Malaria Journal (Dec 2011)

Similar efficacy and safety of artemether-lumefantrine (Coartem<sup>®</sup>) in African infants and children with uncomplicated falciparum malaria across different body weight ranges

  • Bassat Quique,
  • González Raquel,
  • Machevo Sónia,
  • Nahum Alain,
  • Lyimo John,
  • Maiga Hamma,
  • Mårtensson Andreas,
  • Bashraheil Mahfudh,
  • Ouma Peter,
  • Ubben David,
  • Walter Verena,
  • Nwaiwu Obiyo,
  • Kipkeu Chemtai,
  • Lefèvre Gilbert,
  • Ogutu Bernhards,
  • Menéndez Clara

DOI
https://doi.org/10.1186/1475-2875-10-369
Journal volume & issue
Vol. 10, no. 1
p. 369

Abstract

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Abstract Background Artemisinin-based combination therapy, including artemether-lumefantrine (AL), is currently recommended for the treatment of uncomplicated Plasmodium falciparum malaria. The objectives of the current analysis were to compare the efficacy and safety of AL across different body weight ranges in African children, and to examine the age and body weight relationship in this population. Methods Efficacy, safety and pharmacokinetic data from a randomized, investigator-blinded, multicentre trial of AL for treatment of acute uncomplicated P. falciparum malaria in infants and children in Africa were analysed according to body weight group. Results The trial included 899 patients (intent-to-treat population 886). The modified intent-to-treat (ITT) population (n = 812) comprised 143 children 5 to Conclusion Efficacy of AL in uncomplicated falciparum malaria is similar across body weight dosing groups as currently recommended in the label with no clinically relevant differences in safety or tolerability. AL dosing based on body weight remains advisable.