title: Efficacy and safety of individualized growth hormone treatment in adult Japanese patients with growth hormone deficiency.
abstract: OBJECTIVE
  The aim of the study was to evaluate the efficacy and safety of growth hormone (GH) treatment in Japanese adult patients with GH-deficiency. In the extension of the efficacy study, the effect of individualized-dosing (ID), based on insulin-like growth factor-I (IGF-I) levels, and fixed-dose (FD) GH regimens on body composition, were compared in Japanese GH-deficient adults.
  
  
  METHODS
  Randomized, double-blind (DB), placebo-controlled, 24-week treatment period followed by 48-week, open-label study in 43 endocrinology clinics in Japan. Patients received DB treatment with GH (0.012 mg/kg/day; n=57) or placebo (n=60) followed by open-label GH in an ID (n=75) or FD (0.012 mg/kg/day; n=38) regimen.
  
  
  METHODS
  Adult Japanese GH-deficient patients (peak GH<3 ng/mL).
  
  
  METHODS
  Trunk and total body fat (BF), lean body mass (LBM), and adverse events were determined.
  
  
  RESULTS
  Percentage trunk fat was reduced significantly more in GH- than in placebo-treated patients at 24 weeks (-16.2 vs. 1.7%, p<0.0001). Open-label treatment with an ID or FD GH regimen provided similar reductions in percentage trunk fat (-8.12 vs. -9.35%), and total BF (-0.92 vs. -0.70 kg) and a comparable increase in LBM (1.032 vs. 0.97 kg). Mean+/-SD GH doses (mg/kg/day) at 48 weeks were significantly lower with the ID GH regimen (ID, 0.0082+/-0.0050; FD, 0.0095+/-0.0033; p<0.05). The safety profile was comparable between ID and FD groups.
  
  
  CONCLUSIONS
  Treatment with GH was associated with a significant reduction in trunk fat and improvement in serum lipid profile in Japanese adult GH-deficient patients. The improvement in body composition and tolerability were comparable between ID and FD GH regimens despite a significantly lower daily GH dose with the ID regimen.
authors.affiliation: Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Chihara
authors.affiliation: Department of Medicine, Shimane University, Izumo, Japan.
authors.forename: Yuzuru
authors.initials: Y
authors.lastname: Kato
authors.affiliation: Clinical Research Center for Endocrine and Metabolic Disease, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Shimatsu
authors.affiliation: Department of Clinical Laboratory Medicine, National Center for Child Health and Development, Tokyo, Japan.
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Tanaka
authors.affiliation: Department of Endocrinology and Metabolism, Fukuoka Children's Hospital, Fukuoka, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Kohno
mesh_terms: D000328:Adult; D001823:Body Composition; D003677:Deficiency Diseases / Q000188:drug therapy; D004311:Double-Blind Method; D005260:Female; D006130:Growth Disorders / Q000188:drug therapy*; D020249:Hormone Replacement Therapy; D019382:Human Growth Hormone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000032:analysis; D007564:Japan; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I