For Publishers
DiscoveryMetadataPeer reviewHostingPublishing
For Researchers
JoinPublishReviewCollect
Register
Blog
About
Search
Advanced search
My ScienceOpen
Search
For Publishers
For Researchers
Blog
About
21
views
13
references
 Top references
cited by
27
    
0 reviews
 Review
0
comments
 Comment
0
recommends
+1 Recommend
1 collections
    0
    shares
      147
      similar
       All similar
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

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

      research-article

      Read this article at

      ScienceOpenPublisherPMC
      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          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.

          Related collections

          Most cited references13

          • Record: found
          • Abstract: found
          • Article: not found

          Long-term mortality and causes of death in isolated GHD, ISS, and SGA patients treated with recombinant growth hormone during childhood in Belgium, The Netherlands, and Sweden: preliminary report of 3 countries participating in the EU SAGhE study.

          Anita Hokken-Koelega, Lars Sävendahl, Kerstin Albertsson-Wikland … (2012)
          The long-term mortality in adults treated with recombinant GH during childhood has been poorly investigated. Recently released data from the French part of the European Union Safety and Appropriateness of GH treatments in Europe (EU SAGhE) study have raised concerns on the long-term safety of GH treatment. To report preliminary data on long-term vital status and causes of death in patients with isolated GH deficiency or idiopathic short stature or born small for gestational age treated with GH during childhood, in Belgium, The Netherlands, and Sweden. Data were retrieved from national registries of GH-treated patients and vital status from National Population Registries. Causes of death were retrieved from a National Cause of Death Register (Sweden), Federal and Regional Death Registries (Belgium), or individual patient records (The Netherlands). All patients diagnosed with isolated GH deficiency or idiopathic short stature or born small for gestational age started on recombinant GH during childhood from 1985-1997 and who had attained 18 yr of age by the end of 2010 were included. Vital status was available for approximately 98% of these 2,543 patients, corresponding to 46,556 person-years of observation. Vital status, causes of death, age at death, year of death, duration of GH treatment, and mean GH dose during treatment were assessed. Among 21 deaths identified, 12 were due to accidents, four were suicides, and one patient each died from pneumonia, endocrine dysfunction, primary cardiomyopathy, deficiency of humoral immunity, and coagulation defect. In these cohorts, the majority of deaths (76%) were caused by accidents or suicides. Importantly, none of the patients died from cancer or from a cardiovascular disease.
          Article 0 comments Cited 58 times – based on 0 reviews     Review now
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Growth hormone treatment for childhood short stature and risk of stroke in early adulthood.

            Amélie Poidvin, Emmanuel Touzé, Emmanuel Ecosse … (2014)
            We investigated the incidence of stroke and stroke subtypes in a population-based cohort of patients in France treated with growth hormone (GH) for short stature in childhood.
            Article 0 comments Cited 31 times – based on 0 reviews     Review now
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Risk of cancer in patients treated with human pituitary growth hormone in the UK, 1959-85: a cohort study.

              P Adlard, M Preece, Gloria Higgins … (2002)
              Growth hormone raises serum concentrations of insulin-like growth factor IGF-I, which is mitogenic and antiapoptotic. There is evidence that raised endogenous levels of growth hormone and IGF-I might be associated with increased risk of certain solid cancers, but there have been no data on long-term risks of solid cancers after growth hormone treatment. We did a cohort study to investigate cancer incidence and mortality in 1848 patients in the UK who were treated during childhood and early adulthood with human pituitary growth hormone during the period from 1959 to 1985. Patients were followed up for cancer incidence to December, 1995 and for mortality to December, 2000. Risk of cancer in the cohort was compared with that in the general population, controlling for age, sex, and calendar period. Patients treated with human pituitary growth hormone had significantly raised risks of mortality from cancer overall (standardised mortality ratio 2.8, 95% CI 1.3-5.1; ten cases), colorectal cancer (10.8, 1.3-38.8; two cases), and Hodgkin's disease (11.4, 1.4-41.3; two cases). Incidence of colorectal cancer was also greatly raised (7.9, 1.0-28.7). After exclusion of patients whose original diagnosis rendered them at high risk of cancer, the significance and size of the risks of colorectal cancer incidence and mortality, and of Hodgkin's disease mortality were increased. Although based on small numbers, the risk of colorectal cancer is of some concern and further investigation in other cohorts is needed. We have no evidence as to whether growth hormone in modern dosage regimens is associated with an increased risk of colorectal cancer.
              Article 0 comments Cited 27 times – based on 0 reviews     Review now
                Bookmark
                All references

                Author and article information

                Journal
                Journal ID (nlm-ta): Horm Res Paediatr
                Journal ID (iso-abbrev): Horm Res Paediatr
                Journal ID (publisher-id): HRP
                Title: Hormone Research in Pædiatrics
                Publisher: S. Karger AG (Allschwilerstrasse 10, P.O. Box · Postfach · Case postale, CH–4009, Basel, Switzerland · Schweiz · Suisse, Phone: +41 61 306 11 11, Fax: +41 61 306 12 34, karger@karger.ch )
                ISSN (Print): 1663-2818
                ISSN (Electronic): 1663-2826
                Publication date (Print): September 2015
                Publication date (Electronic): 23 July 2015
                Publication date PMC-release: 23 July 2015
                Volume: 84
                Issue: 3
                Pages: 172-183
                Affiliations
                [1] aDivision of Genetics and Epidemiology, Institute of Cancer Research, London, UK
                [2] bDivision of Breast Cancer Research, Institute of Cancer Research, London, UK
                [3] cInstitute of Neuroscience, Department of Physiology/Endocrinology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
                [4] dDepartment of Clinical Science, Intervention, and Technology, Karolinska Institutet, Stockholm, Sweden
                [5] eUCL Institute of Child Health, London, UK
                [6] fUniversity College London Hospitals NHS Foundation Trust, London, UK
                [7] gDipartimento Pediatrico Universitario Ospedaliero ‘Bambino Gesù’ Children's Hospital, Tor Vergata University, Rome, Italy
                [8] hDepartment of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden
                [9] iRoyal Manchester Children's Hospital, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK
                [10] jCentre for Paediatrics and Child Health, Institute of Human Development, Faculty of Medical and Human Sciences, University of Manchester, Manchester, UK
                [11] kBiostatistics and Epidemiology Unit, and Approches Psychologiques et Epidémiologiques des Maladies Chroniques Equipe d'Accueil, Paris, France
                [12] lGroupe Hospitalier Cochin-Saint Vincent de Paul and University Paris Descartes, Paris, France
                [13] mHospital for Children and Adolescents and Centre of Pediatric Research, University of Leipzig, Leipzig, Germany
                [14] nDipartimento di Medicina Pediatrica ‘Bambino Gesù’ Children's Hospital, Rome, Italy
                [15] oDutch Growth Research Foundation, Rotterdam, The Netherlands
                [16] pErasmus Medical Center/Sophia Children's Hospital, Rotterdam, The Netherlands
                [17] qInstitute of Social and Preventive Medicine, University of Bern, Bern, Switzerland
                [18] rUniversity Paris Diderot, Sorbonne Paris Cité, Assistance Publique-Hôpitaux de Paris
                [19] sService d'Endocrinologie Diabétologie Pédiatrique et Centre de Référence des Maladies Endocriniennes Rares de la Croissance, Hôpital Robert Debré, Assistance Publique-Hôpitaux de Paris
                [20] tInstitut National de la Santé et de la Recherche Médicale Unité CIE-5, Paris, France
                [21] uDivision of Pediatric Endocrinology, Department of Pediatrics, Cliniques Universitaires St. Luc, Université Catholique de Louvain, Brussels, Belgium
                [22] vDivision of Paediatric Endocrinology, Diabetology and Metabolism, University Children's Hospital Bern, Inselspital, Bern, Switzerland
                [23] wDivision of Pediatric Endocrinology, Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden
                [24] xBelgian Study Group for Pediatric Endocrinology (BSGPE), Brussels, Belgium
                Author notes
                *Prof. Anthony J. Swerdlow, DSc, Division of Genetics and Epidemiology, Institute of Cancer Research, Sir Richard Doll Building, Sutton, Surrey SM2 5NG (UK), E-Mail anthony.swerdlow@ 123456icr.ac.uk
                Article
                Publisher ID: hrp-0084-0172
                DOI: 10.1159/000435856
                PMC ID: 4611066
                PubMed ID: 26227295
                SO-VID: a8f348d5-828b-40db-ad91-aa329798a659
                Copyright © Copyright © 2015 by S. Karger AG, Basel
                License:

                This article is licensed under the Creative Commons Attribution 4.0 International License (CC BY) (http://www.karger.com/Services/OpenAccessLicense). Usage, derivative works and distribution are permitted provided that proper credit is given to the author and the original publisher.

                History
                Date received : 4 February 2015
                Date accepted : 9 June 2015
                Page count
                Tables: 8, References: 29, Pages: 12
                Categories
                Subject: Original Paper

                Keywords: growth hormone,cohort,europe,cancer,mortality
                Data availability:
                Keywords: growth hormone, cohort, europe, cancer, mortality

                Comments

                Comment on this article

                scite_

                Similar content147

                See all similar

                Cited by23

                See all cited by