Efficacy and safety of sustained-release recombinant human growth hormone in Korean adults with growth hormone deficiency.

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) 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 >/=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.