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

CO Falade, AO Ogundele, BO Yusuf… - Tropical Medicine & …, 2008 - Wiley Online Library
CO Falade, AO Ogundele, BO Yusuf, OG Ademowo, SM Ladipo
Tropical Medicine & International Health, 2008Wiley Online Library
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 …
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, ρ = 0.66). Using Kaplan–Meier product‐limit estimates of failure, the median survival time for ASAQ was 21 days and for AL 28 days (P = 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.
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