Efficacy and tolerability of a new formulation of artesunate-mefloquine for the treatment of uncomplicated malaria in adult in Senegal: open randomized trialReportar como inadecuado




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Malaria Journal

, 11:416

First Online: 12 December 2012Received: 06 July 2012Accepted: 21 November 2012

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.

Electronic supplementary materialThe online version of this article doi:10.1186-1475-2875-11-416 contains supplementary material, which is available to authorized users.

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Autor: Roger CK Tine - Babacar Faye - Khadime Sylla - Jean L Ndiaye - Magatte Ndiaye - Doudou Sow - Aminata C Lo - Annie Abiol

Fuente: https://link.springer.com/







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