PMID- 23001148
OWN - NLM
STAT- MEDLINE
DCOM- 20130722
LR  - 20221207
IS  - 1348-4540 (Electronic)
IS  - 0918-8959 (Linking)
VI  - 60
IP  - 1
DP  - 2013
TI  - An observational study of the effectiveness and safety of growth hormone 
      (Humatrope((R))) treatment in Japanese children with growth hormone deficiency or 
      Turner syndrome.
PG  - 57-64
AB  - This study assessed the effectiveness and safety of growth hormone (GH; 
      Humatrope((R))) therapy in Japanese children with GH deficiency (GHD) or Turner 
      syndrome (TS) enrolled in the Genetics and Neuroendocrinology of Short Stature 
      International Study (GeNeSIS). GeNeSIS is an open-label, multinational, 
      multicenter, observational study conducted in 30 countries. In this interim 
      report, there were 1129 GH treatment-naive children with GHD, with a mean 
      chronological age (+/- standard deviation) of 8.75 (3.32) years, and 90 girls with 
      TS, with a mean chronological age of 8.93 (3.67) years. The mean height standard 
      deviation score (SDS) increased from -2.73 (0.63) SD and -2.71 (0.63) SD at study 
      entry to -2.22 (0.68) SD and -2.20 (0.60) SD after 1 year of treatment in the GHD 
      and TS groups, respectively. In both groups, mean height SDS increased further 
      with each year of treatment to 4 years; however, the magnitude of change in 
      height SDS declined with time. The mean insulin-like growth factor-I SDS 
      increased from below the mean of the reference population at study entry to a 
      level similar to (GHD group) or higher than (TS group) the mean of the reference 
      population during the 4-year treatment period. The incidence of serious adverse 
      events (AEs), treatment-related AEs, and AEs related to glucose intolerance was 
      low in both groups (0.1% to 3.0%). In conclusion, GH treatment in Japanese 
      children with GHD or TS resulted in increased growth over a 4-year treatment 
      period with a favorable safety profile; however, the improvements in growth 
      declined with time.
FAU - Tai, Shigeru
AU  - Tai S
AD  - Tai Clinic, Osaka 555-0001, Japan. tai_shigeru@network.lilly.com
FAU - Tanaka, Toshiaki
AU  - Tanaka T
FAU - Hasegawa, Tomonobu
AU  - Hasegawa T
FAU - Ozono, Keichi
AU  - Ozono K
FAU - Tanaka, Hiroyuki
AU  - Tanaka H
FAU - Kanzaki, Susumu
AU  - Kanzaki S
FAU - Yokoya, Susumu
AU  - Yokoya S
FAU - Fujieda, Kenji
AU  - Fujieda K
FAU - Chihara, Kazuo
AU  - Chihara K
FAU - Seino, Yoshiki
AU  - Seino Y
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20121020
PL  - Japan
TA  - Endocr J
JT  - Endocrine journal
JID - 9313485
RN  - 12629-01-5 (Human Growth Hormone)
SB  - IM
MH  - Asian People
MH  - Body Height
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - *Hormone Replacement Therapy
MH  - Human Growth Hormone/adverse effects/deficiency/*therapeutic use
MH  - Humans
MH  - Hypopituitarism/*drug therapy
MH  - Infant
MH  - Male
MH  - Treatment Outcome
MH  - Turner Syndrome/*drug therapy
EDAT- 2012/09/25 06:00
MHDA- 2013/07/23 06:00
CRDT- 2012/09/25 06:00
PHST- 2012/09/25 06:00 [entrez]
PHST- 2012/09/25 06:00 [pubmed]
PHST- 2013/07/23 06:00 [medline]
AID - DN/JST.JSTAGE/endocrj/EJ11-0386 [pii]
AID - 10.1507/endocrj.ej11-0386 [doi]
PST - ppublish
SO  - Endocr J. 2013;60(1):57-64. doi: 10.1507/endocrj.ej11-0386. Epub 2012 Oct 20.