# Effectiveness of Hypoglycemic Medications Among Veterans with CKD

> **NIH VA I01** · VETERANS HEALTH ADMINISTRATION · 2024 · —

## Abstract

Approximately 30 million adults have diabetes (DM) in the United States and DM confers a risk for
cardiovascular disease (CVD). Whether CVD is prevented by antidiabetic therapies which target glycemic
control remains relatively unknown. Between 2013-2017 there were multiple pivotal trials of newer agent called
sodium–glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor agonists (GLP1RA)
vs placebo. These newer agents demonstrated reduction in CVD and kidney outcomes. These new
medications demonstrated lower risk of major adverse cardiovascular events (MACE) versus placebo with a
pronounced effect among those with pre-existing CVD, and less data for those without CVD. But the trials also
demonstrated increased risks of adverse events including a two-fold risk of amputations. There were both trial
and post-marketing reports of fractures with SGLT2 because of impaired bone metabolite excretion.
These medications are high cost; $300-$500 per month of treatment under VHA contracting. Use of these high
cost medications if they prevented CVD would provide a return on investment. However, their efficacy is
demonstrated vs placebo; their effectiveness relative to other commonly used medications remains unknown
because data from real world cohorts is methodologically limited. Methodologically strong comparative
effectiveness observational studies are necessary to determine the relative benefits We propose to conduct a
National longitudinal study using administrative, clinical and laboratory data to quantify the relative risks/
benefits of DM agents among Veterans in two cohorts with and without CVD.
This proposal will answer the question: Among patients with DM, what are the absolute risks of adverse
events and potential cardiovascular and renal benefits for those who add on SGLT2 or GLP1RA
compared to dipeptidyl peptidase 4 inhibitors (DPP4)? We will expand the cohort through FY2020 of
Veterans with diabetes: utilizing national Veterans Health Administration (VHA) data (corporate data
warehouse-vital signs; pharmacy, medical datasets, Medicare/ Medicaid data and vital status files), national
death index and additional data on ankle brachial index and echocardiograms. Eligible veterans will be new
users of SGLT2, GLP1RA or DPP4 aged >18 years who utilize VHA from 10/1/2000 through 09/30/2020. The
current data (through FY 2016) has 35,799 SGLT2 new users; 68,876 new users of GLP1RA; and 203,030
new users of DPP4 (reference). We propose to evaluate the risks and benefits in 2 cohorts, those with and
without CVD. The proposed study follows this cohort from new drug initiation until an outcome or censoring
event (leave VHA, change therapy or death). The comparisons of interest will be: SGLT2 or GLP1RA vs.
DPP4. Aim 1 will test the hypothesis that the risk of MACE (4 component- AMI/ Stroke/ CV death/ Heart failure)
in patients treated with SGLT2 or GLP1RA is lower than the risk in patients treated with DPP4. Aim 2 will test
the hypoth...

## Key facts

- **NIH application ID:** 10731382
- **Project number:** 5I01CX000570-12
- **Recipient organization:** VETERANS HEALTH ADMINISTRATION
- **Principal Investigator:** Christianne L. Roumie
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2024
- **Award amount:** —
- **Award type:** 5
- **Project period:** 2012-10-01 → 2024-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10731382

## Citation

> US National Institutes of Health, RePORTER application 10731382, Effectiveness of Hypoglycemic Medications Among Veterans with CKD (5I01CX000570-12). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10731382. Licensed CC0.

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