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Pharmacodynamics and pharmacokinetics of oral levosimendan and its metabolites in patients with severe congestive heart failure: a dosing interval study
- Source :
- Journal of clinical pharmacology. 44(10)
- Publication Year :
- 2004
-
Abstract
- 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 (Por = .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.
- Subjects :
- Inotrope
Chronotropic
Male
medicine.medical_specialty
Cmax
Administration, Oral
Drug Administration Schedule
Double-Blind Method
Internal medicine
Heart rate
medicine
Humans
Pharmacology (medical)
Simendan
Pharmacology
Heart Failure
Analysis of Variance
business.industry
Hydrazones
Levosimendan
Middle Aged
medicine.disease
Pyridazines
Blood pressure
Pharmacodynamics
Anesthesia
Heart failure
Cardiology
Female
business
medicine.drug
Subjects
Details
- ISSN :
- 00912700
- Volume :
- 44
- Issue :
- 10
- Database :
- OpenAIRE
- Journal :
- Journal of clinical pharmacology
- Accession number :
- edsair.doi.dedup.....652347f8513057ee96601cb04d6864c2