Journal
AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE
Volume 85, Issue 5, Pages 793-804Publisher
AMER SOC TROP MED & HYGIENE
DOI: 10.4269/ajtmh.2011.11-0069
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Funding
- Novartis Pharma AG (Basel, Switzerland)
- Novartis
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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.
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