CLINICAL STUDY An individualized GH dose regimen for long-term GH treatment in Japanese patients with adult GH deficiency

med.kobe-u.ac.jp) Objectives: To investigate the effects of growth hormone (GH) treatment, using a dose-adjustment regi-men based on serum insulin-like growth factor (IGF)-I concentrations, in adult Japanese hypopitui-tary patients with GH deficiency. Study design: Japanese patients who had initially been administered GH (n 31) or placebo (n 28) in a 24-week double-blind study received individualized GH treatment in an open-label study for 48 weeks. Body composition from dual-energy X-ray absorptiometry (DXA) and serum IGF-I, IGF-binding protein 3 (IGFBP-3) and lipid levels were determined centrally. Results: Significant increases in lean body mass (4.5%) and decreases in fat mass (210.5%) were observed in the group that received individualized GH doses in the present open-label study following placebo in the double-blind study. This was comparable with the changes observed in these par-ameters (4.7 and 29.2%, respectively) with fixed-dose GH treatment in the double-blind study; this latter group maintained these improvements throughout the open-label study. Individualized dose adjustment allowed for more moderate dose increases than the fixed-dose titration method. Indi