ONCE-DAILY SUBCUTANEOUS GROWTH HORMONE-RELEASING HORMONE-THERAPY ACCELERATES GROWTH IN GROWTH HORMONE-DEFICIENT CHILDREN DURING THE FIRST YEAR OF THERAPY

The efficacy and safety of 1 yr of GH-releasing hormone [GHRH(1-29)] t herapy in GH-deficient children were determined. One hundred and ten p reviously untreated prepubertal GH-deficient children were treated for up to 1 yr in a multicenter, open label study with 30 mu g/kg GHRH-(1 -29)/day, sc, given at bedtime. Eighty-six of the 110 patients were el igible for efficacy analysis. The main outcome measures, monitored eve ry 3-6 months, were linear growth enhancement (height velocity), bone age progression, and safety measures including clinical chemistry. The mean height velocity for the group increased from 4.1 +/- 0.9 cm/yr a t baseline to 8.0 +/- 1.5 and 7.2 +/- 1.3 cm/yr after 6 and 12 months of therapy, respectively. At 6 months, 74% of the children were consid ered to have a good response to GHRH. The ratio of the change in bone age to height age was not significantly different from unity at 12 mon ths (1.04 +/- 0.58; P = 0.63). No adverse changes in general biochemic al or hormonal analyses were noted. No change in fasting glucose conce ntration or excessive generation of insulin-like growth factor I occur red, and overall GHRH was well tolerated. We conclude that GHRH admini stered as a once daily dose of 30 mu g/kg GHRH-(1-29), sc, was effecti ve in increasing height velocity in GH-deficient children.