Format

Send to

Choose Destination
Horm Res Paediatr. 2018;90(1):44-53. doi: 10.1159/000491016. Epub 2018 Aug 15.

Effect of Growth Hormone Therapy on Height Velocity in Korean Children with Idiopathic Short Stature: A Phase III Randomised Controlled Trial.

Author information

1
Department of Pediatrics, Inje University Busan Paik Hospital, Busan, Republic of Korea.
2
Department of Pediatrics, Asan Medical Centre, University of Ulsan College of Medicine, Seoul, Republic of Korea.
3
Department of Pediatrics, Ajou University Hospital, Ajou University School of Medicine, Suwon, Republic of Korea.
4
Department of Pediatrics, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, Republic of Korea.
5
Department of Pediatrics, Severance Children's Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
6
Department of Pediatrics, Samsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
7
Department of Pediatrics, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.
8
Department of Pediatrics, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea.
9
Merck Ltd, Korea, Seoul, Republic of Korea.
10
Department of Pediatrics, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.

Abstract

BACKGROUND/AIMS:

The SYNERGY (Saizen® for Your New Life and Brighter Tomorrow without Growth Deficiency) study is the first randomised multi-centre, open-label study to assess the short-term efficacy and safety of this recombinant human growth hormone (r-hGH) preparation for prepubertal children with idiopathic short stature in South Korea.

METHODS:

The SYNERGY study (ClinicalTrials.gov NCT01746862) was conducted at 9 centres throughout South Korea between December 2012 and March 2015. The primary endpoint was difference in height velocity from baseline to 6 months in the treatment and control arms.

RESULTS:

97 children were screened; 90 were randomly assigned: 60 children to 0.067 mg/kg/day r-hGH for 12 months (treatment) and 30 children to 6 months of no treatment followed by 0.067 mg/kg/day r-hGH for 6 months (control). The 6-month mean height velocity in the treatment group increased from 5.63 cm/year (SD 1.62) to 10.08 cm/year (SD 1.92) (p < 0.0001) and from 4.94 cm/year (SD 1.91) to 5.92 cm/year (SD 2.01) (p = 0.0938) in the control group (between-group difference 3.47 cm/year, 95% CI 2.17-4.78; p < 0.0001). Adherence was > 90% throughout the study. The safety profile was consistent with that already known for r-hGH.

CONCLUSION:

Treatment with r-hGH in the SYNERGY study demonstrated a statistically significant increase in height velocity at 6 months.

KEYWORDS:

Efficacy; Height velocity; Idiopathic short stature; Recombinant human growth hormone; Safety

PMID:
30110706
PMCID:
PMC6214610
DOI:
10.1159/000491016
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for S. Karger AG, Basel, Switzerland Icon for PubMed Central
Loading ...
Support Center