title: Comparative safety of artemether-lumefantrine and other artemisinin-based combinations in children: a systematic review.
abstract: BACKGROUND
  The purpose of the study was to compare the safety of artemether-lumefantrine (AL) with other artemisinin-based combinations in children.
  
  
  METHODS
  A search of EMBASE (from 1974 to April 2013), MEDLINE (from 1946 to April 2013) and the Cochrane library of registered controlled trials for randomized controlled trials (RCTs) which compared AL with other artemisinin-based combinations was done. Only studies involving children ≤ 17 years old in which safety of AL was an outcome measure were included.
  
  
  RESULTS
  Four thousand, seven hundred and twenty six adverse events (AEs) were recorded in 6,000 patients receiving AL. Common AEs (≥ 1/100 and <1/10) included: coryza, vomiting, anaemia, diarrhoea, vomiting and abdominal pain; while cough was the only very commonly reported AE (≥ 1/10). AL-treated children have a higher risk of body weakness (64.9%) than those on artesunate-mefloquine (58.2%) (p = 0.004, RR: 1.12 95% CI: 1.04-1.21). The risk of vomiting was significantly lower in patients on AL (8.8%) than artesunate-amodiaquine (10.6%) (p = 0.002, RR: 0.76, 95% CI: 0.63-0.90). Similarly, children on AL had a lower risk of vomiting (1.2%) than chlorproguanil-dapsone-artesunate (ACD) treated children (5.2%) (p = 0.002, RR: 0.63, 95% CI: 0.47-0.85). The risk of serious adverse events was significantly lower for AL (1.3%) than ACD (5.2%) (p = 0.002, RR: 0.45, 95% CI: 0.27-0.74).
  
  
  CONCLUSIONS
  Artemether-lumefantrine combination is as safe as ASAQ and DP for use in children. Common adverse events are cough and gastrointestinal symptoms. More studies comparing AL with artesunate-mefloquine and artesunate-azithromycin are needed to determine the comparative safety of these drugs.
authors.affiliation: Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby DE22 3DT, UK. mzxoe@nottingham.ac.uk.
authors.forename: Oluwaseun
authors.initials: O
authors.lastname: Egunsola
authors.forename: Kazeem A
authors.initials: KA
authors.lastname: Oshikoya
mesh_terms: D000293:Adolescent; D000962:Antimalarials / Q000008:administration & dosage* / Q000009:adverse effects*; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins / Q000008:administration & dosage* / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D003371:Cough / Q000139:chemically induced / Q000473:pathology; D004338:Drug Combinations; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D004415:Dyspepsia / Q000139:chemically induced / Q000473:pathology; D004983:Ethanolamines / Q000008:administration & dosage* / Q000009:adverse effects*; D005449:Fluorenes / Q000008:administration & dosage* / Q000009:adverse effects*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D016032:Randomized Controlled Trials as Topic
chemical_list: D000962:Antimalarials; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes; C031327:artemisinin