RESOURCE: Vol. 297 No. 17, May 2, 2007 JAMA ( 2007;297:1883-1891. )
TITLE: Levosimendan vs Dobutamine for Patients With Acute Decompensated Heart Failure:The SURVIVE Randomized Trial
AUTHOR: Alexandre Mebazaa, MD, PhD; Markku S. Nieminen, MD, PhD; Milton Packer, MD; Alain Cohen-Solal, MD, PhD; Franz X. Kleber, MD; Stuart J. Pocock, PhD; Roopal Thakkar, MD; Robert J. Padley, MD; Pentti Põder, MD, PhD; Matti Kivikko, MD, PhD; for the SURVIVE Investigators
ABSTRACT
Context Because acute decompensated heart failure causes substantial morbidity and mortality, there is a need for agents that at least improve hemodynamics and relieve symptoms without adversely affecting survival.
Objective To assess the effect of a short-term intravenous infusion of levosimendan or dobutamine on long-term survival.
Design, Setting, and Patients The Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support (SURVIVE) study was a randomized, double-blind trial comparing the efficacy and safety of intravenous levosimendan or dobutamine in 1327 patients hospitalized with acute decompensated heart failure who required inotropic support. The trial was conducted at 75 centers in 9 countries and patients were randomized between March 2003 and December 2004.
Interventions Intravenous levosimendan (n = 664) or intravenous dobutamine (n = 663).
Main Outcome Measure All-cause mortality at 180 days.
Results All-cause mortality at 180 days occurred in 173 (26%) patients in the levosimendan group and 185 (28%) patients in the dobutamine group (hazard ratio, 0.91; 95% confidence interval, 0.74-1.13; P = .40). The levosimendan group had greater decreases in B-type natriuretic peptide level at 24 hours that persisted through 5 days compared with the dobutamine group (P<.001 for all time points). There were no statistical differences between treatment groups for the other secondary end points (all-cause mortality at 31 days, number of days alive and out of the hospital, patient global assessment, patient assessment of dyspnea at 24 hours, and cardiovascular mortality at 180 days). There was a higher incidence of cardiac failure in the dobutamine group. There were higher incidences of atrial fibrillation, hypokalemia, and headache in the levosimendan group.
Conclusion Despite an initial reduction in plasma B-type natriuretic peptide level in patients in the levosimendan group compared with patients in the dobutamine group, levosimendan did not significantly reduce all-cause mortality at 180 days or affect any secondary clinical outcomes.
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RESOURCE: Vol. 297 No. 17, May 2, 2007 JAMA ( 2007;297:1883-1891. )
TITLE: Levosimendan vs Dobutamine for Patients With Acute Decompensated Heart Failure:The SURVIVE Randomized Trial
随机化生存实验：左西孟旦和多巴酚丁胺在治疗急性失代偿性心衰病人中疗效的对比
AUTHOR: Alexandre Mebazaa, MD, PhD; Markku S. Nieminen, MD, PhD; Milton Packer, MD; Alain Cohen-Solal, MD, PhD; Franz X. Kleber, MD; Stuart J. Pocock, PhD; Roopal Thakkar, MD; Robert J. Padley, MD; Pentti Põder, MD, PhD; Matti Kivikko, MD, PhD; for the SURVIVE Investigators
ABSTRACT
Context Because acute decompensated heart failure causes substantial morbidity and mortality, there is a need for agents that at least improve hemodynamics and relieve symptoms without adversely affecting survival.
背景：由于急性失代偿性心衰能导致实际发病率和病死率上升，这就要求药物不仅能改善血液流变学和减轻症状，而且不会相反地影响生存率。
Objective To assess the effect of a short-term intravenous infusion of levosimendan or dobutamine on long-term survival.
目的：获得短期静脉注射左西孟旦或多巴酚丁胺对长期生存率的影响的数据。
Design, Setting, and Patients The Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support (SURVIVE) study was a randomized, double-blind trial comparing the efficacy and safety of intravenous levosimendan or dobutamine in 1327 patients hospitalized with acute decompensated heart failure who required inotropic support. The trial was conducted at 75 centers in 9 countries and patients were randomized between March 2003 and December 2004.
设计，设定和病人：将患有急性心衰并需要静脉收缩药物支持的病人随机分组，双盲实验条件下比较1327名患有急性失代偿性心衰并需要收缩药物支持的病人在静脉注射左西孟旦或多巴酚丁胺后的效力和安全性。这个实验在9个国家的75个中心进行，病人从2003年3月到2004年12月之间的病人中随机抽取。
Interventions Intravenous levosimendan (n = 664) or intravenous dobutamine (n = 663).
干预：静脉注射左西孟旦（n=664），静脉注射多巴酚丁胺（n=663）。
Main Outcome Measure All-cause mortality at 180 days.
主要测量结果：180天内所有原因的死亡率
Results All-cause mortality at 180 days occurred in 173 (26%) patients in the levosimendan group and 185 (28%) patients in the dobutamine group (hazard ratio, 0.91; 95% confidence interval, 0.74-1.13; P = .40). The levosimendan group had greater decreases in B-type natriuretic peptide level at 24 hours that persisted through 5 days compared with the dobutamine group (P<.001 for all time points). There were no statistical differences between treatment groups for the other secondary end points (all-cause mortality at 31 days, number of days alive and out of the hospital, patient global assessment, patient assessment of dyspnea at 24 hours, and cardiovascular mortality at 180 days). There was a higher incidence of cardiac failure in the dobutamine group. There were higher incidences of atrial fibrillation, hypokalemia, and headache in the levosimendan group.
结果：180天内所有原因的死亡率左西孟旦为173例(26%)，多巴酚丁胺为183例(28%)，（危害比 0.91；95%可信区间，0.74~1.13；P=.40）。和多巴酚丁胺组相比，左西孟旦组在注射药物后24小时至5天，B型利钠肽水平下降更明显（在所有时间点P<0.001）。其他次级观察指标，包括在31天所有原因死亡率，出院后存活的天数，病人整体评价，病人在24小时时呼吸困难的评价，180天内心血管病的死亡率等在两个治疗组中没有统计学差别。多巴酚丁胺组心衰发生率更高，而左西孟旦组房颤，低钾血症和头痛的发生率更高。
Conclusion Despite an initial reduction in plasma B-type natriuretic peptide level in patients in the levosimendan group compared with patients in the dobutamine group, levosimendan did not significantly reduce all-cause mortality at 180 days or affect any secondary clinical outcomes.
结论：尽管和多巴酚丁胺组相比，左西孟旦组能降低病人初期血浆B型利钠肽水平，但是左西孟旦并不能显著地降低180天所有原因死亡率或其他任何次级观察结果。
编译：
Alexandre Mebazaa等人通过随机化实验观察左西孟旦和多巴酚丁胺在治疗急性失代偿性心衰病人中疗效。他们将在2003年3月到2004年12月之间， 9个国家的75个中心的1327名患有急性失代偿性心衰并需要收缩药物支持的病人随机分组，双盲实验条件下给病人短期静脉注射左西孟旦或多巴酚丁胺，观察两种药物注射对病人长期生存率的影响。结果发现：180天内所有原因的死亡人数左西孟旦为173例(占实验人数的26%)，多巴酚丁胺为183例(占实验人数的28%)，（危害比 0.91；95%可信区间，0.74~1.13；P=.40）。和多巴酚丁胺组相比，左西孟旦组在注射药物后24小时至5天，B型利钠肽水平下降更明显（在所有时间点P<0.001）。其他次级观察指标，包括在31天所有原因死亡率，出院后存活的天数，病人整体评价，病人在24小时时呼吸困难的评价，180天内心血管病的死亡率等在两个治疗组中没有统计学差别。多巴酚丁胺组心衰发生率更高，而左西孟旦组房颤，低钾血症和头痛的发生率更高。他们的出结论：尽管和多巴酚丁胺组相比，左西孟旦组能降低病人初期血浆B型利钠肽水平，但是左西孟旦并不能显著地降低180天所有原因死亡率或其他任何次级观察结果。
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