Free Content A randomized open study to assess the efficacy and tolerability of dihydroartemisinin–piperaquine for the treatment of uncomplicated falciparum malaria in Cambodia

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Abstract:

Summary Objectives  To compare the efficacy and tolerability of dihydroartemisinin–piperaquine (DHA–PQP) with that of a 3-day regimen of mefloquine and artesunate (MAS3) for the treatment of uncomplicated falciparum malaria in Cambodia. Method  Randomized open-label non-inferiority study over 64 days. Results  Four hundred and sixty-four patients were included in the study. The polymerase chain reaction genotyping-adjusted cure rates on day 63 were 97.5% (95% confidence interval, CI, 93.8–99.3) for DHA–PQP and 97.5% (95% CI, 93.8–99.3) for MAS3,  = 1. There were no serious adverse events, but significantly more episodes of vomiting ( = 0.03), dizziness ( = 0.002), palpitations ( = 0.04), and sleep disorders ( = 0.03) reported in the MAS3 treatment group, consistent with the side-effect profile of mefloquine. Conclusions  DHA–PQP was as efficacious as MAS3, but much better tolerated, making it more appropriate for use in a routine programme setting. This highly efficacious, safe and more affordable fixed-dose combination could become the treatment of choice for malaria in Cambodia.

French
Objectifs 

Comparer l'efficacité et la tolérance du dihydroartémisinine-pipéraquine (DHA–PQP) à celles d'un régime à base de méfloquine de trois jours (MAS3) pour le traitement de la malaria falciparum non compliquée au Cambodge. Methode 

Etude Randomisée ouverte de non infériorité sur 64 jours. Resultats 

464 patients ont été inclus dans l’étude. Les taux guérison au jour 63 ajustés par les résultats du génotypage par la réaction en chaîne de la polymérase étaient de 97,5% (IC95%: 93.8–99.3) pour le DHA–PQP et de 97,5% (IC95%: 93,8–99,3) pour le MAS3, P = 1. Il n'y avait aucun effet adverse sérieux, mais de façon significative, des épisodes de vomissement (P = 0,03), des vertiges (P = 0,002), des palpitations (P = 0,04), et des troubles de sommeil (P = 0.03) ont été rapportés dans le groupe du traitement au MAS3, ce qui était consistant avec les profiles d'effets secondaires du méfloquine. Conclusion 

le DHA–PQP était aussi efficace que le MAS3, mais bien mieux toléré, le rendant ainsi plus approprié pour l'usage en routine dans le cadre d'un programme. Cette combinaison à dose fixe de grande efficacité, sûre et plus accessible pourrait devenir le traitement de choix pour la malaria àPlasmodium falciparum au Cambodge.

Keywords: dihidroartemisinina-piperaquina; dihydroartemisinin–piperaquine; dihydroartémisinine-pipéraquine; efficacité; efficacy; eficacia; falciparum malaria; malaria falciparum; malaria por falciparum; tolerabilidad; tolerability; tolérance

Document Type: Research Article

DOI: http://dx.doi.org/10.1111/j.1365-3156.2006.01786.x

Affiliations: 1:  Médecins Sans Frontières, Phnom Penh, Cambodia 2:  Médecins Sans Frontières, Operational Centre Brussels, Brussels, Belgium 3:  National Center for Parasitology, Entomology and Malaria Control, Ministry of Health, Phnom Penh, Cambodia 4:  Shoklo Malaria Research Unit, Mae Sot, Thailand

Publication date: February 1, 2007

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