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Efficacy and safety of growth hormone (GH) in the treatment of adult Japanese patients with GH deficiency: a randomised, placebo-controlled study.
Growth Horm IGF Res. 2006 Apr; 16(2):132-42.GH

Abstract

OBJECTIVE

The aim of this study was to assess the effect of growth hormone (GH) replacement therapy on lean body mass (LBM) and other variables including body fat mass, serum lipids and quality of life measures in GH-deficient Japanese adults.

DESIGN

This was a multicentre, double-blind, placebo-controlled, parallel group study. Following initial screening, patients were randomly assigned to GH treatment (n=37) or placebo (n=36). GH treatment was started at an initial dose 0.003 mg/kg/day s.c. each day for the first 4 weeks after which the dose was increased to 0.006 mg/kg/day for 4 weeks and then to 0.012 mg/kg/day for the last 16 weeks (n=37). Body composition, serum lipids, serum IGF-I and IGFBP-3 levels were measured during the 24-week study. Short Form-36 and Quality of Life Assessment of GH Deficiency in Adults scores were also determined.

RESULTS

LBM was significantly increased from baseline at 24 weeks in GH-treated patients, with a mean (+/-SD) increase of 4.7% (+/-5.3%) compared with an increase of 1.0% (+/-4.4%) in the placebo group (p<0.0001 versus baseline, p=0.0003 versus placebo). Percentage body fat decreased significantly from baseline in GH-treated patients (9.3%, p<0.0001), compared with a non-significant 0.2% increase in the placebo group (p<0.0004 for difference between treatment groups). In addition, significantly increased serum IGF-I and IGFBP-3 levels and improvements in the patients' serum lipid profiles were observed in patients who received GH therapy. Changes in quality of life measures did not differ between treatments, probably because of the small number of patients studied. GH therapy was well tolerated, with adverse events of any cause reported in 86.5% of the GH treatment group and 83.3% of the placebo group.

CONCLUSION

GH treatment significantly improved body composition and serum lipid profiles in adult Japanese patients with GH deficiency compared with placebo and had no clinically relevant adverse effects.

Authors+Show Affiliations

Division of Endocrinology, Metabolism, Hematology and Oncology, Department of Clinical Molecular Medicine, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho Chuo-ku, Kobe 650-0017, Japan. chiharak@med.kobe-u.ac.jpNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

16702006

Citation

Chihara, K, et al. "Efficacy and Safety of Growth Hormone (GH) in the Treatment of Adult Japanese Patients With GH Deficiency: a Randomised, Placebo-controlled Study." Growth Hormone & IGF Research : Official Journal of the Growth Hormone Research Society and the International IGF Research Society, vol. 16, no. 2, 2006, pp. 132-42.
Chihara K, Kato Y, Kohno H, et al. Efficacy and safety of growth hormone (GH) in the treatment of adult Japanese patients with GH deficiency: a randomised, placebo-controlled study. Growth Horm IGF Res. 2006;16(2):132-42.
Chihara, K., Kato, Y., Kohno, H., Takano, K., Tanaka, T., Teramoto, A., & Shimatsu, A. (2006). Efficacy and safety of growth hormone (GH) in the treatment of adult Japanese patients with GH deficiency: a randomised, placebo-controlled study. Growth Hormone & IGF Research : Official Journal of the Growth Hormone Research Society and the International IGF Research Society, 16(2), 132-42.
Chihara K, et al. Efficacy and Safety of Growth Hormone (GH) in the Treatment of Adult Japanese Patients With GH Deficiency: a Randomised, Placebo-controlled Study. Growth Horm IGF Res. 2006;16(2):132-42. PubMed PMID: 16702006.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of growth hormone (GH) in the treatment of adult Japanese patients with GH deficiency: a randomised, placebo-controlled study. AU - Chihara,K, AU - Kato,Y, AU - Kohno,H, AU - Takano,K, AU - Tanaka,T, AU - Teramoto,A, AU - Shimatsu,A, Y1 - 2006/05/15/ PY - 2005/10/06/received PY - 2006/03/12/revised PY - 2006/03/13/accepted PY - 2006/5/17/pubmed PY - 2006/11/4/medline PY - 2006/5/17/entrez SP - 132 EP - 42 JF - Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society JO - Growth Horm IGF Res VL - 16 IS - 2 N2 - OBJECTIVE: The aim of this study was to assess the effect of growth hormone (GH) replacement therapy on lean body mass (LBM) and other variables including body fat mass, serum lipids and quality of life measures in GH-deficient Japanese adults. DESIGN: This was a multicentre, double-blind, placebo-controlled, parallel group study. Following initial screening, patients were randomly assigned to GH treatment (n=37) or placebo (n=36). GH treatment was started at an initial dose 0.003 mg/kg/day s.c. each day for the first 4 weeks after which the dose was increased to 0.006 mg/kg/day for 4 weeks and then to 0.012 mg/kg/day for the last 16 weeks (n=37). Body composition, serum lipids, serum IGF-I and IGFBP-3 levels were measured during the 24-week study. Short Form-36 and Quality of Life Assessment of GH Deficiency in Adults scores were also determined. RESULTS: LBM was significantly increased from baseline at 24 weeks in GH-treated patients, with a mean (+/-SD) increase of 4.7% (+/-5.3%) compared with an increase of 1.0% (+/-4.4%) in the placebo group (p<0.0001 versus baseline, p=0.0003 versus placebo). Percentage body fat decreased significantly from baseline in GH-treated patients (9.3%, p<0.0001), compared with a non-significant 0.2% increase in the placebo group (p<0.0004 for difference between treatment groups). In addition, significantly increased serum IGF-I and IGFBP-3 levels and improvements in the patients' serum lipid profiles were observed in patients who received GH therapy. Changes in quality of life measures did not differ between treatments, probably because of the small number of patients studied. GH therapy was well tolerated, with adverse events of any cause reported in 86.5% of the GH treatment group and 83.3% of the placebo group. CONCLUSION: GH treatment significantly improved body composition and serum lipid profiles in adult Japanese patients with GH deficiency compared with placebo and had no clinically relevant adverse effects. SN - 1096-6374 UR - https://www.unboundmedicine.com/medline/citation/16702006/Efficacy_and_safety_of_growth_hormone__GH__in_the_treatment_of_adult_Japanese_patients_with_GH_deficiency:_a_randomised_placebo_controlled_study_ DB - PRIME DP - Unbound Medicine ER -