Authentic recombinant human growth hormone. Results of a multicenter clinical trial in patients with growth hormone deficiency.
197 patients with growth hormone deficiency (144 boys, 53 girls, age 1.5-19.5 [mean 11 +/- 3.6], bone age 0.3-15 [mean 8.9 +/- 3.5] years) were treated for one year with authentic recombinant human growth hormone (r-hGH, Norditropin] in several European paediatric centers. 107 patients were newly treated (group A), and 90 transferred from pituitary or methionine hGH (groups B and C). In 19 of the latter, treatment was interrupted for 6 months (group B), in the others, it was changed without interruption (group C). The dosage was 0.45 +/- 0.2 IU/kg/week given s.c. 6-7 times a week. Height velocity increased from 4.1 +/- 2.4 to 8.3 +/- 2.5 (group A), 2.6 +/- 1.8 to 8.3 +/- 2.3 (group B), and 6.2 +/- 2.7 to 6.8 +/- 2.2 cm/year (group C). Few patients complained of local discomfort at the injection site, but this disappeared after changing metacresol in the solvent to 0.9% benzyl alcohol. Only 3 patients developed antibodies to hGH in low titers, which did not interfere with growth. No changes in E. coli protein antibodies were observed. It is concluded that r-hGH is an efficient and safe treatment for children with growth hormone deficiency.
Rasmussen
L H
LH
Nordisk Gentofte A/S, Gentofte, Denmark.
Zachmann
M
M
Nilsson
P
P
D000293:Adolescent; D001827:Body Height / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004393:Dwarfism, Pituitary / Q000628:therapy*; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D013006:Growth Hormone / Q000008:administration & dosage* / Q000172:deficiency; D006801:Humans; D007223:Infant; D008297:Male; D011994:Recombinant Proteins / Q000008:administration & dosage
D011994:Recombinant Proteins; D013006:Growth Hormone