours after the onset of chest pain or other symptoms of acute myocardial infarction, without prior (full or concomitant) thrombolytic or other clot-dissolving therapy. Elective PCI is performed in all other less-urgent cases in patients with coronary artery disease (CAD).
PCI是一个用于开启那些因为动脉粥样硬化和动脉血栓而导致的冠状动脉狭窄的治疗方法。当心肌梗塞或心绞痛时，在急性或亚急性闭塞动脉中，PCI可以恢复冠状动脉血流量（或冠脉灌注）。PCI包括球囊扩张及冠状动脉内支架的植入。PCI需要长期关注的是再狭窄。但是，使用涂层和药物涂层支架已被证实能够减少这方面的风险。初期PCI的定义是：当事先未（全部或伴随）用血栓溶解剂或其它溶栓治疗时，在胸痛或急性心肌梗死等其它症状发作的12小时内，对患者进行介入。选择性PCI是用在所有其它的非紧急冠心病患者。

About Clexane® / Lovenox® (enoxaparin)
关于 Clexane® / Lovenox®（依诺肝素）

Lovenox® is a unique chemical entity in a class of antithrombotic agents known as low-molecular weight heparin (LMWH). The no. 1 selling low-molecular weight heparin in the world, Lovenox® is obtained by alkaline degradation of heparin benzyl ester and is about one-third the molecular size of unfractionated heparin. Lovenox® is the most widely studied LMWH, with 20 years of use in the treatment of 185 million patients in 96 countries.
Lovenox®属于一类称为低分子量肝素的抗血栓药物，是一个单独的化学实体。作为全球低分子量肝素销售冠军，Lovenox®通过肝素苄酯碱降解法得到，它的分子量是未降解肝素的三分之一。Lovenox®是被最广泛研究的低分子量肝素，20年的临床治疗中，在96个国家有185百万患者使用过该药。

Its clinical applications are linked to its antithrombotic properties. It is used to inhibit clot formation in venous and arterial vessels to prevent potential acute or chronic complications of venous or arterial thrombosis. As with all anticoagulants, the most frequently reported side effect with Lovenox® is bleeding. Clinical indications for Lovenox® may vary from one country to another.
其临床应用与其抗血栓特性相关。它用来抑制静脉和动脉血管内的血栓形成，以防止由于静脉或动脉血栓形成而导致的潜在的急性或慢性并发症。和所有的抗凝剂一样，Lovenox®最常报道的副作用是出血，其临床适应症可能因人种不同而异。

编译：
巴黎，九月二日/新华美通/--赛诺菲今天宣布，通过具有里程碑意义的 ExTRACT-TIMI 25 和STEEPLE 的为期一年的研究，有力的证实了对于急性ST段抬高型心肌梗塞（STEMI）， Lovenox®比未分馏肝素（UFH）具有明显临床疗效。
为期一年的ExTRACT-TIMI 25和STEEPLE 研究结果的发布之际，正值欧洲心脏病学会会议在维也纳，澳大利亚如火如荼的进行。
ExTRACT-TIMI 25 （在急性心肌梗塞，心肌梗死溶栓中使用依诺肝素和血栓溶解再灌注—研究25）试验证明，在一年中，用纤维组蛋白溶解来治疗抬高型心梗患者，主要终点死亡或者非致命性心肌梗死指标依然是依诺肝素优于 UFH (15.8%比17.0% p-0.01)。通过一年的随访发现，净临床效果（全部死因/非致命性MI/非致命性中风）也是依诺肝素优于 UFH (16.0% 比 17.3% p=0.007)。
“三十天得出这个明确的结论是项很大的试验。全年治疗后，持续的明显净临床疗效进一步证明，在抬高型心梗患者人群中，使用依诺肝素作为辅助抗凝剂来治疗纤维蛋白溶解的方法是可行的，” ExTRACT TIMI 25 原理的研究者埃利奥特波博士是TIMI 研究小组高级研究员，塞缪午.路易威的布里格姆和妇女医院主任，哈佛大学医学院医学教授，由他领导ExTRACT-TIMI 25 小组的研究。
ExTRACT TIMI 25 是一个可以支持全球数据提交的重大随机对照临床试验，随后新 Lovenox®用于急性ST段抬高型心肌梗死患者的适应症也得到FDA和一些欧洲国家的批准。
随后一年的STEEPLE（依诺肝素在经皮冠状动脉介入治疗中的安全性和有效性）试验结果显示，一年中的所有死亡和出血原因的综合因素，对于 Lovenox? 0.5 mg/kg (p=0.06 vs. UFH) 是3.1%，Lovenox® 0.75 mg/kg (p=0.07 vs. UFH)是3.4%，两种 Lovenox®组合为 3.3% (p=0.03 vs. UFH)而UFH为4.7% 。
在选择性经皮冠脉介入治疗（PCI） 期间及之后，依诺肝素组和UFH（0.5mg/kg 或 0.75 mg/kg）中，一年的死亡率很低且统计学相似。此外，还发现，一年内包括缺血性事件和严重出血患者的危险因素和死亡无关。
法国巴黎心脏研究所，圣皮尔斯医院心脏研究所的吉尔斯.蒙特斯科特教授对该结果评论到，“大面积出血的显著减少及与UFH相类似的疗效说明，Lovenox®对于选择性PCI治疗来说是种合适的抗凝剂”
关于冠心病（CAD）和急性冠脉综合症（ACS）
就全球来说，CAD是种最常见的心脏病，也是全球性的健康难题。CAD每年大约导致1700万人死亡：相当于全世界每3例死亡中就有1例为CAD导致的死亡。根据美国心脏协会的统计，超过1300万美国人有CAD史并且有750万人曾遭受心脏病发作。
急性冠状综合症（ACS）可用雨伞一词表示，它描述了一组涵盖了任何符合急性心肌缺血临床症状且由冠状动脉狭窄导致的临床诊断，这种急性心肌缺血是由于CAD而导致心肌氧供需不平衡。
所有的急性冠脉综合症（ACS） 都需要即时治疗。治疗是全方面的，目的是尽量保护受损心脏肌内免受进一步损伤，恢复通过动脉的血流并减少心脏的需氧量。在急诊室，首要的任务是快速鉴别患者是否为MI(STEMI),排除其它原因导致的胸痛，并将病人分层为低风险和高风险群体，提供合适的治疗使缺血心肌的损伤降到最低。
恢复血液向心脏的流动（灌流），要么通过一种过去用于破碎血液凝块的药物（溶纤物），要么通过手术实现，例如经皮冠状动脉介入治疗（PCI）。通过药理方法来治疗ACS包括使用抗血小板试剂，它可以防止血小板粘在一起而形成血块。抗凝剂的作用是阻止血块的生长和新血块的生成，但是它们并不溶解血块。
关于经皮冠状动脉介入治疗（PCI）
PCI是一个用于开启那些因为动脉粥样硬化和动脉血栓而导致的冠状动脉狭窄的治疗方法。当心肌梗塞或心绞痛时，在急性或亚急性闭塞动脉中，PCI可以恢复冠状动脉血流量（或冠脉灌注）。PCI包括球囊扩张及冠状动脉内支架的植入。PCI需要长期关注的是再狭窄。但是，使用涂层和药物涂层支架已被证实能够减少这方面的风险。初期PCI的定义是：当事先未（全部或伴随）用血栓溶解剂或其它溶栓治疗时，在胸痛或急性心肌梗死等其它症状发作的12小时内，对患者进行介入。选择性PCI是用在所有其它的非紧急冠心病患者。
关于 Clexane® / Lovenox®（依诺肝素）
Lovenox®属于一类称为低分子量肝素的抗血栓药物，是一个单独的化学实体。作为全球低分子量肝素销售冠军，Lovenox®通过肝素苄酯碱降解法得到，它的分子量是未降解肝素的三分之一。Lovenox®是被最广泛研究的低分子量肝素，20年的临床治疗中，在96个国家有185百万患者使用过该药。
其临床应用与其抗血栓特性相关。它用来抑制静脉和动脉血管内的血栓形成，以防止由于静脉或动脉血栓形成而导致的潜在的急性或慢性并发症。和所有的抗凝剂一样，Lovenox®最常报道的副作用是出血，其临床适应症可能因人种不同而异。
2007-09-04 12:55
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