Kirstine Stochholm1,2, Wieland Kiess3. 1. Department of Internal Medicine and Diabetes, Endocrinology, Aarhus University Hospital, Aarhus, Denmark. 2. Department of Pediatrics, Center of Rare Diseases, Aarhus University Hospital, Aarhus, Denmark. 3. Department of Women and Child Health, Hospital for Children and Adolescents, University Hospitals, University of Leipzig, Leipzig, Germany.
Abstract
OBJECTIVES: Preliminary data from the French cohort of the Safety and Appropriateness of Growth hormone treatments in Europe (SAGhE) study raised concerns regarding the safety of recombinant human GH, suggesting that GH may increase mortality and incidence of stroke in patients treated during childhood for GH deficiency or short stature. We evaluated published safety data, focusing on mortality, neoplasms, cerebrovascular events and diabetes across a number of large-scale pharmaceutical company GH registries. DESIGN: A literature review was conducted using PubMed, EMBASE and Google Scholar to identify all relevant safety data from manufacturers' GH registries published between 1988 and April 2016. Results were hand-sorted to exclude nonrelevant publications; bibliographic references from retrieved articles were evaluated for any additional references. RESULTS: The published data do not support an increased risk of mortality in children or adults treated with GH. There was no evidence of an increased risk of stroke, new malignancy, leukaemia, nonleukaemic extracranial tumours or recurrence of intracranial malignancy in patients without risk factors. The risk of a second neoplasm is increased, particularly if patients have received radiation therapy for a central nervous system tumour. There may be an increased risk of type 2 diabetes in GH-treated patients, but this appears to be confined to those with pre-existing risk factors. CONCLUSIONS: Patients with risk factors for malignancy or type 2 diabetes should be treated with caution and monitored during follow-up, but current published data provide reassurance on the long-term safety profile of GH in patients receiving GH treatment.
OBJECTIVES: Preliminary data from the French cohort of the Safety and Appropriateness of Growth hormone treatments in Europe (SAGhE) study raised concerns regarding the safety of recombinant human GH, suggesting that GH may increase mortality and incidence of stroke in patients treated during childhood for GH deficiency or short stature. We evaluated published safety data, focusing on mortality, neoplasms, cerebrovascular events and diabetes across a number of large-scale pharmaceutical company GH registries. DESIGN: A literature review was conducted using PubMed, EMBASE and Google Scholar to identify all relevant safety data from manufacturers' GH registries published between 1988 and April 2016. Results were hand-sorted to exclude nonrelevant publications; bibliographic references from retrieved articles were evaluated for any additional references. RESULTS: The published data do not support an increased risk of mortality in children or adults treated with GH. There was no evidence of an increased risk of stroke, new malignancy, leukaemia, nonleukaemic extracranial tumours or recurrence of intracranial malignancy in patients without risk factors. The risk of a second neoplasm is increased, particularly if patients have received radiation therapy for a central nervous system tumour. There may be an increased risk of type 2 diabetes in GH-treated patients, but this appears to be confined to those with pre-existing risk factors. CONCLUSIONS:Patients with risk factors for malignancy or type 2 diabetes should be treated with caution and monitored during follow-up, but current published data provide reassurance on the long-term safety profile of GH in patients receiving GH treatment.
Authors: Christopher L Mendias; Elizabeth R Sibilsky Enselman; Adam M Olszewski; Jonathan P Gumucio; Daniel L Edon; Maxwell A Konnaris; James E Carpenter; Tariq M Awan; Jon A Jacobson; Joel J Gagnier; Ariel L Barkan; Asheesh Bedi Journal: Am J Sports Med Date: 2020-05-26 Impact factor: 6.202
Authors: Christopher J Child; Alan G Zimmermann; George P Chrousos; Elisabeth Cummings; Cheri L Deal; Tomonobu Hasegawa; Nan Jia; Sarah Lawrence; Agnès Linglart; Sandro Loche; Mohamad Maghnie; Jacobo Pérez Sánchez; Michel Polak; Barbara Predieri; Annette Richter-Unruh; Ron G Rosenfeld; Diego Yeste; Tohru Yorifuji; Werner F Blum Journal: J Clin Endocrinol Metab Date: 2019-02-01 Impact factor: 5.958
Authors: Lars Sävendahl; Michel Polak; Philippe Backeljauw; Jo Blair; Bradley S Miller; Tilman R Rohrer; Alberto Pietropoli; Vlady Ostrow; Judith Ross Journal: J Clin Endocrinol Metab Date: 2019-10-01 Impact factor: 5.958
Authors: Paolo Beck-Peccoz; Charlotte Höybye; Robert D Murray; Suat Simsek; Markus Zabransky; Hichem Zouater; Günter Stalla Journal: BMC Endocr Disord Date: 2019-12-11 Impact factor: 2.763