Publication: 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
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Issued Date
2006-11-01
Resource Type
ISSN
0001706X
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2-s2.0-33751504559
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Mahidol University
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SCOPUS
Bibliographic Citation
Acta Tropica. Vol.100, No.1-2 (2006), 41-53
Suggested Citation
Edgar A. Mueller, Michele van Vugt, Wilhelm Kirch, Kim Andriano, Philip Hunt, Patricia Ibarra de Palacios 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. Acta Tropica. Vol.100, No.1-2 (2006), 41-53. doi:10.1016/j.actatropica.2006.09.007 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/23295
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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
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.