Description of the SAGhE cohort: A large european study of mortality and cancer incidence risks after childhood treatment with recombinant growth hormone

Anthony J. Swerdlow, Rosie Cooke, Kerstin Albertsson-Wikland, Birgit Borgström, Gary Butler, Stefano Cianfarani, Peter Clayton, Joël Coste, Annalisa Deodati, Emmanuel Ecosse, Ruth Gausche, Claudio Giacomozzi, Wieland Kiess, Anita C S Hokken-Koelega, Claudia E. Kuehni, Fabienne Landier, Marc Maes, Primus E. Mullis, Roland Pfaffle, Lars SävendahlGrit Sommer, Muriel Thomas, Sally Tollerfield, Gladys R J Zandwijken, Jean Claude Carel

Research output: Contribution to journalArticlepeer-review

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. Patients and 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. Conclusion: 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.

Original languageEnglish
Pages (from-to)172-183
Number of pages12
JournalHormone Research in Paediatrics
Volume84
Issue number3
DOIs
Publication statusPublished - Sep 22 2015

Keywords

  • Cancer
  • Cohort
  • Europe
  • Growth hormone
  • Mortality

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Endocrinology
  • Endocrinology, Diabetes and Metabolism

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