# Clinical and economic value of novel diabetes medications for prevention of cardiovascular disease in type 2 diabetes

> **NIH NIH R01** · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · 2022 · $682,248

## Abstract

PROJECT SUMMARY/ABSTRACT
Individuals with type 2 diabetes (T2D) are at substantially increased risk for atherosclerotic cardiovascular
disease (ASCVD) and heart failure, as well as other important outcomes such as end-stage renal disease
(ESRD). Therefore, strategies to reduce these adverse health events in the T2D population are critically
important. Cardiovascular safety concerns related to rosiglitazone led the Food and Drug Administration (FDA)
to mandate cardiovascular outcome trials for new glucose lowering therapies. The cardiovascular outcome trials
on two recently introduced glucose lowering classes of drugs, sodium glucose transporter 2 (SGLT2) inhibitors
and glucagon-like peptide 1 (GLP-1) receptor agonists unexpectedly showed cardiovascular benefits with
reduced rates of myocardial infarction, stroke, heart failure, and renal outcomes, particularly in those with
established ASCVD. As a result, the FDA approved a new indication for three SGLT-2 inhibitors (empagliflozin,
canagliflozin and dapagliflozin) and three GLP-1 receptor agonists (liraglutide, dulaglutide and semaglutide) for
reduction of cardiovascular events in those with T2D and established ASCVD. However, cardiovascular
outcomes of these novel diabetes agents in T2D have only been evaluated in the context of very high ASCVD
risk and as add-on treatment to standard T2D therapy. Wider use of these expensive novel medications by
replacing cheaper standard drug regimens may yield uncertain effects on clinical outcomes and costs to the
patient and the health system. We propose a decision-analytic approach to compare long-term clinical and
economic outcomes of guideline-based and alternative treatment algorithms and identify optimal strategies for
the use of SGLT2 inhibitors and GLP-1 receptor agonists. Insurance coverage and cost sharing can affect access
and adherence to these agents and we will therefore additionally evaluate economic implications of their use
from a patient perspective and address the potential disparities in utilization and cost-effectiveness across
patients with T2D at different cardiovascular risk levels. Our specific aims are to assess differences in long-term
clinical outcomes of strategies utilizing novel diabetes medications vs conventional care by combining meta-
analysis of reconstructed trial survival data with prognostic and simulation modeling of epidemiologic data. First,
we will compare guideline-based strategies of novel diabetes medication as second-line therapy vs alternative
strategies including first-line usage and combination therapy across different target patient populations. Second,
we will evaluate differences in lifetime quality-adjusted survival and costs of these various strategies utilizing
novel diabetes medication with generally accepted societal benchmarks for cost-effective care as the criterion
and address the impact of insurance coverage and cost sharing on treatment decisions. Thus, our research will
rigorously evaluate clini...

## Key facts

- **NIH application ID:** 10396100
- **Project number:** 5R01HL153456-02
- **Recipient organization:** ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
- **Principal Investigator:** Bart Ferket
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $682,248
- **Award type:** 5
- **Project period:** 2021-05-01 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10396100

## Citation

> US National Institutes of Health, RePORTER application 10396100, Clinical and economic value of novel diabetes medications for prevention of cardiovascular disease in type 2 diabetes (5R01HL153456-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10396100. Licensed CC0.

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