Similar efficacy and safety of artemether-lumefantrine (Coartem®) in African infants and children with uncomplicated falciparum malaria across different body weight ranges
1 Barcelona Centre for International Health Research (CRESIB), Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Rosselló 132, 4°, 08036 Barcelona, Spain
2 Centro de Investigação em Saúde de Manhiça (CISM), Manhiça, Mozambique
3 Centre de Recherche Entomologique de Cotonou, Cotonou, Benin
4 Ifakara Health Research and Development Centre, Dar es Salaam, Tanzania
5 Malaria Research and Training Center, University of Bamako, Bamako, Mali
6 Division of Global Health, Dept of Public Health Sciences, Karolinska Institutet, Unit of Infectious Diseases, Dept of Medicine, Karolinska Institutet/Karolinska University Hospital, Stockholm, Sweden and Zanzibar Malaria Research Unit of the Karolinska Institutet, Zanzibar, Tanzania
7 Kenya Medical Research Institute, Kilifi, Kenya
8 Kenya Medical Research Institute/Center for Disease Control, Kisumu, Kenya
9 Medicines for Malaria Venture (MMV), Geneva, Switzerland
10 Novartis Pharma AG, Basel, Switzerland
11 Novartis Pharma AG, Mushin, Lagos, Nigeria
12 Novartis Pharma Services AG, Africa Re Centre, Hospital Road, Nairobi, Kenya
13 Walter Reed Project, Kenya Medical Research Institute, Kisumu, Kenya
Malaria Journal 2011, 10:369 doi:10.1186/1475-2875-10-369Published: 16 December 2011
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.
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.
The trial included 899 patients (intent-to-treat population 886). The modified intent-to-treat (ITT) population (n = 812) comprised 143 children 5 to < 10 kg, 334 children 10 to < 15 kg, 277 children 15 to < 25 kg, and 58 children 25 to < 35 kg. The 28-day PCR cure rate, the primary endpoint, was comparable across all four body weight groups (97.2%, 98.9%, 97.8% and 98.3%, respectively). There were no clinically relevant differences in safety or tolerability between body weight groups. In the three AL body weight dosing groups (5 to < 15 kg, 15 to < 25 kg and 25 to < 35 kg), 80% of patients were aged 10-50 months, 46-100 months and 90-147 months, respectively.
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.