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

Swerdlow, Anthony J; Cooke, Rosie; Albertsson-Wikland, Kerstin; Borgström, Birgit; Butler, Gary; Cianfarani, Stefano; Clayton, Peter; Coste, Joël; Deodati, Annalisa; Ecosse, Emmanuel; Gausche, Ruth; Giacomozzi, Claudio; Kiess, Wieland; Hokken-Koelega, Anita C S; Kuehni, Claudia E; Landier, Fabienne; Maes, Marc; Mullis, Primus-E; Pfaffle, Roland; Sävendahl, Lars; ... (2015). 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, 84(3), pp. 172-183. Karger 10.1159/000435856

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine

UniBE Contributor:

Kühni, Claudia and Sommer, Grit

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

1663-2818

Publisher:

Karger

Language:

English

Submitter:

Doris Kopp Heim

Date Deposited:

11 Feb 2016 10:44

Last Modified:

01 Oct 2017 02:30

Publisher DOI:

10.1159/000435856

PubMed ID:

26227295

BORIS DOI:

10.7892/boris.77144

URI:

https://boris.unibe.ch/id/eprint/77144

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