1. Description of the SAGhE Cohort: A Large European Study of Mortality and Cancer Incidence Risks after Childhood Treatment with Recombinant Growth Hormone
- Author
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Swerdlow , Anthony, 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, Kuehni , Claudia, Landier , Fabienne, Maes , Marc, Mullis , Primus-E, Pfaffle , Roland, Sävendahl , Lars, Sommer , Grit, Thomas , Muriel, Tollerfield , Sally, Zandwijken , Gladys, Carel , Jean-Claude, UCL - SSS/IREC/PEDI - Pôle de Pédiatrie, UCL - (SLuc) Unité d'endocrinologie pédiatrique, Institute of Cancer Research - ICR [London, U.K.], Sahlgrenska Academy at University of Gothenburg [Göteborg], Karolinska Institutet [Stockholm], Institute of Child Health [London], University College of London [London] (UCL), University College London Hospitals (UCLH), IRCCS Ospedale Pediatrico Bambino Gesù [Roma], Royal Manchester Children's Hospital, University of Manchester [Manchester], Unité d’Epidémiologie et de Biostatistiques [APHP Cochin-Broca-Hôtel Dieu], AP-HP - Hôpital Cochin Broca Hôtel Dieu [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Maladies chroniques, santé perçue, et processus d'adaptation (APEMAC), Université Paris Descartes - Paris 5 (UPD5)-Université de Lorraine (UL), Universität Leipzig [Leipzig], Erasmus University Medical Center [Rotterdam] (Erasmus MC), Sophia Children's Hospital, Institute of Social and Preventive Medicine [Bern] (ISPM), Universität Bern [Bern], Centre de Référence des Maladies Endocriniennes Rares de la Croissance [APHP Robert Debré], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Robert Debré-Université Paris Diderot - Paris 7 (UPD7), Service d'endocrinologie diabétologie pédiatrique [CHU Debré], AP-HP Hôpital universitaire Robert-Debré [Paris], Université Paris Diderot - Paris 7 (UPD7), Centre d'Investigation Clinique - Epidemiologie Clinique/essais Cliniques Hopital Robert Debre, Institut National de la Santé et de la Recherche Médicale (INSERM), Cliniques universitaires St Luc [Bruxelles], Inselspital Bern, Belgian Study Group for Pediatric Endocrinology (BSGPE), Universitair Ziekenhuis Brussel, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Robert Debré-Université Paris Diderot - Paris 7 (UPD7), University College of London [London] ( UCL ), University College London Hospitals ( UCLH ), Maladies chroniques, santé perçue, et processus d'adaptation. Approches épidémiologiques et psychologiques. ( APEMAC - EA 4360 ), Université Paris Descartes - Paris 5 ( UPD5 ) -Université de Lorraine ( UL ), Erasmus Medical Center / Dutch Growth Research Foundation, Erasmus University Medical Center [Rotterdam], Institute of Social and Preventive Medicine [Bern] ( ISPM ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Robert Debré-Université Paris Diderot - Paris 7 ( UPD7 ), Université Paris Diderot - Paris 7 ( UPD7 ), Institut National de la Santé et de la Recherche Médicale ( INSERM ), Belgian Study Group for Pediatric Endocrinology ( BSGPE ), and Pediatrics
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Male ,MESH : Risk ,MESH : Child, Preschool ,Cohort Studies ,MESH: Cause of Death ,MESH: Recombinant Proteins ,MESH : Child ,Cause of Death ,Neoplasms ,MESH: Child ,MESH: Human Growth Hormone ,MESH : Female ,MESH: Neoplasms ,MESH: Incidence ,Child ,MESH: Cohort Studies ,Growth Disorders ,Cancer ,MESH: Risk ,Human Growth Hormone ,Incidence ,MESH: Infant, Newborn ,Cohort ,MESH : Infant ,[ SDV.SPEE ] Life Sciences [q-bio]/Santé publique et épidémiologie ,MESH: Follow-Up Studies ,MESH: Growth Disorders ,MESH: Infant ,MESH : Incidence ,Recombinant Proteins ,Europe ,MESH: Young Adult ,Child, Preschool ,Female ,Risk ,Adolescent ,MESH : Recombinant Proteins ,MESH : Male ,MESH : Europe ,MESH : Young Adult ,MESH : Cohort Studies ,610 Medicine & health ,MESH : Infant, Newborn ,Young Adult ,SDG 3 - Good Health and Well-being ,360 Social problems & social services ,MESH : Adolescent ,Humans ,MESH : Growth Disorders ,MESH : Human Growth Hormone ,Mortality ,Growth hormone ,MESH : Cause of Death ,Settore MED/38 - Pediatria Generale e Specialistica ,MESH: Adolescent ,Original Paper ,MESH: Humans ,MESH : Humans ,MESH: Child, Preschool ,Infant, Newborn ,Infant ,MESH : Follow-Up Studies ,MESH : Neoplasms ,MESH: Male ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,MESH: Europe ,MESH: Female ,Follow-Up Studies - Abstract
International audience; 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.
- Published
- 2015
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