Treatment of Acute Uncomplicated Falciparum Malaria with Artemether-Lumefantrine in Non-immune Populations: A Safety, Efficacy, and Pharmacokinetic Study

Abstract

The efficacy and safety of artemether-lumefantrine for the treatment of malaria in nonimmune populations are not well defined. In this study, 165 nonimmune patients from Europe and non-malarious areas of Colombia with acute, uncomplicated falciparum malaria or mixed infection including P. falciparum were treated with the six-dose regimen of artemether-lumefantrine. The parasitologic cure rate at 28 days was 96.0% for the per protocol population (119/124 patients). Median times to parasite clearance and fever clearance were 41.5 and 36.8 hours, respectively. No patient had gametocytes after Day 7. Treatment was well tolerated; most adverse events were mild to moderate and seemed to be related to malaria. There were few serious adverse events, none of which were considered to be drug-related. No significant effects on ECG or laboratory parameters were observed. In conclusion, the six-dose regimen of artemether-lumefantrine was effective and well tolerated in the treatment of acute uncomplicated falciparum malaria in nonimmune patients.

Efficacy of six-dose regimen of artemether-lumefantrine for the treatment of uncomplicatedfalciparummalaria, three years after its introduction into Ethiopia

“…In addition to its rapid parasitological and malaria symptoms clearance, AL showed high gametocyte reduction during the follow-up. This observation supports the implication that artemisinin-based combination therapy could have additional benefit to the community by reducing falciparum malaria transmission if the drug is widely deployed in endemic areas (Targett et al, 2001;Guthmann et al, 2006;Van den Broek et al, 2006;Mulenga et al, 2006;Hatz et al, 2008). Compared to baseline data, a significant increase in the mean of haemoglobin level was observed on day 28 post-treatment, which also indicates the added benefit of treating patients with this combination therapy as anemia could be aggravated by resistant parasite (Guthmann et al, 2006;Van den Broek et al, 2006;Mulenga et al, 2006).…”

Artemether-Lumefantrine Compared to Atovaquone-Proguanil as a Treatment for Uncomplicated Plasmodium falciparum Malaria in Travelers

“…13,15 Our study also showed that the fever clearance time was 44 ± 22.7 hours in patients treated with AL. Although somewhat longer than that reported in previous AL studies, 16,18 it was shorter by 33 hours (a 57% reduction) than the fever clearance time on AP, which was 77 ± 28.0 hours (similar to that seen in other AP studies). 7,8 This difference in favor of AL was statistically highly significant.…”

“…Previous non-comparative studies in non-immune population had suggested that AL has a parasite clearance time around 32-41.5 hours and fever clearance time around 24-36.8 hours. 16,18 This appears to be much shorter than for AP, which had a parasite clearance time around 63-79.2 hours and fever clearance time around 60.3-88.8 hours. 7,8 On the other hand, in a recent study describing the experience with different regimens for uncomplicated malaria in multiple European hospitals, AP and AL were found to have similar fever and parasite clearance time (48 and 72 hours, respectively).…”

“…[13][14][15] A recent study evaluated the tolerability and efficacy of a standard 6 doses course of AL in non-immune patients and found a 96% cure rate. 16 The relative efficacy of AP and AL has not been evaluated in head-to-head clinical trials. The aim of this study was to compare, for the first time, the treatment outcome of uncomplicated malaria in non-immune travelers, treated with either AP or AL.…”

Haga usted el diagnóstico. Segunda parte

“…Estos medicamentos son absorbidos rápidamente por el organismo, produciendo una disminución acelerada de la parasitemia, con una consecuente resolución de los síntomas (18). Se ha demostrado efectividad y buena tolerancia del tratamiento con arteméter-lumefantrina para malaria por P. falciparum y aún no hay evidencia de resistencia o falla terapéutica a este esquema en Colombia (19).…”