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Effectiveness and S...
Effectiveness and Safety of rhIGF-1 Therapy in Children: The European Increlex (R) Growth Forum Database Experience
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- Bang, Peter (författare)
- Linköpings universitet,Avdelningen för kliniska vetenskaper,Medicinska fakulteten
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- Polak, Michel (författare)
- University of Paris 05, France
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- Woelfle, Joachim (författare)
- University of Bonn, Germany
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- Houchard, Aude (författare)
- Ipsen Pharma, France
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(creator_code:org_t)
- 2015-03-21
- 2015
- Engelska.
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Ingår i: Hormone Research in Paediatrics. - : KARGER. - 1663-2818 .- 1663-2826. ; 83:5, s. 345-357
- Relaterad länk:
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https://www.karger.c...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Background/Aims: We report data from the EU Increlex (R) Growth Forum Database (IGFD) Registry, an ongoing, open-label, observational study monitoring clinical practice use of recombinant human insulin-like growth factor-1 (rhIGF-1) therapy in children. Methods: Safety and effectiveness data on rhIGF-1 treatment of 195 enrolled children with growth failure were collected from December 2008 to September 2013. Results: Mean +/- SD (95% CI) height velocity during first year of rhIGF-1 treatment was 6.9 +/- 2.2 cm/year (6.5; 7.2) (n = 144); in prepubertal patients naive to treatment, this was 7.3 +/- 2.0 cm/year (6.8; 7.7) (n = 81). Female sex, younger age at start of rhIGF-1 therapy, and lower baseline height SDS predicted first-year change in height SDS. The most frequent targeted treatment-emergent adverse events (% patients) were hypoglycemia (17.6%, predictors: young age, diagnosis of Laron syndrome, but not rhIGF-1 dose), lipohypertrophy (10.6%), tonsillar hypertrophy (7.4%), injection site reactions (6.4%), and headache (5.9%). Sixty-one serious adverse events (37 related to rhIGF-1 therapy) were reported in 31 patients (16.5%). Conclusion: Safety and effectiveness data on use of rhIGF-1 in a real-world setting were similar to those from controlled randomized trials. Severe growth phenotype and early start of rhIGF-1 improved height response and predicted risk of hypoglycemia. (C) 2015 S. Karger AG, Basel
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine (hsv//eng)
Nyckelord
- Height; rhIGF-1 therapy; EU IGFD Registry; Short stature; Severe primary insulin-like growth factor-1 deficiency
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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