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作者：tomato
来源：生物谷
关键词：安进,急性心力衰竭,omecamtiv mecarbil
日讯 /BIOON/ --安进（Amgen）和合作伙伴Cytokinetics公司9月3日在2013年欧洲心脏病学会年会（ESC 2013）上，首次公布了有关肌球蛋白激活剂omecamtiv mecarbil II期ATOMIC-AHF研究的数据。
该研究是一项随机、双盲、安慰剂对照II期研究，旨在评估一种静脉注射配方omecamtiv mecarbil用于治疗急性心力衰竭（AHF）的安全性、药代动力学、药效学、潜在疗效。该项研究共招募了613例住院治疗的AHF患者，以omecamtiv mecarbil或安慰剂治疗48小时。数据表明，该项研究未能达到呼吸困难响应（用李克特七点量表法评价）的主要终点（p=0.33），但呼吸困难响应表现出良好的剂量和浓度相关性趋势。
目前，双方也正在开展一项名为COSMIC-HF的II期临床研究，评估口服配方omecamtiv mecarbil用于治疗慢性心力衰竭和左心室收缩功能不全患者的安全性和疗效。
安进将根据这2项研究的汇总数据，决定是否推进omecamtiv mecarbil至III期临床开发。
Omecamtiv mecarbil (CK-1827452)是一种新型小分子心肌蛋白直接激动剂，由安进从Cytokinetics公司授权获得，旨在开发用于治疗心力衰竭，该药有静脉注射和口服两种剂型。
心脏的收缩有赖于心脏肌球蛋白的正常功能，当这种蛋白收缩功能减弱时就会发生心力衰竭。omecamtiv mecarbil可以激活心脏肌球蛋白，有希望成为一种新的心力衰竭治疗药物。（生物谷）
英文原文：Amgen And Cytokinetics Announce The First Presentation Of Data From Phase 2 ATOMIC-AHF Study Of Omecamtiv Mecarbil
First Trial to Evaluate Cardiac Myosin Activator in Patients with Acute Heart Failure Presented at ESC Congress 2013
THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., Sept. 3, 2013 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Cytokinetics Incorporated (NASDAQ: CYTK) today announced the first presentation of data from the ATOMIC-AHF (Acute Treatment with Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure) study at the ESC Congress 2013, organized by the European Society of Cardiology, in Amsterdam. ATOMIC-AHF was a randomized, double-blind, placebo-controlled Phase 2 study that enrolled 613 patients hospitalized with acute heart failure (AHF) treated for 48 hours with omecamtiv mecarbil or placebo and designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and potential efficacy of an intravenous formulation of omecamtiv mecarbil in patients with AHF. The study did not meet its primary endpoint of dyspnea (shortness of breath) response as measured by the 7-point Likert scale through 48 hours (p=0.33) but showed favorable dose and concentration-related trends on dyspnea response.
ATOMIC-AHF enrolled three, sequential, dose escalation cohorts of patients treated for 48 hours with omecamtiv mecarbil or placebo. The primary efficacy endpoint in ATOMIC-AHF was dyspnea symptom response. Secondary endpoints included other clinical and pharmacodynamic (echocardiographic) effects including death or worsening heart failure within seven days. The omecamtiv mecarbil treatment groups were not statistically different in their 7-point Likert scale dyspnea symptom response rates compared to the pooled placebo group (p=0.33); therefore, the primary endpoint was not met. Omecamtiv mecarbil demonstrated favorable dose- and concentration-related trends (nominal p=0.025 and nominal p=0.007, respectively) on dyspnea response. Improvement in dyspnea was observed in the highest omecamtiv mecarbil dose group when compared against its paired placebo group in the third cohort (dyspnea symptom response in 51 percent of subjects on omecamtiv mecarbil versus 37 percent on placebo, nominal p=0.03). The incidence of worsening heart failure within seven days of initiating treatment was 17 percent in the pooled placebo group and was 13 percent, 8 percent and 9 percent on omecamtiv mecarbil in the first, second and third cohorts, respectively. Systolic ejection time, the echocardiographic signature of omecamtiv mecarbil, increased in a concentration-dependent manner.
Rates of adverse events (AEs), serious AEs, adjudicated deaths and hospitalizations were similar between omecamtiv mecarbil and placebo groups. There were seven post-randomization myocardial infarctions in the omecamtiv mecarbil treated groups compared with three in the placebo groups (2.3 percent vs. 1.0 percent, respectively). However, there was no relationship between the maximum increase from the baseline troponin (a biomarker specific for cardiac muscle damage) and increasing plasma concentrations of omecamtiv mecarbil. Omecamtiv mecarbil was not associated with an increased incidence of tachyarrhythmias nor were heart rate or blood pressure adversely affected.
"Although ATOMIC-AHF did not achieve its primary efficacy endpoint, we are encouraged by the data from this study," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Omecamtiv mecarbil is a unique investigational therapy for patients with acute and chronic heart failure. We look forward to the data from the COSMIC-HF study, which together with the data from ATOMIC-AHF will inform our decision on whether to progress omecamtiv mecarbil into Phase 3 clinical trials."
"We are pleased with the results from ATOMIC-AHF," stated Robert I. Blum, President and CEO at Cytokinetics. "This novel mechanism drug candidate has consistently been associated with dose-related and plasma concentration-related pharmacodynamic and other effects in a robust program of Phase 1 and Phase 2 clinical trials. We look forward to results from COSMIC-HF and the potential& progression of omecamtiv mecarbil in development."
ATOMIC-AHF and COSMIC-HF
ATOMIC-AHF is a completed Phase 2 clinical trial designed to evaluate an intravenous formulation of omecamtiv mecarbil in 613 patients enrolled in three sequential, ascending-dose cohorts. In each cohort, patients were randomized 1:1 to omecamtiv mecarbil or placebo. The primary objective of this trial was to evaluate the effect of 48 hours of intravenous omecamtiv mecarbil compared to placebo on dyspnea in patients with left ventricular systolic dysfunction hospitalized for acute heart failure. The secondary objectives were to assess the safety and tolerability of the three dose levels of omecamtiv mecarbil compared with placebo and to evaluate the effects of 48 hours of treatment with intravenous omecamtiv mecarbil on additional clinical and pharmacodynamic measures.
Oral formulations of omecamtiv mecarbil are currently being evaluated in a Phase 2 trial known as COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure). COSMIC-HF is a double-blind, randomized, placebo-controlled, multicenter, dose escalation study designed to evaluate the safety and efficacy of omecamtiv mecarbil in approximately 420 patients with chronic heart failure and left ventricular systolic dysfunction.
ATOMIC-AHF and COSMIC-HF are clinical trials of omecamtiv mecarbil conducted by Amgen in collaboration with Cytokinetics. Amgen holds an exclusive, worldwide license to& develop and commercialize omecamtiv mecarbil and related compounds, subject to Cytokinetics' specified development and commercialization participation rights.
About Omecamtiv Mecarbil
Omecamtiv mecarbil is a novel cardiac myosin activator and is the subject of a collaboration between Cytokinetics and Amgen. Cardiac myosin is the cytoskeletal motor protein in the cardiac muscle cell that is directly responsible for converting chemical energy into the mechanical force resulting in cardiac contraction. Cardiac myosin activators are thought to accelerate the rate-limiting step of the myosin enzymatic cycle and shift the enzymatic cycle in favor of the force-producing state. Preclinical research has shown that cardiac myosin activators increase contractility in the absence of changes in favor of the force-producing state. the absence of changes in intracellular calcium in cardiac myocytes. intracellular calcium in cardiac myocytes.&
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作者：jewell
来源：生物谷
7月10日，美国公司Pernix Therapeutics宣布，Omeclamox-Pak已在美国境内药店上架，该药用于幽门螺旋杆菌（Helicobacter pylori）感染及十二指肠溃疡，以根治成人中幽门螺旋杆菌感染。
Omeclamox-Pak是服药期为10天的三重组合口服药，包括奥美拉唑（omeprazole）缓释胶囊（20 mg）、克拉霉素（clarithromycin）片剂（500 mg）及阿莫西林（amoxicillin）胶囊（500 mg）。
Omeclamox-Pak是第一个可在10天内根除幽门螺旋杆菌感染的三重组合药物。现行幽门螺旋杆菌感染治疗方法包括双重疗法（含一种质子泵抑制剂及一种抗生素药物）及每日两次、共需服用14天的三重组合疗法。
Omeprazole是一种抗分泌药，通过降低胃酸的分泌量而发挥药效。2011年，FDA批准组合药Omeclamox-Pak在美上市。
Omeclamox-Pak禁用于对奥美拉唑、大环内酯类抗生素及盘尼西林过敏人群。（）
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中国的市场的确存在很大的隐患，干细胞行业是个专业性要求较高的行业
个体化医疗是未来医学研究与应用的趋势，而个体化治疗的关键在基于生物分子标志物的诊疗策略
中国疫苗市场的巨大潜力，吸引了世界排名最领先的跨国疫苗制造巨头前来淘金。键盘上的H ome是什么意思_百度知道
键盘上的H ome是什么意思
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跟END相对应一般是是顶端的意思。一个最前、一个最后
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把虚拟内存开大的,24寸..,铁,,开成物理内存的2倍半就行了
至於内存,进了奥格有时会停顿会大哥你行啊,总体上还过的去.
保证你不卡
另外还有一点，,再加一个同样的就行了,打成就行了,,暴风,或把分辨率打下来,最简单的方法是,KLZ,
说下我的破机器
P4 2,换个显示器就OK了.8C
DDR400 512M*2
七彩虹6600GT 512M&#47,你以为电脑显示屏越大越好啊,有20--50点真数
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出门在外也不愁安进心衰药物Omecamtiv mecarbil中期临床试验未达目标
作者：fyc5078
安进与Cytokinetics公司的一款心力衰竭试验药物Omecamtiv mecarbil在一项中期临床试验中未能达到改善呼吸短促的试验目标，从而使这款药物的前景扑朔迷离。 在这项613名患者参与的临床试验中，尽管这款静脉注射剂药物没能达到试验目标，但安进表示在一项单独的II期临床研究中将会继续试验这款药物的一种口服剂型药物。试验的合并结果将决定这款药物是进行下一步的III期临床试验还是被中止研究。&在决定这款药物的前途之前，我们将会非常细致地检查所有数据。&安进的执行医疗主任Scott Wasserman说。 心力衰竭反映心脏的泵血功能障碍，并且这种疾病往往是致命的。大约有一半的确诊患者会在五年内死亡，自19世纪70年代以来，这种疾病的治疗已有所进步。 Omecamtiv mecarbil采用一种新途径，即通过激活心脏细胞中负责将化学能换化成心肌收缩的心肌肌球蛋白来治疗心力衰竭，安进对这款药物的许可权是其从Cytokinetics公司获得。这款静脉注射药物的研究数据于9月1日在阿姆斯特丹举行的欧洲心脏病学术大会上发布，在会上，开发新的心力衰竭治疗药物的艰难已成为医生们谈论的一个主要话题。 杜克大学医学中心的Christopher Granger博士未参与过这项临床研究，他表示临床试验的结果令人失望，尽管结果有令人鼓舞的、向着一种良好响应发展的趋势。&对此我会感到气馁，因为这款药物很重要的影响。&他指出来自诺华的另一款药物Serelaxin有更好的结果。 但美国心脏协会主席Mariell Jessup博士表示，放弃安进这款药物的想法还不成熟，她指出要在临床上显示出疗效是非常困难的。&仍然有希望。即使你不能对急性症状显示出效果，但只要没有不良信号，我认为研究这款口服药物的等效性也是值得的。&她补充说。 美国生物巨头安进在传统上较关注于肿瘤药物，但最近该公司又多样化地进入心脏病药物领域，在该领域安进还在开发一种新型的称作PCSK9抑制剂的降胆固醇药物。7月份，安进还通过一项交易，从法国制药商Servier那里获得一种治疗慢性心力衰竭和心绞痛的药物商业权。
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[医]奥美拉唑洛赛克，H2受体拮抗剂，治疗消化道溃疡。
大家都在背：
1. Results The total efficiencies of omeprazole and famotidine 100 % and %, respectively.
结果奥美拉唑的总100%, 法莫替丁%.
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2. Esomeprazole, a new proton pump inhibitor, is the S - isomer of omeprazole.
艾司奥美拉唑是一种新型的质子泵抑制剂, 它是奥美拉唑的S - 型光学异构体.
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3. And in Group II we treat them with omeprazole ( 20 mg , Po , bid , 3 weeks ).
奥美拉唑组50例,给奥美拉唑 20mg, Po, bid, 共3周.
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4. OBJECTIVE : To objectively evaluate the domestic omeprazole Aoke.
目的: 对奥克(国产奥美拉唑)进行客观评价.
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5. OBJECTIVE To develop the enteric coated omeprazole pellets.
目的研制奥美拉唑肠溶微丸.
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1. antacid (trade name Prilosec) that suppresses acid secretion in the stomach
1.奥美拉唑洛赛克，H2受体拮抗剂，治疗消化道溃疡。
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