Efficacy and safety of individualized growth hormone treatment in adult Japanese patients with growth hormone deficiency

ObjectiveThe 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.DesignRandomized, 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.SubjectsAdult Japanese GH-deficient patients (peak GH < 3 ng/mL).MeasurementsTrunk and total body fat (BF), lean body mass (LBM), and adverse events were determined.ResultsPercentage 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.ConclusionsTreatment 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.