Cherney, D.Z.I. and Charbonnel, B. and Cosentino, F. and Dagogo-Jack, S. and McGuire, D.K. and Pratley, R. and Shih, W.J. and Frederich, R. and Maldonado, M. and Pong, A. and Cannon, C.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) Effects of ertugliflozin on kidney composite outcomes, renal function and albuminuria in patients with type 2 diabetes mellitus: an analysis from the randomised VERTIS CV trial. Diabetologia, 64. pp. 1256-1267. ISSN 0012-186X (Print),1432-0428 (Online)
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Abstract
Aims/hypothesis In previous work, we reported the HR for the risk (95% CI) of the secondary kidney composite endpoint (time to first event of doubling of serum creatinine from baseline, renal dialysis/transplant or renal death) with ertugliflozin compared with placebo as 0.81 (0.63, 1.04). The effect of ertugliflozin on exploratory kidney-related outcomes was evaluated using data from the eValuation of ERTugliflozin effIcacy and Safety CardioVascular outcomes (VERTIS CV) trial (NCT01986881). Methods Individuals with type 2 diabetes mellitus and established atherosclerotic CVD were randomised to receive ertugliflozin 5 mg or 15 mg (observations from both doses were pooled), or matching placebo, added on to existing treatment. The kidney composite outcome in VERTIS CV (reported previously) was time to first event of doubling of serum creatinine from baseline, renal dialysis/transplant or renal death. The pre-specified exploratory composite outcome replaced doubling of serum creatinine with sustained 40% decrease from baseline in eGFR. In addition, the impact of ertugliflozin on urinary albumin/creatinine ratio (UACR) and eGFR over time was assessed. Results A total of 8246 individuals were randomised and followed for a mean of 3.5 years. The exploratory kidney composite outcome of sustained 40% reduction from baseline in eGFR, chronic kidney dialysis/transplant or renal death occurred at a lower event rate (events per 1000 person-years) in the ertugliflozin group than with the placebo group (6.0 vs 9.0); the HR (95% CI) was 0.66 (0.50, 0.88). At 60 months, in the ertugliflozin group, placebo-corrected changes from baseline (95% CIs) in UACR and eGFR were −16.2% (−23.9, −7.6) and 2.6 ml min−1 [1.73 m]−2 (1.5, 3.6), respectively. Ertugliflozin was associated with a consistent decrease in UACR and attenuation of eGFR decline across subgroups, with a suggested larger effect observed in the macroalbuminuria and Kidney Disease: Improving Global Outcomes in Chronic Kidney Disease (KDIGO CKD) high/very high-risk subgroups. Conclusions/interpretation Among individuals with type 2 diabetes and atherosclerotic CVD, ertugliflozin reduced the risk for the pre-specified exploratory composite renal endpoint and was associated with preservation of eGFR and reduced UACR. Trial registration ClinicalTrials.gov NCT01986881
| Item Type: | Article |
|---|---|
| Additional Information: | Impact Factor ™ журнала 2020 - 10.122; пять лет- 9.097. Категория JCR ENDOCRINOLOGY & METABOLISM (в SCIE редакция); Ранг категории 9/146; Квартиль категории Q1 |
| Uncontrolled Keywords: | Cardiovascular disease; Diabetic nephropathies; Ertugliflozin; Type 2 diabetes mellitus. |
| Subjects: | Diabetes Endocrinology |
| Divisions: | Departments > Department of Internal Medicine 3 (formerly - hospital therapy 2) Departments > Department of Internal Medicine |
| Depositing User: | Елена Шрамко |
| Date Deposited: | 10 Mar 2022 11:35 |
| Last Modified: | 10 Mar 2022 11:51 |
| URI: | http://repo.dma.dp.ua/id/eprint/7312 |
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