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August 1, 2008Critical Care Medicine197 citations

Levosimendan is superior to enoximone in refractory cardiogenic shock complicating acute myocardial infarction*

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JFJoerg T. FuhrmannASAlexander SchmeißerMSMatthias R. Schulze

Key Result

Levosimendan significantly improved the 30-day survival rate compared with enoximone (69% vs 37%, p=0.023) in patients with refractory cardiogenic shock complicating acute myocardial infarction.

Study Design

Type

RCT (n=32)

Randomization

randomized

Multicenter

No

Structured PICO

Does levosimendan improve survival compared to enoximone in patients with refractory cardiogenic shock complicating acute myocardial infarction?

P
Population
32 patients with refractory cardiogenic shock complicating acute myocardial infarction requiring additional therapy, followed for 30 days.
I
Intervention
Levosimendan infusion (12 microg/kg over 10 min, followed by 0.1 microg/kg/min over 50 min, and 0.2 microg/kg/min for the next 23 hrs) added to current therapy (revascularization, intra-aortic balloon pump counterpulsation, and inotropes).
C
Comparator
Enoximone infusion (fractional loading dose of 0.5 mg/kg, followed by 2-10 microg/kg/min continuously) added to current therapy (revascularization, intra-aortic balloon pump counterpulsation, and inotropes).
O
Outcome
Survival rate at 30 dayshard clinical

In patients with refractory cardiogenic shock complicating acute myocardial infarction, levosimendan added to standard therapy significantly improved 30-day survival compared to enoximone.

Main Result

Absolute Event Rate: 69% vs 37%

p-value: p=0.023

Abstract

OBJECTIVE: Cardiogenic shock is the leading cause of death in patients hospitalized for acute myocardial infarction. The objectives were to investigate the effects of levosimendan, a novel inodilator, compared with the phosphodiesterase-III inhibitor enoximone in refractory cardiogenic shock complicating acute myocardial infarction, on top of current therapy. DESIGN: Prospective, randomized, controlled single-center clinical trial. SETTING: Medical and coronary intensive care unit in a university hospital. PATIENTS: Thirty-two patients with refractory cardiogenic shock for at least 2 hrs requiring additional therapy. INTERVENTIONS: Infusion of either levosimendan (12 microg/kg over 10 min, followed by 0.1 microg/kg/min over 50 min, and of 0.2 microg/kg/min for the next 23 hrs) or enoximone (fractional loading dose of 0.5 mg/kg, followed by 2-10 microg/kg/min continuously) after initiation of current therapy, always including revascularization, intra-aortic balloon pump counterpulsation, and inotropes. MEASUREMENTS AND MAIN RESULTS: Survival rate at 30 days was significantly higher in the levosimendan-treated group (69%, 11 of 16) compared with the enoximone group (37%, 6 of 16, p = 0.023). Invasive hemodynamic parameters during the first 48 hrs were comparable in both groups. Levosimendan induced a trend toward higher cardiac index, cardiac power index, left ventricular stroke work index, and mixed venous oxygen saturation. In addition, lower cumulative values for catecholamines at 72 hrs and for clinical signs of inflammation were seen in the levosimendan-treated patients. Multiple organ failure leading to death occurred exclusively in the enoximone group (4 of 16 patients). CONCLUSIONS: In severe and refractory cardiogenic shock complicating acute myocardial infarction, levosimendan, added to current therapy, may contribute to improved survival compared with enoximone.

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Cite This Study

Fuhrmann et al. (2008) conducted an RCT in refractory cardiogenic shock complicating acute myocardial infarction (n=32). Levosimendan vs. Enoximone was evaluated on Survival rate at 30 days (p=0.023). Levosimendan significantly improved the 30-day survival rate compared with enoximone (69% vs 37%, p=0.023) in patients with refractory cardiogenic shock complicating acute myocardial infarction.

synapsesocial.com/papers/6a1ff6bff35583189204bf0ahttps://doi.org/10.1097/ccm.0b013e3181809846
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