Do paediatric drug formulations of artemisinin combination therapies improve the treatment of children with malaria? A systematic review and meta-analysis

• Published in: The Lancet infectious diseases 2010-02, Vol.10 (2), p.125-132
• Main Authors: Kurth, Florian, MD, Bélard, Sabine, MD, Adegnika, Ayola A, MD, Gaye, Oumar, Prof, Kremsner, Peter G, Prof, Ramharter, Michael, Dr
• Format: Article
• Language: English
• Subjects: Anti-Infective Agents - administration & dosage; Anti-Infective Agents - pharmacokinetics; Anti-Infective Agents - therapeutic use; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiparasitic agents; Artemisinins - administration & dosage; Artemisinins - pharmacokinetics; Artemisinins - therapeutic use; Biological and medical sciences; Child; Child, Preschool; Clinical Trials as Topic; Drug Therapy, Combination; Human protozoal diseases; Humans; Infant; Infectious Disease; Infectious diseases; Malaria; Malaria - drug therapy; Medical sciences; Parasitic diseases; Patient Selection; Pharmacology. Drug treatments; Protozoal diseases; Tablets; Treatment Outcome; Vector-borne diseases
• ISSN: 1473-3099; 1474-4457
• DOI: 10.1016/S1473-3099(09)70327-5

Summary 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.