Pharmacokinetics of levosimendan and its circulating metabolites in patients with heart failure after an extended continuous infusion of levosimendan

Br J Clin Pharmacol. 2004 Apr;57(4):412-5. doi: 10.1111/j.1365-2125.2003.02043.x.

Abstract

Aims: The purpose of the study was to characterize the pharmacokinetics of levosimendan and its metabolites OR-1855 and OR-1896 in patients with congestive heart failure.

Methods: Levosimendan was administered as a continuous intravenous infusion for 7 days. Twelve subjects received the drug at an infusion rate of 0.05 micro g kg(-1) min(-1) and 12 at a rate 0.1 micro g kg(-1) min(-1).

Results: Steady state concentrations of levosimendan were achieved within 4 h. Peak concentrations of the metabolites occurred after termination of the infusion. The mean (+/- SD) half-life of the active metabolite OR-1896 was 81 +/- 37 h after the lower dose and 81 +/- 28 h after the higher dose (P = 0.992, 95% confidence interval on the difference -27.5, 27.7).

Conclusions: The metabolites of levosimendan, OR-1855 and OR-1896, were formed and eliminated slowly, their peak concentrations occurring after termination of the 7-day infusion of the drug.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Controlled Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetamides / metabolism
  • Cardiotonic Agents / administration & dosage
  • Cardiotonic Agents / pharmacokinetics*
  • Female
  • Heart Failure / drug therapy*
  • Heart Failure / metabolism
  • Humans
  • Hydrazones / administration & dosage
  • Hydrazones / metabolism
  • Hydrazones / pharmacokinetics*
  • Infusions, Intravenous
  • Male
  • Protein Binding
  • Pyridazines / administration & dosage
  • Pyridazines / metabolism
  • Pyridazines / pharmacokinetics*
  • Simendan

Substances

  • Acetamides
  • Cardiotonic Agents
  • Hydrazones
  • N-(4-(4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl)phenyl)acetamide
  • Pyridazines
  • Simendan