title: 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.
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.
authors.affiliation: Kenya Medical Research Institute, Kilifi, Kenya/EDCTP, Tygerberg, South Africa.
authors.forename: Michael
authors.initials: M
authors.lastname: Makanga
authors.forename: Zul
authors.initials: Z
authors.lastname: Premji
authors.forename: Catherine
authors.initials: C
authors.lastname: Falade
authors.forename: Juntra
authors.initials: J
authors.lastname: Karbwang
authors.forename: Edgar A
authors.initials: EA
authors.lastname: Mueller
authors.forename: Kim
authors.initials: K
authors.lastname: Andriano
authors.forename: Philip
authors.initials: P
authors.lastname: Hunt
authors.forename: Patricia Ibarra
authors.initials: PI
authors.lastname: De Palacios
mesh_terms: D000818:Animals; D000962:Antimalarials / Q000008:administration & dosage / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use*; D000077549:Artemether; D037621:Artemisinins / Q000008:administration & dosage / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use*; D001835:Body Weight; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004334:Drug Administration Schedule; D064420:Drug-Related Side Effects and Adverse Reactions; D004562:Electrocardiography / Q000187:drug effects; D004983:Ethanolamines / Q000008:administration & dosage / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use*; D005260:Female; D005334:Fever; D005449:Fluorenes / Q000008:administration & dosage / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D008018:Life Cycle Stages / Q000187:drug effects; D000078102:Lumefantrine; D016778:Malaria, Falciparum / Q000188:drug therapy*; D008297:Male; D013997:Time Factors
chemical_list: D000962:Antimalarials; D037621:Artemisinins; D004983:Ethanolamines; D005449:Fluorenes; D000077549:Artemether; D000078102:Lumefantrine