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Artemisinin derivatives appeared effective in treating malaria in pregnant women

Piola P. Lancet. 2010;doi:10.1016/S1473-3099(10)70202-4.

A difference in Falciparum malaria cure rates of less than 2% was observed in pregnant women treated with artemether-lumefantrine compared with pregnant women treated with quinine, according to recent study results.

The aim was to determine whether artemether-lumefantrine was as effective as oral quinine in treating uncomplicated F. malaria among a cohort of pregnant women from Mbarara, Uganda, in their second or third trimester. Although WHO recommended in 2006 that artemether-lumefantrine can reduce morbidity and mortality in pregnant women, data from African cohorts were limited.

The open-label, non-inferiority trial was conducted between October 2006 and May 2009 at the antenatal clinics of Mbarara University of Science and Technology Hospital.

Pregnant women were randomly assigned in a 1:1 ratio to receive quinine hydrochloride or artemether–lumefantrine. Follow-up was conducted weekly until delivery.

The primary outcome measure was cure rate as determined by polymerase chain reaction at day 42 of treatment. The pre-determined non-inferiority margin was a difference in cure rate of 5%.

There were 152 women in each arm at study outset. Among women who followed through to day 42, results indicated that 137 of 138 women (99.3%) in the artemether–lumefantrine arm and 122 of 125 women (97.6%) in the quinine arm achieved clinical cure, for a difference of 1.7% (lower limit of 95% CI, –0.9).

“Cure rates were high and the lower limit of the one-sided 95% CI was never lower than –5%,” the researchers wrote.

There were 141 adverse events reported in the artemether–lumefantrine arm and 290 events reported in the quinine arm.

“Artemisinin derivatives are not inferior to oral quinine for the treatment of uncomplicated malaria in pregnancy and might be preferable on the basis of safety and efficacy,” the researchers wrote. “This confirmation of efficacy of both drugs in this region of Africa is reassuring.”

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