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Title: Efficacy and safety of the six-dose regimen of artemether-lumefantrine for treatment of uncomplicated Plasmodium falciparum malaria in adolescents and adults: A pooled analysis of individual patient data from randomized clinical trials
Authors: Edgar A. Mueller
Michele van Vugt
Wilhelm Kirch
Kim Andriano
Philip Hunt
Patricia Ibarra de Palacios
Dresden University Faculty of Medicine and University Hospital Carl Gustav Carus
Mahidol University
University of Amsterdam
Novartis Pharmaceuticals Corporation
Novartis Horsham Research Centre
Novartis International AG
Keywords: Immunology and Microbiology;Medicine
Issue Date: 1-Nov-2006
Citation: Acta Tropica. Vol.100, No.1-2 (2006), 41-53
Abstract: To demonstrate the superiority of the six-dose over the four-dose regimen of artemether-lumefantrine (co-artemether, Coartem®) in patients >12 years, data from 11 randomized clinical trials were pooled and analyzed. A total of 1368 patients with uncomplicated Plasmodium falciparum malaria (six-dose: 598; four-dose: 770) were included in the analysis, together with 717 patients treated with comparators. Analysis of the 28-day cure rate based on the ITT and evaluable populations yielded corrected cure rates for the six-dose regimen of 87% and 97% compared with 74% and 87%, respectively, with the four-dose regimen (P < 0.0001, for both comparisons). For mefloquine/artesunate, the most frequently used comparator, cure rates were 87% and 99%, respectively. The six-dose regimen was well tolerated and not markedly different to the four-dose regimen. The main finding of our analysis is that the six-dose regimen of co-artemether is more effective than the four-dose regimen in adolescents and adults without compromising safety. © 2006 Elsevier B.V. All rights reserved.
ISSN: 0001706X
Appears in Collections:Scopus 2006-2010

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