Efficacy and safety of Valtropin in the treatment of short stature in girls with Turner's syndrome.
Valtropin (somatropin, BioPartners and LG Life Sciences [LGLS]) is a recombinant human growth hormone (GH) preparation produced using a yeast expression system. An open single-arm phase III study was conducted to evaluate efficacy and safety at a dose of 0.16 IU/kg/day (0.053 mg/kg/day) s.c. for 12 months in the treatment of short stature in girls (n = 30, aged 2-9 years) with Turner's syndrome. The primary efficacy variable was height velocity (HV) at 12 months. Secondary efficacy variables included serum GH dependent growth factors. HV increased from 3.8 +/- 1.8 cm/yr at baseline to 9.7 +/- 1.6 cm/yr (mean +/- SD) after 12 months of treatment. Marked treatment effects were also observed on other growth parameters, serum insulin-like growth factor-I (IGF-I) and insulin-like growth factor binding protein-3 (IGFBP-3). Treatment was well tolerated with no significant adverse events. It is concluded that Valtropin is as safe and effective as other human GH preparations for the treatment of growth failure in girls with Turner's syndrome.
Peterkova
V
V
Endocrinological Scientific Centre of Russian Academy of Science, Paediatric Endocrinology, Moscow, Russia.
Savoy
C
C
Bezlepkina
O
O
Ivanov
A
A
Orlova
E
E
Nagaeva
E
E
Kim
J
J
Lee
Y P
YP
Saenger
P H
PH
Stanhope
R
R
D001827:Body Height / Q000187:drug effects*; D002648:Child; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D006130:Growth Disorders / Q000150:complications / Q000188:drug therapy*; D019382:Human Growth Hormone / Q000627:therapeutic use*; D006801:Humans; D018972:Insulin-Like Growth Factor Binding Protein 3 / Q000097:blood; D007334:Insulin-Like Growth Factor I / Q000032:analysis; D011994:Recombinant Proteins; D016896:Treatment Outcome; D014424:Turner Syndrome / Q000150:complications / Q000188:drug therapy*
D018972:Insulin-Like Growth Factor Binding Protein 3; D011994:Recombinant Proteins; D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I