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
    JournalHormone research in paediatrics
    Volume84
    Issue number3
    DOIs
    Publication statusPublished - 2015

    Fingerprint

    Dive into the research topics of 'Description of the SAGhE Cohort: A Large European Study of Mortality and Cancer Incidence Risks after Childhood Treatment with Recombinant Growth Hormone.'. Together they form a unique fingerprint.

    Cite this