Bioavailability and preliminary clinical efficacy of intrarectal artesunate in Ghanaian children with moderate malaria

Antimicrob Agents Chemother. 2001 Feb;45(2):509-16. doi: 10.1128/AAC.45.2.509-516.2001.

Abstract

We report the first detailed pharmacokinetic assessment of intrarectal (i.r.) artesunate (ARS) in African children. Artesunate was given intravenously (i.v.; 2.4 mg/kg of body weight) and i.r. (10 or 20 mg/kg formulated as 50- or 200-mg suppositories [Rectocaps]) in a crossover study design to 34 Ghanaian children with moderate falciparum malaria. The median relative bioavailability of dihydroartemisinin (DHA), the active antimalarial metabolite of ARS, was higher in the low-dose i.r. group (10 mg/kg) than in the high-dose i.r. group (20 mg/kg) (58 versus 23%; P = 0.018). There was wide interpatient variation in the area under the concentration-time curve after i.r. ARS administration (up to 9-fold in the high-dose group and 20-fold in the low-dose group). i.r. administered ARS was more rapidly absorbed in the low-dose group than the high-dose group (median [range] absorption half-lives, 0.7 h [0.3 to 1.24 h] versus 1.1 h [0.6 to 2.7 h] [P = 0.023]. i.r. administered ARS was eliminated with a median (range) half-life of 0.8 h (0.4 to 2.7 h) (low-dose group and 0.9 h (0.1 to 2.5 h) (high-dose group) (P = 1). The fractional clearances of DHA were 3.9, 2.6, and 1.5 liters/kg/h for the 20-mg/kg, 10-mg/kg and i.v. groups, respectively (P = 0.001 and P = 0.06 for the high-and low-dose i.r. groups compared with the i.v. groups, respectively). The median volumes of distribution for DHA were 1.5 liters kg (20 mg/kg, i.r. group), 1.8 liters/kg (10 mg/kg, i.r. group), and 0.6 liters/kg (i.v. group) (P < 0.05 for both i.r. groups compared with the i.v. group). Parasite clearance kinetics were comparable in all treatment groups. i.r. administered ARS may be a useful alternative to parenterally administered ARS in the management of moderate childhood malaria and should be studied further.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Rectal
  • Antimalarials / administration & dosage
  • Antimalarials / pharmacokinetics*
  • Antimalarials / therapeutic use*
  • Artemisinins*
  • Artesunate
  • Child
  • Child, Preschool
  • Chloroquine / therapeutic use
  • Female
  • Follow-Up Studies
  • Ghana
  • Humans
  • Infant
  • Injections, Intravenous
  • Malaria / drug therapy*
  • Malaria, Cerebral / drug therapy
  • Male
  • Sesquiterpenes / administration & dosage
  • Sesquiterpenes / pharmacokinetics*
  • Sesquiterpenes / therapeutic use*

Substances

  • Antimalarials
  • Artemisinins
  • Sesquiterpenes
  • Artesunate
  • Chloroquine