TY - JOUR

T1 - Long-term Safety of Growth Hormone in Adults With Growth Hormone Deficiency

T2 - Overview of 15 809 GH-Treated Patients

AU - Johannsson, Gudmundur

AU - Touraine, Philippe

AU - Feldt-Rasmussen, Ulla

AU - Pico, Antonio

AU - Vila, Greisa

AU - Mattsson, Anders F.

AU - Carlsson, Martin

AU - Korbonits, Márta

AU - Van Beek, Andr Crossed D.sign© P.

AU - Wajnrajch, Michael P.

AU - Gomez, Roy

AU - Yuen, Kevin C.J.

N1 - Publisher Copyright: © 2022 The Author(s) 2022. Published by Oxford University Press on behalf of the Endocrine Society.

PY - 2022

Y1 - 2022

N2 - 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.

AB - 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.

KW - adult growth hormone deficiency

KW - cancer

KW - growth hormone

KW - hypopituitarism

KW - KIMS

KW - safety

UR - http://www.scopus.com/inward/record.url?scp=85132454167&partnerID=8YFLogxK

U2 - 10.1210/clinem/dgac199

DO - 10.1210/clinem/dgac199

M3 - Journal article

C2 - 35368070

AN - SCOPUS:85132454167

VL - 107

SP - 1906

EP - 1919

JO - Journal of Clinical Endocrinology and Metabolism

JF - Journal of Clinical Endocrinology and Metabolism

SN - 0021-972X

IS - 7

ER -