Research Article: Efficacy and Safety of Artemether-Lumefantrine in the Treatment of Acute, Uncomplicated Plasmodium falciparum Malaria: A Pooled Analysis

Date Published: November 01, 2011

Publisher: The American Society of Tropical Medicine and Hygiene

Author(s): Michael Makanga, Quique Bassat, Catherine O. Falade, Zulfiqarali G. Premji, Srivicha Krudsood, Philip Hunt, Verena Walter, Hans-Peter Beck, Anne-Claire Marrast, Marc Cousin, Philip J. Rosenthal.


Randomized trials have confirmed the efficacy and safety of artemether-lumefantrine (AL) for treatment of uncomplicated Plasmodium falciparum malaria. Data from seven studies supported by Novartis (1996–2007), including 647 adults (> 16 years of age, 83.3% completed the study) and 1,332 children (≤ 16 years of age, 89.3% completed the study) with microscopically confirmed uncomplicated P. falciparum malaria and treated with the recommended regimen of AL, were pooled. The 28-day polymerase chain reaction–corrected parasitologic cure rate (primary efficacy endpoint) was 97.1% (495 of 510) in adults and 97.3% (792 of 814) in children (evaluable population). Gametocytemia prevalence after day was 4.2% (23 of 554) in adults and 0.9% (8 of 846) in children. No noteworthy safety signals were observed. Serious adverse events occurred in 1.4% of the adults and 1.3% of the children. This study is the largest data set to date assessing AL therapy for treatment of acute uncomplicated P. falciparum malaria. Artemether-lumefantrine showed high cure rates and rapid resolution of parasitemia, fever, and gametocytemia in adults and children, and showed an excellent safety and tolerability profile.

Partial Text

The World Health Organization (WHO) recommends that artemisinin-based combination therapies (ACTs) be used as first-line treatment of uncomplicated Plasmodium falciparum malaria.1 Treatment with ACTs is currently considered more effective than available non-artemisinin regimens,2 resulting in faster symptomatic improvement and parasite clearance1,3 and a reduction in gametocyte carriage, which could help to reduce malaria transmission.1,4–6

In this pooled analysis, the largest of its type so far to assess AL therapy for the treatment of acute uncomplicated P. falciparum malaria, AL achieved high cure rates and rapid symptom relief in adults and children and a good safety and tolerability profile. The efficacy of AL was similar for patients of all ages in malaria-endemic regions. In the only study of travelers from non-endemic regions, analysis was complicated by poor follow-up rates, but efficacy of AL also appeared to be excellent in the per protocol population.36 In addition, gametocyte carriage decreased markedly from baseline after AL administration, which suggested that use of AL can contribute to reducing malaria transmission.