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Submitted on October 25, 2006
Accepted on December 14, 2006
Department of Pediatrics (SDC, PFB), University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, Tercica, Incorporated (JK), Brisbane, California, 94005, Santa Monica (JF), California 90403, and Department of Pediatrics (LEU), University of North Carolina, Chapel Hill, North Carolina, 27599
* To whom correspondence should be addressed. E-mail: steven.chernausek{at}cchmc.org.
Context: Children with severe IGF-I deficiency due to congenital or acquired defects in GH action have short stature that cannot be remedied by GH treatment.
Objectives: To examine the long-term efficacy and safety of recombinant human IGF-I (rhIGF-I) therapy for short children with severe IGF-I deficiency.
Design: Seventy-six children with IGF-I deficiency due to GH insensitivity were treated with rhIGF-I for up to 12 years under a predominantly open-label design.
Setting: General clinical research centers and collaborating endocrinologists.
Subjects: Entry criteria included: age > 2 yr, SD scores for height and circulating IGF-I concentration < -2 for age and sex, and evidence of resistance to GH.
Intervention: rhIGF-I was administered sc in doses between 60-120 µg/kg twice daily.
Main outcome measures: Height velocity, skeletal maturation, and adverse events.
Results: Height velocity increased from 2.8 cm/yr on average at baseline to 8.0 cm/year during the first year of treatment (p< 0.0001) and was dependent on the dose administered. Height velocities were lower during subsequent years, but remained above baseline for up to 8 years. The most common adverse event was hypoglycemia, which was observed both before and during therapy. It was reported by 49% of treated subjects. The next most common adverse events were injection site lipohypertrophy (32%) and tonsillar/adenoidal hypertrophy (22%).
Conclusions: Treatment with rhIGF-I stimulates linear growth in children with severe IGF-I deficiency due to GH insensitivity. Adverse events are common, but are rarely of sufficient severity to interrupt or modify treatment.
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