Abstract
During 1985-86 a multricentric trial to evaluate the safety and efficacy of Somatrem (SomatonormR) in children with growth hormone deficiency (GHD) was performed in Spain. 49 patients “new” as well as previously treated (“old”), with peak plasma hGH <7ng/ml height SD <-2.0 for chronological age (CA), growth velocity (CV) <4 cms/year, bone age (BA) <10 “years” in girls and 11 “years” in boys and idiopathic were involved in the trial. Dosage was 4 IU, 3 times a week i.m. EFFICACY: In “new” patients (N=21) GV changed from 3.39 cm/yr to 9.22 in the “young group” (CA<10 yrs) and from 2.52 to 6.62 in the “prepuberal” group (CA:10-16 yrs). In “old” patients (N=28), the majority of them, irregularly treated, the change in GV was from 4.8 cm/yr to 6.62 (“young group”) and 3.15 to 6.02 (prepuberal group). BA evolved parallely to CA. with an improvement of adult heigth prognosis. SAFETY: The study of hGH antibodies (hGH-ab) in new patients showed a 29% of positive cases from the end of first quarter reaching a plateau between 36.6-28.5% later. In the “old” group the percentage was significantly less. The Binding capacity of hGH-ab was very low (M=0.05 mg/l) E.coli polypeptide-ab fluctuated throughout treatment witli no clear correlation with hGH-ab. CONCLUSION: Somatrem is as effective in patients with GHD as pit-hGH was and is a safe product since the ab found produce no deleterious metabolic effects and do not interfere with growth.
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Vicens-Calvet, E., Cuatrecasas, J. & Vicens-Calvet, E. SPANISH MULTICENTRIC TRIAL ON SOMATREM. Pediatr Res 23, 116 (1988). https://doi.org/10.1203/00006450-198801000-00088
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DOI: https://doi.org/10.1203/00006450-198801000-00088