PMID- 37579214
OWN - NLM
STAT- MEDLINE
DCOM- 20231225
LR  - 20231225
IS  - 1945-7197 (Electronic)
IS  - 0021-972X (Print)
IS  - 0021-972X (Linking)
VI  - 109
IP  - 1
DP  - 2023 Dec 21
TI  - Frequency and Predictive Factors of Hypoglycemia in Patients Treated With 
      rhIGF-1: Data From the Eu-IGFD Registry.
PG  - 46-56
LID - 10.1210/clinem/dgad479 [doi]
AB  - CONTEXT: The European Increlex(R) 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 >/= 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.
CI  - (c) The Author(s) 2023. Published by Oxford University Press on behalf of the 
      Endocrine Society.
FAU - Bang, Peter
AU  - Bang P
AD  - Division of Pediatrics, Department of Biomedical and Clinical Sciences, Faculty 
      of Health Sciences, Linkoping University, 581 83 Linkoping, Sweden.
FAU - Polak, Michel
AU  - Polak M
AD  - Department of Pediatric Endocrinology, Gynaecology, and Diabetology, Assistance 
      Publique-Hopitaux de Paris, Hopital Universitaire Necker-Enfants Malades, 75015 
      Paris, France.
AD  - IMAGINE Institute, INSERM U1016, France University of Paris Cite, 75015 Paris, 
      France.
FAU - Bossowski, Artur
AU  - Bossowski A
AUID- ORCID: 0000-0002-6316-5342
AD  - Department of Pediatrics, Endocrinology, Diabetology with Cardiology Division, 
      Medical University of Bialystok, 15-274 Bialystok, Poland.
FAU - Maghnie, Mohamad
AU  - Maghnie M
AUID- ORCID: 0000-0002-7183-5238
AD  - Department of Pediatrics, IRCCS Istituto Giannina Gaslini, 16100 Genova, Italy.
AD  - Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and 
      Child Health University of Genova, 16132 Genova, Italy.
FAU - Argente, Jesus
AU  - Argente J
AUID- ORCID: 0000-0001-5826-0276
AD  - Department of Endocrinology, Hospital Infantil Universitario Nino Jesus, 
      Instituto de Investigacion La Princesa, 28009 Madrid, Spain.
AD  - Department of Pediatrics, Universidad Autonoma de Madrid, 28029 Madrid, Spain.
AD  - Centro de Investigacion Biomedica en Red de la Fisiopatologia (CIBER) de 
      Fisiopatologia de Obesidad y Nutricion, Instituto de Salud Carlos III, 28029 
      Madrid, Spain.
AD  - IMDEA Food Institute, 28049 Madrid, Spain.
FAU - Ramon-Krauel, Marta
AU  - Ramon-Krauel M
AUID- ORCID: 0000-0003-3027-9105
AD  - Hospital Sant Joan de Deu, Institut de Recerca Sant Joan de Deu, 08950 Barcelona, 
      Spain.
AD  - Centro de Investigacion Biomedica en Red de Diabetes y Enfermedades Metabolicas 
      Asociadas (CIBERDEM), Instituto de Salud Carlos III, 28029 Madrid, Spain.
FAU - Sert, Caroline
AU  - Sert C
AD  - Ipsen Pharma, 92100 Boulogne-Billancourt, France.
FAU - Perrot, Valerie
AU  - Perrot V
AD  - Ipsen Pharma, 92100 Boulogne-Billancourt, France.
FAU - Mazain, Sarah
AU  - Mazain S
AD  - Ipsen Pharma, 92100 Boulogne-Billancourt, France.
FAU - Woelfle, Joachim
AU  - Woelfle J
AUID- ORCID: 0000-0002-9132-6174
AD  - Department of Pediatrics and Adolescent Medicine, Friedrich-Alexander-University 
      (FAU) Erlangen-Nurnberg, 91054 Erlangen, Germany.
LA  - eng
GR  - Ipsen/
PT  - Journal Article
PL  - United States
TA  - J Clin Endocrinol Metab
JT  - The Journal of clinical endocrinology and metabolism
JID - 0375362
RN  - 67763-96-6 (Insulin-Like Growth Factor I)
RN  - 0 (Recombinant Proteins)
SB  - IM
MH  - Child
MH  - Adolescent
MH  - Humans
MH  - *Laron Syndrome
MH  - *Hypoglycemia/chemically induced/epidemiology
MH  - Longitudinal Studies
MH  - Insulin-Like Growth Factor I
MH  - Recombinant Proteins/adverse effects
MH  - Databases, Factual
MH  - Logistic Models
PMC - PMC10735455
OTO - NOTNLM
OT  - Eu-IGFD registry
OT  - hypoglycemia
OT  - mecasermin
OT  - rhIGF-1
OT  - severe primary insulin-like growth factor-1 deficiency
EDAT- 2023/08/14 18:42
MHDA- 2023/12/25 06:43
PMCR- 2023/08/14
CRDT- 2023/08/14 15:33
PHST- 2023/02/03 00:00 [received]
PHST- 2023/12/25 06:43 [medline]
PHST- 2023/08/14 18:42 [pubmed]
PHST- 2023/08/14 15:33 [entrez]
PHST- 2023/08/14 00:00 [pmc-release]
AID - 7242466 [pii]
AID - dgad479 [pii]
AID - 10.1210/clinem/dgad479 [doi]
PST - ppublish
SO  - J Clin Endocrinol Metab. 2023 Dec 21;109(1):46-56. doi: 10.1210/clinem/dgad479.