Evidence map›Paper›PMID 42046405›Full record

Trial reportDiabetes, obesity & metabolism2026

Effects of Dapagliflozin on Cardiovascular Outcomes in Patients With Type 2 Diabetes at Risk of Liver Fibrosis.

Jan Oscarsson, Monika Huhn, Yunyun Jiang, Ingrid Gause-Nilsson, Stephen D Wiviott, Filipe A Moura, John P H Wilding, Simona Cernea, Luc Van Gaal, Avivit Cahn and 3 more

Abstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Trial
  2. 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

13 authors.

Jan OscarssonLate-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.ORCID 0000-0002-4573-517X
Monika HuhnLate-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Yunyun JiangLate-stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
Ingrid Gause-NilssonLate-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Stephen D WiviottLate-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Boston, Massachusetts, USA.
Filipe A MouraSection of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut, USA.ORCID 0000-0001-8017-1675
John P H WildingDepartment of Cardiovascular and Metabolic Medicine, University of Liverpool, Liverpool, UK.ORCID 0000-0003-2839-8404
Simona CerneaDepartment M3/Internal Medicine I, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Târgu Mureş, Târgu Mureş, Romania.ORCID 0000-0002-9494-6571
Luc Van GaalDepartment of Endocrinology, Diabetology and Metabolism, Antwerp University Hospital, Antwerp, Belgium.
Avivit CahnInternal Medicine Department A, Hadassah Hebrew University Hospital, Jerusalem, Israel.ORCID 0000-0002-7830-9994
Deepak L BhattMount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, New York, USA.ORCID 0000-0002-1278-6245
Peter A JohanssonLate-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
C David SjöströmLate-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.ORCID 0000-0002-8380-9766

Funding

AstraZeneca
6 · The paper itself

Abstract

aimsThe fibrosis-4 (FIB-4) score is used to identify risk of advanced liver fibrosis. This post hoc analysis investigated its prognostic value for cardiovascular (CV) outcomes and its relevance to the effects of dapagliflozin. MATERIALS AND

methodsDECLARE-TIMI 58 was a randomised, placebo-controlled phase 3 trial investigating dapagliflozin in patients with type 2 diabetes (T2D) and either atherosclerotic cardiovascular disease (ASCVD) or high ASCVD risk. Participants were stratified by baseline FIB-4 scores (< 1.30, 1.30 to < 2.67, and ≥ 2.67). Hazard ratios (HRs) and 95% confidence intervals (CIs) for dapagliflozin versus placebo were calculated for the two primary outcomes (major adverse cardiovascular events [MACE] and the composite of CV death and hospitalisation for heart failure [HHF]).

resultsOf 17 160 patients enrolled, 16 361 were included (median follow-up of 4.2 years). Distribution across FIB-4 categories was: < 1.30, n = 9084 (55.5%); 1.30 to < 2.67, n = 6556 (40.7%); and ≥ 2.67, n = 621 (3.8%), with similar ASCVD prevalence across groups (40%-43%). In the placebo arm, the ≥ 2.67 FIB-4 group had the highest event rates for MACE, HHF, CV death, and all-cause death. MACE HRs (95% CIs) for dapagliflozin versus placebo were 0.95 (0.83-1.10), 0.92 (0.79-1.08), and 0.61 (0.38-0.97) across ascending FIB-4 groups. For the CV death and HHF composite endpoint, they were 0.81 (0.67-0.98), 0.90 (0.73-1.10), and 0.50 (0.28-0.90). Dapagliflozin reduced aspartate aminotransferase and alanine aminotransferase levels compared with placebo.

conclusionHighest FIB-4 scores were associated with increased CV risk in patients with T2D. Dapagliflozin reduced CV risk across FIB-4 categories without significant interactions.

Indexed as

Benzhydryl CompoundsCardiovascular DiseasesDiabetes Mellitus, Type 2GlucosidesLiver CirrhosisSodium-Glucose Transporter 2 InhibitorsAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedPrognosisBenzhydryl CompoundsdapagliflozinGlucosidesSodium-Glucose Transporter 2 Inhibitorscardiovascular deathhospitalisation for heart failureliver fibrosisMASLDsodium–glucose co‐transporter‐2 inhibitor

Identifiers

PMID42046405
PMCPMC13243968

What OpenQuestion holds

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Registered trials

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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.