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


METHODS
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.
Janssens
B
B
Médecins Sans Frontières, Phnom Penh, Cambodia. b.janssens@bigfoot.com
van Herp
M
M
Goubert
L
L
Chan
S
S
Uong
S
S
Nong
S
S
Socheat
D
D
Brockman
A
A
Ashley
E A
EA
Van Damme
W
W
D000293:Adolescent; D000328:Adult; D000368:Aged; D000740:Anemia / Q000150:complications / Q000453:epidemiology; D000962:Antimalarials / Q000009:adverse effects / Q000627:therapeutic use*; D037621:Artemisinins / Q000009:adverse effects / Q000627:therapeutic use*; D000077332:Artesunate; D002160:Cambodia / Q000453:epidemiology; D002648:Child; D002675:Child, Preschool; D004359:Drug Therapy, Combination; D005260:Female; D018503:Genome, Protozoan; D006801:Humans; D007223:Infant; D016778:Malaria, Falciparum / Q000188:drug therapy* / Q000453:epidemiology / Q000469:parasitology; D016780:Malaria, Vivax / Q000188:drug therapy / Q000453:epidemiology / Q000469:parasitology; D008297:Male; D015767:Mefloquine / Q000627:therapeutic use; D008875:Middle Aged; D011804:Quinolines / Q000009:adverse effects / Q000627:therapeutic use*; D012008:Recurrence; D012717:Sesquiterpenes / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D010879:Piperazines
D000962:Antimalarials; D037621:Artemisinins; D000077332:Artesunate; D015767:Mefloquine; D011804:Quinolines; D012717:Sesquiterpenes; C039060:artenimol; C034759:piperaquine; D010879:Piperazines