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. 2007 Nov 15:6:150.
doi: 10.1186/1475-2875-6-150.

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

Philippe Brasseur  1 , Patrice Agnamey, Oumar Gaye, Michel Vaillant, Walter R J Taylor, Piero L Olliaro
Affiliations

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

Philippe Brasseur et al. Malar J. .

Abstract

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

Methods and findings: 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).

Conclusion: 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.

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Figures

Figure 1
Figure 1
Age structure of the malaria cases treated by year of enrolment and mean over 2000–05.
Figure 2
Figure 2
Mean (95% CI) doses of AS and AQ taken by patients treated with the weight based loose and aged based co-blistered drug regimens as a function of age. a = AS-Loose, b = AS-Blister, c = AQ-Loose, d = AQ-Blister.
Figure 3
Figure 3
Kaplan-Meier of one minus survival curves to show cumulative parasitological failure rates overall (2000–05) and by year of treatment (all ages combined).
Figure 4
Figure 4
Boxplots of laboratory parameters over time. (ALT = aspartate transaminase; ALT = alanine transaminase).
See this image and copyright information in PMC

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