Evidence mapPaperPMID 38635113Full record

SynthesisPaediatric drugs2024

Dapagliflozin and Empagliflozin in Paediatric Indications: A Systematic Review.

Sebastiano A G Lava, Craig Laurence, Alessandro Di Deo, Nicole Sekarski, Michael Burch, Oscar Della Pasqua

Registry-linked trialAbstract readSystematic Review
PubMed Publisher
In one paragraph

Synthesis in Paediatric drugs, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06643442 (Repurposing Empagliflozin for Duchenne Muscular Dystrophy - Associated Cardiomyopathy), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
5.0field-weighted citation impact, top 4% 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.

NCT06643442 phase2not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Repurposing Empagliflozin for Duchenne Muscular Dystrophy - Associated Cardiomyopathy: a Pharmacokinetics, Safety and Proof-of-concept Study Among Children 6-18 Years of Age

TypeinterventionalSponsorSebastiano LavaRan2025 to 2027Enrolled12ConditionsDMD-associated Dilated CardiomyopathyArmsEmpagliflozin Tablets
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Pros and Cons of Early Treatment with GLP-1 Receptor Agonist and SGLT-2 Inhibitors for Youth with Type 2 Diabetes: A Narrative Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026
    Review
  6. Review
  7. Article
  8. Review
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

6 authors at 3 institutions in 2 countries.

Sebastiano A G LavaPediatric Cardiology Unit, Department of Pediatrics, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Rue du Bugnon 46, 1011, Lausanne, Switzerland. webmaster@sebastianolava.ch.ORCID http://orcid.org/0000-0002-8391-5462
Craig LaurenceHeart Failure and Transplantation, Department of Paediatric Cardiology, Great Ormond Street Hospital, London, UK.
Alessandro Di DeoClinical Pharmacology and Therapeutics Group, University College London, London, UK.
Nicole SekarskiPediatric Cardiology Unit, Department of Pediatrics, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Rue du Bugnon 46, 1011, Lausanne, Switzerland.
Michael BurchHeart Failure and Transplantation, Department of Paediatric Cardiology, Great Ormond Street Hospital, London, UK.
Oscar Della PasquaClinical Pharmacology and Therapeutics Group, University College London, London, UK.
Great Ormond Street Hospital · GBUniversity College London · GBUniversity Hospital of Lausanne · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn adults, sodium-glucose cotransporter type 2 inhibitors have revolutionised the treatment of type 2 diabetes mellitus, heart failure, and chronic kidney disease.

objectiveWe aimed to review information on compassionate use, clinical pharmacology, efficacy, and safety of dapagliflozin and empagliflozin in children.

methodsWe conducted a systematic review of published clinical trials, case reports, and observational studies in Medline, Excerpta Medica, and Web of Science databases from inception to September 2023. For the two randomised controlled trials on type 2 diabetes mellitus (T2DM), we implemented a meta-analysis on the primary outcome (mean difference in glycosylated haemoglobin [HbA1c] between intervention and placebo groups). Review Manager (RevMan), version 5.4.1, was used for this purpose.

resultsThirty-five articles (nine case reports, ten case series, one prospective non-controlled trial, four controlled randomised trials, two surveys, six pharmacokinetic studies, and three pharmacovigilance studies) were selected, in which 415 children were exposed to either dapagliflozin or empagliflozin: 189 diabetic patients (mean age 14.7 ± 2.9 years), 32 children with glycogen storage disease type Ib (GSD Ib), glucose-6-phosphatase catalytic subunit 3 (G6PC3) deficiency, or severe congenital neutropenia type 4 (8.5 ± 5.1 years), 47 children with kidney disease or heart failure (11.2 ± 6.1 years), 84 patients in pharmacokinetic studies (15.1 ± 2.3 years), and 63 patients in toxicological series. The effect of dapagliflozin and empagliflozin in T2DM was demonstrated by HbA1c reduction in two randomised trials among a total of 177 adolescents, with a mean HbA1c difference of -0.82% (95% confidence interval -1.34 to -0.29) as compared to placebo (no heterogeneity, I

conclusionEarly evidence suggests that dapagliflozin and empagliflozin are well tolerated in children. A clinical pharmacology rationale currently exists only for adolescents with diabetes mellitus. PROSPERO REGISTRATION NUMBER: CRD42023438162.

Indexed as

Benzhydryl CompoundsDiabetes Mellitus, Type 2GlucosidesAdolescentChildHumansSodium-Glucose Transporter 2 InhibitorsBenzhydryl CompoundsdapagliflozinempagliflozinGlucosidesSodium-Glucose Transporter 2 Inhibitors

Identifiers

PMID38635113
OpenAlexW4394914971

What Socratic holds

Textmetadata
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.