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    A multi-center controlled trial of growth hormone treatment in children with cystic fibrosis

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    Authors
    Stalvey, Michael S.
    Anbar, Ran D.
    Konstan, Michael W.
    Jacobs, Joan R.
    Bakker, Bert
    Lippe, Barbara
    Geller, David E.
    UMass Chan Affiliations
    Department of Pediatrics
    Document Type
    Journal Article
    Publication Date
    2012-03-01
    Keywords
    Cystic Fibrosis
    Human Growth Hormone
    Allergy and Immunology
    Pediatrics
    Respiratory Tract Diseases
    
    Metadata
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    Link to Full Text
    http://dx.doi.org/10.1002/ppul.21546
    Abstract
    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 childrenCF, 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.
    Source
    Pediatr Pulmonol. 2012 Mar;47(3):252-63. doi: 10.1002/ppul.21546. Epub 2011 Sep 8.
    DOI
    10.1002/ppul.21546
    Permanent Link to this Item
    http://hdl.handle.net/20.500.14038/43856
    PubMed ID
    21905270
    Related Resources
    Link to article in PubMed
    ae974a485f413a2113503eed53cd6c53
    10.1002/ppul.21546
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