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Randomized Controlled Trial
. 2006 Aug 21:5:73.
doi: 10.1186/1475-2875-5-73.

Safety and efficacy of lumefantrine-artemether (Coartem) for the treatment of uncomplicated Plasmodium falciparum malaria in Zambian adults

Modest Mulenga  1 , Jean-Pierre VangGeertruyden, Lawrence Mwananyanda, Victor Chalwe, Filip Moerman, Roma Chilengi, Chantal Van Overmeir, Jean-Claude Dujardin, Umberto D'Alessandro
Affiliations
Randomized Controlled Trial

Safety and efficacy of lumefantrine-artemether (Coartem) for the treatment of uncomplicated Plasmodium falciparum malaria in Zambian adults

Modest Mulenga et al. Malar J. .

Abstract

Background: In Zambia, unacceptably high resistance to commonly used antimalarial drugs prompted the choice of artemether-lumefantrine (AL) as first line treatment for uncomplicated Plasmodium falciparum malaria. Although the safety and efficacy of AL have been extensively documented, no clinical trials had been carried out in Zambia.

Methods: Nine hundred seventy one adult patients with uncomplicated malaria were randomized to either sulfadoxine-pyrimethamine (SP)(486) or AL (485) and followed up for 45 days. Outcome of treatment was defined according to the standard WHO classification. Recurrent parasitaemia were genotyped to distinguish between recrudescence and new infection.

Results: Fever at day 3 was significantly lower (AL: 0.9%; 4/455; SP: 3,5%; 15/433; p = 0.007) and the mean haemoglobin at day 45 significantly higher (AL: 134 g/l; SP 130 g/l; p = 0.02) in the AL group. Almost all clinical symptoms cleared faster with AL. Early treatment failure was significantly higher in the SP (25/464) than in the AL (2/463) (OR: 13.1 95% CI: 3.08-55.50; P < 0.001). The rate of new infections was similar in both groups (18 with SP and 19 with AL). Late clinical failure (OR: 2.55; 95% CI: 1.34-4.84; P = 0.004) and late parasitological failure (OR:3.18; 95% CI: 1.25-8.09; P = 0.02) were significantly higher in the SP group. Total treatment failure was significantly higher in the SP group (96/393; 19.3%) as compared to the AL (22/403; 5.4%) group (OR: 4.15; 95% CI: 2.52-6.83; P < 0.001).

Conclusion: In Zambia, the new first line regimen AL is far more efficacious than SP in treating uncomplicated P. falciparum malaria in adults. Data on safety and efficacy of AL in pregnant women are urgently needed.

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Figures

Figure 1
Figure 1
Trial profile. Legend: † 2 ETF in HIV-1 were serious adverse events. †† Patients facing an event (excluded, lost to follow up or new infection) were censored at the time of the last recorded visit and included in the survival analysis.
Figure 2
Figure 2
The cumulative risk of recrudescence in adults with non-complicated malaria (N = 971). All patients were censored at their last visit. A dotted line represents sulfadoxine-Pyrimethamine and a solid line Artemether-Lumefantrine (Zambia 2005).
See this image and copyright information in PMC

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