title: Efficacy and tolerability of a new formulation of artesunate-mefloquine for the treatment of uncomplicated malaria in adult in Senegal: open randomized trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Artesunate-mefloquine (25 mg/Kg mefloquine) is efficacious and well-tolerated for the treatment of uncomplicated P. falciparum malaria in adult patients.
authors.affiliation: Department of Parasitology, Faculty of Medicine, University Cheikh Anta DIOP, Dakar, Senegal. roger.tine@ucad.edu.sn
authors.forename: Roger C K
authors.initials: RC
authors.lastname: Tine
authors.forename: Babacar
authors.initials: B
authors.lastname: Faye
authors.forename: Khadime
authors.initials: K
authors.lastname: Sylla
authors.forename: Jean L
authors.initials: JL
authors.lastname: Ndiaye
authors.forename: Magatte
authors.initials: M
authors.lastname: Ndiaye
authors.forename: Doudou
authors.initials: D
authors.lastname: Sow
authors.forename: Aminata C
authors.initials: AC
authors.lastname: Lo
authors.forename: Annie
authors.initials: A
authors.lastname: Abiola
authors.forename: Mamadou C
authors.initials: MC
authors.lastname: Ba
authors.forename: Oumar
authors.initials: O
authors.lastname: Gaye
mesh_terms: D000293:Adolescent; D000328:Adult; D000953:Antigens, Protozoan / Q000235:genetics; D000962:Antimalarials / Q000008:administration & dosage* / Q000009:adverse effects; D037621:Artemisinins / Q000008:administration & dosage* / Q000009:adverse effects; D000077332:Artesunate; D001483:Base Sequence; D002626:Chemistry, Pharmaceutical; D016054:DNA, Protozoan / Q000235:genetics; D004338:Drug Combinations; D005260:Female; D017125:Genes, Protozoan; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy* / Q000469:parasitology; D008297:Male; D015767:Mefloquine / Q000008:administration & dosage* / Q000009:adverse effects; D020066:Merozoite Surface Protein 1 / Q000235:genetics; D059208:Parasite Load; D010963:Plasmodium falciparum / Q000187:drug effects / Q000235:genetics; D016133:Polymerase Chain Reaction; D015800:Protozoan Proteins / Q000235:genetics; D012675:Senegal; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000953:Antigens, Protozoan; D000962:Antimalarials; D037621:Artemisinins; D016054:DNA, Protozoan; D004338:Drug Combinations; D020066:Merozoite Surface Protein 1; D015800:Protozoan Proteins; C065974:merozoite surface protein 2, Plasmodium; D000077332:Artesunate; D015767:Mefloquine