title: Description of the SAGhE Cohort: A Large European Study of Mortality and Cancer Incidence Risks after Childhood Treatment with Recombinant Growth Hormone.
abstract: BACKGROUND
  The long-term safety of growth hormone treatment is uncertain. Raised risks of death and certain cancers have been reported inconsistently, based on limited data or short-term follow-up by pharmaceutical companies.
  
  
  METHODS
  The SAGhE (Safety and Appropriateness of Growth Hormone Treatments in Europe) study assembled cohorts of patients treated in childhood with recombinant human growth hormone (r-hGH) in 8 European countries since the first use of this treatment in 1984 and followed them for cause-specific mortality and cancer incidence. Expected rates were obtained from national and local general population data. The cohort consisted of 24,232 patients, most commonly treated for isolated growth failure (53%), Turner syndrome (13%) and growth hormone deficiency linked to neoplasia (12%). This paper describes in detail the study design, methods and data collection and discusses the strengths, biases and weaknesses consequent on this.
  
  
  CONCLUSIONS
  The SAGhE cohort is the largest and longest follow-up cohort study of growth hormone-treated patients with follow-up and analysis independent of industry. It forms a major resource for investigating cancer and mortality risks in r-hGH patients. The interpretation of SAGhE results, however, will need to take account of the methods of cohort assembly and follow-up in each country.
authors.affiliation: Division of Genetics and Epidemiology, Institute of Cancer Research, London, UK.
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Swerdlow
authors.forename: Rosie
authors.initials: R
authors.lastname: Cooke
authors.forename: Kerstin
authors.initials: K
authors.lastname: Albertsson-Wikland
authors.forename: Birgit
authors.initials: B
authors.lastname: Borgström
authors.forename: Gary
authors.initials: G
authors.lastname: Butler
authors.forename: Stefano
authors.initials: S
authors.lastname: Cianfarani
authors.forename: Peter
authors.initials: P
authors.lastname: Clayton
authors.forename: Joël
authors.initials: J
authors.lastname: Coste
authors.forename: Annalisa
authors.initials: A
authors.lastname: Deodati
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Ecosse
authors.forename: Ruth
authors.initials: R
authors.lastname: Gausche
authors.forename: Claudio
authors.initials: C
authors.lastname: Giacomozzi
authors.forename: Wieland
authors.initials: W
authors.lastname: Kiess
authors.forename: Anita C S
authors.initials: AC
authors.lastname: Hokken-Koelega
authors.forename: Claudia E
authors.initials: CE
authors.lastname: Kuehni
authors.forename: Fabienne
authors.initials: F
authors.lastname: Landier
authors.forename: Marc
authors.initials: M
authors.lastname: Maes
authors.forename: Primus-E
authors.initials: PE
authors.lastname: Mullis
authors.forename: Roland
authors.initials: R
authors.lastname: Pfaffle
authors.forename: Lars
authors.initials: L
authors.lastname: Sävendahl
authors.forename: Grit
authors.initials: G
authors.lastname: Sommer
authors.forename: Muriel
authors.initials: M
authors.lastname: Thomas
authors.forename: Sally
authors.initials: S
authors.lastname: Tollerfield
authors.forename: Gladys R J
authors.initials: GR
authors.lastname: Zandwijken
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Carel
mesh_terms: D000293:Adolescent; D002423:Cause of Death; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D005060:Europe / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006130:Growth Disorders / Q000188:drug therapy; D019382:Human Growth Hormone / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D009369:Neoplasms / Q000453:epidemiology* / Q000401:mortality*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012306:Risk; D055815:Young Adult
chemical_list: D011994:Recombinant Proteins; D019382:Human Growth Hormone