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Efficacy of a Long-Acting Growth Hormone (GH) Preparation in Patients with Adult GH Deficiency

Veterans Affairs Palo Alto Health Care System and Stanford University (A.R.H.), Palo Alto, California 94304; Harvard Medical School and Massachusetts General Hospital (B.M.K.B.), Boston, Massachusetts 02114; Oregon Health Sciences University (D.C.), Portland, Oregon 97201; Medical Affairs (J.B., L.D., K.M.A., P.F., T.M., B.L.), Genentech, Inc., South San Francisco, California 94080; and Alkermes, Inc. (B.L.S.), Cambridge, Massachusetts 02139

Address all correspondence and requests for reprints to: Andrew R. Hoffman, M.D., Building 100, Room D4-132, Department of Veterans Affairs Palo Alto Health Care System, 3801 Miranda Avenue, Palo Alto, California 94304. E-mail: arhoffman{at}stanford.edu.

Context: Treatment of adult GH deficiency (AGHD) with daily injections of GH results 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.

Main 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.

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