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CLINICAL STUDY |
1 Department of Clinical Molecular Medicine, Kobe University Graduate School of Medicine, Kobe, Japan 2 Eli Lilly Japan K.K., Kobe, Japan 3 Clinical Research Center for Endocrine and Metabolic Disease, Kyoto Medical Center, Kyoto, Japan 4 Division of Endocrinology, Metabolism, Hematology and Oncology, Shimane University, Izumo, Japan 5 Department of Endocrinology and Metabolism, Fukuoka Children’s Hospital, Fukuoka, Japan 6 Division of Endocrinology and Metabolism, National Center for Child Health and Development, Tokyo, Japan 7 Department of Neurosurgery, Nippon Medical School, Tokyo, Japan 8 Cambridge Medical Writing Services, Ickleton, Cambridge CB10 1SH, UK 9 Cascina del Rosone, Agliano Terme, Italy
(Correspondence should be addressed to K Chihara, Division of Endocrinology/Metabolism, Neurology and Hematology/Oncology, Department of Clinical Molecular Medicine, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan; Email: chiharak{at}med.kobe-u.ac.jp)
Objectives: To investigate the effects of growth hormone (GH) treatment, using a dose-adjustment regimen based on serum insulin-like growth factor (IGF)-I concentrations, in adult Japanese hypopituitary 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 (–10.5%) 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 parameters (4.7 and –9.2%, 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. Individualized dosing also resulted in a lower mean dose for adult-onset compared with childhood-onset GH-deficient patients (0.032±0.019 versus 0.061±0.023 mg/kg per week for patients treated with GH for 48 weeks in the open-label study following placebo in the double-blind study). Dosing patterns in the two groups were paralleled by the changes in IGF-I and IGFBP-3. The incidence of oedema and cases with high IGF-I level were less frequent under the IGF-I controlled regimen compared with those during the fixed-dose titration method.
Conclusion: Individualized GH administration based on IGF-I levels was safe and effective. This regimen demonstrated differences in dose requirements between adult- and childhood-onset patients. An individualized dose regimen is recommended in adult Japanese GH-deficient patients.
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  H. Urushihara, S. Fukuhara, S. Tai, S. Morita, and K. Chihara Heterogeneity in responsiveness of perceived quality of life to body composition changes between adult- and childhood-onset Japanese hypopituitary adults with GH deficiency during GH replacement Eur. J. Endocrinol., June 1, 2007; 156(6): 637 - 645. [Abstract] [Full Text] [PDF]
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 M. Bidlingmaier, J. Kim, C. Savoy, M. J. Kim, N. Ebrecht, S. de la Motte, and C. J. Strasburger Comparative Pharmacokinetics and Pharmacodynamics of a New Sustained-Release Growth Hormone (GH), LB03002, Versus Daily GH in Adults with GH Deficiency J. Clin. Endocrinol. Metab., August 1, 2006; 91(8): 2926 - 2930. [Abstract] [Full Text] [PDF]
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