title: Efficacy and safety of artesunate plus amodiaquine in routine use for the treatment of uncomplicated malaria in Casamance, southern Sénégal.
abstract: BACKGROUND
  There are no data on the long term use of an artemisinin combination treatment in moderate or high transmission areas of Africa.
  
  
  RESULTS
  Artesunate plus amodiaquine (AS+AQ) was used to treat slide-proven Plasmodium falciparum-infected patients of all ages in the Oussouye district, Casamance, Senegal, over a period of six years (2000 to 2005). Efficacy, by Kaplan Meier survival analysis (n = 966), and safety (adverse event rates, n = 752) were determined over 28 days. A weight-based dosing regimen was used for the loose tablets during 2000-2003 (n = 731) and a commercially available co-blister was used during 2004-2005 (n = 235). Annual crude (non PCR corrected) rates remained stable over the study period [range 88.5-96.7%; overall 94.6 (95% CI 92.9-95.9)]. Nine co-blister treated patients (0.9%) withdrew because of drug-related adverse events; seven had gastrointestinal complaints of whom two were hospitalized for vomiting. By Day 28, the mean total bilirubin (n = 72), AST (n = 94) and ALT (n = 95) values decreased. Three patients had Day 28 AST/ALT values > 40 < 200 IU/L. Changes in white cell counts were unremarkable (n = 87).
  
  
  CONCLUSIONS
  AS+AQ in combination was highly efficacious and well-tolerated in this area and justifies the decision to use it as first line treatment. Long-term monitoring of safety and efficacy should continue.
authors.affiliation: UR 077, IRD, Dakar, Sénégal. brasseur@ird.sn
authors.forename: Philippe
authors.initials: P
authors.lastname: Brasseur
authors.forename: Patrice
authors.initials: P
authors.lastname: Agnamey
authors.forename: Oumar
authors.initials: O
authors.lastname: Gaye
authors.forename: Michel
authors.initials: M
authors.lastname: Vaillant
authors.forename: Walter R J
authors.initials: WR
authors.lastname: Taylor
authors.forename: Piero L
authors.initials: PL
authors.lastname: Olliaro
mesh_terms: D000655:Amodiaquine / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D000818:Animals; D000962:Antimalarials / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D037621:Artemisinins / Q000627:therapeutic use*; D000077332:Artesunate; D004338:Drug Combinations; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy* / Q000453:epidemiology / Q000469:parasitology; D010045:Outpatients; D010963:Plasmodium falciparum / Q000187:drug effects / Q000235:genetics / Q000254:growth & development; D012449:Safety; D012675:Senegal / Q000453:epidemiology; D012717:Sesquiterpenes / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000962:Antimalarials; D037621:Artemisinins; D004338:Drug Combinations; D012717:Sesquiterpenes; D000655:Amodiaquine; D000077332:Artesunate