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Cited by 116Growth Hormone and Insulin-like Growth FactorsGenetic and Clinical Aspects of Sex Determination and Chromosomal AbnormalitiesPituitary Gland Disorders and Treatments

Long-term safety of recombinant human growth hormone in Turner syndrome

Bolar, Katrina, Hoffman, Andrew R., Maneatis, Thomas, Lippe, Barbara·2008·The Journal of Clinical Endocrinology & Metabolism
DOI 10.1210/jc.2007-1723
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Abstract

CONTEXT: Turner syndrome (TS) affects more than 50,000 girls and women in the United States. The National Cooperative Growth Study (NCGS) has collected efficacy and safety data for 5220 TS children treated with recombinant human GH (rhGH) during the last 20 yr. OBJECTIVES: Our objective was to determine frequencies of specific targeted adverse events (AEs) and additional AEs of interest in TS patients. Corresponding safety data in non-TS patients or normal populations were compared for selected AEs. METHODS: Patients may be enrolled at rhGH initiation and followed until discontinuation. Investigators submit AE reports describing any event that is potentially rhGH related or is a targeted event. RESULTS: The Genentech Drug Safety department received 442 AE reports for TS NCGS patients as of June 30, 2006, including 117 serious AEs. Seven deaths occurred; five resulted from aortic dissections/ruptures. The incidence of certain events known to be associated with rhGH (targeted events), including intracranial hypertension, slipped capital femoral epiphysis, scoliosis, and pancreatitis, was increased compared with other non-TS patients in NCGS. There were 10 new-onset malignancies that occurred, including six in patients without known risk factors. Type 1 diabetes also appeared to be increased compared with other NCGS groups. CONCLUSIONS: Children with TS who were treated with rhGH exhibit an increased underlying risk for selected AEs associated with rhGH and for type 1 diabetes, which is likely unrelated to rhGH. The aortic dissection/rupture incidence reflects the higher baseline risk for these events in TS, was consistent with current epidemiological data in smaller TS populations, and is likely unrelated to rhGH. It is not known whether the reported malignancies represent an inherently increased risk in TS patients. Twenty years of experience in 5220 patients indicates no new rhGH-related safety signals in the TS population. The NCGS and similar registries, although focused on the years during rhGH treatment, may also be a window into the natural history of TS in childhood.

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Crossref · 10.1210/jc.2007-1723

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Authors
Bolar, K., Hoffman, A. R., Maneatis, T., & Lippe, B.
Affiliations
  • The University of Texas Medical Branch at Galveston (US)
  • VA Palo Alto Health Care System (US)
  • Genentech (US)
Corresponding author
Bolar, Katrina
ORCID
Hoffman, Andrew R.
Venue
The Journal of Clinical Endocrinology & Metabolism
Publisher
The Endocrine Society
Published
2008-02-01
Volume
93
Issue
2
Pages
344-351
ISSN
  • 0021-972X (ISSN-L)
  • 1945-7197
DOI
10.1210/jc.2007-1723
OpenAlex
W2011646161
Cited by
116
References
57
Citations by year
2026: 2 · 2025: 2 · 2024: 5 · 2023: 6 · 2022: 3 · 2021: 2 · 2020: 8 · 2019: 7 · 2018: 9 · 2017: 4 · 2016: 4 · 2015: 9 · 2014: 6 · 2013: 9 · 2012: 6
FWCI
6.09
Type
journal article
Language
en
Open access
closed
Locations
  • The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
  • PubMed (publishedVersion)
Funders
Genentech
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Growth Hormone and Insulin-like Growth Factors
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Genetic and Clinical Aspects of Sex Determination and Chromosomal Abnormalities
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Pituitary Gland Disorders and Treatments
Keywords
Turner syndrome, recombinant human growth hormone, long-term safety, adverse events, aortic dissection, intracranial hypertension, slipped capital femoral epiphysis, scoliosis, pancreatitis, type 1 diabetes, growth hormone therapy
MeSH terms
Adolescent, Adult, Aortic Aneurysm, Child, Child, Preschool, Diabetes Mellitus, Epiphyses, Slipped, Female, Humans, Male, Neoplasms, Pancreatitis, Recombinant Proteins, Scoliosis, Turner Syndrome, Human Growth Hormone, Intracranial Hypertension

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