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Randomized, controlled dose-optimization studies of dihydroartemisinin-piperaquine for the treatment of uncomplicated multidrug-resistant falciparum malaria in Thailand

Ashley, E. A., Krudsood, S., Phaiphun, L., Srivilairit, S., McGready, R., Leowattana, W., Hutagalung, R., Wilairatana, P., Brockman, Alan, Looareesuwan, S., Nosten, F. O. and White, Nicholas J. (2004). Randomized, controlled dose-optimization studies of dihydroartemisinin-piperaquine for the treatment of uncomplicated multidrug-resistant falciparum malaria in Thailand. Journal of Infectious Diseases,190(10):1773-1782.

Document type: Journal Article
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Title Randomized, controlled dose-optimization studies of dihydroartemisinin-piperaquine for the treatment of uncomplicated multidrug-resistant falciparum malaria in Thailand
Author Ashley, E. A.
Krudsood, S.
Phaiphun, L.
Srivilairit, S.
McGready, R.
Leowattana, W.
Hutagalung, R.
Wilairatana, P.
Brockman, Alan
Looareesuwan, S.
Nosten, F. O.
White, Nicholas J.
Journal Name Journal of Infectious Diseases
Publication Date 2004
Volume Number 190
Issue Number 10
ISSN 0022-1899   (check CDU catalogue open catalogue search in new window)
Start Page 1773
End Page 1782
Place of Publication Chicago
Publisher University of Chicago Press
HERDC Category C1 - Journal Article (DEST)
Abstract Background. Dihydroartemisinin-piperaquine (DP) is a new and relatively inexpensive artemisinin-containing fixed-combination antimalarial treatment. An adult treatment course contained 6.4 mg/kg dihydroartemisinin (DHA), which is >40% lower than the level in most artemisinin-containing combinations. This raised the possibility that the efficacy of the current coformulation may not be optimal in the treatment of multidrug-resistant falciparum malaria. Methods. In 2 large randomized, controlled studies in Thailand, the recommended dose of DP was compared with a regimen with additional artemisinin derivative ( 12 mg/kg; DP+) and with mefloquine plus artesunate (MAS3). Results. A total of 731 patients were included: 201 in a hospital-based study and 530 in a community study. Day-28 cure rates in the hospital-based study were 100% (95% confidence interval [CI], 93.9%-100%) in the MAS3 and DP+ groups and 98.3% (95% CI, 91%-99.7%) in the DP group, with a single recrudescence on day 21. In the community study, polymerase chain reaction genotyping-adjusted cure rates on day 63 were 96.1% ( 95% CI, 92.6%-99.7%) in the DP group, 98.3% ( 95% CI, 96.1%-100%) in the DP+ group, and 94.9% (95% CI, 91.2%-98.6%) in the MAS3 group (P = .2). Adverse events were few, with an excess of mild abdominal pain in the DP group. Conclusions. The current dosage of DP ( 6.4 mg/kg DHA and 51.2 mg/kg piperaquine phosphate) given over the course of 48 h is highly effective, safe, and well tolerated for the treatment of multidrug-resistant falciparum malaria, and its efficacy is not improved by the addition of more DHA.
Keywords bioavailability
bisquinolines
artesunate
volunteers
 
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