Yonsei Med J.  2014 Jul;55(4):1042-1048. 10.3349/ymj.2014.55.4.1042.

Efficacy and Safety of Sustained-Release Recombinant Human Growth Hormone in Korean Adults with Growth Hormone Deficiency

• Kim Y
• Hong JW
• Chung YS
• Kim SW
• Cho YW
• Kim JH
• Kim BJ
• Lee EJ

• KMID: 2130831
• DOI: http://doi.org/10.3349/ymj.2014.55.4.1042

Abstract

PURPOSE
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(TM)) supplement in patients with growth hormone deficiency were evaluated.
MATERIALS AND METHODS
This trial is 12-week prospective, single-arm, open-label trial. Men and women aged > or =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.
CONCLUSION
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.

Keyword

Growth hormone deficiency; sustained-release recombinant human GH; quality of life

MeSH Terms

Adult
Aged
Delayed-Action Preparations
Female
Growth Hormone/administration & dosage/*adverse effects/*therapeutic use
Human Growth Hormone/*deficiency
Humans
Male
Middle Aged
Prospective Studies
Recombinant Proteins/administration & dosage/*adverse effects/*therapeutic use
Delayed-Action Preparations
Growth Hormone
Human Growth Hormone
Recombinant Proteins

Figure

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  Fig. 1 Efficacy at week 12 compared with baseline. The differences between baseline and week 12 show statistical significance in IGF-1 and QoL-AGHDA but not in total cholesterol.

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  Fig. 2 Administration site local reaction weekly result summary (safety set). Side effects included pain, edema, rash, and a warm sensation at the administration sites, but most of the side effects disappeared during the investigation.

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