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Am Heart J. 2018 Dec;206:11-23. doi: 10.1016/j.ahj.2018.08.016. Epub 2018 Sep 5.

Design and baseline characteristics of the eValuation of ERTugliflozin effIcacy and Safety CardioVascular outcomes trial (VERTIS-CV).

Author information

1
Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Baim Institute for Clinical Research, Boston, MA. Electronic address: cpcannon@bwh.harvard.edu.
2
University of Texas Southwestern Medical Center, Dallas, TX.
3
Florida Hospital Translational Research Institute for Metabolism and Diabetes, Orlando, FL.
4
University of Tennessee Health Science Center, Memphis, TN.
5
Pfizer Inc., Groton, CT.
6
Merck & Co., Inc., Kenilworth, NJ.
7
University of Nantes, France.
8
Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick NJ.
9
Pfizer Inc., Berlin, Germany.
10
Unit of Cardiology, Karolinska University Hospital Solna, Stockholm, Sweden.
11
Pfizer Inc., Andover, MA.

Abstract

BACKGROUND:

Ertugliflozin is an inhibitor of sodium-glucose co-transporter-2 (SGLT2), approved in the United States and European Union to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). The VERTIS cardiovascular (CV) outcomes trial (NCT01986881) has a primary objective to demonstrate non-inferiority of ertugliflozin versus placebo on major adverse CV events: time to the first event of CV death, nonfatal myocardial infarction, or nonfatal stroke. Secondary objectives are to demonstrate superiority of ertugliflozin versus placebo on time to: 1) the composite outcome of CV death or hospitalization for heart failure (HF); 2) CV death; and 3) the composite outcome of renal death, dialysis/transplant, or doubling of serum creatinine from baseline.

METHODS:

Patients ≥40 years old with T2DM (HbA1c 7.0-10.5%) and established atherosclerotic cardiovascular disease (ASCVD) of the coronary, cerebral, and/or peripheral arterial systems, were randomized 1:1:1 to once daily double-blind placebo, ertugliflozin 5 mg or 15 mg added to existing therapy.

RESULTS:

8246 patients were randomized and 8238 received at least 1 dose of investigational product. Mean age was 64.4 years, 11.0% were ≥75 years old, and mean diabetes duration was 12.9 years with screening HbA1c of 8.3%. At entry, coronary artery disease, cerebrovascular disease, and peripheral arterial disease were present in 76.3%, 23.1%, and 18.8% of patients, respectively. HF was present in 23.1%, and Stage 3 kidney disease in 21.6% of patients.

CONCLUSION:

The results from the VERTIS-CV trial will define the CV and renal safety and efficacy of ertugliflozin in patients with T2DM and ASCVD.

PMID:
30290289
DOI:
10.1016/j.ahj.2018.08.016
[Indexed for MEDLINE]
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