title: An observational study of the effectiveness and safety of growth hormone (Humatrope(®)) treatment in Japanese children with growth hormone deficiency or Turner syndrome.
abstract: This study assessed the effectiveness and safety of growth hormone (GH; Humatrope(®)) 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-naïve 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.
authors.affiliation: Tai Clinic, Osaka 555-0001, Japan. tai_shigeru@network.lilly.com
authors.forename: Shigeru
authors.initials: S
authors.lastname: Tai
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Tanaka
authors.forename: Tomonobu
authors.initials: T
authors.lastname: Hasegawa
authors.forename: Keichi
authors.initials: K
authors.lastname: Ozono
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Tanaka
authors.forename: Susumu
authors.initials: S
authors.lastname: Kanzaki
authors.forename: Susumu
authors.initials: S
authors.lastname: Yokoya
authors.forename: Kenji
authors.initials: K
authors.lastname: Fujieda
authors.forename: Kazuo
authors.initials: K
authors.lastname: Chihara
authors.forename: Yoshiki
authors.initials: Y
authors.lastname: Seino
mesh_terms: D044466:Asian People; D001827:Body Height; D002648:Child; D002675:Child, Preschool; D005260:Female; D020249:Hormone Replacement Therapy; D019382:Human Growth Hormone / Q000009:adverse effects / Q000172:deficiency / Q000627:therapeutic use*; D006801:Humans; D007018:Hypopituitarism / Q000188:drug therapy*; D007223:Infant; D008297:Male; D016896:Treatment Outcome; D014424:Turner Syndrome / Q000188:drug therapy*
chemical_list: D019382:Human Growth Hormone