Seven years of safety and efficacy of the recombinant human growth hormone Omnitrope in the treatment of growth hormone deficient children: results of a phase III study.
OBJECTIVE
This phase III clinical study in growth hormone deficiency (GHD) children with growth retardation was designed to compare efficacy and safety of Omnitrope((R)) with Genotropin((R)) and assess the long-term safety and efficacy of Omnitrope((R)). The results of 7 years of treatment with Omnitrope((R)) are presented.


METHODS
Eighty-nine treatment-naïve, prepubertal children with GHD were randomized (part 1) to Omnitrope((R)) lyophilisate (group A, n = 44) or Genotropin((R)) (group B, n = 45) for 9 months and received a subcutaneous dose of 0.03 mg/kg/day. In part 2, patients receiving Omnitrope((R))lyophilisate continued the same treatment for a further 6 months, while patients on Genotropin((R)) were switched to Omnitrope((R)) liquid for the subsequent 6 months. In part 3, patients in both groups received Omnitrope((R))liquid for a period up to 69 months.


RESULTS
The development of the 4 auxological parameters (height, height SD score, height velocity and height velocity SD score) and IGF-1 and IGFBP-3 levels were comparable between both groups of patients and confirmed the well-known growth response of GHD children to recombinant human GH treatment. Omnitrope((R)) was well tolerated and safe over 7 years of treatment.


CONCLUSIONS
The clinical comparability between Omnitrope((R)) and Genotropin((R)) was demonstrated within 9 months of treatment. Long-term safety and efficacy of 7 years of treatment with Omnitrope((R)) was proven.
Department of Endocrinology, Children's Memorial Health Institute, Warsaw, Poland.
T
T
Romer
P
P
Saenger
F
F
Peter
M
M
Walczak
Y
Y
Le Bouc
J
J
Khan-Boluki
A
A
Berghout
D000293:Adolescent; D001827:Body Height / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D005260:Female; D006130:Growth Disorders / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D019382:Human Growth Hormone / Q000008:administration & dosage / Q000009:adverse effects / Q000172:deficiency* / Q000627:therapeutic use*; D006801:Humans; D018972:Insulin-Like Growth Factor Binding Protein 3; D018969:Insulin-Like Growth Factor Binding Proteins / Q000097:blood; D007334:Insulin-Like Growth Factor I / Q000378:metabolism; D008297:Male; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D015430:Weight Gain / Q000187:drug effects
C515497:IGFBP3 protein, human; D018972:Insulin-Like Growth Factor Binding Protein 3; D018969:Insulin-Like Growth Factor Binding Proteins; D011994:Recombinant Proteins; D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I