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

Trop Med Int Health. 2007 Feb;12(2):251-9. doi: 10.1111/j.1365-3156.2006.01786.x.

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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anemia / complications
  • Anemia / epidemiology
  • Antimalarials / adverse effects
  • Antimalarials / therapeutic use*
  • Artemisinins / adverse effects
  • Artemisinins / therapeutic use*
  • Artesunate
  • Cambodia / epidemiology
  • Child
  • Child, Preschool
  • Drug Therapy, Combination
  • Female
  • Genome, Protozoan
  • Humans
  • Infant
  • Malaria, Falciparum / drug therapy*
  • Malaria, Falciparum / epidemiology
  • Malaria, Falciparum / parasitology
  • Malaria, Vivax / drug therapy
  • Malaria, Vivax / epidemiology
  • Malaria, Vivax / parasitology
  • Male
  • Mefloquine / therapeutic use
  • Middle Aged
  • Quinolines / adverse effects
  • Quinolines / therapeutic use*
  • Recurrence
  • Sesquiterpenes / adverse effects
  • Sesquiterpenes / therapeutic use*
  • Treatment Outcome

Substances

  • Antimalarials
  • Artemisinins
  • Quinolines
  • Sesquiterpenes
  • Artesunate
  • dihydroartemisinin
  • piperaquine
  • Mefloquine