title: Electrocardiographic safety evaluation of dihydroartemisinin piperaquine in the treatment of uncomplicated falciparum malaria.
abstract: Dihydroartemisinin-piperaquine (DP) could become a leading fixed combination malaria treatment worldwide. Although there is accumulating evidence of efficacy and safety from clinical trials, data on cardiotoxicity are limited. In two randomized controlled trials in Thailand, 56 patients had ECGs performed before treatment, 4 hours after the first dose, and 4 hours after the last dose. The mean (95% CI) changes in QTc interval (Bazett's correction) were 2 (-6 to 9) ms and 14 (7 to 21) ms, respectively. These small changes on the third day of treatment are similar to those observed elsewhere in the convalescent phase following antimalarial treatment with drugs known to have no cardiac effects and are therefore likely to result from recovery from acute malaria and not the treatment given. At therapeutic doses, DP does not have clinically significant effects on the electrocardiogram.
authors.affiliation: Shoklo Malaria Research Unit, Mae Sot, Thailand.
authors.forename: Oliver T
authors.initials: OT
authors.lastname: Mytton
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Ashley
authors.forename: Leon
authors.initials: L
authors.lastname: Peto
authors.forename: Ric N
authors.initials: RN
authors.lastname: Price
authors.forename: Yar
authors.initials: Y
authors.lastname: La
authors.forename: Rae
authors.initials: R
authors.lastname: Hae
authors.forename: Pratap
authors.initials: P
authors.lastname: Singhasivanon
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: White
authors.forename: François
authors.initials: F
authors.lastname: Nosten
mesh_terms: D001145:Arrhythmias, Cardiac / Q000139:chemically induced*; D037621:Artemisinins / Q000009:adverse effects* / Q000627:therapeutic use*; D004562:Electrocardiography; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy*; D012717:Sesquiterpenes / Q000009:adverse effects* / Q000627:therapeutic use*