Long-term safety of growth hormone in adults with growth hormone deficiency: Overview of 15,809 GH-treated patients.
Por:
Johannsson G, Touraine P, Feldt-Rasmussen U, Pico A, Vila G, Mattsson AF, Carlsson M, Korbonits M, van Beek AP, Wajnrajch MP, Gomez R and Yuen KCJ
Publicada:
16 jun 2022
Ahead of Print:
3 abr 2022
Resumen:
CONTEXT: Data on long-term safety of growth hormone (GH) replacement in adults with GH deficiency (GHD) are needed. OBJECTIVE: To evaluate the safety of GH in the full KIMS (Pfizer International Metabolic Database) cohort. DESIGN, PATIENTS, SETTING, AND INTERVENTION: 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. MAIN OUTCOME MEASURES: Adverse events (AEs) and clinical characteristics (e.g., lipid profile, glucose) were collected. RESULTS: 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. 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. CONCLUSIONS: These final KIMS cohort data support the safety of long-term GH replacement in adults with GHD as prescribed in routine clinical practice.
Filiaciones:
Johannsson G:
Department of Endocrinology, Sahlgrenska University Hospital & Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Touraine P:
Department of Endocrinology and Reproductive Medicine, Center for Rare Endocrine and Gynecological Disorders, Sorbonne Université, Assistance Publique Hopitaux de Paris, Paris, France
Feldt-Rasmussen U:
Department of Endocrinology and Metabolism, Rigshospitalet, and Department of Clinical Medicine, Faculty of Health and Clinical Science, Copenhagen University, Copenhagen, Denmark
:
Biomedical Research Networking Center in Rare Diseases (CIBERER), Institute of Health Carlos III (ISCIII), Madrid, Spain
Hospital General Universitario de Alicante-Institute for Health and Biomedical Research (ISABIAL), Alicante, Spain
Department of Clinical Medicine, Miguel Hernández University, Elche, Spain
Vila G:
Clinical Division of Endocrinology and Metabolism, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria
Mattsson AF:
Pfizer Endocrine Care, Pfizer Health AB, Sollentuna, Sweden
Carlsson M:
Rare Disease, Biopharmaceuticals, Pfizer, New York, NY, USA
Korbonits M:
Centre for Endocrinology, William Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom
van Beek AP:
Department of Endocrinology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands
Wajnrajch MP:
Rare Disease, Biopharmaceuticals, Pfizer, New York, NY, USA
Department of Pediatrics, New York University Langone Medical Center, New York, NY, USA
Gomez R:
European Medical Affairs, Pfizer, Brussels, Belgium
Yuen KCJ:
Barrow Pituitary Center, Barrow Neurological Institute, University of Arizona College of Medicine and Creighton School of Medicine, Phoenix, AZ, USA
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