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

Brasseur P, Agnamey P, Gaye O, Vaillant M, Taylor WR, Olliaro PL - Malar. J. (2007)

Bottom Line: Efficacy, by Kaplan Meier survival analysis (n = 966), and safety (adverse event rates, n = 752) were determined over 28 days.By Day 28, the mean total bilirubin (n = 72), AST (n = 94) and ALT (n = 95) values decreased.Long-term monitoring of safety and efficacy should continue.

View Article: PubMed Central - HTML - PubMed

Affiliation: UR 077, IRD, Dakar, Sénégal. brasseur@ird.sn

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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Related in: MedlinePlus

Boxplots of laboratory parameters over time. (ALT = aspartate transaminase; ALT = alanine transaminase).
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Figure 4: Boxplots of laboratory parameters over time. (ALT = aspartate transaminase; ALT = alanine transaminase).

Mentions: There were no significant changes in mean values between Day 0 and Day 28 for the haematocrit (mean diff. 0.31 ± 6.10%, p = 0.51) and total WBC (mean diff. -395 ± 2940, p = 0.21) but there were significant decrease from Day 0 to Day 7 (2.52 ± 5.56%, p < 0.0001) and increase from Day 7 to Day 28 (-1.91 ± 4.70%, p < 0.0001) for haematocrit. The mean AST, ALT and bilirubin decreased significantly while there was a small (0.16 mg/dL) but statistically significant increase in the mean creatinine values between Day 0 and Day 28 (Figure 4).


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

Brasseur P, Agnamey P, Gaye O, Vaillant M, Taylor WR, Olliaro PL - Malar. J. (2007)

Boxplots of laboratory parameters over time. (ALT = aspartate transaminase; ALT = alanine transaminase).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2211754&req=5

Figure 4: Boxplots of laboratory parameters over time. (ALT = aspartate transaminase; ALT = alanine transaminase).
Mentions: There were no significant changes in mean values between Day 0 and Day 28 for the haematocrit (mean diff. 0.31 ± 6.10%, p = 0.51) and total WBC (mean diff. -395 ± 2940, p = 0.21) but there were significant decrease from Day 0 to Day 7 (2.52 ± 5.56%, p < 0.0001) and increase from Day 7 to Day 28 (-1.91 ± 4.70%, p < 0.0001) for haematocrit. The mean AST, ALT and bilirubin decreased significantly while there was a small (0.16 mg/dL) but statistically significant increase in the mean creatinine values between Day 0 and Day 28 (Figure 4).

Bottom Line: Efficacy, by Kaplan Meier survival analysis (n = 966), and safety (adverse event rates, n = 752) were determined over 28 days.By Day 28, the mean total bilirubin (n = 72), AST (n = 94) and ALT (n = 95) values decreased.Long-term monitoring of safety and efficacy should continue.

View Article: PubMed Central - HTML - PubMed

Affiliation: UR 077, IRD, Dakar, Sénégal. brasseur@ird.sn

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.

Show MeSH
Related in: MedlinePlus