Efficacy and safety of artemether-lumefantrine in the treatment of acute, uncomplicated Plasmodium falciparum malaria: A pooled analysis
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 childre...
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th-mahidol.119752018-05-03T15:24:01Z Efficacy and safety of artemether-lumefantrine in the treatment of acute, uncomplicated Plasmodium falciparum malaria: A pooled analysis 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 Immunology and Microbiology Medicine 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. 2018-05-03T08:14:30Z 2018-05-03T08:14:30Z 2011-11-01 Article American Journal of Tropical Medicine and Hygiene. Vol.85, No.5 (2011), 793-804 10.4269/ajtmh.2011.11-0069 00029637 2-s2.0-81155131418 https://repository.li.mahidol.ac.th/handle/123456789/11975 Mahidol University SCOPUS https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=81155131418&origin=inward |
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Immunology and Microbiology Medicine 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 |
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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. |
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European & Developing Countries Clinical Trials Partnership |
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European & Developing Countries Clinical Trials Partnership 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 |
format |
Article |
author |
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 |
author_sort |
Michael Makanga |
title |
Efficacy and safety of artemether-lumefantrine in the treatment of acute, uncomplicated Plasmodium falciparum malaria: A pooled analysis |
title_short |
Efficacy and safety of artemether-lumefantrine in the treatment of acute, uncomplicated Plasmodium falciparum malaria: A pooled analysis |
title_full |
Efficacy and safety of artemether-lumefantrine in the treatment of acute, uncomplicated Plasmodium falciparum malaria: A pooled analysis |
title_fullStr |
Efficacy and safety of artemether-lumefantrine in the treatment of acute, uncomplicated Plasmodium falciparum malaria: A pooled analysis |
title_full_unstemmed |
Efficacy and safety of artemether-lumefantrine in the treatment of acute, uncomplicated Plasmodium falciparum malaria: A pooled analysis |
title_sort |
efficacy and safety of artemether-lumefantrine in the treatment of acute, uncomplicated plasmodium falciparum malaria: a pooled analysis |
publishDate |
2018 |
url |
https://repository.li.mahidol.ac.th/handle/123456789/11975 |
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1763491873769390080 |