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January 10, 2025European Journal of Heart FailureOpen Access

Heart Failure Outcomes Captured by Adverse Event Reporting in Participants with Type 2 Diabetes and Atherosclerotic Cardiovascular Disease: Observations from the VERTIS CV Trial

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Why the study?

To evaluate the impact of ertugliflozin on the broader spectrum of all reported heart failure events independent of adjudication confirmation in patients with type 2 diabetes and atherosclerotic cardiovascular disease.

Does ertugliflozin reduce investigator-reported heart failure adverse events in participants with type 2 diabetes and atherosclerotic cardiovascular disease?

Population

8238 participants with type 2 diabetes and atherosclerotic cardiovascular disease

Comparison

Pooled ertugliflozin (5 or 15 mg) vs placebo

Design

Post hoc or secondary trial analysis

Follow-up

Mean 3.5 years

Key result

Ertugliflozin reduced the risk of first investigator-reported heart failure adverse events (HR 0.69; 95% CI 0.57-0.84; p < 0.001) in patients with type 2 diabetes and ASCVD.

Authors

APAmbarish PandeyAKAhmed A. KolkailahDMDarren K. McGuire

Discussion

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Overview

Supports ertugliflozin for HF risk reduction in T2D with ASCVD; reinforces SGLT2i benefit across investigator-reported and adjudicated endpoints.

Study Design

Type

RCT (n=8,238)

Structured PICO

Does ertugliflozin reduce investigator-reported heart failure adverse events in participants with type 2 diabetes and atherosclerotic cardiovascular disease?

P
Population
8,238 participants with type 2 diabetes and atherosclerotic cardiovascular disease
I
Intervention
Ertugliflozin (5 or 15 mg)
C
Comparator
Placebo
O
Outcome
First and total investigator-reported heart failure adverse events (AEs) and serious AEs (SAEs) based on the narrow standardized MedDRA query 'cardiac failure'safety

Main Result

Effect estimate: HR 0.69 (95% CI 0.57-0.84)

p-value: p=<0.001

Ertugliflozin consistently reduces the risk of investigator-reported heart failure adverse events in patients with T2D and ASCVD, with an effect size similar to that seen for adjudicated heart failure hospitalizations.

Cite This Study

Pandey et al. (2025) conducted an RCT in Type 2 diabetes and atherosclerotic cardiovascular disease (n=8,238). Ertugliflozin vs. Placebo was evaluated on First investigator-reported heart failure adverse event (HR 0.69, 95% CI 0.57-0.84, p=<0.001). Ertugliflozin reduced the risk of first investigator-reported heart failure adverse events (HR 0.69; 95% CI 0.57-0.84; p < 0.001) in patients with type 2 diabetes and ASCVD.

synapsesocial.com/papers/6a15d560d9ab26d82ed117eahttps://doi.org/10.1002/ejhf.3511
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