Publication: Efficacy and safety of artemether-lumefantrine in the treatment of acute, uncomplicated Plasmodium falciparum malaria: A pooled analysis
Issued Date
2011-11-01
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video/youtube
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00029637
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2-s2.0-81155131418
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Mahidol University
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SCOPUS
Bibliographic Citation
American Journal of Tropical Medicine and Hygiene. Vol.85, No.5 (2011), 793-804
Suggested Citation
Michael Makanga, Quique Bassat, Catherine O. Falade, Zulfiqarali G. Premji, Srivicha Krudsood, Philip Hunt, Verena Walter, Hans Peter Beck, Anne Claire Marrast, Marc Cousin, Philip J. Rosenthal Efficacy and safety of artemether-lumefantrine in the treatment of acute, uncomplicated Plasmodium falciparum malaria: A pooled analysis. American Journal of Tropical Medicine and Hygiene. Vol.85, No.5 (2011), 793-804. doi:10.4269/ajtmh.2011.11-0069 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/11975
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Title
Efficacy and safety of artemether-lumefantrine in the treatment of acute, uncomplicated Plasmodium falciparum malaria: A pooled analysis
Other Contributor(s)
European & Developing Countries Clinical Trials Partnership
Universitat de Barcelona
Centro de Investigação em Saúde de Manhiça
University of Ibadan
Muhimbili University of Health and Allied Sciences
Mahidol University
Novartis Horsham Research Centre
Novartis International AG
Universitat Basel
University of California, San Francisco
Universitat de Barcelona
Centro de Investigação em Saúde de Manhiça
University of Ibadan
Muhimbili University of Health and Allied Sciences
Mahidol University
Novartis Horsham Research Centre
Novartis International AG
Universitat Basel
University of California, San Francisco
Abstract
Randomized trials have confirmed the efficacy and safety of artemether-lumefantrine (AL) for treatment of uncomplicated Plasmodium falciparum malaria. Data from seven studies supported by Novartis (1996-2007), including 647 adults ( > 16 years of age, 83.3% completed the study) and 1,332 children (≤ 16 years of age, 89.3% completed the study) with microscopically confirmed uncomplicated P. falciparum malaria and treated with the recommended regimen of AL, were pooled. The 28-day polymerase chain reaction-corrected parasitologic cure rate (primary efficacy endpoint) was 97.1% (495 of 510) in adults and 97.3% (792 of 814) in children (evaluable population). Gametocytemia prevalence after day was 4.2% (23 of 554) in adults and 0.9% (8 of 846) in children. No noteworthy safety signals were observed. Serious adverse events occurred in 1.4% of the adults and 1.3% of the children. This study is the largest data set to date assessing AL therapy for treatment of acute uncomplicated P. falciparum malaria. Artemether-lumefantrine showed high cure rates and rapid resolution of parasitemia, fever, and gametocytemia in adults and children, and showed an excellent safety and tolerability profile. Copyright © 2011 by The American Society of Tropical Medicine and Hygiene.