Evidence map›Paper›PMID 34113318›Full record

ArticleFrontiers in endocrinology2021

Effectiveness and Overall Safety of NutropinAq

Regis Coutant, Jordi Bosch Muñoz, Cristina Patricia Dumitrescu, Dirk Schnabel, Caroline Sert, Valerie Perrot, Mehul Dattani

Open access · goldAbstract readMulticenter Study
In one paragraph

Article in Frontiers in endocrinology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 14% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Guideline
  2. Review
  3. GH Therapy in Non-Growth Hormone-Deficient Children.Children (Basel, Switzerland) · 2024
    Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Effectiveness and Overall Safety of NutropinAqFrontiers in endocrinology · 2021
    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

7 authors at 6 institutions in 5 countries.

Regis CoutantPediatric Endocrinology, Centre Hospitalier Universitaire d'Angers, Angers, France.
Jordi Bosch MuñozPediatric Endocrinology, Hospital Arnau de Vilanova, Lleida, Spain.
Cristina Patricia DumitrescuPediatric Endocrinology, Constantin Ion Parhon (C.I.) Parhon National Institute of Endocrinology, Bucharest, Romania.
Dirk SchnabelCenter for Chronic Sick Children, Pediatric Endocrinology, Charitè, University Medicine, Berlin, Germany.
Caroline SertIpsen, Boulogne-Billancourt, France.
Valerie PerrotIpsen, Boulogne-Billancourt, France.
Mehul DattaniUniversity College London (UCL) Great Ormond Street (GOS) Institute of Child Health and Great Ormond Street Hospital for Children, London, United Kingdom.
Ipsen (France) · FRCentre Hospitalier Universitaire d'Angers · FRCharité - Universitätsmedizin Berlin · DEHospital Arnau de Vilanova · ESInstitutul Național de Endocrinologie C.I. Parhon · ROUniversity College London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: The International Cooperative Growth Study, NutropinAq Methods: Open-label, non-interventional, post-marketing surveillance study recruiting children with growth disorders. Endpoints included gain in height standard deviation score (SDS), adult height, and occurrence of adverse events (AEs). Results: 2792 patients were enrolled. 2082 patients (74.6%) had growth hormone deficiency (GHD), which was isolated idiopathic in 1825 patients (87.7%). Non-GHD diagnoses included Turner syndrome (TS) (n=199), chronic renal insufficiency (CRI) (n=10), other non-GHD (n=498), and missing data for three participants. Improvements from baseline height SDS occurred at all time points to Month 132, and in all subgroups by disease aetiology. At Month 12, mean (95% CI) change in height SDS by aetiology was: idiopathic GHD 0.63 (0.61;0.66), organic GHD 0.71 (0.62;0.80), TS 0.59 (0.53; 0.65), CRI 0.54 (-0.49;1.56), and other non-GHD 0.64 (0.59;0.69). Mean height ( ± SD) at the last visit among the 235 patients with adult or near-adult height recorded was 154.0 cm ( ± 8.0) for girls and 166.7 cm ( ± 8.0) for boys. The most frequent biological and clinical non-serious drug-related AEs were increased insulin-like growth factor concentrations (314 events) and injection site haematoma (99 events). Serious AEs related to rhGH according to investigators were reported (n=30); the most frequent were scoliosis (4 events), epiphysiolysis (3 events), and strabismus (2 events). Conclusions: There was an improvement in mean height SDS in all aetiology subgroups after rhGH treatment. No new safety concerns were identified.

Indexed as

Case-Control StudiesChildChild, PreschoolFemaleFollow-Up StudiesGrowth DisordersHuman Growth HormoneHumansInfantInternational AgenciesMaleProduct Surveillance, PostmarketingPrognosisRecombinant ProteinsRegistriesRenal Insufficiency, ChronicHuman Growth HormoneRecombinant Proteinsgrowth hormone deficiencyNutropinAq® (somatropin)paediatric GH disordersrhGH, recombinant human GHsafety

Identifiers

PMID34113318
PMCPMC8185283
OpenAlexW3165597359

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 OpenQuestion graph.