Document Detail


A multi-center controlled trial of growth hormone treatment in children with cystic fibrosis.
MedLine Citation:
PMID:  21905270     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: We evaluated safety and efficacy of recombinant human growth hormone (rhGH) for improving growth, lean body mass (LBM), pulmonary function, and exercise tolerance in children with cystic fibrosis (CF) and growth restriction.
STUDY DESIGN: Multicenter, open-label, controlled clinical trial comparing outcomes in prepubertal children <14 years with CF, randomized in a 1:1 ratio to receive daily rhGH (Nutropin AQ) or no treatment (control) for 12 months, followed by a 6-month observation (month 18). Safety was monitored at each visit, including assessments of glucose tolerance.
RESULTS: Sixty-eight subjects were randomized (control n = 32; rhGH n = 36). Mean height standard deviation score (SDS) in the rhGH group increased by 0.5 ± 0.4 at 12 months (mean ± SD, P < 0.001); the control group height SDS remained unchanged. Weight increased by 3.8 ± 1.8 versus 2.8 ± 1.5 kg, (mean ± SD, P = 0.0356) and LBM increased by 3.8 ± 1.8 versus 2.1 ± 1.4 kg (P = 0.0002) in the rhGH group versus controls, respectively. Forced vital capacity increased by 325 ± 319 in the rhGH group compared with 178 ± 152 ml in controls (mean ± SD, P = 0.032). Forced expiratory volume in 1 sec improved in both groups with a significant difference between groups after adjustment for baseline severity (LS mean ± SE: rhGH, 224 ± 37, vs. controls, 108 ± 40 ml; P = 0.04). There was no difference between groups in exercise tolerance (6-min walk distance) at 1 year. Changes in glucose tolerance for the two groups were similar over the 12-month study period, with three subjects developing IGT and one CFRD in each group. One rhGH-treated patient developed increased intracranial pressure.
CONCLUSIONS: Treatment with rhGH in prepubertal children with CF was effective in promoting growth, weight, LBM, lung volume, and lung flows, and had an acceptable safety profile.
Authors:
Michael S Stalvey; Ran D Anbar; Michael W Konstan; Joan R Jacobs; Bert Bakker; Barbara Lippe; David E Geller
Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2011-09-08
Journal Detail:
Title:  Pediatric pulmonology     Volume:  47     ISSN:  1099-0496     ISO Abbreviation:  Pediatr. Pulmonol.     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-02-15     Completed Date:  2012-06-12     Revised Date:  2014-06-04    
Medline Journal Info:
Nlm Unique ID:  8510590     Medline TA:  Pediatr Pulmonol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  252-63     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 Wiley Periodicals, Inc.
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Body Composition / drug effects*
Body Height / drug effects*
Body Weight / drug effects
Child
Child, Preschool
Cystic Fibrosis / drug therapy*
Exercise Tolerance / drug effects*
Female
Forced Expiratory Volume / drug effects
Human Growth Hormone / therapeutic use*
Humans
Lung / drug effects
Male
Recombinant Proteins / therapeutic use
Treatment Outcome
Grant Support
ID/Acronym/Agency:
P30 DK027651/DK/NIDDK NIH HHS
Chemical
Reg. No./Substance:
0/Recombinant Proteins; 12629-01-5/Human Growth Hormone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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