title: Efficacy and safety of sustained-release recombinant human growth hormone in Korean adults with growth hormone deficiency.
abstract: OBJECTIVE
  The administration of recombinant human growth hormone in adults with growth hormone deficiency has been known to improve metabolic impairment and quality of life. Patients, however, have to tolerate daily injections of growth hormone. The efficacy, safety, and compliance of weekly administered sustained-release recombinant human growth hormone (SR-rhGH, Declage™) supplement in patients with growth hormone deficiency were evaluated.
  
  
  METHODS
  This trial is 12-week prospective, single-arm, open-label trial. Men and women aged ≥20 years with diagnosed growth hormone deficiency (caused by pituitary tumor, trauma and other pituitary diseases) were eligible for this study. Each subject was given 2 mg (6 IU) of SR-rhGH once a week, subcutaneously for 12 weeks. Efficacy and safety at baseline and within 30 days after the 12th injection were assessed and compared. Score of Assessment of Growth Hormone Deficiency in Adults (AGHDA score) for quality of life and serum IGF-1 level.
  
  
  RESULTS
  The IGF-1 level of 108.67±74.03 ng/mL was increased to 129.01±68.37 ng/mL (p=0.0111) and the AGHDA QoL score was decreased from 9.80±6.51 to 7.55±5.76 (p<0.0001) at week 12 compared with those at baseline. Adverse events included pain, swelling, erythema, and warmth sensation at the administration site, but many adverse events gradually disappeared during the investigation.
  
  
  CONCLUSIONS
  Weekly administered SR-rhGH for 12 weeks effectively increased IGF-1 level and improved the quality of life in patients with GH deficiency without serious adverse events.
authors: Division of Endocrinology, Department of Internal Medicine, College of Medicine, Yonsei University, Seoul, Korea.
authors: Youngsook
authors: Y
authors: Kim
authors: Division of Endocrinology, Department of Internal Medicine, College of Medicine, Yonsei University, Seoul, Korea.
authors: Jae Won
authors: JW
authors: Hong
authors: Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea.
authors: Yoon-Sok
authors: YS
authors: Chung
authors: Department of Endocrinology and Metabolism, Kyung Hee Medical Center, Kyung Hee University School of Medicine, Seoul, Korea.
authors: Sung-Woon
authors: SW
authors: Kim
authors: Department of Internal Medicine, Division of Endocrinology & Metabolism, CHA Bundang Medical Center, CHA University School of Medicine, Bundang, Korea.
authors: Yong-Wook
authors: YW
authors: Cho
authors: Division of Endocrinology, Department of Internal Medicine, College of Medicine, Chosun University, Gwangju, Korea.
authors: Jin Hwa
authors: JH
authors: Kim
authors: Diabetes and Thyroid Center Division of Endocrinology, Konyang University School of Medicine, Daejeon, Korea.
authors: Byung-Joon
authors: BJ
authors: Kim
authors: Division of Endocrinology, Department of Internal Medicine, College of Medicine, Yonsei University, Seoul, Korea. EJLEE423@yuhs.ac.
authors: Eun Jig
authors: EJ
authors: Lee
mesh_terms: D000328:Adult; D000368:Aged; D003692:Delayed-Action Preparations; D005260:Female; D013006:Growth Hormone / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D019382:Human Growth Hormone / Q000172:deficiency*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*
chemical_list: D003692:Delayed-Action Preparations; D011994:Recombinant Proteins; D019382:Human Growth Hormone; D013006:Growth Hormone
keywords: Growth hormone deficiency; quality of life; sustained-release recombinant human GH