Abstract
Once daily subcutaneously synthetic GH-RH 1-44 NH2 (Sanofi Recherche France) was given in double blind fashion, for six months to 111 prepubertal children (70 boys, 41 girls, aged 2.5 to 14.3 years) with growth failure (height 2 SD below the mean for chronological age and height velocity HV < the 10th ccntile for bone age) due to idiopathic GH deficiency (peak GH<20mUl/L to 2 standard provocative tests). Patients were stratified in 2 classes according to body weight and randomly allocate to 1 of 7 GH-RH doses, from 30 to 300 mcg/daily dose. Mean HV, expressed in SD (+/- SEM) for bone age, increased from -2.6(+/-0.1) during 6 months pretreatment up to -0.3 (+/-0.2) during treatment period. No relationship was found between the GH-RH dose (ranging from 1.3 to 23.1 mcg/Kg/day) and either absolute HV or the net increment in HV. During treatment HV was equal or above the mean for bone age (catch up growth criteria) in 47/111 (42%) patients. The highest height velocities HV during treatment were observed in children with less retarded growth. No clinical adverse effect was observed. Low titer antibodies to GH-RH developed in 18 patients (16%).
In summary this study documented a net increase in HV but failed to relate it to the dose of GH-RH used. Tolerance to GH-RH treatment was good. The demonstration of dose-response effect of GH-RH on HV requires to investigate a broader range of doses of GH-RH and/or different daily dosage regimen.
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Tatò, L. 44 HEIGHT VELOCITY OF III PREPUBERIAL CHILDREN WITH GROWTH HORMONE (GH) DEFICIENCY TREATED WITH GROWTH HORMONE-RELEASING HORMONE (GH-RH 1–44 NH2): A RANDOMIZED DOUBLE-8LIND DOSE RANGING STUDY. Pediatr Res 24, 524 (1988). https://doi.org/10.1203/00006450-198810000-00065
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DOI: https://doi.org/10.1203/00006450-198810000-00065