A randomized trial of artesunate-amodiaquine versus artemether-lumefantrine for the treatment of acute uncomplicated malaria in pregnancy

Objective To compare the artesunate-amodiaquine and artemether-lumefantrine combinations in the treatment of acute uncomplicated falciparum malaria during pregnancy. Methods Between January and July, 2013, a double-blind randomized trial was undertaken of symptomatic pregnant women (second/third trimester) with malaria parasitemia who attended a center in Ile-Ife, Nigeria. Participants were assigned to receive artesunate-amodiaquine or artemether-lumefantrine (twice daily on days 1-3) according to a computer-generated randomization sequence. Participants and investigators were masked to group allocation. Clinical evaluations and malaria parasite counts were performed at baseline and on days 2, 3, 7, and 28. Mean interval to symptomatic relief, day-3 parasite clearance, day-28 cure rate, and adverse effects were assessed. Results Of 75 women assigned to each group, 65 in the artesunate-amodiaquine group and 71 in the artemether-lumefantrine group completed the study. No significant differences between the artesunate-amodiaquine and artemether-lumefantrine groups were recorded for mean interval to symptomatic relief (2.2 ± 1.0 days vs 2.0 ± 0.8 days; P = 0.090), day-3 parasite clearance (58/65 [89.2%] vs 66/71 [93.0%]; P = 0.444), and day-28 cure rate (64/65 [98.5%] vs 67/71 [94.4%]; P = 0.138). Adverse effects (body weakness and pruritus) were more common among women assigned to artesunate-amodiaquine (30/75 [40.0%]) than among those assigned to artemether-lumefantrine (2/75 [2.7%]; P < 0.001). Conclusion Efficacies of the regimens are similar among pregnant women. However, adverse effects are more common with artesunate-amodiaquine. Pan-African Clinical Trial Registry: PACTR201310000484185.