Pharmacokinetics of dihydroartemisinin following oral artesunate treatment of pregnant women with acute uncomplicated falciparum malaria

Eur J Clin Pharmacol. 2006 May;62(5):367-71. doi: 10.1007/s00228-006-0118-y. Epub 2006 Mar 22.

Abstract

Objective: To determine the pharmacokinetic properties of dihydroartemisinin (DHA) following oral artesunate treatment in women with recrudescent multi-drug resistant falciparum malaria, in the second and third trimesters of pregnancy.

Methods: Serial plasma concentrations of artesunate and DHA were measured in 24 women after the final dose of a 3 day treatment with artesunate (4 mg kg(-1) day(-1)) and atovaquone (20 mg kg(-1) day(-1)) plus proguanil (8 mg kg(-1) day(-1)), daily. Conventional non-compartmental modelling and a population one-compartment pharmacokinetic model were applied to the data.

Results: Artesunate was very rapidly eliminated. For DHA the median [90% range] estimate of oral clearance (CI/F) was 4.0 [0.8-20.7] l hour(-1) kg(-1), total apparent volume of distribution (Vd/f) was 3.4 [0.9-60.7] l/kg, and terminal elimination half-life was 1.0 [0.6-2.4] h.

Conclusion: The kinetics of DHA are modified by pregnancy. The plasma levels of the active antimalarial metabolite DHA are lower than reported previously in non-pregnant adults. Dose-optimisation studies in pregnant women are needed.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Adolescent
  • Adult
  • Analysis of Variance
  • Antimalarials / administration & dosage
  • Antimalarials / pharmacokinetics*
  • Antimalarials / therapeutic use
  • Artemisinins / administration & dosage
  • Artemisinins / pharmacokinetics*
  • Artemisinins / therapeutic use
  • Artesunate
  • Atovaquone / administration & dosage
  • Atovaquone / pharmacokinetics
  • Atovaquone / therapeutic use
  • Drug Combinations
  • Drug Resistance, Multiple
  • Drug Therapy, Combination
  • Female
  • Half-Life
  • Humans
  • Malaria, Falciparum / blood
  • Malaria, Falciparum / drug therapy*
  • Malaria, Falciparum / metabolism
  • Pregnancy
  • Pregnancy Complications, Parasitic / blood
  • Pregnancy Complications, Parasitic / drug therapy*
  • Pregnancy Complications, Parasitic / metabolism
  • Pregnancy Outcome
  • Pregnancy Trimester, Second
  • Pregnancy Trimester, Third
  • Proguanil / administration & dosage
  • Proguanil / pharmacokinetics
  • Proguanil / therapeutic use
  • Sesquiterpenes / administration & dosage
  • Sesquiterpenes / pharmacokinetics*
  • Sesquiterpenes / therapeutic use
  • Thailand

Substances

  • Antimalarials
  • Artemisinins
  • Drug Combinations
  • Sesquiterpenes
  • Artesunate
  • artenimol
  • Proguanil
  • Atovaquone