Evidence map›Paper›PMID 39371577›Full record

ArticleTherapeutic advances in endocrinology and metabolism2024

Growth hormone treatment in children with Prader-Willi syndrome: safety and effectiveness data from the PATRO Children study.

Constanze Lämmer, Philippe Backeljauw, Maite Tauber, Shankar Kanumakala, Sandro Loche, Karl Otfried Schwab, Roland Pfäffle, Charlotte Höybye, Elena Lundberg, Jovanna Dahlgren and 5 more

Abstract read
In one paragraph

Article in Therapeutic advances in endocrinology and metabolism, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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

6 citing papers in PubMed.

  1. Review
  2. Article
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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

15 authors.

Constanze LämmerDepartment of Pediatrics, KJF Josefinum, Joseph-Mayer-Straße 1, Augsburg 86154, Germany.
Philippe BackeljauwCincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Maite TauberUnité d'Endocrinologie, Obésité, Maladies Osseuses, Génétique et Gynécologie Médicale, Centre de Référence du Syndrome de Prader-Willi et Autres Syndrome avec Obésité et Troubles du Comportement Alimentaire, Hôpital des Enfants, Toulouse, France.
Shankar KanumakalaDepartment of Pediatrics, Royal Alexandra Children's Hospital, University Hospitals Sussex NHS Foundation Trust, Brighton, UK.
Sandro LocheSSD Endocrinologia Pediatrica e Centro, Screening Neonatale, Ospedale Pediatrico Microcitemico 'A. Cao', Cagliari, Italy.
Karl Otfried SchwabDepartment of General Pediatrics, Adolescent Medicine and Neonatology, Faculty of Medicine, Medical Centre, University of Freiburg, Freiburg, Germany.
Roland PfäffleDepartment of Pediatrics, University of Leipzig, Leipzig, Germany.
Charlotte HöybyeDepartment of Endocrinology, Karolinska University Hospital, Stockholm, Sweden.
Elena LundbergDepartment of Pediatrics, Institution of Clinical Science, Umeå University, Umeå, Sweden.
Jovanna DahlgrenDepartment of Pediatrics, Göteborg Pediatric Growth Research Center, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden.
Anna E EkDivision of Pediatrics, Intervention and Technology, Department of Clinical Science, Karolinska Institute, Stockholm, Sweden.
Tadej BattelinoDepartment of Paediatric Endocrinology, Diabetes and Metabolic Diseases, Faculty of Medicine, University Children's Hospital, University Medical Centre, University of Ljubljana, Ljubljana, Slovenia.
Berit KriströmDepartment of Pediatrics, Institution of Clinical Science, Umeå University, Umeå, Sweden.
Altaher EsmaelHEXAL AG (a Sandoz Company), Holzkirchen, Germany.
Markus ZabranskyHEXAL AG (a Sandoz Company), Holzkirchen, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Recombinant human growth hormone (rhGH, somatropin) therapy is approved in children with Prader-Willi syndrome (PWS). Objectives: To report safety and effectiveness data for children with PWS treated with biosimilar rhGH (Omnitrope Design: PATRO Children was a multicenter, non-interventional, postmarketing surveillance study. Methods: Children with PWS received Omnitrope according to standard clinical practice. Adverse events (AEs) were monitored for the duration of Omnitrope treatment. Effectiveness outcomes were also assessed, including height standard deviation (SD) scores (HSDS). Results: As of July 2020 (study completion), 235 patients with PWS had been enrolled. At baseline, 95.7% ( Conclusion: These data suggest that biosimilar rhGH is well tolerated and effective in patients with PWS managed in real-life clinical practice. Patients with PWS should continue to be closely monitored for well-known safety issues (including respiratory, sleep, and glucose metabolism disorders, and scoliosis) during rhGH treatment.

Indexed as

biosimilargrowth hormone replacement therapyOmnitrope®PATRO ChildrenPrader–Willi syndromesomatropin

Identifiers

PMID39371577
PMCPMC11450727

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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.