Dataset Information

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.

SUBMITTER: Swerdlow AJ

PROVIDER: S-EPMC4611066 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Publications

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 AJ Cooke Rosie R Albertsson-Wikland Kerstin K Borgström Birgit B Butler Gary G Cianfarani Stefano S Clayton Peter P Coste Joël J Deodati Annalisa A Ecosse Emmanuel E Gausche Ruth R Giacomozzi Claudio C Kiess Wieland W Hokken-Koelega Anita C S AC Kuehni Claudia E CE Landier Fabienne F Maes Marc M Mullis Primus-E PE Pfaffle Roland R Sävendahl Lars L Sommer Grit G Thomas Muriel M Tollerfield Sally S Zandwijken Gladys R J GR Carel Jean-Claude JC

Hormone research in paediatrics 20150723 3

<h4>Background</h4>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.<h4>Patients and methods</h4>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 treat ...[more]

PMID: 26227295

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Dataset Information

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

Background

Patients and methods

Conclusion

Publications

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

Similar Datasets

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