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Frequency and Predi...
Frequency and Predictive Factors of Hypoglycemia in Patients Treated With rhIGF-1: Data From the Eu-IGFD Registry
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- Bang, Peter (författare)
- Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten,Region Östergötland, H.K.H. Kronprinsessan Victorias barn- och ungdomssjukhus
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- Polak, Michel (författare)
- Hop Univ Necker Enfants Malad, France; France Univ Paris Cite, France
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- Bossowski, Artur (författare)
- Med Univ Bialystok, Poland
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- Maghnie, Mohamad (författare)
- IRCCS Ist Giannina Gaslini, Italy; Univ Genoa, Italy
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- Argente, Jesus (författare)
- Univ Nino Jesus, Spain; Univ Autonoma Madrid, Spain; Inst Salud Carlos III, Spain; IMDEA Food Inst, Spain
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- Ramon-Krauel, Marta (författare)
- Hosp St Joan De Deu, Spain; Inst Salud Carlos III, Spain
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- Sert, Caroline (författare)
- Ipsen Pharma, France
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- Perrot, Valerie (författare)
- Ipsen Pharma, France
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- Mazain, Sarah (författare)
- Ipsen Pharma, France
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- Woelfle, Joachim (författare)
- Friedrich Alexander Univ FAU Erlangen Nurnberg, Germany; Friedrich Alexander Univ FAU Erlangen Nurnberg, Germany
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(creator_code:org_t)
- ENDOCRINE SOC, 2024
- 2024
- Engelska.
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Ingår i: Journal of Clinical Endocrinology and Metabolism. - : ENDOCRINE SOC. - 0021-972X .- 1945-7197. ; 109:1, s. 46-56
- Relaterad länk:
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https://liu.diva-por... (primary) (Raw object)
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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
- Context The European Increlex & REG; Growth Forum Database (Eu-IGFD) is an ongoing surveillance registry (NCT00903110) established to collect long-term safety and effectiveness data on the use of recombinant human insulin-like growth factor-1 (rhIGF-1, mecasermin, Increlex) for the treatment of children/adolescents with severe primary insulin-like growth factor-1 deficiency (SPIGFD).Objective This analysis of Eu-IGFD data aimed to identify the frequency and predictive factors for hypoglycemia adverse events (AEs) in children treated with rhIGF-1.Methods Data were collected from December 2008 to May 2021. Logistic regression was performed to identify predictive risk factors for treatment-induced hypoglycemia AEs. Odds ratios (ORs) are presented with 95% CIs for each factor.Results In total, 306 patients were enrolled in the registry; 84.6% were diagnosed with SPIGFD. Patients who experienced & GE; 1 hypoglycemia AE (n = 80) compared with those with no hypoglycemia AEs (n = 224) had a lower mean age at treatment start (8.7 years vs 9.8 years), a more frequent diagnosis of Laron syndrome (27.5% vs 10.3%), and a history of hypoglycemia (18.8% vs 4.5%). Prior history of hypoglycemia (OR 0.25; 95% CI: [0.11; 0.61]; P = .002) and Laron syndrome diagnosis (OR 0.36; 95% CI: [0.18; 0.72]; P = .004) predicted future hypoglycemia AEs. Total hypoglycemia AEs per patient per treatment year was 0.11 and total serious hypoglycemia AEs per patient per treatment year was 0.01.Conclusion Hypoglycemia occurs more frequently in patients with prior history of hypoglycemia and/or Laron syndrome compared with patients without these risk factors, and these patients should be carefully monitored for this AE throughout treatment.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
Nyckelord
- hypoglycemia; severe primary insulin-like growth factor-1 deficiency; mecasermin; rhIGF-1; Eu-IGFD registry
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Bang, Peter
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Polak, Michel
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Bossowski, Artur
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Maghnie, Mohamad
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Argente, Jesus
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Ramon-Krauel, Ma ...
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Sert, Caroline
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Perrot, Valerie
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Mazain, Sarah
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Woelfle, Joachim
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Linköpings universitet