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Please use this identifier to cite or link to this item: http://repository.li.mahidol.ac.th/dspace/handle/123456789/11975
Title: Efficacy and safety of artemether-lumefantrine in the treatment of acute, uncomplicated Plasmodium falciparum malaria: A pooled analysis
Authors: 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
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
Keywords: Immunology and Microbiology;Medicine
Issue Date: 1-Nov-2011
Citation: American Journal of Tropical Medicine and Hygiene. Vol.85, No.5 (2011), 793-804
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.
URI: https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=81155131418&origin=inward
http://repository.li.mahidol.ac.th/dspace/handle/123456789/11975
ISSN: 00029637
Appears in Collections:Scopus 2011-2015

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