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EFFICACY AND SAFETY OF THE SIX-DOSE REGIMEN OF ARTEMETHER-LUMEFANTRINE IN PEDIATRICS WITH UNCOMPLICATED PLASMODIUM FALCIPARUM MALARIA: A POOLED ANALYSIS OF INDIVIDUAL PATIENT DATA

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  • 1 Kenya Medical Research Institute, Kilifi, Kenya/EDCTP, Tygerberg, South Africa; Muhimbili University College of Health Sciences, Dar es Salaam, Tanzania; Department of Pharmacology and Therapeutics, College of Medicine, University of Ibadan, Ibadan, Nigeria; Special Programme for Research and Training in Tropical Diseases, World Health Organization, Geneva, Switzerland; Institute for Clinical Pharmacology, Public Health Research Association Saxony, Technical University, Dresden, Germany; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey; Novartis Horsham Research Centre, Horsham, United Kingdom; Novartis Pharma AG, Basel, Switzerland

Patient data from eight clinical trials were pooled and analyzed to study the efficacy and safety of the six-dose versus four-dose regimen of artemether-lumefantrine (coartemether; Coartem) in children weighing 5–25 kg. A total of 544 patients with uncomplicated P. falciparum malaria (six-dose: 343; four-dose: 201), matched for demographic and baseline characteristics and individual coartemether doses were included in the analysis. Analysis of day 28 cure rate based on the intention-to-treat and evaluable populations yielded corrected cure rates for the six-dose regimen of 93% and 96% compared with 61% and 76%, respectively, for the four-dose regimen (P < 0.0001 for both comparisons). Similarly high cure rates were achieved with the six-dose regimen in non-immune infants weighing as little as 5 kg. The six- and four-dose regimens were equally well tolerated. The main finding of this analysis is that the six-dose regimen of coartemether is safe and more efficacious than the four-dose regimen in children.

Author Notes

Reprint requests: Edgar A. Mueller, MD, Institute for Clinical Pharmacology, Public Health Research Association Saxony, Medical Faculty, Technical University, Fiedlerstrasse 27, D-01307 Dresden, Germany. E-mail: Edgar.Mueller@mailbox.tu-dresden.de.
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