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

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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; Pupp, Ingrid; Niklasson, Aimon; Domellof, Magnus; Friberg, Lena E.; Borg, Jan; Lofqvist, Chatarina; Hellgren, Gunnel; Smith, Lois E. H.; Hard, Anna-Lena; Hellstrom, Ann.

I: Pediatric Research, Vol. 73, Nr. 1, 2013, s. 68-74.

Forskningsoutput: TidskriftsbidragArtikel i vetenskaplig tidskrift

Harvard

Ley, D, Pupp, I, Niklasson, A, Domellof, M, Friberg, LE, Borg, J, Lofqvist, C, Hellgren, G, Smith, LEH, Hard, A-L & Hellstrom, A 2013, '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', Pediatric Research, vol. 73, nr. 1, s. 68-74. https://doi.org/10.1038/pr.2012.146

APA

Ley, D., Pupp, I., Niklasson, A., Domellof, M., Friberg, L. E., Borg, J., Lofqvist, C., Hellgren, G., Smith, L. E. H., Hard, A-L., & Hellstrom, A. (2013). 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. Pediatric Research, 73(1), 68-74. https://doi.org/10.1038/pr.2012.146

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Author

Ley, David ; Pupp, Ingrid ; Niklasson, Aimon ; Domellof, Magnus ; Friberg, Lena E. ; Borg, Jan ; Lofqvist, Chatarina ; Hellgren, Gunnel ; Smith, Lois E. H. ; Hard, Anna-Lena ; Hellstrom, Ann. / 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. I: Pediatric Research. 2013 ; Vol. 73, Nr. 1. s. 68-74.

RIS

TY - JOUR

T1 - 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

AU - Ley, David

AU - Pupp, Ingrid

AU - Niklasson, Aimon

AU - Domellof, Magnus

AU - Friberg, Lena E.

AU - Borg, Jan

AU - Lofqvist, Chatarina

AU - Hellgren, Gunnel

AU - Smith, Lois E. H.

AU - Hard, Anna-Lena

AU - Hellstrom, Ann

PY - 2013

Y1 - 2013

N2 - 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.

AB - 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.

U2 - 10.1038/pr.2012.146

DO - 10.1038/pr.2012.146

M3 - Article

C2 - 23095978

VL - 73

SP - 68

EP - 74

JO - Pediatric Research

JF - Pediatric Research

SN - 1530-0447

IS - 1

ER -