Hemodynamic and neurohumoral effects of continuous infusion of levosimendan in patients with congestive heart failure.
J Am Coll Cardiol
; 36(6): 1903-12, 2000 Nov 15.
Article
en En
| MEDLINE
| ID: mdl-11092663
ABSTRACT
OBJECTIVES:
We sought to define the therapeutic dose range of levosimendan in patients with New York Heart Association class II-IV heart failure of ischemic origin.BACKGROUND:
Levosimendan is a calcium sensitizer for treatment of acute decompensated heart failure.METHODS:
A double-blind, placebo-controlled, randomized, multicenter, parallel-group study included 151 adult patients. Levosimendan was given as a 10-min intravenous bolus of 3, 6, 12, 24 or 36 microg/kg, followed by a 24-h infusion of 0.05, 0.1, 0.2, 0.4 or 0.6 microg/kg/min, respectively. Dobutamine, for comparative purposes, was given as an open-label infusion (6 microg/kg/min). The primary efficacy variable was the proportion of patients achieving in each treatment group at least one of the following 1) a > or =15% increase in stroke volume (SV) at 23 h to 24 h; 2) a > or =25% decrease in pulmonary capillary wedge pressure (PCWP) (and > or =4 mm Hg) at 23 h to 24 h; 3) a > or =40% increase in cardiac output (CO) (with change in heart rate [HR] <20%); 4) a > or =50% decrease in PCWP during two consecutive measurements.RESULTS:
The response rate to levosimendan ranged from 50% at the lowest dose to 88% at the highest dose (compared with placebo 14%, dobutamine 70%). A dose-response relationship was demonstrated for levosimendan on increases in CO and SV, and reductions in PCWP during the infusion (for all, p< or =0.001). Headache (9%), nausea (5%) and hypotension (5%) were the most frequently reported adverse events at higher dosages.CONCLUSIONS:
Dosing of levosimendan with a 10-min bolus of 6 to 24 microg/kg followed by an infusion of 0.05 to 0.2 microg/kg/min is well tolerated and leads to favorable hemodynamic effects.
Buscar en Google
Banco de datos:
MEDLINE
Asunto principal:
Piridazinas
/
Cardiotónicos
/
Insuficiencia Cardíaca
/
Hidrazonas
Tipo de estudio:
Clinical_trials
Límite:
Adult
/
Aged
/
Aged80
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
J Am Coll Cardiol
Año:
2000
Tipo del documento:
Article
País de afiliación:
Finlandia