Long-term Safety of Growth Hormone in Adults With Growth Hormone Deficiency: Overview of 15 809 GH-Treated Patients
Year: 2022
Type: article
Study design: Observational Study
Abstract: 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.
Institutions: Sahlgrenska University Hospital, University of Gothenburg, Sorbonne Université, Assistance Publique – Hôpitaux de Paris, University of Copenhagen, Rigshospitalet, Universitat de Miguel Hernández d'Elx, Instituto de Salud Carlos III, Centre for Biomedical Network Research on Rare Diseases, Hospital General Universitario de Alicante Doctor Balmis, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Medical University of Vienna, Pfizer (Sweden), Pfizer (United States), Queen Mary University of London, William Harvey Research Institute, University Medical Center Groningen, University of Groningen, NYU Langone Health, Pfizer (Belgium), Barrow Neurological Institute, University of Arizona, University of Arizona College of Medicine- Phoenix
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,400
Funder: Pfizer
OpenAlex ID: W4226188475