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November 17, 2022Diabetes Obesity and MetabolismOpen Access

Cardiorenal outcomes by indices of liver steatosis and fibrosis in individuals with type 2 diabetes and atherosclerotic cardiovascular disease: Analyses from VERTIS CV , a randomized trial of the sodium‐glucose cotransporter‐2 inhibitor ertugliflozin

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Why the study?

To explore the associations between indices of hepatic steatosis and fibrosis and cardiorenal outcomes in individuals with type 2 diabetes and atherosclerotic cardiovascular disease.

Do indices of liver steatosis and fibrosis predict cardiorenal outcomes, and does ertugliflozin affect these indices in patients with type 2 diabetes and atherosclerotic cardiovascular disease?

Population

Patients with type 2 diabetes and atherosclerotic cardiovascular disease

Comparison

Stratification by baseline HSI and FIB-4 quartiles, and ertugliflozin vs placebo

Design

Post hoc analysis of a randomized trial

Key result

Higher baseline FIB-4 score (Q4 vs Q1) was associated with an increased risk of MACE (HR 1.48; 95% CI 1.25-1.76; P<0.0001) in patients with type 2 diabetes and atherosclerotic CV disease.

Authors

KCKaren D. CorbinSDSamuel Dagogo‐JackCCChristopher P. Cannon

Discussion

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Member takes

Overview

Supports FIB-4-guided risk stratification in T2D/ASCVD; extends liver indices as prognostic markers in this population.

Study Design

Type

RCT

Structured PICO

Do indices of liver steatosis and fibrosis predict cardiorenal outcomes, and does ertugliflozin affect these indices in patients with type 2 diabetes and atherosclerotic cardiovascular disease?

P
Population
Patients with type 2 diabetes and atherosclerotic cardiovascular disease
I
Intervention
Ertugliflozin
C
Comparator
Placebo
O
Outcome
Major adverse CV events (MACE); hospitalization for heart failure (HHF)/CV death; CV death; HHF; and a composite kidney outcomecomposite

Main Result

Effect estimate: HR 1.48 (95% CI 1.25-1.76)

p-value: p=<0.0001

In patients with type 2 diabetes and ASCVD, higher baseline liver fibrosis and steatosis indices are associated with increased risk of cardiovascular events and heart failure hospitalization, while ertugliflozin treatment reduces these liver indices.

Cite This Study

Corbin et al. (2022) conducted an RCT in Type 2 diabetes and atherosclerotic cardiovascular disease. Ertugliflozin vs. Placebo was evaluated on Major adverse CV events (MACE) by FIB-4 score quartile (Q4 vs. Q1) (HR 1.48, 95% CI 1.25-1.76, p=<0.0001). Higher baseline FIB-4 score (Q4 vs Q1) was associated with an increased risk of MACE (HR 1.48; 95% CI 1.25-1.76; P<0.0001) in patients with type 2 diabetes and atherosclerotic CV disease.

synapsesocial.com/papers/6a1790658008e5848e6ecb1bhttps://doi.org/10.1111/dom.14923
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Long‐term weight loss and cardiorenal outcomes by baseline <scp>BMI</scp> in the <scp>VERTIS CV</scp> trial2024 · 3 citations
  2. 2Mediators of ertugliflozin effects on heart failure and kidney outcomes among patients with type 2 diabetes mellitus2022 · 45 citations
  3. 3Heart Failure Outcomes Captured by Adverse Event Reporting in Participants with Type 2 Diabetes and Atherosclerotic Cardiovascular Disease: Observations from the VERTIS CV Trial2025 · 1 citations
  4. 4Safety and efficacy of ertugliflozin on heart failure outcomes across cardiovascular diseases: a systematic review and meta-analysis2026
  5. 5Heterogeneity in cardiorenal protection by Sodium glucose cotransporter 2 inhibitors in heart failure across the ejection fraction strata: Systematic review and meta-analysis2023 · 11 citations