The online version of this article (doi:10.1186/1475-2875-11-416) contains supplementary material, which is available to authorized users.
The authors declare that they have no competing interests.
RCT, BF, KS, JLN, OG conceived and designed the study. RCT, and KS monitored the data collection. RCT analysed the data. MN, ACL, AA were responsible for the PCR analysis. RCT wrote the first draft of the manuscript. All authors read and approved the final manuscript.
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 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.
Overall, 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.
Artesunate-mefloquine (25 mg/Kg mefloquine) is efficacious and well-tolerated for the treatment of uncomplicated P. falciparum malaria in adult patients.
WHO: World Malaria Report. 2011, Geneva: World Health Organization
WHO: Guidelines for the treatment of malaria. 2010, Geneva:WHO Press, Second,
WHO: Guidelines for the treatment of malaria. 2006, Geneva: World HealthOrganization,
WHO: Antimalarial drug combination therapy: Report of a WHO Technical Consultation. 2001, Geneva: WHO Press
Ashley EA, Lwin KM, McGready R, Simon WH, Phaiphun L, Proux S, Wangseang N, Taylor W, Stepniewska K, Nawamaneerat W, Thwai KL, Barends M, Leowattana W, Olliaro P, Singhasivanon P, White NJ, Nosten F: An open label randomized comparison of mefloquine-artesunate as separate tablets vs. a new co-formulated combination for the treatment of uncomplicated multidrug-resistant falciparum malaria in Thailand. Trop Med Int Health. 2006, 11: 1653-1660. 10.1111/j.1365-3156.2006.01724.x. CrossRefPubMed
Faye BNJ, Dieng Y, Faye O, Gaye O: Efficacy and tolerability of four antimalarial combinations in the treatment of uncomplicated Plasmodium falciparum malaria in Senegal. Malar J. 2006, 6: 80- CrossRef
Sagara I, Diallo A, Kone M, Coulibaly M, Diawara SI, Guindo O, Maiga H, Niambele MB, Sissoko M, Dicko A, Djimde A, Doumbo OK: A randomized trial of artesunate-mefloquine versus artemether-lumefantrine for treatment of uncomplicated Plasmodium falciparum malaria in Mali. Am J Trop Med Hyg. 2008, 79: 655-661. PubMed
Faye B, Ndiaye JL, Tine R, Sylla K, Gueye A, Lo AC, Gaye O: A randomized trial of artesunate mefloquine versus artemether lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Senegalese children. Am J Trop Med Hyg. 2010, 82: 140-144. 10.4269/ajtmh.2010.09-0265. PubMedCentralCrossRefPubMed
WHO: Assessment and monitoring of antimalarial drug efficacy for the treatment of uncomplicated falciparum malaria. Geneva: World HealthOrganization, WHO/HTM/RBM/2003.50,
WHO: Methods and techniques for clinical trials on antimalarial drug efficacy: genotyping to identify parasite populations: Informal consultation organized by the Medicines for Malaria Venture and cosponsored by the World Health Organization, 29–31 May 2007. 2008, Amsterdam, The Netherlands: WHO, http://whqlibdoc.who.int/publications/2008/9789241596305_eng.pdf%5D,
Toure OA, Kouame MG, Didier YJ, Berenger AA, Djerea K, Genevieve GO, Penali LK: Artesunate/mefloquine paediatric formulation vs. artemether/lumefantrine for the treatment of uncomplicated Plasmodium falciparum in Anonkoua koute, Côte d'Ivoire. Trop Med Int Health. 2011, 16: 290-297. 10.1111/j.1365-3156.2010.02701.x. CrossRefPubMed
Sowunmi A, Gbotosho GO, Happi C, Okuboyejo T, Folarin O, Balogun S, Michael O: Therapeutic efficacy and effects of artesunate-mefloquine and mefloquine alone on malaria-associated anemia in children with uncomplicated Plasmodium falciparum malaria in southwest Nigeria. Am J Trop Med Hyg. 2009, 81: 979-986. 10.4269/ajtmh.2009.09-0394. CrossRefPubMed
Ramharter M, Kurth FM, Belard S, Bouyou-Akotet MK, Mamfoumbi MM, Agnandji ST, Missinou MA, Adegnika AA, Issifou S, Cambon N, Heidecker JL, Kombila M, Kremsner PG: Pharmacokinetics of two paediatric artesunate mefloquine drug formulations in the treatment of uncomplicated falciparum malaria in Gabon. J Antimicrob Chemother. 2007, 60: 1091-1096. 10.1093/jac/dkm355. CrossRefPubMed
Ambler MT, Dubowitz LM, Arunjerdja R, Hla EP, Thwai KL, Viladpainguen J, Singhasivanon P, Luxemburger C, Nosten F, McGready R: The neurological assessment in young children treated with artesunate monotherapy or artesunate-mefloquine combination therapy for uncomplicated Plasmodium falciparum malaria. Malar J. 2009, 8: 207-10.1186/1475-2875-8-207. PubMedCentralCrossRefPubMed
WHO: Review of the central nervous system adverse effects related to the antimalarial drug, mefloquine. 1991, Geneva: World Health Organization
Nosten F, Van Vugt M: Neuropsychiatric adverse effects of mefloquine: what do we know and what should we do?. CNS Drugs. 1999, 11: 1-8. 10.2165/00023210-199911010-00001. CrossRef
- Efficacy and tolerability of a new formulation of artesunate-mefloquine for the treatment of uncomplicated malaria in adult in Senegal: open randomized trial
Roger CK Tine
Jean L Ndiaye
Aminata C Lo
Mamadou C Ba
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