Similar efficacy and safety of artemether-lumefantrine (Coartem ® ) in African infants and children with uncomplicated falciparum malaria across different body weight ranges
Abstract Background Artemisinin-based combination therapy, including artemether-lumefantrine (AL), is currently recommended for the treatment of uncomplicated Plasmodium falciparum malaria. The objectives of the current analysis were to compare the efficacy and safety of AL across different body wei...
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ftdoajarticles:oai:doaj.org/article:c197db8dd11542a39f95f94a3411fb6b 2023-05-15T15:12:27+02:00 Similar efficacy and safety of artemether-lumefantrine (Coartem ® ) in African infants and children with uncomplicated falciparum malaria across different body weight ranges Bassat Quique González Raquel Machevo Sónia Nahum Alain Lyimo John Maiga Hamma Mårtensson Andreas Bashraheil Mahfudh Ouma Peter Ubben David Walter Verena Nwaiwu Obiyo Kipkeu Chemtai Lefèvre Gilbert Ogutu Bernhards Menéndez Clara 2011-12-01T00:00:00Z https://doi.org/10.1186/1475-2875-10-369 https://doaj.org/article/c197db8dd11542a39f95f94a3411fb6b EN eng BMC http://www.malariajournal.com/content/10/1/369 https://doaj.org/toc/1475-2875 doi:10.1186/1475-2875-10-369 1475-2875 https://doaj.org/article/c197db8dd11542a39f95f94a3411fb6b Malaria Journal, Vol 10, Iss 1, p 369 (2011) Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 article 2011 ftdoajarticles https://doi.org/10.1186/1475-2875-10-369 2022-12-31T00:42:14Z Abstract Background Artemisinin-based combination therapy, including artemether-lumefantrine (AL), is currently recommended for the treatment of uncomplicated Plasmodium falciparum malaria. The objectives of the current analysis were to compare the efficacy and safety of AL across different body weight ranges in African children, and to examine the age and body weight relationship in this population. Methods Efficacy, safety and pharmacokinetic data from a randomized, investigator-blinded, multicentre trial of AL for treatment of acute uncomplicated P. falciparum malaria in infants and children in Africa were analysed according to body weight group. Results The trial included 899 patients (intent-to-treat population 886). The modified intent-to-treat (ITT) population (n = 812) comprised 143 children 5 to < 10 kg, 334 children 10 to < 15 kg, 277 children 15 to < 25 kg, and 58 children 25 to < 35 kg. The 28-day PCR cure rate, the primary endpoint, was comparable across all four body weight groups (97.2%, 98.9%, 97.8% and 98.3%, respectively). There were no clinically relevant differences in safety or tolerability between body weight groups. In the three AL body weight dosing groups (5 to < 15 kg, 15 to < 25 kg and 25 to < 35 kg), 80% of patients were aged 10-50 months, 46-100 months and 90-147 months, respectively. Conclusion Efficacy of AL in uncomplicated falciparum malaria is similar across body weight dosing groups as currently recommended in the label with no clinically relevant differences in safety or tolerability. AL dosing based on body weight remains advisable. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Malaria Journal 10 1 |
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Directory of Open Access Journals: DOAJ Articles |
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Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
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Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 Bassat Quique González Raquel Machevo Sónia Nahum Alain Lyimo John Maiga Hamma Mårtensson Andreas Bashraheil Mahfudh Ouma Peter Ubben David Walter Verena Nwaiwu Obiyo Kipkeu Chemtai Lefèvre Gilbert Ogutu Bernhards Menéndez Clara Similar efficacy and safety of artemether-lumefantrine (Coartem ® ) in African infants and children with uncomplicated falciparum malaria across different body weight ranges |
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Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
description |
Abstract Background Artemisinin-based combination therapy, including artemether-lumefantrine (AL), is currently recommended for the treatment of uncomplicated Plasmodium falciparum malaria. The objectives of the current analysis were to compare the efficacy and safety of AL across different body weight ranges in African children, and to examine the age and body weight relationship in this population. Methods Efficacy, safety and pharmacokinetic data from a randomized, investigator-blinded, multicentre trial of AL for treatment of acute uncomplicated P. falciparum malaria in infants and children in Africa were analysed according to body weight group. Results The trial included 899 patients (intent-to-treat population 886). The modified intent-to-treat (ITT) population (n = 812) comprised 143 children 5 to < 10 kg, 334 children 10 to < 15 kg, 277 children 15 to < 25 kg, and 58 children 25 to < 35 kg. The 28-day PCR cure rate, the primary endpoint, was comparable across all four body weight groups (97.2%, 98.9%, 97.8% and 98.3%, respectively). There were no clinically relevant differences in safety or tolerability between body weight groups. In the three AL body weight dosing groups (5 to < 15 kg, 15 to < 25 kg and 25 to < 35 kg), 80% of patients were aged 10-50 months, 46-100 months and 90-147 months, respectively. Conclusion Efficacy of AL in uncomplicated falciparum malaria is similar across body weight dosing groups as currently recommended in the label with no clinically relevant differences in safety or tolerability. AL dosing based on body weight remains advisable. |
format |
Article in Journal/Newspaper |
author |
Bassat Quique González Raquel Machevo Sónia Nahum Alain Lyimo John Maiga Hamma Mårtensson Andreas Bashraheil Mahfudh Ouma Peter Ubben David Walter Verena Nwaiwu Obiyo Kipkeu Chemtai Lefèvre Gilbert Ogutu Bernhards Menéndez Clara |
author_facet |
Bassat Quique González Raquel Machevo Sónia Nahum Alain Lyimo John Maiga Hamma Mårtensson Andreas Bashraheil Mahfudh Ouma Peter Ubben David Walter Verena Nwaiwu Obiyo Kipkeu Chemtai Lefèvre Gilbert Ogutu Bernhards Menéndez Clara |
author_sort |
Bassat Quique |
title |
Similar efficacy and safety of artemether-lumefantrine (Coartem ® ) in African infants and children with uncomplicated falciparum malaria across different body weight ranges |
title_short |
Similar efficacy and safety of artemether-lumefantrine (Coartem ® ) in African infants and children with uncomplicated falciparum malaria across different body weight ranges |
title_full |
Similar efficacy and safety of artemether-lumefantrine (Coartem ® ) in African infants and children with uncomplicated falciparum malaria across different body weight ranges |
title_fullStr |
Similar efficacy and safety of artemether-lumefantrine (Coartem ® ) in African infants and children with uncomplicated falciparum malaria across different body weight ranges |
title_full_unstemmed |
Similar efficacy and safety of artemether-lumefantrine (Coartem ® ) in African infants and children with uncomplicated falciparum malaria across different body weight ranges |
title_sort |
similar efficacy and safety of artemether-lumefantrine (coartem ® ) in african infants and children with uncomplicated falciparum malaria across different body weight ranges |
publisher |
BMC |
publishDate |
2011 |
url |
https://doi.org/10.1186/1475-2875-10-369 https://doaj.org/article/c197db8dd11542a39f95f94a3411fb6b |
geographic |
Arctic |
geographic_facet |
Arctic |
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Arctic |
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Arctic |
op_source |
Malaria Journal, Vol 10, Iss 1, p 369 (2011) |
op_relation |
http://www.malariajournal.com/content/10/1/369 https://doaj.org/toc/1475-2875 doi:10.1186/1475-2875-10-369 1475-2875 https://doaj.org/article/c197db8dd11542a39f95f94a3411fb6b |
op_doi |
https://doi.org/10.1186/1475-2875-10-369 |
container_title |
Malaria Journal |
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10 |
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1 |
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1766343127253123072 |