title: Increased risk of early vomiting among infants and young children treated with dihydroartemisinin-piperaquine compared with artemether-lumefantrine for uncomplicated malaria.
abstract: Artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DP) are highly efficacious antimalarial therapies in Africa. However, there are limited data regarding the tolerability of these drugs in young children. We used data from a randomized control trial in rural Uganda to compare the risk of early vomiting (within one hour of dosing) for children 6-24 months of age randomized to receive DP (n = 240) or AL (n = 228) for treatment of uncomplicated malaria. Overall, DP was associated with a higher risk of early vomiting than AL (15.1% versus 7.1%; P = 0.007). The increased risk of early vomiting with DP was only present among breastfeeding children (relative risk [RR] = 3.35, P = 0.001) compared with children who were not breastfeeding (RR = 1.03, P = 0.94). Age less than 18 months was a risk factor for early vomiting independent of treatment (RR = 3.27, P = 0.02). Our findings indicate that AL may be better tolerated than DP among young breastfeeding children treated for uncomplicated malaria.
authors.affiliation: Department of Medicine, San Francisco General Hospital, University of California, San Francisco, California, USA. darrencreek@gmail.com
authors.forename: Darren
authors.initials: D
authors.lastname: Creek
authors.forename: Victor
authors.initials: V
authors.lastname: Bigira
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Arinaitwe
authors.forename: Humphrey
authors.initials: H
authors.lastname: Wanzira
authors.forename: Abel
authors.initials: A
authors.lastname: Kakuru
authors.forename: Jordan
authors.initials: J
authors.lastname: Tappero
authors.forename: Moses R
authors.initials: MR
authors.lastname: Kamya
authors.forename: Grant
authors.initials: G
authors.lastname: Dorsey
authors.forename: Taylor G
authors.initials: TG
authors.lastname: Sandison
mesh_terms: D000962:Antimalarials / Q000009:adverse effects*; D000077549:Artemether; D037621:Artemisinins / Q000008:administration & dosage / Q000627:therapeutic use; D002675:Child, Preschool; D004983:Ethanolamines / Q000008:administration & dosage / Q000627:therapeutic use; D005449:Fluorenes / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D007223:Infant; D000078102:Lumefantrine; D008288:Malaria / Q000188:drug therapy* / Q000453:epidemiology; D011804:Quinolines / Q000008:administration & dosage / Q000627:therapeutic use; D012306:Risk; D014454:Uganda / Q000453:epidemiology; D014839:Vomiting / Q000139:chemically induced* / Q000453:epidemiology; D010879:Piperazines
chemical_list: D000962:Antimalarials; D000077549:Artemether; D037621:Artemisinins; D004983:Ethanolamines; D005449:Fluorenes; D000078102:Lumefantrine; D011804:Quinolines; C039060:artenimol; C034759:piperaquine; D010879:Piperazines