title: Do paediatric drug formulations of artemisinin combination therapies improve the treatment of children with malaria? A systematic review and meta-analysis.
abstract: Paediatric formulations of artemisinin combination therapies (ACTs) have recently been developed for the treatment of children with falciparum malaria. Compared with conventional tablet formulations, the new non-tablet preparations have shown equivalent efficacy, safety, and tolerability in individual trials. We aimed to investigate whether objective evidence supports the development and use of paediatric ACTs. A systematic review identified seven studies involving 2515 children that were eligible for meta-analysis. Similar efficacy and safety were seen in pooled analyses of paediatric and conventional formulations. 23 (2.0%) of 1154 patients in the paediatric formulation groups and 19 (1.7%) of 1137 in the tablet formulation groups were not cured (RR 1.27, 95% CI 0.66-2.44). Despite similar overall tolerability, the tolerability of drug administration was improved for paediatric formulations as shown by significantly fewer patients with drug-induced vomiting (93 of 1018 and 114 of 837 patients; risk ratio [RR] 0.78, 95% CI 0.61-0.99), and drug-related gastrointestinal disorders (8 of 545 and 15 of 358 patients; RR 0.36, 95% CI 0.15-0.85). These data provide, for the first time, evidence for improved management of children by use of paediatric formulations, and support the further development and use of paediatric ACTs.
authors.affiliation: Medical Research Unit, Albert Schweitzer Hospital, Lambaréné, Gabon.
authors.forename: Florian
authors.initials: F
authors.lastname: Kurth
authors.forename: Sabine
authors.initials: S
authors.lastname: Bélard
authors.forename: Ayola A
authors.initials: AA
authors.lastname: Adegnika
authors.forename: Oumar
authors.initials: O
authors.lastname: Gaye
authors.forename: Peter G
authors.initials: PG
authors.lastname: Kremsner
authors.forename: Michael
authors.initials: M
authors.lastname: Ramharter
mesh_terms: D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D037621:Artemisinins / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004359:Drug Therapy, Combination; D006801:Humans; D007223:Infant; D008288:Malaria / Q000188:drug therapy*; D018579:Patient Selection; D013607:Tablets; D016896:Treatment Outcome
chemical_list: D000890:Anti-Infective Agents; D037621:Artemisinins; D013607:Tablets; C031327:artemisinin