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Growth hormone therapy with three dosage regimens in children with idiopathic short stature. European Study Group
L T Rekers-Mombarg1, G G Massa, J M Wit
1Department of Pediatrics of the University Hospital of Leiden, The Netherlands.
Insights
Recombinant human growth hormone (rhGH) therapy improved growth in children with idiopathic short stature (ISS). Higher doses and dose adjustments showed modest but significant gains in height over four years.
Area of Science:
- Pediatrics
- Endocrinology
- Growth Disorders
Background:
- Idiopathic short stature (ISS) affects children's growth.
- Recombinant human growth hormone (rhGH) is used to treat ISS.
- Optimizing rhGH dosage regimens is crucial for maximizing growth outcomes.
Purpose of the Study:
- To evaluate the 4-year growth-promoting effects of rhGH in children with ISS across three different dose regimens.
- To determine if increasing rhGH dosage after the first year could mitigate the decline in height velocity (HV).
Main Methods:
- 223 children with ISS received subcutaneous rhGH (6 days/week).
- Randomized to three groups: 3 IU/m²/day, 4.5 IU/m²/day, or 3 IU/m²/day (year 1) then 4.5 IU/m²/day (subsequent years).
- Growth outcomes compared to 229 untreated children with ISS.
Main Results:
- rhGH therapy nearly doubled height velocity (HV) in the first year, with higher doses yielding greater effects.
- HV differences diminished in year two, but dose escalation slowed HV decline.
- Over 4 years, height SD score increased significantly; predicted adult height improved, with the 4.5 IU/m² group showing slightly better results.
Conclusions:
- Four years of rhGH therapy improved growth and final height prognosis in children with ISS.
- A dosage of 4.5 IU/m² showed slightly superior results compared to 3 IU/m² or a stepped-up regimen.
- Despite significant bone age advancement (4.8 years), the overall effect on final adult height is likely modest.
Objective:
In children with idiopathic short stature (ISS) we studied the growth-promoting effect at 4 years of recombinant human growth hormone (rhGH) therapy in three dose regimens and evaluated whether increasing the dosage after the first year could prevent a decline in height velocity (HV).
Design:
Included were 223 patients who were treated with subcutaneous administrations of rhGH 6 days per week. They were randomized to three groups: 3 IU/m2 body surface/day, 4.5 IU/m2/day, and 3 IU/m2/day during the first year and 4.5 IU/m2/day thereafter, corresponding with dosages of 0.2 and 0.3 mg/kg body weight/week, respectively. Growth was compared with a standard of 229 untreated children with ISS [ISS standard].
Results:
During the first year of treatment HV almost doubled and was higher with 4.5 IU/m2 than with 3 IU/m2. In the second year HV no longer differed among the groups, but increasing the dosage slowed the rate of the fall of HV. During 4 years of therapy the height SD score for age increased by a mean (SD) of 2.5 (1.0) [ISS standards], or 1.2 (0.7) (British standards), bone age increased by 4.8 (1.3) years, and predicted adult height SD score increased by 1.5 (0.7). After 4 years the results of the group with 4.5 IU/m2 were slightly better than those of the other groups. When dropouts were included in the analysis (assuming a stable height SD score after discontinuation of rhGH therapy), height gain was still significant.
Conclusions:
During 4 years of rhGH therapy, growth and final height prognosis improved, slightly more with 4.5 IU/m2 than with 3 IU/m2 or 3 to 4.5 IU/m2. However, bone age advanced on average 4.8 years during this period; therefore, any effect on final height will probably be modest.
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