Clinical experience with authentic recombinant somatropin--German Collaborative Study

A multicentre clinical 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. To the present time, 41 patients with hGH deficiency not previously treated (naïve) and 28 patients previously treated with pituitary hGH have been admitted. Recombinant somatropin is given, 12 IU/m2/week s.c., divided into six doses. Height velocities during treatment rose dramatically for naïve patients from 3.5 cm/year (n = 40, before treatment), to 15.0 cm/year (n = 19, calculated at 3 months), and 13.3 cm/year (n = 8, calculated at 6 months). For previously treated patients, the increase in height velocity was from 5.8 cm/year (n = 20) to 9.2 cm/year (n = 19, after 3 months) and 8.6 cm/year (n = 9) at 6 months. Tolerance of recombinant somatropin was good, and no anti-hGH antibodies were detected in any of the patients.