Abstract
The new oral fixed combination artemether-lumefantrine (CGP 56697) has proved to be an effective and well-tolerated treatment of multi-drug resistant Plasmodium falciparum malaria, although cure rates using the four-dose regimen have been lower than with the currently recommended alternative of artesunate-mefloquine. Two six-dose schedules (total adult dose = 480 mg of artemether and 2,880 mg of lumefantrine) were therefore compared with the previously used four-dose regimen (320 mg of artemether and 1,920 mg of lumefantrine) in a double-blind trial involving 359 patients with uncomplicated multidrug-resistant falciparum malaria. There were no differences between the three treatment groups in parasite and fever clearance times, and reported adverse effects. The two six-dose regimens gave adjusted 28-day cure rates of 96.9% and 99.12%, respectively, compared with 83.3% for the four-dose regimen (P < 0.001). These six-dose regimens of artemether-lumefantrine provide a highly effective and very well-tolerated treatment for multidrug-resistant falciparum malaria.
Publication types
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Clinical Trial
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Clinical Trial, Phase III
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Comparative Study
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Multicenter Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Adolescent
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Adult
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Aged
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Animals
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Antimalarials / administration & dosage
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Antimalarials / adverse effects
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Antimalarials / standards
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Antimalarials / therapeutic use*
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Artemether, Lumefantrine Drug Combination
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Artemisinins*
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Child
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Child, Preschool
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DNA, Protozoan / blood
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Dose-Response Relationship, Drug
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Double-Blind Method
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Drug Combinations
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Drug Resistance, Multiple
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Ethanolamines
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Female
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Fluorenes / administration & dosage
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Fluorenes / adverse effects
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Fluorenes / standards
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Fluorenes / therapeutic use*
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Humans
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Malaria, Falciparum / drug therapy*
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Male
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Middle Aged
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Plasmodium falciparum / drug effects*
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Recurrence
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Sesquiterpenes / administration & dosage
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Sesquiterpenes / adverse effects
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Sesquiterpenes / standards
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Sesquiterpenes / therapeutic use*
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Thailand
Substances
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Antimalarials
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Artemether, Lumefantrine Drug Combination
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Artemisinins
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DNA, Protozoan
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Drug Combinations
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Ethanolamines
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Fluorenes
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Sesquiterpenes