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Updated: Feb 16, 2026

In Silico Clinical Trials for Cardiovascular Disease
Published on: May 27, 2022
Exploring heart failure events in contemporary cardiovascular outcomes trials in type 2 diabetes mellitus
Shilpa Vijayakumar1, Muthiah Vaduganathan2, Javed Butler3
1a Department of Medicine , Stony Brook University , Stony Brook , NY , USA.
Insights
Type 2 diabetes mellitus (DM) and heart failure (HF) are linked, with one worsening the other. Current glucose-lowering therapies
Area of Science:
- Cardiology
- Endocrinology
- Pharmacology
Background:
- Type 2 diabetes mellitus (DM) and heart failure (HF) share a strong bidirectional relationship, where each condition independently exacerbates the other.
- The complex interplay and full clinical impact of comorbid DM and HF remain incompletely understood.
- Glucose-lowering therapies exhibit varied cardiovascular effects, necessitating formal evaluation of their impact on heart failure outcomes.
Purpose of the Study:
- To evaluate the ascertainment and availability of heart failure (HF) outcome data in contemporary cardiovascular outcome trials (CVOTs) of glucose-lowering therapies.
- To highlight the increasing recognition of HF events as critical endpoints in trials for type 2 diabetes treatments.
Main Methods:
- A comprehensive literature search was conducted on recent cardiovascular outcome trials (CVOTs) involving glucose-lowering therapies.
- Analysis focused on the methods and extent of data collection for heart failure outcomes within these trials.
Main Results:
- Heart failure outcomes were not a primary focus in earlier cardiovascular outcome trials.
- Contemporary trials increasingly incorporate HF events as significant endpoints.
- There is variability in the ascertainment and standardization of HF data across trials.
Conclusions:
- Heart failure outcomes are crucial endpoints in evaluating glucose-lowering therapies for patients with type 2 diabetes.
- Standardized and routine ascertainment of HF data in clinical trials is essential for better understanding treatment effects.
- Improved data collection will enhance clinical decision-making for managing patients with both DM and HF.
Introduction:
Type 2 diabetes mellitus (DM) and heart failure (HF) are closely related, with the onset of one serving as an independent risk factor for the development or progression of the other. The true impact of their relationship is poorly understood. Since various classes of glucose-lowering therapies have been shown to have differing impact on cardiovascular outcomes, cardiovascular effects of such therapies have been increasingly formally evaluated. Areas covered: With the increasing prevalence of concomitant HF and type 2 DM, HF outcomes serve as important endpoints in trials of glucose-lowering therapies. A thorough literature search of recent cardiovascular outcome trials of glucose-lowering therapies was performed. The authors focus on the availability and extent of ascertainment of data related to HF outcomes in these contemporary clinical trial experiences. Expert commentary: Although early cardiovascular outcome trials did not focus on HF events, these outcomes have been increasingly recognized as meaningful end points in cardiovascular outcome trials. The ascertainment of HF end point data needs to become routine and standardized.
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