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Longitudinal infusion of a complex of insulin-like growth factor-I and IGF-binding protein-3 in five preterm infants: pharmacokinetics and short-term safety

Ley, David LU ; Pupp, Ingrid LU ; Niklasson, Aimon; Domellof, Magnus; Friberg, Lena E.; Borg, Jan; Lofqvist, Chatarina; Hellgren, Gunnel; Smith, Lois E. H. and Hard, Anna-Lena, et al. (2013) In Pediatric Research 73(1). p.68-74
Abstract
BACKGROUND: In preterm infants, low levels of insulin-like growth factor-I (IGF-1) 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 may decrease the prevalence of ROP. METHODS: In a phase II pharmacokinetics and safety study, five infants (three girls) with a median (range) gestational age (GA) of 26 wk + 6 d (26 wk + 0 d to 27 wk + 2 d) and birth weight of 990 (900-1,212) g received continuous intravenous infusion of recombinant human (rh)IGF-I/rhIGFBP-3. Treatment was initiated during the first postnatal day and continued for a median (range) duration of 168 (47-168) h in dosages between 21 and 111... (More)
BACKGROUND: In preterm infants, low levels of insulin-like growth factor-I (IGF-1) 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 may decrease the prevalence of ROP. METHODS: In a phase II pharmacokinetics and safety study, five infants (three girls) with a median (range) gestational age (GA) of 26 wk + 6 d (26 wk + 0 d to 27 wk + 2 d) and birth weight of 990 (900-1,212) g received continuous intravenous infusion of recombinant human (rh)IGF-I/rhIGFBP-3. Treatment was initiated during the first postnatal day and continued for a median (range) duration of 168 (47-168) h in dosages between 21 and 111 mu g/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. Of 74 IGF-I samples measured during study drug infusion, 37 (50%) were within the target range, 4 (5%) were above, and 33 (45%) were below. The predicted dose of rhIGF-I/rhIGFBP-3 required to establish circulating levels of IGF-I within the intrauterine range in a 1,000 g infant was 75-100 mu g/kg/24 h. No hypoglycemia or other adverse effects were recorded. CONCLUSION: In this study, continuous intravenous infusion of rhIGF-I/rhIGFBP-3 was effective in increasing serum concentrations of IGF-I and IGFBP-3, and was found to be safe. (Less)
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Contribution to journal
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published
subject
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Pediatric Research
volume
73
issue
1
pages
68 - 74
publisher
International Pediatric Foundation Inc.
external identifiers
  • wos:000313307900011
  • pmid:23095978
  • scopus:84872069596
ISSN
1530-0447
DOI
10.1038/pr.2012.146
language
English
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yes
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92cae022-4ed8-4e38-a55e-37c6157585b1 (old id 3476837)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/23095978?dopt=Abstract
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2013-03-01 07:47:28
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2019-10-16 01:33:07
@article{92cae022-4ed8-4e38-a55e-37c6157585b1,
  abstract     = {BACKGROUND: In preterm infants, low levels of insulin-like growth factor-I (IGF-1) 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 may decrease the prevalence of ROP. METHODS: In a phase II pharmacokinetics and safety study, five infants (three girls) with a median (range) gestational age (GA) of 26 wk + 6 d (26 wk + 0 d to 27 wk + 2 d) and birth weight of 990 (900-1,212) g received continuous intravenous infusion of recombinant human (rh)IGF-I/rhIGFBP-3. Treatment was initiated during the first postnatal day and continued for a median (range) duration of 168 (47-168) h in dosages between 21 and 111 mu g/kg/24h. RESULTS: Treatment with rhIGF-I/rhIGFBP-3 was associated with higher serum IGF-I and IGFBP-3 concentrations (P &lt; 0.001) than model-predicted endogenous levels. Of 74 IGF-I samples measured during study drug infusion, 37 (50%) were within the target range, 4 (5%) were above, and 33 (45%) were below. The predicted dose of rhIGF-I/rhIGFBP-3 required to establish circulating levels of IGF-I within the intrauterine range in a 1,000 g infant was 75-100 mu g/kg/24 h. No hypoglycemia or other adverse effects were recorded. CONCLUSION: In this study, continuous intravenous infusion of rhIGF-I/rhIGFBP-3 was effective in increasing serum concentrations of IGF-I and IGFBP-3, and was found to be safe.},
  author       = {Ley, David and Pupp, Ingrid and Niklasson, Aimon and Domellof, Magnus and Friberg, Lena E. and Borg, Jan and Lofqvist, Chatarina and Hellgren, Gunnel and Smith, Lois E. H. and Hard, Anna-Lena and Hellstrom, Ann},
  issn         = {1530-0447},
  language     = {eng},
  number       = {1},
  pages        = {68--74},
  publisher    = {International Pediatric Foundation Inc.},
  series       = {Pediatric Research},
  title        = {Longitudinal infusion of a complex of insulin-like growth factor-I and IGF-binding protein-3 in five preterm infants: pharmacokinetics and short-term safety},
  url          = {http://dx.doi.org/10.1038/pr.2012.146},
  volume       = {73},
  year         = {2013},
}