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352 Longitudinal Infusion of Insulin-Like Growth Factor-I and Igf-Binding Protein-3 Complex to Five Preterm Infants - Pharmacokinetics and Short Term Safety
  1. D Ley1,
  2. I HansenPupp1,
  3. A Niklasson2,
  4. M Domellöf3,
  5. L Friberg4,
  6. J Borg5,
  7. C Löfquist2,
  8. G Hellgren2,
  9. L Smith6,
  10. AL Hård2,
  11. A Hellström2
  1. 1Lund University, Lund
  2. 2Gothenburg University, Gothenburg
  3. 3Umeå University, Umeå
  4. 4Uppsala University
  5. 5Premacure AB, Uppsala, Sweden
  6. 6Harvard Medical School, Boston, MA, USA

Abstract

Introduction In preterm infants, low levels of insulin like growth factor-I (IGF-I) and IGF binding protein 3 (IGFBP-3) are associated with impaired brain growth and retinopathy of prematurity (ROP).

Treatment with IGF-I/IGFBP-3 may be beneficial for brain development and decrease the prevalence of ROP.

Methods In a phase II pharmacokinetic and safety study, five infants (3 girls) with a median (range) gestational age (GA) of 26+6 (26+0 – 27+2) weeks and birth weight (BW) of 990 (900–1212) g received continuous intravenous infusion of rhIGF-I/rhIGFBP-3. Treatment was initiated during the first postnatal day and continued for a median (range) duration of 168 h (47–168) in doses between 21–111 µg/kg/24h.

Results Treatment with rhIGF-I/rhIGFBP-3 was associated with higher serum IGF-I and IGFBP-3 concentrations (p<0.001) than model-predicted endogenous levels. Out of 74 IGF-I samples measured during study drug infusion, 37 (50%) were within target range, 4 (5%) above and 33 (45%) were below. Predicted dose of rhIGF-I/rhIGFBP-3 to establish circulating levels of IGF-I within the intrauterine range in a 1000 g infant was 75–100 µg/kg/24 h. No hypoglycemia or other adverse effects were recorded.

Discussion Continuous intravenous infusion of rhIGF-I/rhIGFBP-3 was effective in increasing serum concentrations of IGF-I and IGFBP-3. Administration under study conditions was safe.

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