| Prospective Safety Surveillance of GH-Deficient Adults: Comparison of GH-Treated vs Untreated Patients. | |
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MedLine Citation:
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PMID: 23345098 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Context:In clinical practice, the safety profile of GH replacement therapy for GH-deficient adults compared with no replacement therapy is unknown.Objective:The objective of this study was to compare adverse events (AEs) in GH-deficient adults who were GH-treated with those in GH-deficient adults who did not receive GH replacement.Design and Setting:This was a prospective observational study in the setting of US clinical practices.Patients and Outcome Measures:AEs were compared between GH-treated (n = 1988) and untreated (n = 442) GH-deficient adults after adjusting for baseline group differences and controlling the false discovery rate. The standardized mortality ratio was calculated using US mortality rates.Results:After a mean follow-up of 2.3 years, there was no significant difference in rates of death, cancer, intracranial tumor growth or recurrence, diabetes, or cardiovascular events in GH-treated compared with untreated patients. The standardized mortality ratio was not increased in either group. Unexpected AEs (GH-treated vs untreated, P ≤ .05) included insomnia (6.4% vs 2.7%), dyspnea (4.2% vs 2.0%), anxiety (3.4% vs 0.9%), sleep apnea (3.3% vs 0.9%), and decreased libido (2.1% vs 0.2%). Some of these AEs were related to baseline risk factors (including obesity and cardiopulmonary disease), higher GH dose, or concomitant GH side effects.Conclusions:In GH-deficient adults, there was no evidence for a GH treatment effect on death, cancer, intracranial tumor recurrence, diabetes, or cardiovascular events, although the follow-up period was of insufficient duration to be conclusive for these long-term events. The identification of unexpected GH-related AEs reinforces the fact that patient selection and GH dose titration are important to ensure safety of adult GH replacement. |
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Authors:
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Mark L Hartman; Rong Xu; Brenda J Crowe; Leslie L Robison; Eva Marie Erfurth; David L Kleinberg; Alan G Zimmermann; Whitney W Woodmansee; Gordon B Cutler; John J Chipman; Shlomo Melmed; |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2013-1-23 |
Journal Detail:
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Title: The Journal of clinical endocrinology and metabolism Volume: - ISSN: 1945-7197 ISO Abbreviation: J. Clin. Endocrinol. Metab. Publication Date: 2013 Jan |
Date Detail:
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Created Date: 2013-1-24 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0375362 Medline TA: J Clin Endocrinol Metab Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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Lilly Research Laboratories (M.L.H., R.X., B.J.C., A.G.Z., G.B.C., J.J.C.), Indianapolis, Indiana 46285; St. Jude Children's Research Hospital (L.L.R.), Memphis, Tennessee 38105; Skånes University Hospital (E.M.E.), SE-221 85 Lund, Sweden; New York University Medical Center (D.L.K.), New York, New York 10016; Brigham and Women's Hospital (W.W.W.), Harvard Medical School, Boston, Massachusetts 02115; and Cedars-Sinai Medical Center (S.M.), University of California at Los Angeles School of Medicine, Los Angeles, California 90048. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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