Evidence map›Paper›PMID 37579214›Full record

ArticleThe Journal of clinical endocrinology and metabolism2023

Frequency and Predictive Factors of Hypoglycemia in Patients Treated With rhIGF-1: Data From the Eu-IGFD Registry.

Peter Bang, Michel Polak, Artur Bossowski, Mohamad Maghnie, Jesús Argente, Marta Ramon-Krauel, Caroline Sert, Valerie Perrot, Sarah Mazain, Joachim Woelfle

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in The Journal of clinical endocrinology and metabolism, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00903110 (Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.2field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00903110 recruitingnot on this map

Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).

Typeobservational_patient_registrySponsorEsteve Pharmaceuticals, S.A.Ran2008 to 2027Enrolled500ConditionsIGF1 DeficiencyArmsIncrelex®
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 6 citations in OpenAlex.

  1. Observational
  2. Review
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 8 institutions in 6 countries.

Peter BangDivision of Pediatrics, Department of Biomedical and Clinical Sciences, Faculty of Health Sciences, Linköping University, 581 83 Linköping, Sweden.
Michel PolakDepartment of Pediatric Endocrinology, Gynaecology, and Diabetology, Assistance Publique-Hôpitaux de Paris, Hôpital Universitaire Necker-Enfants Malades, 75015 Paris, France.
Artur BossowskiDepartment of Pediatrics, Endocrinology, Diabetology with Cardiology Division, Medical University of Białystok, 15-274 Białystok, Poland.ORCID 0000-0002-6316-5342
Mohamad MaghnieDepartment of Pediatrics, IRCCS Istituto Giannina Gaslini, 16100 Genova, Italy.ORCID 0000-0002-7183-5238
Jesús ArgenteDepartment of Endocrinology, Hospital Infantil Universitario Niño Jesús, Instituto de Investigación La Princesa, 28009 Madrid, Spain.ORCID 0000-0001-5826-0276
Marta Ramon-KrauelHospital Sant Joan de Déu, Institut de Recerca Sant Joan de Déu, 08950 Barcelona, Spain.ORCID 0000-0003-3027-9105
Caroline SertIpsen Pharma, 92100 Boulogne-Billancourt, France.
Valerie PerrotIpsen Pharma, 92100 Boulogne-Billancourt, France.
Sarah MazainIpsen Pharma, 92100 Boulogne-Billancourt, France.
Joachim WoelfleDepartment of Pediatrics and Adolescent Medicine, Friedrich-Alexander-University (FAU) Erlangen-Nürnberg, 91054 Erlangen, Germany.ORCID 0000-0002-9132-6174
Ipsen (France) · FRFriedrich-Alexander-Universität Erlangen-Nürnberg · DEHôpital Necker-Enfants Malades · FRHospital Sant Joan de Déu Barcelona · ESInstituto de Salud Carlos III · ESIstituto Giannina Gaslini · ITLinköping University · SEMedical University of Białystok · PL

Funding

Ipsen
6 · The paper itself

Abstract

contextThe European Increlex® 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).

objectiveThis analysis of Eu-IGFD data aimed to identify the frequency and predictive factors for hypoglycemia adverse events (AEs) in children treated with rhIGF-1.

methodsData 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.

resultsIn 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.

conclusionHypoglycemia 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.

Indexed as

HypoglycemiaLaron SyndromeAdolescentChildDatabases, FactualHumansInsulin-Like Growth Factor ILogistic ModelsLongitudinal StudiesRecombinant ProteinsInsulin-Like Growth Factor IRecombinant ProteinsEu-IGFD registryhypoglycemiamecaserminrhIGF-1severe primary insulin-like growth factor-1 deficiency

Identifiers

PMID37579214
PMCPMC10735455
OpenAlexW4385800261

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.