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Long-term Safety of Growth Hormone in Adults With Growth Hormone Deficiency: Overview of 15 809 GH-Treated Patients

CONTEXT: Data on long-term safety of growth hormone (GH) replacement in adults with GH deficiency (GHD) are needed. OBJECTIVE: We aimed to evaluate the safety of GH in the full KIMS (Pfizer International Metabolic Database) cohort. METHODS: The worldwide, observational KIMS study included adults and...

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Autores principales: Johannsson, Gudmundur, Touraine, Philippe, Feldt-Rasmussen, Ulla, Pico, Antonio, Vila, Greisa, Mattsson, Anders F, Carlsson, Martin, Korbonits, Márta, van Beek, André P, Wajnrajch, Michael P, Gomez, Roy, Yuen, Kevin C J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9202689/
https://www.ncbi.nlm.nih.gov/pubmed/35368070
http://dx.doi.org/10.1210/clinem/dgac199
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author Johannsson, Gudmundur
Touraine, Philippe
Feldt-Rasmussen, Ulla
Pico, Antonio
Vila, Greisa
Mattsson, Anders F
Carlsson, Martin
Korbonits, Márta
van Beek, André P
Wajnrajch, Michael P
Gomez, Roy
Yuen, Kevin C J
author_facet Johannsson, Gudmundur
Touraine, Philippe
Feldt-Rasmussen, Ulla
Pico, Antonio
Vila, Greisa
Mattsson, Anders F
Carlsson, Martin
Korbonits, Márta
van Beek, André P
Wajnrajch, Michael P
Gomez, Roy
Yuen, Kevin C J
author_sort Johannsson, Gudmundur
collection PubMed
description CONTEXT: Data on long-term safety of growth hormone (GH) replacement in adults with GH deficiency (GHD) are needed. OBJECTIVE: We aimed to evaluate the safety of GH in the full KIMS (Pfizer International Metabolic Database) cohort. METHODS: The worldwide, observational KIMS study included adults and adolescents with confirmed GHD. Patients were treated with GH (Genotropin [somatropin]; Pfizer, NY) and followed through routine clinical practice. Adverse events (AEs) and clinical characteristics (eg, lipid profile, glucose) were collected. RESULTS: A cohort of 15 809 GH-treated patients were analyzed (mean follow-up of 5.3 years). AEs were reported in 51.2% of patients (treatment-related in 18.8%). Crude AE rate was higher in patients who were older, had GHD due to pituitary/hypothalamic tumors, or adult-onset GHD. AE rate analysis adjusted for age, gender, etiology, and follow-up time showed no correlation with GH dose. A total of 606 deaths (3.8%) were reported (146 by neoplasms, 71 by cardiac/vascular disorders, 48 by cerebrovascular disorders). Overall, de novo cancer incidence was comparable to that in the general population (standard incidence ratio 0.92; 95% CI, 0.83-1.01). De novo cancer risk was significantly lower in patients with idiopathic/congenital GHD (0.64; 0.43-0.91), but similar in those with pituitary/hypothalamic tumors or other etiologies versus the general population. Neither adult-onset nor childhood-onset GHD was associated with increased de novo cancer risks. Neutral effects were observed in lipids/fasting blood glucose levels. CONCLUSION: These final KIMS cohort data support the safety of long-term GH replacement in adults with GHD as prescribed in routine clinical practice.
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spelling pubmed-92026892022-06-21 Long-term Safety of Growth Hormone in Adults With Growth Hormone Deficiency: Overview of 15 809 GH-Treated Patients Johannsson, Gudmundur Touraine, Philippe Feldt-Rasmussen, Ulla Pico, Antonio Vila, Greisa Mattsson, Anders F Carlsson, Martin Korbonits, Márta van Beek, André P Wajnrajch, Michael P Gomez, Roy Yuen, Kevin C J J Clin Endocrinol Metab Clinical Research Article CONTEXT: Data on long-term safety of growth hormone (GH) replacement in adults with GH deficiency (GHD) are needed. OBJECTIVE: We aimed to evaluate the safety of GH in the full KIMS (Pfizer International Metabolic Database) cohort. METHODS: The worldwide, observational KIMS study included adults and adolescents with confirmed GHD. Patients were treated with GH (Genotropin [somatropin]; Pfizer, NY) and followed through routine clinical practice. Adverse events (AEs) and clinical characteristics (eg, lipid profile, glucose) were collected. RESULTS: A cohort of 15 809 GH-treated patients were analyzed (mean follow-up of 5.3 years). AEs were reported in 51.2% of patients (treatment-related in 18.8%). Crude AE rate was higher in patients who were older, had GHD due to pituitary/hypothalamic tumors, or adult-onset GHD. AE rate analysis adjusted for age, gender, etiology, and follow-up time showed no correlation with GH dose. A total of 606 deaths (3.8%) were reported (146 by neoplasms, 71 by cardiac/vascular disorders, 48 by cerebrovascular disorders). Overall, de novo cancer incidence was comparable to that in the general population (standard incidence ratio 0.92; 95% CI, 0.83-1.01). De novo cancer risk was significantly lower in patients with idiopathic/congenital GHD (0.64; 0.43-0.91), but similar in those with pituitary/hypothalamic tumors or other etiologies versus the general population. Neither adult-onset nor childhood-onset GHD was associated with increased de novo cancer risks. Neutral effects were observed in lipids/fasting blood glucose levels. CONCLUSION: These final KIMS cohort data support the safety of long-term GH replacement in adults with GHD as prescribed in routine clinical practice. Oxford University Press 2022-04-03 /pmc/articles/PMC9202689/ /pubmed/35368070 http://dx.doi.org/10.1210/clinem/dgac199 Text en © The Author(s) 2022. Published by Oxford University Press on behalf of the Endocrine Society. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Clinical Research Article
Johannsson, Gudmundur
Touraine, Philippe
Feldt-Rasmussen, Ulla
Pico, Antonio
Vila, Greisa
Mattsson, Anders F
Carlsson, Martin
Korbonits, Márta
van Beek, André P
Wajnrajch, Michael P
Gomez, Roy
Yuen, Kevin C J
Long-term Safety of Growth Hormone in Adults With Growth Hormone Deficiency: Overview of 15 809 GH-Treated Patients
title Long-term Safety of Growth Hormone in Adults With Growth Hormone Deficiency: Overview of 15 809 GH-Treated Patients
title_full Long-term Safety of Growth Hormone in Adults With Growth Hormone Deficiency: Overview of 15 809 GH-Treated Patients
title_fullStr Long-term Safety of Growth Hormone in Adults With Growth Hormone Deficiency: Overview of 15 809 GH-Treated Patients
title_full_unstemmed Long-term Safety of Growth Hormone in Adults With Growth Hormone Deficiency: Overview of 15 809 GH-Treated Patients
title_short Long-term Safety of Growth Hormone in Adults With Growth Hormone Deficiency: Overview of 15 809 GH-Treated Patients
title_sort long-term safety of growth hormone in adults with growth hormone deficiency: overview of 15 809 gh-treated patients
topic Clinical Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9202689/
https://www.ncbi.nlm.nih.gov/pubmed/35368070
http://dx.doi.org/10.1210/clinem/dgac199
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