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Estudio abierto y aleatorizado para evaluar la eficacia y la tolerabilidad de la dihidroartemisinina‐piperaquina para el tratamiento de la malaria no complicada por falciparum en Cambodia
Author(s) -
Janssens B.,
Van Herp M.,
Goubert L.,
Chan S.,
Uong S.,
g S.,
Socheat D.,
Brockman A.,
Ashley E. A.,
Van Damme W.
Publication year - 2007
Publication title -
tropical medicine and international health
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.056
H-Index - 114
eISSN - 1365-3156
pISSN - 1360-2276
DOI - 10.1111/j.1365-3156.2006.01786.x
Subject(s) - medicine , tolerability , malaria , mefloquine , artesunate , adverse effect , regimen , artemisinin , plasmodium falciparum , surgery , immunology
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, P = 1. There were no serious adverse events, but significantly more episodes of vomiting ( P = 0.03), dizziness ( P = 0.002), palpitations ( P = 0.04), and sleep disorders ( P = 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 Plasmodium falciparum malaria in Cambodia.