Spanish multicentre trial on somatrem (1985-1986).

In an open multicentre trial, the safety and efficacy of somatrem, 4 IU i.m. three times weekly for 12 months, were evaluated in children with hGH deficiency with or without previous treatment with pituitary hGH. Patients were divided into young and prepubertal groups according to chronological age, and catch-up growth after treatment was greater in the former. Bone age evolved at the same rate as chronological age, irrespective of whether patients were previously untreated (naïve) or previously treated. Fewer previously treated patients exhibited anti-hGH antibodies than naïve patients. Somatrem appears to be a safe, efficient product for treating different degrees of hGH deficiency.