title: Efficacy of a long-acting growth hormone (GH) preparation in patients with adult GH deficiency.
abstract: BACKGROUND
  Treatment of adult GH deficiency (AGHD) with daily injections of GH results in decreased adipose mass, increased lean body mass (LBM), increased bone mineral density, and improved quality of life.
  
  
  OBJECTIVE
  This study seeks to determine whether a depot preparation of GH given every 14 d would lead to comparable decreases in trunk adipose tissue as daily GH.
  
  
  METHODS
  This open-label, randomized study compares subjects receiving depot GH, daily GH, or no therapy.
  
  
  METHODS
  The study was performed at 23 university or local referral endocrine centers.
  
  
  METHODS
  One hundred thirty-five adults with AGHD syndrome participated in the study.
  
  
  METHODS
  Subjects were randomized to receive depot GH (n = 51), daily GH (n = 53), or no treatment (n = 31) for 32 wk. The dose of GH was titrated so that IGF-I was less than or equal to +2 SD of the age-adjusted normal range.
  
  
  METHODS
  Trunk adipose tissue was the main outcome measure as measured by dual energy x-ray absorptiometry.
  
  
  RESULTS
  The percentage of the trunk region that is fat increased by 0.4 in the no treatment group, but decreased by 3.2 (P = 0.001 vs. untreated) in the GH depot group and by 2.5 (P < 0.004 vs. untreated) in the daily GH group. Visceral adipose tissue area decreased by 9.1% in the GH depot group and by 6.8% in the daily GH group. LBM and high-density lipoprotein increased in both treatment groups. Side effect profiles were similar. Three subjects receiving GH experienced serious episodes of adrenal insufficiency.
  
  
  CONCLUSIONS
  GH diminishes trunk and visceral adipose tissue and increases LBM in AGHD. A depot form of GH that is administered every 14 d is as safe and effective as daily GH injections.
authors.affiliation: Department of Veterans Affairs Palo Alto Health Care System, 3801 Miranda Avenue, Palo Alto, California 94304, USA. arhoffman@stanford.edu
authors.forename: Andrew R
authors.initials: AR
authors.lastname: Hoffman
authors.forename: Beverly M K
authors.initials: BM
authors.lastname: Biller
authors.forename: David
authors.initials: D
authors.lastname: Cook
authors.forename: Joyce
authors.initials: J
authors.lastname: Baptista
authors.forename: Bernard L
authors.initials: BL
authors.lastname: Silverman
authors.forename: Le
authors.initials: L
authors.lastname: Dao
authors.forename: Kenneth M
authors.initials: KM
authors.lastname: Attie
authors.forename: Paul
authors.initials: P
authors.lastname: Fielder
authors.forename: Thomas
authors.initials: T
authors.lastname: Maneatis
authors.forename: Barbara
authors.initials: B
authors.lastname: Lippe
mesh_terms: D000328:Adult; D017668:Age of Onset; D001823:Body Composition / Q000187:drug effects; D002097:C-Reactive Protein / Q000378:metabolism; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D005260:Female; D019382:Human Growth Hormone / Q000008:administration & dosage* / Q000009:adverse effects / Q000172:deficiency* / Q000627:therapeutic use; D006801:Humans; D007279:Injections, Subcutaneous; D007334:Insulin-Like Growth Factor I / Q000378:metabolism; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D012727:Sex Characteristics; D043202:Steroid Metabolism, Inborn Errors / Q000097:blood / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000453:epidemiology; D014057:Tomography, X-Ray Computed
chemical_list: D003692:Delayed-Action Preparations; D008055:Lipids; D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I; D002097:C-Reactive Protein