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.

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.

• Authors: 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 Sävendahl, Grit Sommer, Muriel Thomas, Sally Tollerfield, Gladys R J Zandwijken, Jean-Claude Carel
• Journal: Hormone research in paediatrics (Horm Res Paediatr) Vol. 84 Issue 3 Pg. 172-83 ( 2015) ISSN: 1663-2826 [Electronic] Switzerland
• PMID: 26227295 (Publication Type: Journal Article)
• Copyright: © 2015 The Author(s) Published by S. Karger AG, Basel.

Chemical References

• Recombinant Proteins
• Human Growth Hormone

Topics

• Adolescent
• Cause of Death
• Child
• Child, Preschool
• Cohort Studies
• Europe (epidemiology)
• Female
• Follow-Up Studies
• Growth Disorders (drug therapy)
• Human Growth Hormone (adverse effects, therapeutic use)
• Humans
• Incidence
• Infant
• Infant, Newborn
• Male
• Neoplasms (epidemiology, mortality)
• Recombinant Proteins (adverse effects, therapeutic use)
• Risk
• Young Adult