Description of the SAGhE Cohort: A Large European Study of Mortality and Cancer Incidence Risks after Childhood Treatment with Recombinant Growth Hormone

Anthony Swerdlow 1 Rosie Cooke 1 Kerstin Albertsson-Wikland 2 Birgit Borgström 3 Gary Butler 4, 5 Stefano Cianfarani 6, 3 Peter Clayton 7, 8 Joël Coste 9, 10 Annalisa Deodati 6 Emmanuel Ecosse 9, 10 Ruth Gausche 11 Claudio Giacomozzi 6 Wieland Kiess 11 Anita Hokken-Koelega 12, 13 Claudia Kuehni 14 Fabienne Landier 15, 16, 17, 18 Marc Maes 19 Primus-E Mullis 20 Roland Pfaffle 11 Lars Sävendahl 3 Grit Sommer 14 Muriel Thomas 21 Sally Tollerfield 4 Gladys Zandwijken 12 Jean-Claude Carel 15, 16, 17, 18
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.
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Anthony Swerdlow, Rosie Cooke, Kerstin Albertsson-Wikland, Birgit Borgström, Gary Butler, et al.. Description of the SAGhE Cohort: A Large European Study of Mortality and Cancer Incidence Risks after Childhood Treatment with Recombinant Growth Hormone. Hormone Research in Paediatrics, Karger, 2015, 84 (3), pp.172 - 183. ⟨10.1159/000435856⟩. ⟨hal-01811057⟩

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