Document Detail


Prospective safety surveillance of GH-deficient adults: comparison of GH-treated vs untreated patients.
MedLine Citation:
PMID:  23345098     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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:
Type:  Comparative Study; Journal Article; Research Support, Non-U.S. Gov't     Date:  2013-01-23
Journal Detail:
Title:  The Journal of clinical endocrinology and metabolism     Volume:  98     ISSN:  1945-7197     ISO Abbreviation:  J. Clin. Endocrinol. Metab.     Publication Date:  2013 Mar 
Date Detail:
Created Date:  2013-03-08     Completed Date:  2013-04-30     Revised Date:  2013-07-12    
Medline Journal Info:
Nlm Unique ID:  0375362     Medline TA:  J Clin Endocrinol Metab     Country:  United States    
Other Details:
Languages:  eng     Pagination:  980-8     Citation Subset:  AIM; IM    
Affiliation:
Lilly Research Laboratories, Indianapolis, Indiana 46285, USA.
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Cardiovascular Diseases / mortality
Comorbidity
Diabetes Mellitus / mortality
Female
Follow-Up Studies
Growth Disorders / drug therapy*,  mortality*
Human Growth Hormone / administration & dosage,  adverse effects*,  deficiency*
Humans
Incidence
Insulin-Like Growth Factor Binding Protein 3 / blood
Insulin-Like Growth Factor I / metabolism
Male
Middle Aged
Neoplasms / mortality
Population Surveillance
Prospective Studies
Risk Factors
Sleep Disorders / mortality
Chemical
Reg. No./Substance:
0/IGFBP3 protein, human; 0/Insulin-Like Growth Factor Binding Protein 3; 12629-01-5/Human Growth Hormone; 67763-96-6/Insulin-Like Growth Factor I
Investigator
Investigator/Affiliation:
R Kloos / ; E Ennis / ; B Trippe / ; R C Biesbroeck / ; P Levy / ; S Kemp / ; A R Barber / ; R Mims / ; I Fishman / ; P Ginier / ; P Norwood / ; R Kaplan / ; G Dailey / ; S Melmed / ; S Korenman / ; J A Linfoot / ; U Masharani / ; S Mayeda / ; E Meyer / ; R Swerdloff / ; C Varma / ; G Poticha / ; E C Ridgway / ; P Zeitler / ; M Stjernholm / ; B Widom / ; J M Cabral / ; R M Harrell / ; S E Crockett / ; L Deeb / ; M S Eidson / ; B Horowitz / ; L Kennedy / ; D Schatz / ; S Lerman / ; C Pacheco / ; R Plasko / ; M Sainz de la Pena / ; A Iezzi / ; R C Smallridge / ; D R Sutton / ; H Delcher / ; S Isaacs / ; A E Karpas / ; K J Lucas / ; L Phillips / ; J Reed / ; R Schultz / ; V Silverman / ; G Umpierrez / ; D H Jacobson / ; S B Leichter / ; W G Schroffner / ; R Christensen / ; G Baumann / ; L Frohman / ; R Levy / ; R Weiss / ; N Soler / ; R Khairi / ; J Cavanaugh / ; J Schlechte / ; M Sokol / ; J Speed / ; T Goodenow / ; R Miller / ; L C Myers / ; E Pedroza / ; M Sandberg / ; T Bigos / ; T Donner / ; G Wand / ; N Aronin / ; P Black / ; B M K Biller / ; R Lechan / ; M Carella / ; V Gossain / ; B M Doeden / ; C Mariash / ; F Nuttall / ; A Sill / ; M Slag / ; R Duda / ; N Fishman / ; G Griffing / ; D W Gardner / ; R Anderson / ; J Larsen / ; R Agrin / ; V Gandhi / ; R Rapaport / ; K Usiskin / ; J Stock / ; R Ferraro / ; J Albu / ; R Fiedler / ; M Harbison / ; D Kleinberg / ; E Merker / ; D Smolyar / ; I Young / ; T W AvRuskin / ; M A Banerji / ; P Dandona / ; S S El Deiry / ; D l Lee / ; Z R Freedman / ; L Jacobs / ; S Wittlin / ; K S Hershon / ; B Feuerstein / ; K Kartun / ; H A Lippes / ; H R Mogul / ; S Quyyumi / ; P Saenger / ; T Spinaris / ; G Trager / ; D Becker / ; A R Barber / ; R Dickey / ; R Bracken / ; N J Kramer / ; S Story / ; R Dodd / ; P Strumph / ; T Walden / ; S Chernausek / ; S Reddy / ; C E Smith / ; J Bagdade / ; B Musa / ; L Olansky / ; D Cook / ; J Amico / ; M B Gordon / ; G Borowski / ; C Y Fan / ; D Barilla / ; M C Greenlee / ; W B Kessler / ; F Lee / ; A Schorr / ; L L Key / ; A J Cohen / ; B Williams-Cleaves / ; M Carlson / ; C A Fassler / ; J Davidson / ; D Feinstein / ; J Rosenstock / ; R Sachson / ; G M Gollapudi / ; M S Kipnes / ; S Miller / ; M Sharma / ; W J Strader / ; J Grua / ; J B Stanchfield / ; J D Wahlen / ; R Adler / ; R Downs / ; M L Vance / ; A Vinik / ; H K Cathcart / ; C Wysham / ; K D McCowen / ; G Merriam / ; L Stonesifer / ; S R Grubb / ; T Hagen / ; Y Shenker /
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