Ertugliflozin and Slope of Chronic eGFR: Prespecified Analyses from the Randomized VERTIS CV Trial

Cherney, David Z.I. and Cosentino, Francesco and Dagogo-Jack, Samuel and McGuire, Darren K. and Pratley, Richard and Frederich, Robert and Maldonado, Mario and Liu, Chih-Chin and Liu, Jie and Pong, Annpey and Cannon, Christopher P. 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 (2021) Ertugliflozin and Slope of Chronic eGFR: Prespecified Analyses from the Randomized VERTIS CV Trial. Clinical Journal of the American Society of Nephrology = CJASN, vol.16 (no. 9). pp. 1345-1354. ISSN 1555-9041 (Print), 1555-905X (Online)

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Abstract

Background and objectives A reduction in the rate of eGFR decline, with preservation of $0.75 ml/min per 1.73 m2 per year, has been proposed as a surrogate for kidney disease progression. We report results from prespecified analyses assessing effects of ertugliflozin versus placebo on eGFR slope from the eValuation of ERTugliflozin effIcacy and Safety CardioVascular outcomes (VERTIS CV) trial (NCT01986881). Design, setting, participants, & measurements Patients with type 2 diabetes mellitus and established atherosclerotic cardiovascular disease were randomized to placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg (1:1:1). The analyses compared the effect of ertugliflozin (pooled doses, n55499) versus placebo (n52747) on eGFR slope per week and per year by random coefficient models. Study periods (weeks 0–6 and weeks 6–52) and total and chronic slopes (week 0 or week 6 to weeks 104, 156, 208, and 260) were modeled separately and by baseline kidney status. Results In the overall population, for weeks 0–6, the least squares mean eGFR slopes (ml/min per 1.73 m2 per week [95% confidence interval (95% CI)]) were 20.07 (20.16 to 0.03) and 20.54 (20.61 to 20.48) for the placebo and ertugliflozin groups, respectively; the difference was 20.47 (20.59 to 20.36). During weeks 6–52, least squares mean eGFR slopes (ml/min per 1.73 m2 per year [95% CI]) were 20.12 (20.70 to 0.46) and 1.62 (1.21 to 2.02) for the placebo and ertugliflozin groups, respectively; the difference was 1.74 (1.03 to 2.45). For weeks 6–156, least squares mean eGFR slopes (ml/min per 1.73 m2 per year [95% CI]) were 21.51 (21.70 to 21.32) and 20.32 (20.45 to 20.19) for the placebo and ertugliflozin groups, respectively; the difference was 1.19 (0.95 to 1.42). During weeks 0–156, the placebo-adjusted difference in least squares mean slope was 1.06 (0.85 to 1.27). These findings were consistent by baseline kidney status. Conclusions Ertugliflozin has a favorable placebo-adjusted eGFR slope .0.75 ml/min per 1.73 m2 per year, documenting the kidney function preservation underlying the clinical benefits of ertugliflozin on kidney disease progression in patients with type 2 diabetes mellitus and atherosclerotic cardiovascular disease. Clinical Trial registry name and registration number: US National Library of Medicine, ClinicalTrials.gov NCT01986881. Date of trial registration: November 13, 2013.

Item Type:	Article
Additional Information:	Ertugliflozin and Slope of Chronic eGFR David Z.I. Cherney, Francesco Cosentino, Samuel Dagogo-Jack, Darren K. McGuire, Richard Pratley, Robert Frederich, Mario Maldonado, Chih-Chin Liu, Jie Liu, Annpey Pong, Christopher P. Cannon CJASN Sep 2021, 16 (9) 1345-1354; DOI: 10.2215/CJN.01130121 Supplemental Material This article contains the following supplemental material online at http://cjasn.asnjournals.org/lookup/suppl/doi:10.2215/CJN. 01130121/-/DCSupplemental. Supplemental Summary 1. VERTIS CV Investigators. Supplemental Table 1. Chronic and total yearly eGFR slope in the overall population. Supplemental Table 2. Chronic and total yearly eGFR slope analyses by baseline kidney status.
Uncontrolled Keywords:	renal protectionrenal, function declineglomerular filtration, ratediabetic nephropathy, type 2 diabetes mellitus, clinical trial, sodium-glucose cotransporter 2 inhibitor
Subjects:	Internal Medicine Nephrology Diabetes
Divisions:	Departments > Department of Internal Medicine 3 (formerly - hospital therapy 2) Departments > Department of Internal Medicine
Depositing User:	Елена Шрамко
Date Deposited:	22 Mar 2022 11:31
Last Modified:	22 Mar 2022 11:58
URI:	http://repo.dma.dp.ua/id/eprint/7386

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