Why the study?
Does oral levosimendan 2 to 8 mg daily improve pharmacodynamic variables in patients with severe congestive heart failure?
Does oral levosimendan 2 to 8 mg daily improve pharmacodynamic variables in patients with severe congestive heart failure?
Oral levosimendan at 4 to 8 mg daily demonstrates moderate inotropic and chronotropic effects with dose-dependent metabolite pharmacokinetics in patients with severe heart failure.
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Supports 4-8 mg dosing for moderate inotropy in severe HF; extends PK/PD data for oral levosimendan in RCTs.
The objective of this study was to explore the pharmacodynamics and pharmacokinetics of oral levosimendan in patients with severe congestive heart failure. This was a randomized, parallel-group, double-blind, placebo-controlled trial. Oral levosimendan 2 to 8 mg daily or placebo was administered to 25 patients with New York Heart Association class III-IV congestive heart failure for 4 weeks. Pharmacodynamic variables consisted of heart rate-corrected electromechanical systole, heart rate, and systolic and diastolic blood pressure. The pharmacokinetics of levosimendan and its metabolites, OR-1855 and OR-1896, was assessed. The 4- to 8-mg daily doses of oral levosimendan showed moderate inotropic effects. Blood pressure remained unchanged with all doses. A moderate increase in heart rate was observed except with the 2-mg dose. Pharmacokinetic parameters of the metabolites increased linearly with the dose (P < or = .002 for Cmax and AUC0-8h for both treatment groups). It was concluded that oral levosimendan has inotropic and chronotropic effects in patients with severe congestive heart failure. Plasma concentrations of its metabolites increase dose dependently.
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Põder et al. (2004) studied this question.
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