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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 Makanga M; Premji Z; Falade C; Karbwang J; Mueller EA; Andriano K; Hunt P; De Palacios PIAm J Trop Med Hyg 2006[Jun]; 74 (6): 991-8Patient 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.|Animals[MESH]|Antimalarials/administration & dosage/adverse effects/standards/*therapeutic use[MESH]|Artemether[MESH]|Artemisinins/administration & dosage/adverse effects/standards/*therapeutic use[MESH]|Body Weight[MESH]|Child[MESH]|Child, Preschool[MESH]|Clinical Trials as Topic[MESH]|Drug Administration Schedule[MESH]|Drug-Related Side Effects and Adverse Reactions[MESH]|Electrocardiography/drug effects[MESH]|Ethanolamines/administration & dosage/adverse effects/standards/*therapeutic use[MESH]|Female[MESH]|Fever[MESH]|Fluorenes/administration & dosage/adverse effects/standards/*therapeutic use[MESH]|Humans[MESH]|Infant[MESH]|Life Cycle Stages/drug effects[MESH]|Lumefantrine[MESH]|Malaria, Falciparum/*drug therapy[MESH]|Male[MESH]|Time Factors[MESH] |
