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

Cannon, Christopher P. and McGuire, Darren K. and Pratley, Richard and Dagogo-Jack, Sam and Mancuso, James and Huyck, Susan and Charbonnel, Bernard and Shih, Weichung J. and Gallo, Silvina and Masiukiewicz, Urszula and Golm, Gregory and Cosentino, Francesco and Lauring, Brett and Terra, Steven G. and on behalf of the VERTIS-CV, Investigators and Ukraine: and Godlevska, Olga and Chopey, Ivan and Teliatnikova, Zinaida and Kuskalo, Petro and Abrahamovych, Orest and Mankovskyi, Borys and Fushtey, Ivan and Myshanych, Galyna and Tykhonova, Susanna and Tseluyko, Vira and Koval, Olena and Parkhomenko, Oleksandr and Prokhorov, Oleksandr and Vayda, Myroslava and Martymianova, Larysa and Zharinova, Viktoriia and Prystupa, Lyudmyla and Pererva, Larysa and Kovalov, Oleksandr and Sokolova, Lyubov and Botsyurko, Volodymyr and Maslyanko, Vitaliy and Vlasenko, Maryna and Khomazyuk, Tetyana and Kulyk, Anna and Synenko, Volodymyr and Karpenko, Oleksandr and Mostovoy, Yuriy and Gyrina, Olga and Dolzhenko, Maryna and Donets, Oleksandra and Sorokina, Inna and Malynovsky, Yaroslav and Lysunets, Olena and Petrovskyy, Roman and Panina, Svitlana (2018) Design and baseline characteristics of the eValuation of ERTugliflozin effIcacy and Safety CardioVascular outcomes trial (VERTIS-CV). American Heart Journal, 206. pp. 11-23. ISSN 0002-8703 (Print), 1097-6744 (Online)

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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. (Am Heart J 2018;206:11-23.)

Item Type: Article
Subjects: Internal Medicine
Divisions: Departments > Department of Internal Medicine 3 (formerly - hospital therapy 2)
Departments > Department of Internal Medicine
Depositing User: Елена Шрамко
Date Deposited: 09 May 2023 13:14
Last Modified: 09 May 2023 13:14

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