Efficacy and safety of artesunate plus amodiaquine in routine use for the treatment of uncomplicated malaria in Casamance, southern Sénégal

• Published in: Malaria journal Vol. 6; no. 1; p. 150
• Main Authors: Brasseur, Philippe, Agnamey, Patrice, Gaye, Oumar, Vaillant, Michel, Taylor, Walter R J, Olliaro, Piero L
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 15.11.2007; BioMed Central; BMC
• Subjects: Amodiaquine - administration & dosage; Amodiaquine - adverse effects; Amodiaquine - pharmacology; Amodiaquine - therapeutic use; Animals; Antimalarials - administration & dosage; Antimalarials - adverse effects; Antimalarials - pharmacology; Antimalarials - therapeutic use; Artemisinins - therapeutic use; Drug Combinations; Humans; Malaria, Falciparum - drug therapy; Malaria, Falciparum - epidemiology; Malaria, Falciparum - parasitology; Outpatients; Plasmodium falciparum - drug effects; Plasmodium falciparum - genetics; Plasmodium falciparum - growth & development; Safety; Senegal - epidemiology; Sesquiterpenes - therapeutic use; Treatment Outcome; Senegal
• ISSN: 1475-2875; 1475-2875
• DOI: 10.1186/1475-2875-6-150

There are no data on the long term use of an artemisinin combination treatment in moderate or high transmission areas of Africa. 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). 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.