Abstract
BackgroundPrompt treatment of malaria attacks with arteminisin-based combination therapy (ACT) is an essential tool for malaria control. A new co-blister tablet of artesunate-mefloquine (AM) with 25 mg/kg mefloquine has been developed for the management of uncomplicated malaria attacks. This non-inferiority randomized trial, was conducted to evaluate the efficacy and safety of the new formulation of AM in comparison to artemether-lumefantrine (AL) for the treatment of acute uncomplicated Plasmodium falciparum malaria in adults in Senegal.MethodsThe study was carried out from September to December 2010 in two health centres in Senegal. The study end points included (i) PCR corrected adequate clinical and parasitological response (ACPR) at day 28, (ii) ACPR at days 42 and 63, (iii) parasites and fever clearance time, (iv) incidence of adverse events and patients biological profile at day 7 using the WHO 2003 protocol for anti-malarial drug evaluation.ResultsOverall, 310 patients were randomized to receive either AM (n = 157) or AL (n = 153). PCR corrected ACPR at day 28 was at 95.5% in the AM arm while that in the AL arm was at 96.7% (p = 0.83). Therapeutic efficacy was at 98.5% in the AM arm versus 98.2% in the AL group at day 42 (p = 1). At day 63, ACPR in the AM and AL arms was at 98.2% and 97.7%, respectively (p = 0.32). The two treatments were well tolerated with similar biological profile at day 7. However, dizziness was more frequent in the AM arm.ConclusionArtesunate-mefloquine (25 mg/Kg mefloquine) is efficacious and well-tolerated for the treatment of uncomplicated P. falciparum malaria in adult patients.
Highlights
Prompt treatment of malaria attacks with arteminisin-based combination therapy (ACT) is an essential tool for malaria control
Studies in Asian countries showed that artesunatemefloquine (AM) is effective and safe for the treatment of uncomplicated malaria [7]
The dosage of 15 mg/kg mefloquine base is below the posology recommended by the World Health Organization (WHO) (25 mg/kg mefloquine), to avoid resistance to mefloquine
Summary
Prompt treatment of malaria attacks with arteminisin-based combination therapy (ACT) is an essential tool for malaria control. A new co-blister tablet of artesunate-mefloquine (AM) with 25 mg/kg mefloquine has been developed for the management of uncomplicated malaria attacks This non-inferiority randomized trial, was conducted to evaluate the efficacy and safety of the new formulation of AM in comparison to artemether-lumefantrine (AL) for the treatment of acute uncomplicated Plasmodium falciparum malaria in adults in Senegal. The paediatric co-formulation was safe and effective in children less than 5 years [10], studies aiming at evaluating the new co-blister in adults patients have become relevant in the context of scaling up anti-malarial drugs in African countries, in order to continue to monitor adverse drug reactions as well as drug efficacy. The aim of this study was to compare the clinical and parasitological efficacy, as well as the clinical safety, laboratory profile, of a new formulation of artesunate-mefloquine (AM) (25 mg/kg mefloquine base) compared to artemether-lumefantrine (AL) for the treatment of uncomplicated P. falciparum malaria in adults in Senegal
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