Efficacy and safety evaluation of human growth hormone therapy in patients with idiopathic short stature in Korea - A randomised controlled trial
DC Field | Value | Language |
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dc.contributor.author | Jung, M.H. | - |
dc.contributor.author | Suh, B.-K. | - |
dc.contributor.author | Ko, C.W. | - |
dc.contributor.author | Lee, K.-H. | - |
dc.contributor.author | Jin, D.-K. | - |
dc.contributor.author | Yoo, H.-W. | - |
dc.contributor.author | Hwang, J.S. | - |
dc.contributor.author | Chung, W.Y. | - |
dc.contributor.author | Han, H.-S. | - |
dc.contributor.author | Prusty, V. | - |
dc.contributor.author | Kim, H.-S. | - |
dc.date.accessioned | 2021-08-31T19:24:57Z | - |
dc.date.available | 2021-08-31T19:24:57Z | - |
dc.date.created | 2021-06-17 | - |
dc.date.issued | 2020 | - |
dc.identifier.issn | 1758-3772 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/60768 | - |
dc.description.abstract | Background: This trial evaluated the efficacy and safety of growth hormone (GH) therapy (Norditropin®; Novo Nordisk, Bagsværd, Denmark) in paediatric patients with idiopathic short stature (ISS) in Korea. Methods: This was an open-label, parallel-group, multicentre, interventional trial (ClinicalTrials.gov identifier: NCT01778023). Pre-pubertal patients (mean age 6.2 years; height, 107.1 cm) were randomised 2:1 to 12 months' GH treatment (0.469 mg/kg/week; group A, n=36) or 6 months untreated followed by 6 months' GH treatment (group B, n=18). Safety analysis was based on adverse events (AEs) in all GH-treated patients. Results: After 6 months, height velocity (Ht-V), change in both height standard deviation score (Ht-SDS) and insulin-like growth factor 1 (mean difference [95% confidence interval {CI}]: 5.15 cm/year [4.09, 6.21]; 0.57 [0.43, 0.71]; 164.56 ng/mL [112.04, 217.08], respectively; all p<0.0001) were greater in group A than in group B. Mean difference in Ht-V for 0-6 months versus 6-12 months was 2.80 cm/year (95% CI 1.55, 4.04) for group A and -4.60 cm/year (95% CI -6.12, -3.09; both p<0.0001) for group B. No unexpected AEs were reported. Conclusions: During the first 6 months, height was significantly increased in GH-treated patients versus untreated patients with ISS. Safety of GH was consistent with the known safety profile. © Touch Medical Media 2020. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | Touch Briefings | - |
dc.subject | human growth hormone | - |
dc.subject | nordilet | - |
dc.subject | somatomedin binding protein 3 | - |
dc.subject | somatomedin C | - |
dc.subject | allergic rhinitis | - |
dc.subject | Article | - |
dc.subject | child | - |
dc.subject | conjunctivitis | - |
dc.subject | controlled study | - |
dc.subject | dermatitis | - |
dc.subject | disease severity | - |
dc.subject | dizziness | - |
dc.subject | drug efficacy | - |
dc.subject | drug safety | - |
dc.subject | evaluation study | - |
dc.subject | eye disease | - |
dc.subject | fatigue | - |
dc.subject | female | - |
dc.subject | fever | - |
dc.subject | hormonal therapy | - |
dc.subject | human | - |
dc.subject | hydrocele | - |
dc.subject | hypertrophy | - |
dc.subject | idiopathic disease | - |
dc.subject | influenza | - |
dc.subject | Korea | - |
dc.subject | major clinical study | - |
dc.subject | male | - |
dc.subject | mucocutaneous lymph node syndrome | - |
dc.subject | multicenter study | - |
dc.subject | pharyngitis | - |
dc.subject | pneumonia | - |
dc.subject | post hoc analysis | - |
dc.subject | preschool child | - |
dc.subject | randomized controlled trial | - |
dc.subject | rhinitis | - |
dc.subject | rhinopharyngitis | - |
dc.subject | short stature | - |
dc.subject | thorax pain | - |
dc.subject | tonsil disease | - |
dc.subject | tonsillitis | - |
dc.subject | upper respiratory tract infection | - |
dc.subject | urticaria | - |
dc.title | Efficacy and safety evaluation of human growth hormone therapy in patients with idiopathic short stature in Korea - A randomised controlled trial | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Lee, K.-H. | - |
dc.identifier.doi | 10.17925/EE.2020.16.1.54 | - |
dc.identifier.scopusid | 2-s2.0-85090372908 | - |
dc.identifier.bibliographicCitation | European Endocrinology, v.16, no.1, pp.54 - 59 | - |
dc.relation.isPartOf | European Endocrinology | - |
dc.citation.title | European Endocrinology | - |
dc.citation.volume | 16 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 54 | - |
dc.citation.endPage | 59 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scopus | - |
dc.subject.keywordPlus | human growth hormone | - |
dc.subject.keywordPlus | nordilet | - |
dc.subject.keywordPlus | somatomedin binding protein 3 | - |
dc.subject.keywordPlus | somatomedin C | - |
dc.subject.keywordPlus | allergic rhinitis | - |
dc.subject.keywordPlus | Article | - |
dc.subject.keywordPlus | child | - |
dc.subject.keywordPlus | conjunctivitis | - |
dc.subject.keywordPlus | controlled study | - |
dc.subject.keywordPlus | dermatitis | - |
dc.subject.keywordPlus | disease severity | - |
dc.subject.keywordPlus | dizziness | - |
dc.subject.keywordPlus | drug efficacy | - |
dc.subject.keywordPlus | drug safety | - |
dc.subject.keywordPlus | evaluation study | - |
dc.subject.keywordPlus | eye disease | - |
dc.subject.keywordPlus | fatigue | - |
dc.subject.keywordPlus | female | - |
dc.subject.keywordPlus | fever | - |
dc.subject.keywordPlus | hormonal therapy | - |
dc.subject.keywordPlus | human | - |
dc.subject.keywordPlus | hydrocele | - |
dc.subject.keywordPlus | hypertrophy | - |
dc.subject.keywordPlus | idiopathic disease | - |
dc.subject.keywordPlus | influenza | - |
dc.subject.keywordPlus | Korea | - |
dc.subject.keywordPlus | major clinical study | - |
dc.subject.keywordPlus | male | - |
dc.subject.keywordPlus | mucocutaneous lymph node syndrome | - |
dc.subject.keywordPlus | multicenter study | - |
dc.subject.keywordPlus | pharyngitis | - |
dc.subject.keywordPlus | pneumonia | - |
dc.subject.keywordPlus | post hoc analysis | - |
dc.subject.keywordPlus | preschool child | - |
dc.subject.keywordPlus | randomized controlled trial | - |
dc.subject.keywordPlus | rhinitis | - |
dc.subject.keywordPlus | rhinopharyngitis | - |
dc.subject.keywordPlus | short stature | - |
dc.subject.keywordPlus | thorax pain | - |
dc.subject.keywordPlus | tonsil disease | - |
dc.subject.keywordPlus | tonsillitis | - |
dc.subject.keywordPlus | upper respiratory tract infection | - |
dc.subject.keywordPlus | urticaria | - |
dc.subject.keywordAuthor | Clinical trial | - |
dc.subject.keywordAuthor | Human growth hormone | - |
dc.subject.keywordAuthor | Idiopathic | - |
dc.subject.keywordAuthor | Short stature | - |
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