Sustained-release recombinant human GH improves quality of life in adults with GH deficiency

Abstract

Background: As studies demonstrate, the administration of recombinant human GH (rhGH) in adults with GH deficiency has been known to improve metabolic impairment and quality of life (QoL). Patients, however, do have to tolerate daily injections of GH (rhGH). Objectives: To evaluate the effects, safety, and compliance of weekly administered sustained-release recombinant human GH (SR-rhGH) supplement in patients with GH deficiency Design: This is a 12-week prospective, single-arm, open-label trial Intervention/Participants: Men and women aged ≥ 20 years with diagnosed GH deficiency (caused by pituitary tumor, trauma, other pituitary disease) are eligible for this study. Once a week each subject was given 2 mg (6 IU) of SR-rhGH, administered subcutaneously. Efficacy and side effects were assessed at baseline and within 30 days after the 12th injection. Then a comparison between baseline values and those at end time was performed.Measurements: We evaluated AGHDA (The Assessment of Growth Hormone Deficiency in Adults) score for quality of life and measured serum IGF-1 (Insulin-like growth factor-1) level.Results: The mean baseline IGF-1 level of 108.67 ± 73.03 ng/ml was increased to 129.01 ± 68.37 ng/ml (P=0.0111) at week 12 and the mean baseline (AGHDA score) was decreased from 9.80 ± 6.51 to 7.55 ± 5.76 (P<0.0001) at week 12. Side effects included pain, edema, rash, and a warm sensation at the administration site, but during the investigation many side effects were gradually disappeared. Conclusions: Weekly administered SH-rhGH for 12 weeks increased IGH-1 level effectively and improved quality of life in patients with GH deficiency without severe side effects.