ESPE Abstracts (2018) 89 P-P3-398

GH & IGFs P3

Recombinant Growth Hormone Therapy in Prepubertal Children with Idiopathic Short Stature in Korea: A Phase III Randomized Trial

Minji Ima, J Kimb, B-K Suhc,d, CW Koe, K-H Leef, CH Shing, JS Hwangh, HS Kimi,j, WY Chungk, CJ Kiml, H-S Hanm, NY Kwonn, SY Choo, H-W Yoop,q & D-K Jina,o


aDepartment of Pediatrics, Samsung Medical Center, Seoul, Republic of Korea bDepartment of Pediatrics, Hanyang University School of Medicine, Seoul, Republic of Korea. cDepartment of Pediatrics, Seoul St. Mary’s Hospital, Seoul, Republic of Korea. dDepartment of Pediatrics, The Catholic University of Korea, Seoul, Republic of Korea. eDepartment of Pediatrics, Kyungpook National University Hospital, Daegu, Republic of Korea. fDepartment of Pediatrics, Korea University Anam Hospital, Seoul, Republic of Korea. gDepartment of Pediatrics, Seoul National University Children’s Hospital, Seoul, Republic of Korea. hDepartment of Pediatrics, Ajou University Hospital, Suwon, Republic of Korea. iDepartment of Pediatrics, Onsei University Health Systerm, Seoul, Republic of Korea. jDepartment of Pediatrics, Severance Hospital, Seoul, Republic of Korea. kDepartment of Pediatrics, Inje University Busan Paik Hospital, Busan, Republic of Korea. lDepartment of Pediatrics, Chonnam National University Hospital, Gwangju, Republic of Korea. mDepartment of Pediatrics, Chungbuk National University Hospital, Cheongju, Republic of Korea. nData Management and Clinical Statistics Team, Dong-A ST Co,. LTD, Seoul, Republic of Korea. oDepartment of Pediatrics, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. pDepartment of Pediatrics, Medical Genetics Clinic and Laboratory, Asan Medical Center Children’s Hospital, Seoul, Republic of Korea. qDepartment of Pediatrics, University of Ulsan College of Medicine, Seoul, Republic of Korea

Several studies have evaluated the effects of growth hormone (GH) on auxological and biochemical parameters in children with non-GH-deficient, idiopathic short stature (ISS). This study evaluated the efficacy and safety of GrowtropinR-II (recombinant human GH) in Korean patients with ISS. This was a 1-year, open-label, multicenter, phase III randomized trial of Growtropin-II in Korean patients with ISS. In total, 70 prepubertal subjects (39 males, 31 females) between 4 and 12 years of age were included in the study. All patients were naive to GH treatment. Annual height velocity was significantly higher in the treatment group (10.68±1.95 cm/year) than the control group (5.72±1.72, p<0.001). Increases in height and weight standar deviation scores (SDSs) at 26 weeks were 0.63±0.16 and 0.64±0.46, repectively, for the treatment group, and 0.06±0.15 and 0.06±0.28, respectively, for the control group (p<0.001). Serum insulin-like growth factor (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3) increased significantly in the treatment group at week 26 compared to baseline. However, the SDS for body mass index(BMI) at 26 weeks did not change significantly in either group. GrowtropinR-II was well tolerated and safe over 1 year of treatment. One-year GH treatment for prepubertal children with ISS demonstrated increased annualized velocity, height and weight SDSs, and IGF-1 and IGFBP-3 levels, with a favorable safety profile. Further evaluations are needed to determine the optimal dose, final adult height, and long-term effects of ISS treatment.

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