ABSTRACT. Fifty‐nine patients with idiopathic growth hormone deficiency were included in a Chinese multicentre trial of recombinant somatropin, 0.5‐0.7 IU/kg/week s.c. given in six or seven divided doses. The height velocity increased from 2.8 ±1.0 cm/year to 13.1 ± 2.5 cm/year during 1 year of treatment, and typical catch‐up growth was observed. The increase in height SDS for chronological age was significant, but the increase in height SDS for bone age was not statistically significant. No adverse reactions to the treatment were recorded. Recombinant somatropin was shown to be very effective and safe during the first year of therapy in patients with growth hormone deficiency.

01 Jan 1988·Acta paediatrica Scandinavica. Supplement

Clinical experience with recombinant somatropin: German collaborative study.

Article

Author: Bierich, J R

A multicentre trial with recombinant somatropin was initiated in West Germany in early 1986. Acceptance of patients to the study was determined according to criteria outlined in a detailed study protocol. A total of 62 patients with GH deficiency has now been treated with recombinant somatropin for a minimum of 12 months. Of these, 34 were previously untreated and 28 had previously received pituitary GH. Recombinant somatropin, 12 IU/m2/week, was administered subcutaneously, divided into six doses. Height velocities increased from 3.4 cm/year (pretreatment) to 10.4 cm/year in the previously untreated group, and from 6.0 cm/year during the last year on pituitary GH to 8.3 cm/year for the previously treated patients. Tolerance of recombinant somatropin was good, and no anti-GH antibodies were detected in any of the patients.

01 Jan 1988·Acta paediatrica Scandinavica. Supplement

Recombinant somatropin in treatment of growth hormone deficient children in Sweden and Finland.

Article

Author: Westphal, O ; Sipilä, I ; Wilton, P ; Westgren, U ; Nilsson, K O ; Ritzén, M ; Perheentupa, J ; Tuvemo, T ; Albertsson-Wikland, K ; Aronson, S

A total of 23 previously untreated and 28 previously treated GH deficient children were included for at least 12 months in a trial of recombinant somatropin, 0.1 IU/kg/day given by subcutaneous injection. All the children increased their height velocity over the pretreatment values, to nearly 11 cm/year, corresponding to a significant increase in height of 1 SD score for chronological age. The increase in height SD score for bone age was also statistically significant. No adverse effects were recorded, though one child experienced local itching and redness at the injection site which did not recur after a short cessation of therapy. One child developed detectable antibodies to recombinant somatropin, but the binding capacity was low and no clinical symptoms or growth attenuation occurred. Recombinant somatropin was shown to be safe and effective during the first year of therapy in children with GH deficiency.

100 Deals associated with Somatropin biosimilar(Bio-Ker s.r.l.)

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