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Safety of recombinant deoxyribonucleic acid-derived growth hormone: The national cooperative growth study experience
Abstract
The National Cooperative Growth Study has monitored the safety of recombinant human GH (rhGH) since 1985. Data have been collected from more than 19,000 children representing over 47,000 patient-years of rhGH treatment. Children receiving GH for renal disease were more likely to develop problems such as intracranial hypertension than those with GH deficiency (P < 0.01). Children with idiopathic short stature were less likely to develop slipped capital femoral epiphysis than those with GH deficiency or Turner's syndrome (P < 0.01). There was no evidence of an increased recurrence of leukemia or central nervous system tumors. There were 3 new cases of leukemia in children without known risk factors for developing leukemia and 5 cases in children with known risk factors. Growth deceleration associated with high affinity, high capacity antibodies to GH was found in only 2 of 5039 subjects tested (0.04%). Major adverse events in association with rhGH treatment have been rare, and preexisting medical conditions such as renal insufficiency may affect their frequency.
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“Large-scale cohort studies have shown that, compared to the general population, the incidence of developing type 2 diabetes for children under GH treatment was increased more than six times, especially in patients with predisposing risk factors, such as obesity (46–48).”
From The progression of secondary diabetes: A review of modeling studies (2022) · cites this paper as [46]
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Metadata
- Authors
- Blethen, S. L., Allen, D. B., Graves, D., August, G., Moshang, T., & Rosenfeld, R.
- Affiliations
- State University of New York (US)
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 1996-05
- Volume
- 81
- Issue
- 5
- Pages
- 1704-1710
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- OpenAlex
- W2090173071
- Cited by
- 246
- References
- 0
- Citations by year
- 2025: 1 · 2024: 4 · 2023: 2 · 2022: 2 · 2021: 1 · 2020: 54 · 2019: 1 · 2018: 5 · 2017: 4 · 2016: 4 · 2015: 8 · 2014: 5 · 2013: 4 · 2012: 5
- FWCI
- 10.44
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Growth Hormone and Insulin-like Growth Factors
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Pituitary Gland Disorders and Treatments
- Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
- Keywords
- recombinant human growth hormone, drug safety, growth hormone deficiency, idiopathic short stature, Turner syndrome, kidney disease, intracranial hypertension, slipped capital femoral epiphysis, leukemia recurrence, central nervous system tumors, anti-growth hormone antibodies, growth slowdown, adverse events
- MeSH terms
- Adolescent, Adult, Carpal Tunnel Syndrome, Child, Edema, Female, Gynecomastia, Humans, Leukemia, Lymphedema, Male, Neoplasms, Nevus, Pseudotumor Cerebri, Recombinant Proteins, Recurrence, Growth Hormone
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