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Human Growth Hormone Replacement in Adult Hypopituitary Patients: Long-Term Effects on Body Composition and Lipid Status—3-Year Results from the HypoCCS Database

Eli Lilly \|[amp ]\| Co. (A.F.A., D.V.), 50019 Florence, Italy; Lilly Research Centre, Windlesham (P.C.B.), Surrey GU20 6PH, United Kingdom; Garvan Institute of Medical Research (K.K.Y.H.), Sydney NSW 2010, Australia; Hospital Santa Creu i Sant Pau (S.M.W.), 08025 Barcelona, Spain; Department of Medicine, Northern General Hospital (R.J.R.), Sheffield S5 7AU, United Kingdom; Ludwig-Maximilians-Universität (C.J.S.), München 80336, Germany; Laboratorium voor Experimentele Geneeskunde en Endocrinologie (R.B.), 3000 Leuven, Belgium; Eli Lilly \|[amp ]\| Co. (B.C., K.S.), Indianapolis, Indiana 46285; and Ziekenhuis Dijkzigt (S.W.J.L.), 3015 GD Rotterdam, The Netherlands

Address all correspondence and requests for reprints to: Andrea F. Attanasio, Eli Lilly & Co., Via Gramsci 731, 50019 Florence, Italy. E-mail: . attanasio_andrea{at}lilly.com

Abstract

The Hypopituitary Control and Complications Study is an international surveillance study evaluating efficacy and safety of GH therapy of adult GH-deficient patients in clinical practice. The present report examined baseline data from 1,123 adult onset (AO) and 362 childhood onset (CO) patients, as well as efficacy in 242 patients who had completed 3 yr of GH treatment. At study entry, mean height, body mass index, waist to hip ratio, and lean body mass were significantly (P < 0.001 for each) lower in CO compared with AO patients. After 3 yr on GH, lean body mass was significantly increased in AO males and females and CO males but not CO females, whereas fat mass was significantly decreased in AO males only. Serum total cholesterol was decreased in females (-0.32 ± 1.00 mmol/liter; P = 0.045) and males (-0.36 ± 0.96 mmol/liter; P = 0.004). High-density lipoprotein (HDL) cholesterol was increased for females (0.10 ± 0.26 mmol/liter; P = 0.026) and males (0.10 ± 0.34 mmol/liter; P = 0.022). The low-density lipoprotein/HDL ratio was decreased in AO males (-0.93 ± 2.00; P = 0.003), AO females (-0.65 ± 0.74; P < 0.001), and CO females (-0.69 ± 0.76; P = 0.038), but the decrease in CO males was not significant (-0.84 ± 2.85; P = 0.273). In AO patients, lean body mass increase from baseline was greatest in the those younger than 40 yr old, less but still significant in the middle group (40–60 yr) and unchanged in older (>60 yr) patients; conversely, decreases in the low-density lipoprotein/HDL ratio were small and not significant in the younger patients but greater and significant in the middle and older age groups. During the 3-yr treatment, 114 (7.7%) patients discontinued, including 9 (0.6%) for tumor recurrences, 9 (0.6%) for neoplasia, and 9 (0.6%) for side effects. Therefore, these observational data showed significant long-term efficacy of adult GH replacement therapy on body composition and lipid profiles and indicate that age is an important predictor of response.

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