Long‐term safety of growth hormone—A combined registry analysis

Long‐term safety of growth hormone—A combined registry analysis BACKGROUNDRecombinant human GH, first licensed to treat GH deficiency (GHD) in children in 1985, is now approved to treat GHD in adults and other paediatric conditions associated with growth impairment. Hence, hundreds of thousands of children and adults have received GH treatment over the past 3 decades.Clinical trials have demonstrated the efficacy and safety of GH treatment. The short‐term safety profile is considered to be good; the incidence of adverse events (AEs) is lower than expected based on patients with natural GH excess (acromegaly). The long‐term safety profile of GH has been well documented by postmarketing registries established by the major manufacturers following GH approval.In 2007, preliminary data from the French cohort of the Safety and Appropriateness of Growth hormone treatments in Europe (SAGhE) study suggested a link between childhood GH treatment and premature death and from a second report, between GH treatment and stroke. However, preliminary data from Belgium, the Netherlands and Sweden (2543 patients) showed no excess deaths due to cancer or cardiovascular disease. Although the validity of the French cohort study has since been questioned, it has nevertheless brought the long‐term safety profile of GH to the forefront. The SAGhE study collected data from cohorts of http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Clinical Endocrinology Wiley

Long‐term safety of growth hormone—A combined registry analysis

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Publisher
Wiley Subscription Services, Inc., A Wiley Company
Copyright
Copyright © 2018 John Wiley & Sons Ltd
ISSN
0300-0664
eISSN
1365-2265
D.O.I.
10.1111/cen.13502
Publisher site
See Article on Publisher Site

Abstract

BACKGROUNDRecombinant human GH, first licensed to treat GH deficiency (GHD) in children in 1985, is now approved to treat GHD in adults and other paediatric conditions associated with growth impairment. Hence, hundreds of thousands of children and adults have received GH treatment over the past 3 decades.Clinical trials have demonstrated the efficacy and safety of GH treatment. The short‐term safety profile is considered to be good; the incidence of adverse events (AEs) is lower than expected based on patients with natural GH excess (acromegaly). The long‐term safety profile of GH has been well documented by postmarketing registries established by the major manufacturers following GH approval.In 2007, preliminary data from the French cohort of the Safety and Appropriateness of Growth hormone treatments in Europe (SAGhE) study suggested a link between childhood GH treatment and premature death and from a second report, between GH treatment and stroke. However, preliminary data from Belgium, the Netherlands and Sweden (2543 patients) showed no excess deaths due to cancer or cardiovascular disease. Although the validity of the French cohort study has since been questioned, it has nevertheless brought the long‐term safety profile of GH to the forefront. The SAGhE study collected data from cohorts of

Journal

Clinical EndocrinologyWiley

Published: Jan 1, 2018

Keywords: ; ; ; ;

References

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