Efficacy and safety of individualized growth hormone treatment in adult Japanese patients with growth hormone deficiency.
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.
Chihara
Kazuo
K
Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.
Kato
Yuzuru
Y
Department of Medicine, Shimane University, Izumo, Japan.
Shimatsu
Akira
A
Clinical Research Center for Endocrine and Metabolic Disease, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
Tanaka
Toshiaki
T
Department of Clinical Laboratory Medicine, National Center for Child Health and Development, Tokyo, Japan.
Kohno
Hitoshi
H
Department of Endocrinology and Metabolism, Fukuoka Children's Hospital, Fukuoka, Japan.
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
D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I