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Long-Term Safety of...
Long-Term Safety of Growth Hormone in Adults With Growth Hormone Deficiency: Overview of 15 809 GH-Treated Patients
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- Johannsson, Gudmundur, 1960 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin,Institute of Medicine
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Touraine, P. (author)
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Feldt-Rasmussen, U. (author)
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Pico, A. (author)
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Vila, G. (author)
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Mattsson, A. F. (author)
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Carlsson, M. (author)
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Korbonits, M. (author)
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van Beek, A. P. (author)
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Wajnrajch, M. P. (author)
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Gomez, R. (author)
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Yuen, K. C. J. (author)
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(creator_code:org_t)
- 2022-04-03
- 2022
- English.
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In: Journal of Clinical Endocrinology & Metabolism. - : The Endocrine Society. - 0021-972X .- 1945-7197. ; 107:7, s. 1906-1919
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
Keyword
- adult growth hormone deficiency
- growth hormone
- hypopituitarism
- cancer
- safety
- KIMS
- quality-of-life
- apolipoprotein b100 kinetics
- cardiovascular
- risk-factors
- replacement therapy
- hypopituitary patients
- primary
- cancers
- mortality
- diagnosis
- glucose
- profile
- Endocrinology & Metabolism
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Johannsson, Gudm ...
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Touraine, P.
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Feldt-Rasmussen, ...
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Pico, A.
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Vila, G.
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Mattsson, A. F.
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show more...
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Carlsson, M.
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Korbonits, M.
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van Beek, A. P.
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Wajnrajch, M. P.
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Gomez, R.
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Yuen, K. C. J.
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show less...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Endocrinology an ...
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Journal of Clini ...
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University of Gothenburg