The efficacy and tolerability of artemisinin-piperaquine (Artequick®) versus artesunate-amodiaquine (Coarsucam™) for the treatment of uncomplicated <it>Plasmodium falciparum</it> malaria in south-central Vietnam

• Main Authors: Thanh Nguyen, Trung Trieu, Phong Nguyen, Quang Huynh, Dai Bui, Shanks G, Chavchich Marina, Edstein Michael D
• Format: Article
• Language: English
• Published: BMC 2012-06-01
• Series: Malaria Journal
• Subjects: Malaria; <it>Plasmodium falciparum</it>; Artemisinin; Piperaquine; Artesunate; Amodiaquine
• Online Access: http://www.malariajournal.com/content/11/1/217

<p>Abstract</p> <p>Background</p> <p>In Vietnam, the artemisinin-based combination therapy (ACT) of dihydroartemisinin-piperaquine is currently used for first-line treatment of uncomplicated <it>Plasmodium falciparum</it> 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 <it>P. falciparum</it> malaria in south-central Vietnam.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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 <it>vs.</it> 36 h, <it>P</it><0.001) and fever clearance times were shorter in the ASAQ group (12 h <it>vs.</it> 24 h, <it>P</it> = 0.07). The two forms of ACT were well tolerated with no serious adverse events.</p> <p>Conclusion</p> <p>Both forms of ACT were highly efficacious in the treatment of uncomplicated <it>P. falciparum</it> 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.</p> <p>Trial registration</p> <p>Australian New Zealand Clinical Trials Registry Number, ACTRN12609000816257</p>