title: Efficacy and safety of losartan in children with Alport syndrome--results from a subgroup analysis of a prospective, randomized, placebo- or amlodipine-controlled trial.
abstract: BACKGROUND
  No prospective, randomized, double-blind trials of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers have previously been reported in adults or children with proteinuria secondary to Alport syndrome.
  
  
  METHODS
  This 12-week, double-blind multinational study investigated the effects of losartan 0.7-1.4 mg/kg/day compared with placebo (normotensive patients) or amlodipine 0.1-0.2 mg/kg/day up to 5 mg/day (hypertensive patients) on proteinuria [early morning-void urinary protein/creatinine ratio (UPr/Cr), baseline ≥ 34 mg/mmol] in 30 children of up to 17 years of age with Alport syndrome.
  
  
  RESULTS
  Twelve weeks of treatment with losartan significantly reduced proteinuria compared with placebo/amlodipine: losartan -14.7 mg/mmol (interquartile range -49.7 to -5.7 mg/mmol) or 31.6% reduction using a mixed model approach versus placebo/amlodipine 2.3 mg/mmol (-26.0 to 18.1 mg/mmol), P = 0.01 or 2.3% increase using a mixed model approach. Adverse event incidence was low and comparable between losartan and placebo/amlodipine groups.
  
  
  CONCLUSIONS
  Losartan significantly lowered proteinuria and was well tolerated after 12 weeks of treatment in children aged 1-17 years with proteinuria secondary to Alport syndrome with or without hypertension, a population that has not previously been rigorously studied.
authors.affiliation: Department of Paediatric Nephrology and Wellcome Trust Children's Clinical Research Facility, The University of Manchester, Manchester Academic Health Science Centre, Royal Manchester Children's Hospital, Manchester, UK. nicholas.webb@cmft.nhs.uk
authors.forename: Nicholas J A
authors.initials: NJ
authors.lastname: Webb
authors.forename: Chun
authors.initials: C
authors.lastname: Lam
authors.forename: Shahnaz
authors.initials: S
authors.lastname: Shahinfar
authors.forename: Juergen
authors.initials: J
authors.lastname: Strehlau
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Wells
authors.forename: Gilbert W
authors.initials: GW
authors.lastname: Gleim
authors.forename: Céline
authors.initials: C
authors.lastname: Le Bailly De Tilleghem
mesh_terms: D000293:Adolescent; D000328:Adult; D017311:Amlodipine / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000188:drug therapy; D007223:Infant; D019808:Losartan / Q000627:therapeutic use*; D008297:Male; D009394:Nephritis, Hereditary / Q000188:drug therapy*; D011379:Prognosis; D011446:Prospective Studies; D011507:Proteinuria / Q000139:chemically induced / Q000188:drug therapy; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000959:Antihypertensive Agents; D017311:Amlodipine; D019808:Losartan