Efficacy of a long-acting growth hormone (GH) preparation in patients with adult GH deficiency

Context: Treatment of adult GH deficiency (AGHD) with daily injections ofGHresults 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. Design: This open-label, randomized study compares subjects receiving depot GH, daily GH, or no therapy. Setting: The study was performed at 23 university or local referral endocrine centers. Patients or Other Participants: One hundred thirty-five adults with AGHD syndrome participated in the study. Intervention: 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. M ain Outcome Measure: 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.