Recombinant insulin-like growth factor (IGF)-I treatment in short children with low IGF-I levels: first-year results from a randomized clinical trial.
J Clin Endocrinol Metab
; 95(2): 611-9, 2010 Feb.
Article
em En
| MEDLINE
| ID: mdl-19880790
ABSTRACT
CONTEXT Short stature in children may be associated with low IGF-I despite normal stimulated GH levels and without other causes. OBJECTIVE:
Our objective was to assess the safety and efficacy of recombinant human IGF-I (rhIGF-I) in short children with low IGF-I levels.DESIGN:
This was a 1-yr, randomized, open-label trial (MS301).SETTING:
The study was conducted at 30 U.S. pediatric endocrinology clinics.SUBJECTS:
A total of 136 short, prepubertal subjects with low IGF-I (height and IGF-I sd scores <-2, stimulated GH > or =7 ng/ml); 124 completed the study, and six withdrew for adverse events and six for other reasons. INTERVENTION rhIGF-I was administered sc, twice daily using weight-based dosing (40, 80, or 120 microg/kg; n = 111) or subjects were observed (n = 25). MAIN OUTCOMEMEASURES:
First-year height velocity (centimeters per year, cm/yr), height sd score, IGF-I, and adverse events were prespecified outcomes.RESULTS:
First-year height velocities for subjects completing the trial were increased for the 80- and 120-microg/kg twice-daily vs. the untreated group (7.0 +/- 1.0, 7.9 +/- 1.4, and 5.2 +/- 1.0 cm/yr, respectively; all P < 0.0001) and for the 120- vs. 80-microg/kg group (P = 0.0002) and were inversely related to age. They were not predicted by GH stimulation or IGF-I generation test results and were not correlated with IGF-I antibody status. The most commonly reported adverse events of special interest during treatment were headache (38% of subjects), vomiting (25%), and hypoglycemia (14%).CONCLUSIONS:
rhIGF-I treatment was associated with age- and dose-dependent increases in first-year height velocity. Adverse events during treatment were less common than in previous studies and were generally transient, easily managed, and without known sequelae.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Fator de Crescimento Insulin-Like I
/
Transtornos do Crescimento
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Limite:
Child
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Child, preschool
/
Female
/
Humans
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Male
Idioma:
En
Revista:
J Clin Endocrinol Metab
Ano de publicação:
2010
Tipo de documento:
Article