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

B Janssens; M Van Herp; L Goubert; S Chan; S Uong; D Socheat; A Brockman; EA Ashley; W Van Damme

doi:10.1111/j.1365-3156.2006.01786.x

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

B Janssens, M Van Herp, L Goubert, S Chan, S Uong, D Socheat, A Brockman, EA Ashley, W Van Damme

Research output: Contribution to journal › A1: Web of Science-article › peer-review

Abstract

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.

Original language	English
Journal	Tropical Medicine and International Health
Volume	12
Issue number	2
Pages (from-to)	251-259
ISSN	1360-2276
DOIs	https://doi.org/10.1111/j.1365-3156.2006.01786.x
Publication status	Published - 2007

Keywords

B780-tropical-medicine
Protozoal diseases
Malaria
Plasmodium falciparum
Drug therapy
Antimalarials
Dihydroartemisinin-piperaquine
Efficacy
Tolerability
Evaluation
Cambodia
Asia-Southeast

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10.1111/j.1365-3156.2006.01786.x

http://lib.itg.be/pdf/itg/2007/2007tmih0251.pdf

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Janssens, B., Van Herp, M., Goubert, L., Chan, S., Uong, S., Socheat, D., Brockman, A., Ashley, EA., & Van Damme, W. (2007). A randomized open study to assess the efficacy and tolerability of dihydroartemisinin-piperaquine for the treatment of uncomplicated falciparum malaria in Cambodia. Tropical Medicine and International Health, 12(2), 251-259. https://doi.org/10.1111/j.1365-3156.2006.01786.x

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title = "A randomized open study to assess the efficacy and tolerability of dihydroartemisinin-piperaquine for the treatment of uncomplicated falciparum malaria in Cambodia",

abstract = "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.",

keywords = "B780-tropical-medicine, Protozoal diseases, Malaria, Plasmodium falciparum, Drug therapy, Antimalarials, Dihydroartemisinin-piperaquine, Efficacy, Tolerability, Evaluation, Cambodia, Asia-Southeast",

author = "B Janssens and {Van Herp}, M and L Goubert and S Chan and S Uong and D Socheat and A Brockman and EA Ashley and {Van Damme}, W",

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Janssens, B, Van Herp, M, Goubert, L, Chan, S, Uong, S, Socheat, D, Brockman, A, Ashley, EA & Van Damme, W 2007, 'A randomized open study to assess the efficacy and tolerability of dihydroartemisinin-piperaquine for the treatment of uncomplicated falciparum malaria in Cambodia', Tropical Medicine and International Health, vol. 12, no. 2, pp. 251-259. https://doi.org/10.1111/j.1365-3156.2006.01786.x

A randomized open study to assess the efficacy and tolerability of dihydroartemisinin-piperaquine for the treatment of uncomplicated falciparum malaria in Cambodia. / Janssens, B; Van Herp, M; Goubert, L et al.
In: Tropical Medicine and International Health, Vol. 12, No. 2, 2007, p. 251-259.

Research output: Contribution to journal › A1: Web of Science-article › peer-review

TY - JOUR

T1 - A randomized open study to assess the efficacy and tolerability of dihydroartemisinin-piperaquine for the treatment of uncomplicated falciparum malaria in Cambodia

AU - Janssens, B

AU - Van Herp, M

AU - Goubert, L

AU - Chan, S

AU - Uong, S

AU - Socheat, D

AU - Brockman, A

AU - Ashley, EA

AU - Van Damme, W

N1 - FTX abonnement

PY - 2007

Y1 - 2007

N2 - 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.

AB - 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.

KW - B780-tropical-medicine

KW - Protozoal diseases

KW - Malaria

KW - Plasmodium falciparum

KW - Drug therapy

KW - Antimalarials

KW - Dihydroartemisinin-piperaquine

KW - Efficacy

KW - Tolerability

KW - Evaluation

KW - Cambodia

KW - Asia-Southeast

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U2 - 10.1111/j.1365-3156.2006.01786.x

DO - 10.1111/j.1365-3156.2006.01786.x

M3 - A1: Web of Science-article

SN - 1360-2276

VL - 12

SP - 251

EP - 259

JO - Tropical Medicine and International Health

JF - Tropical Medicine and International Health

IS - 2

ER -

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

Abstract

Keywords

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