title: The efficacy and tolerability of artemisinin-piperaquine (Artequick®) versus artesunate-amodiaquine (Coarsucam™) for the treatment of uncomplicated Plasmodium falciparum malaria in south-central Vietnam.
abstract: BACKGROUND
  In Vietnam, the artemisinin-based combination therapy (ACT) of dihydroartemisinin-piperaquine is currently used for first-line treatment of uncomplicated Plasmodium falciparum malaria. However, limited efficacy and tolerability data are available on alternative forms of ACT in Vietnam in case there is a reduction in the susceptibility of dihydroartemisinin-piperaquine. A study was conducted to compare the efficacy and tolerability of two fixed-dose formulations of ACT, artemisinin-piperaquine (Artequick®, ARPQ) and artesunate-amodiaquine (Coarsucam™, ASAQ) for the treatment of P. falciparum malaria in south-central Vietnam.
  
  
  METHODS
  A randomized, open-label trial was conducted comparing the efficacy of a two-day regimen of ARPQ (~2.8 mg/kg artemisinin plus ~17.1 mg/kg of piperaquine per day) and a three-day regimen of ASAQ (~4.7 mg/kg of artesunate plus ~12.6 mg/kg of amodiaquine per day) for the treatment of children and adults with uncomplicated falciparum malaria. Primary efficacy endpoint was day 42, PCR-corrected, parasitological cure rate. Secondary endpoints were parasite and fever clearance times and tolerability.
  
  
  RESULTS
  Of 128 patients enrolled, 63 were administered ARPQ and 65 ASAQ. Of the patients who completed the 42 days follow-up period or had a recurrence of malaria, 55 were on ARPQ (30 children, 25 adults) and 59 were on ASAQ (31 children, 28 adults). Recrudescent parasitaemia was PCR-confirmed for one patient in each treatment group, with cure rates at day 42 of 98% (95% CI: 88-100) for both forms of ACT. The median parasite clearance time was significantly slower in the ARPQ group compared with the ASAQ group (48 h vs. 36 h, P<0.001) and fever clearance times were shorter in the ASAQ group (12 h vs. 24 h, P=0.07). The two forms of ACT were well tolerated with no serious adverse events.
  
  
  CONCLUSIONS
  Both forms of ACT were highly efficacious in the treatment of uncomplicated P. falciparum malaria. Although the two-day course of ARPQ was equally as effective as the three-day course of ASAQ, parasite and fever clearance times were shorter with ASAQ. Further studies are warranted in different regions of Vietnam to determine the nationwide efficacy of ASAQ.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry Number, ACTRN12609000816257.
authors: Military Institute of Hygiene and Epidemiology, Hanoi, Vietnam.
authors: Nguyen Xuan
authors: NX
authors: Thanh
authors: Trieu Nguyen
authors: TN
authors: Trung
authors: Nguyen Chinh
authors: NC
authors: Phong
authors: Huynh Hong
authors: HH
authors: Quang
authors: Bui
authors: B
authors: Dai
authors: G Dennis
authors: GD
authors: Shanks
authors: Marina
authors: M
authors: Chavchich
authors: Michael D
authors: MD
authors: Edstein
mesh_terms: D000293:Adolescent; D000328:Adult; D000655:Amodiaquine / Q000008:administration & dosage* / Q000009:adverse effects; D000818:Animals; D037621:Artemisinins / Q000008:administration & dosage* / Q000009:adverse effects; D001769:Blood / Q000469:parasitology; D002648:Child; D002675:Child, Preschool; D004338:Drug Combinations; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006801:Humans; D008288:Malaria / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010963:Plasmodium falciparum / Q000235:genetics / Q000302:isolation & purification; D016133:Polymerase Chain Reaction; D011804:Quinolines / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D014744:Vietnam; D055815:Young Adult; D010879:Piperazines
chemical_list: D000655:Amodiaquine; D037621:Artemisinins; D004338:Drug Combinations; D011804:Quinolines; C515299:amodiaquine, artesunate drug combination; C031327:artemisinin; C034759:piperaquine; D010879:Piperazines