PMID- 23823978
OWN - NLM
STAT- MEDLINE
DCOM- 20140602
LR  - 20190907
IS  - 1348-4540 (Electronic)
IS  - 0918-8959 (Linking)
VI  - 60
IP  - 10
DP  - 2013
TI  - Efficacy and safety of growth hormone replacement therapy in Japanese adults with 
      growth hormone deficiency: a post-marketing observational study.
PG  - 1131-44
AB  - This large-scale observational study examined the long-term effectiveness and 
      safety of growth hormone (GH) replacement therapy for adult GH deficiency (GHD) 
      in Japanese clinical practice using the Hypopituitary Control and Complications 
      Study database. The study included 402 GHD patients for safety analyses and a 
      subset of 209 patients (149 adult-onset and 60 childhood-onset GHD patients) who 
      had not previously received GH replacement therapy for the efficacy analyses. 
      Data on clinical, metabolic, quality of life (QoL) characteristics, and all 
      adverse events (AEs) were collected at baseline (start of GH treatment), 6 
      months, 1 year and 2 years. Over the observation period, there were improvements 
      from baseline in insulin-like growth factor-I standard deviation scores 
      (P<0.001), although the changes in metabolic parameters were minimal. QoL (Short 
      Form-36) Z-scores significantly increased from baseline in both onset-type groups 
      for several subscale domains (P<0.05). A total of 145 (36.1%) patients 
      experienced >/=1 AE. Common AEs were hyperlipidaemia (2.7%) and hyperinsulinaemia 
      (2.2%). Some patients experienced recurrent hypothalamic/pituitary tumour (events 
      per 1000 patient-years: 2.78), new benign (0.93), malignant tumour (10.28) or 
      other new tumour (0.93), new diabetes mellitus (7.45), and new stroke (3.71). 
      Seven patients died during the observation period. Our safety findings are 
      inconclusive about the associations between GH replacement and AEs, although the 
      incidence of diabetes mellitus and cardiovascular events are similar to those 
      reported in the Japanese general population. In conclusion, the key beneficial 
      effects of GH replacement therapy for GHD are observed in routine clinical 
      practice in Japan.
FAU - Shimatsu, Akira
AU  - Shimatsu A
AD  - Clinical Research Institute, National Hospital Organization Kyoto Medical Center, 
      Kyoto 612-8555, Japan.
FAU - Tai, Shigeru
AU  - Tai S
FAU - Imori, Makoto
AU  - Imori M
FAU - Ihara, Katsuichiro
AU  - Ihara K
FAU - Taketsuna, Masanori
AU  - Taketsuna M
FAU - Funai, Jumpei
AU  - Funai J
FAU - Tanaka, Toshiaki
AU  - Tanaka T
FAU - Teramoto, Akira
AU  - Teramoto A
FAU - Irie, Minoru
AU  - Irie M
FAU - Chihara, Kazuo
AU  - Chihara K
LA  - eng
SI  - ClinicalTrials.gov/NCT01088399
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20130704
PL  - Japan
TA  - Endocr J
JT  - Endocrine journal
JID - 9313485
RN  - 12629-01-5 (Human Growth Hormone)
RN  - 67763-96-6 (Insulin-Like Growth Factor I)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Cardiovascular Diseases/chemically induced
MH  - Diabetes Mellitus/chemically induced
MH  - Female
MH  - Hormone Replacement Therapy/adverse effects
MH  - Human Growth Hormone/adverse effects/deficiency/*therapeutic use
MH  - Humans
MH  - Insulin-Like Growth Factor I/metabolism
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Neoplasms/chemically induced
MH  - Quality of Life
EDAT- 2013/07/05 06:00
MHDA- 2014/06/03 06:00
CRDT- 2013/07/05 06:00
PHST- 2013/07/05 06:00 [entrez]
PHST- 2013/07/05 06:00 [pubmed]
PHST- 2014/06/03 06:00 [medline]
AID - DN/JST.JSTAGE/endocrj/EJ13-0083 [pii]
AID - 10.1507/endocrj.ej13-0083 [doi]
PST - ppublish
SO  - Endocr J. 2013;60(10):1131-44. doi: 10.1507/endocrj.ej13-0083. Epub 2013 Jul 4.