Journal Article

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

Cannon, Christopher P., Shih, Weichung J., Gallo, Silvina, Dagogo-Jack, Sam, Golm, Gregory, Mancuso, James, Terra, Steven G., Huyck, Susan, McGuire, Darren K., Cosentino, Francesco, Charbonnel, Bernard, Pratley, Richard, Lauring, Brett, Masiukiewicz, Urszula

2018

Overview

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

• Publisher: Elsevier Inc,Elsevier Limited
• Subject: Adult / Adults / Aged / Arteriosclerosis / Atherosclerosis / Blood Glucose - metabolism / Blood pressure / Bridged Bicyclo Compounds, Heterocyclic - administration & dosage / Cardiovascular disease / Cardiovascular diseases / Cardiovascular Diseases - epidemiology / Cardiovascular Diseases - etiology / Cardiovascular Diseases - prevention & control / Cerebral infarction / Coronary artery / Coronary artery disease / Coronary vessels / Creatinine / Death / Diabetes / Diabetes mellitus / Diabetes mellitus (non-insulin dependent) / Diabetes Mellitus, Type 2 - blood / Diabetes Mellitus, Type 2 - complications / Diabetes Mellitus, Type 2 - drug therapy / Diabetic neuropathy / Dialysis / Dose-Response Relationship, Drug / Double-Blind Method / Equivalence Trials as Topic / Europe - epidemiology / FDA approval / Female / Follow-Up Studies / Glucose transporter / Glycated Hemoglobin - metabolism / Heart attacks / Heart diseases / Humans / Incidence / Kidney diseases / Kidney transplantation / Male / Meta-analysis / Middle Aged / Mortality / Multicenter Studies as Topic / Myocardial infarction / Patients / Prospective Studies / Randomization / Randomized Controlled Trials as Topic / Regulatory approval / Safety / Sodium / Sodium-Glucose Transporter 2 Inhibitors - administration & dosage / Stroke / Survival Rate - trends / Treatment Outcome / United States - epidemiology