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

Michael Makanga, Zul Premji, Catherine Falade, Juntra Karbwang, Edgar A. Mueller, Kim Andriano, Philip Hunt, Patricia Ibarra De Palacios

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72 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)991-998
Number of pages8
JournalAmerican Journal of Tropical Medicine and Hygiene
Volume74
Issue number6
DOIs
Publication statusPublished - Jun 2006
Externally publishedYes

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