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Free Content High efficacy of two artemisinin-based combinations (artemether–lumefantrine and artesunate plus amodiaquine) for acute uncomplicated malaria in Ibadan, Nigeria

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Abstract:

Summary Objective  To test the hypothesis that artesunate plus amodiaquine (ASAQ) is as effective as artemether–lumefantrine (AL) in the treatment of acute uncomplicated malaria in Nigerian children. Methods  In an open label, randomized controlled clinical trial, children aged 6 months to 10 years were randomized to receive artesunate (4 mg/kg daily) plus amodiaquine (10 mg/kg daily) or AL (5–14 kg, one tablet; 15–24 kg, two tablets and 25–34 kg, three tablets twice daily). Both drug regimens were given for 3 days and follow-up was for 28 days. Results  A total of 132 children (66 in each group) were randomized to receive either ASAQ or AL. Day 28 cure rates in the per protocol (PP) population were 93% for ASAQ and 95% for AL (OR = 0.71, 95% CI = 0.12–3.99,  = 0.66). Using Kaplan–Meier product-limit estimates of failure, the median survival time for ASAQ was 21 days and for AL 28 days ( = 0.294). PCR corrected day 28 cure rate for PP populations were 98.4% for ASAQ and 100% for AL. Both drugs were well-tolerated. Conclusion  ASAQ is as effective as AL and both combinations were efficacious and safe.

French
Objectif 

Tester l’hypothèse selon laquelle artésunate + amodiaquine (ASAQ) est aussi efficace que artéméther + luméfantrine (AL) dans le traitement de la malaria aiguë non compliquée chez les enfants nigérians. Méthodes 

Dans un essai clinique randomisé contrôlé ouvert, des enfants âgés de 6 mois à 10 ans ont été randomisés pour recevoir de l’artésunate (4 mg/kg/jour) plus amodiaquine (10 mg/kg/jour) ou de l’artéméther-luméfantrine (un comprimé pour les 5–14 kg, deux comprimés pour les 15–24 kg, et trois comprimés pour les 25–34 kg; deux fois par jour). Les deux types de médication ont été administrés durant 3 jours et un suivi a été effectué pendant 28 jours. Résultats 

132 enfants (66 dans chaque groupe) ont été randomisés pour recevoir soit ASAQ ou AL. Le taux de guérison au jour 28 dans la population per protocole était de 93% pour ASAQ et 95% pour l’AL (OR = 0,71; IC95%: 0,12–3,99; ρ = 0,66). En utilisant les limites d’estimation de l’échec selon le produit de Kaplan Meier, la durée médiane de survie était de 21 jours pour ASAQ et 28 jours pour AL (P = 0,294). Les taux de guérison au jour 28 corrigés par les résultats de la PCR pour les populations per protocole étaient de 98,4% pour ASAQ et de 100% pour l’AL. Les deux médicaments étaient bien tolérés. Conclusion 

ASAQ est aussi efficace que l’AL et les deux combinaisons sont efficaces et sans danger.

Keywords: Co-artemeter; Co-artéméther; Nigeria; Nigéria; artesunate plus amodiaquine; artesunato + amodiaquina; artésunate + amodiaquine malaria infantile; childhood; co-artemether; malaria; niñez

Document Type: Research Article

DOI: https://doi.org/10.1111/j.1365-3156.2008.02043.x

Affiliations: 1:  Department of Clinical Pharmacology, University College Hospital, Ibadan, Nigeria 2:  Department of Environmental Health, Statistics and Epidemiology, University of Ibadan, Ibadan, Nigeria 3:  General Out Patients Department, University College Hospital, Ibadan, Nigeria

Publication date: 2008-05-01

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