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      GH safety workshop position paper: a critical appraisal of recombinant human GH therapy in children and adults


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          Recombinant human GH (rhGH) has been in use for 30 years, and over that time its safety and efficacy in children and adults has been subject to considerable scrutiny. In 2001, a statement from the GH Research Society (GRS) concluded that ‘for approved indications, GH is safe’; however, the statement highlighted a number of areas for on-going surveillance of long-term safety, including cancer risk, impact on glucose homeostasis, and use of high dose pharmacological rhGH treatment. Over the intervening years, there have been a number of publications addressing the safety of rhGH with regard to mortality, cancer and cardiovascular risk, and the need for long-term surveillance of the increasing number of adults who were treated with rhGH in childhood. Against this backdrop of interest in safety, the European Society of Paediatric Endocrinology (ESPE), the GRS, and the Pediatric Endocrine Society (PES) convened a meeting to reappraise the safety of rhGH. The ouput of the meeting is a concise position statement.

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          Most cited references9

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          Consensus statement on the diagnosis and treatment of children with idiopathic short stature: a summary of the Growth Hormone Research Society, the Lawson Wilkins Pediatric Endocrine Society, and the European Society for Paediatric Endocrinology Workshop.

          Our objective was to summarize important advances in the management of children with idiopathic short stature (ISS). Participants were 32 invited leaders in the field. Evidence was obtained by extensive literature review and from clinical experience. Participants reviewed discussion summaries, voted, and reached a majority decision on each document section. ISS is defined auxologically by a height below -2 sd score (SDS) without findings of disease as evident by a complete evaluation by a pediatric endocrinologist including stimulated GH levels. Magnetic resonance imaging is not necessary in patients with ISS. ISS may be a risk factor for psychosocial problems, but true psychopathology is rare. In the United States and seven other countries, the regulatory authorities approved GH treatment (at doses up to 53 microg/kg.d) for children shorter than -2.25 SDS, whereas in other countries, lower cutoffs are proposed. Aromatase inhibition increases predicted adult height in males with ISS, but adult-height data are not available. Psychological counseling is worthwhile to consider instead of or as an adjunct to hormone treatment. The predicted height may be inaccurate and is not an absolute criterion for GH treatment decisions. The shorter the child, the more consideration should be given to GH. Successful first-year response to GH treatment includes an increase in height SDS of more than 0.3-0.5. The mean increase in adult height in children with ISS attributable to GH therapy (average duration of 4-7 yr) is 3.5-7.5 cm. Responses are highly variable. IGF-I levels may be helpful in assessing compliance and GH sensitivity; levels that are consistently elevated (>2.5 SDS) should prompt consideration of GH dose reduction. GH therapy for children with ISS has a similar safety profile to other GH indications.
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            Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II: a statement of the GH Research Society in association with the European Society for Pediatric Endocrinology, Lawson Wilkins Society, European Society of Endocrinology, Japan Endocrine Society, and Endocrine Society of Australia.

            Ken Ho (2007)
            The GH Research Society held a Consensus Workshop in Sydney, Australia, 2007 to incorporate the important advances in the management of GH deficiency (GHD) in adults, which have taken place since the inaugural 1997 Consensus Workshop. Two commissioned review papers, previously published Consensus Statements of the Society and key questions were circulated before the Workshop, which comprised a rigorous structure of review with breakout discussion groups. A writing group transcribed the summary group reports for drafting in a plenary forum on the last day. All participants were sent a polished draft for additional comments and gave signed approval to the final revision. Testing for GHD should be extended from hypothalamic-pituitary disease and cranial irradiation to include traumatic brain injury. Testing may indicate isolated GHD; however, idiopathic isolated GHD occurring de novo in the adult is not a recognized entity. The insulin tolerance test, combined administration of GHRH with arginine or growth hormone-releasing peptide, and glucagon are validated GH stimulation tests in the adult. A low IGF-I is a reliable diagnostic indicator of GHD in the presence of hypopituitarism, but a normal IGF-I does not rule out GHD. GH status should be reevaluated in the transition age for continued treatment to complete somatic development. Interaction of GH with other axes may influence thyroid, glucocorticoid, and sex hormone requirements. Response should be assessed clinically by monitoring biochemistry, body composition, and quality of life. There is no evidence that GH replacement increases the risk of tumor recurrence or de novo malignancy.
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              Consensus statement on the management of the GH-treated adolescent in the transition to adult care.

              The European Society for Paediatric Endocrinology held a consensus workshop in Manchester, UK in December 2003 to discuss issues relating to the care of GH-treated patients in the transition from paediatric to adult life. Clinicians experienced in the care of paediatric and adult patients on GH treatment, from a wide range of countries, as well as medical representatives from the pharmaceutical manufacturers of GH participated.

                Author and article information

                Eur J Endocrinol
                Eur. J. Endocrinol
                European Journal of Endocrinology
                Bioscientifica Ltd (Bristol )
                February 2015
                11 November 2015
                : 174
                : 2
                : P1-P9
                [1]University of Wisconsin School of Medicine and Public Health , Madison, Wisconsin, USA
                [2]Cincinnati Children's Hospital Medical Center , Cincinnati, Ohio, USA
                [3]Medizinische Klinik und Poliklinik IV, Klinikum der Universität München , Munich, Germany
                [4]Massachusetts General Hospital , Boston, Massachusetts, UK
                [5]Federal University of Parana , Curitiba, Brazil
                [6]Department of Endocrinology, Skane University Hospital , Malmö, Sweden
                [7]University College London Hospital and UCL Institute of Child Health , London, UK
                [8]Hyogo Prefectural Kakogawa Medical Center , Hyogo, Japan
                [9]Aarhus University Hospital , Aarhus, Denmark
                [10]Molecular Endocrinology Unit, ‘Bambino Gesù’ Children's Hospital, Tor Vergata University , Rome, Italy
                [11]University of Manchester and Manchester Academic Health Science Centre , Manchester, UK
                [12]UNC School of Medicine , Chapel Hill, North Carolina, USA
                [13]USC Leonard Davis School of Gerontology, University of Southern California , Los Angeles, California, USA
                [14]Istanbul Faculty of Medicine , Istanbul, Turkey
                [15]Centre Hospitalier Universitaire-Ste-Justine , Montreal, Quebec, Canada
                [16]University of Cambridge , Cambridge, UK
                [17]Indiana University School of Medicine , Indianapolis, Indiana, USA
                [18]Perelman School of Medicine, Children's Hospital of Philadelphia, University of Pennsylvania , Philadelphia, Pennsylvania, USA
                [19]Baylor College of Medicine , Houston, Texas, USA
                [20]Christie Hospital NHS Foundation Trust , Manchester, UK
                [21]Princess Alexandra Hospital , Brisbane, Queensland, Australia
                [22]Stanford University School of Medicine , Stanford, California, Australia
                [23]Erasmus University Medical Center , Rotterdam, The Netherlands
                [24]Department of Endocrinology, Sahlgrenska Academy, Sahlgrenska University Hospital and Institute of Medicine, University of Gothenburg , Gothenburg, Sweden
                [25]Department of Growth and Reproduction and EDMaRC, Rigshospitalet , København, Denmark
                [26]Edison Biotechnology Institute, Ohio University , Athens, Ohio, USA
                [27]Penn State College of Medicine, Hershey Medical Center , Hershey, Pennsylvania, USA
                [28]McGill University , London, UK
                [29]Johns Hopkins University School of Medicine , Baltimore, Maryland, USA
                [30]St. Jude Children's Research Hospital , Memphis, UK
                [31]Oregon Health and Science University , Portland, Oregon, USA
                [32]University of Sheffield , Sheffield, UK
                [33]University of Sheffield , Sheffield, UK
                [34]Winthrop University Hospital, SUNY Stony Brook , Mineola, New York, USA
                [35]Aarhus University Hospital , 8000, Aarhus, Denmark
                [36]Charité Universitätsmedizin Berlin , Berlin, Germany
                [37]Institute of Cancer Research, University of London , London, UK
                [38]Emeritus University of Virginia , Charlottesville, Virginia, USA
                Author notes
                Correspondence should be addressed to R J Ross or P Clayton Email: r.j.ross@ 123456sheffield.ac.uk , peter.clayton@ 123456manchester.ac.uk
                © 2016 The authors

                This work is licensed under a Creative Commons Attribution 3.0 Unported License

                : 28 August 2015
                : 11 November 2015
                Position Statement

                Endocrinology & Diabetes
                Endocrinology & Diabetes


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