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Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. / EMPA-REG OUTCOME Trial.

в: New England Journal of Medicine, Том 373, № 22, 26.11.2015, стр. 2117-2128.

Результаты исследований: Научные публикации в периодических изданияхстатьяРецензирование

Harvard

EMPA-REG OUTCOME Trial 2015, 'Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes', New England Journal of Medicine, Том. 373, № 22, стр. 2117-2128. https://doi.org/10.1056/NEJMoa1504720

APA

EMPA-REG OUTCOME Trial (2015). Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. New England Journal of Medicine, 373(22), 2117-2128. https://doi.org/10.1056/NEJMoa1504720

Vancouver

EMPA-REG OUTCOME Trial. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. New England Journal of Medicine. 2015 Нояб. 26;373(22):2117-2128. https://doi.org/10.1056/NEJMoa1504720

Author

EMPA-REG OUTCOME Trial. / Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. в: New England Journal of Medicine. 2015 ; Том 373, № 22. стр. 2117-2128.

BibTeX

@article{02c9ef8a6d4144f284afb94d48f40753,
title = "Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes",
abstract = "BACKGROUND The effects of empagliflozin, an inhibitor of sodium-glucose cotransporter 2, in addition to standard care, on cardiovascular morbidity and mortality in patients with type 2 diabetes at high cardiovascular risk are not known. METHODS We randomly assigned patients to receive 10 mg or 25 mg of empagliflozin or placebo once daily. The primary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, as analyzed in the pooled empagliflozin group versus the placebo group. The key secondary composite outcome was the primary outcome plus hospitalization for unstable angina. RESULTS A total of 7020 patients were treated (median observation time, 3.1 years). The primary outcome occurred in 490 of 4687 patients (10.5%) in the pooled empagliflozin group and in 282 of 2333 patients (12.1%) in the placebo group (hazard ratio in the empagliflozin group, 0.86; 95.02% confidence interval, 0.74 to 0.99; P = 0.04 for superiority). There were no significant between-group differences in the rates of myocardial infarction or stroke, but in the empagliflozin group there were significantly lower rates of death from cardiovascular causes (3.7%, vs. 5.9% in the placebo group; 38% relative risk reduction), hospitalization for heart failure (2.7% and 4.1%, respectively; 35% relative risk reduction), and death from any cause (5.7% and 8.3%, respectively; 32% relative risk reduction). There was no significant between-group difference in the key secondary outcome (P = 0.08 for superiority). Among patients receiving empagliflozin, there was an increased rate of genital infection but no increase in other adverse events. CONCLUSIONS Patients with type 2 diabetes at high risk for cardiovascular events who received empagliflozin, as compared with placebo, had a lower rate of the primary composite cardiovascular outcome and of death from any cause when the study drug was added to standard care.",
author = "{EMPA-REG OUTCOME Investigators} and Bernard Zinman and Christoph Wanner and Lachin, {John M.} and David Fitchett and Erich Bluhmki and Stefan Hantel and Michaela Mattheus and Theresa Devins and Johansen, {Odd Erik} and Woerle, {Hans J.} and Broedl, {Uli C.} and Inzucchi, {Silvio E.} and D. Aizenberg and M. Ulla and J. Waitman and {De Loredo}, L. and J. Far{\'i}as and H. Fideleff and M. Lagrutta and N. Maldonado and H. Colombo and {Ferre Pacora}, F. and A. Wasserman and L. Maffei and R. Lehman and J. Selvanayagam and M. d{\textquoteright}Emden and P. Fasching and B. Paulweber and H. Toplak and A. Luger and H. Drexel and R. Prager and C. Schnack and G. Schernthaner and E. Fliesser-G{\"o}rzer and S. Kaser and A. Scheen and {Van Gaal}, L. and G. Hollanders and Y. Kockaerts and L. Capiau and A. Chachati and A. Persu and M. Hermans and D. Vantroyen and C. Vercammen and {Van de Borne}, P. and S. Gupta and A. Obrezan",
year = "2015",
month = nov,
day = "26",
doi = "10.1056/NEJMoa1504720",
language = "English",
volume = "373",
pages = "2117--2128",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "22",

}

RIS

TY - JOUR

T1 - Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes

AU - EMPA-REG OUTCOME Investigators

AU - Zinman, Bernard

AU - Wanner, Christoph

AU - Lachin, John M.

AU - Fitchett, David

AU - Bluhmki, Erich

AU - Hantel, Stefan

AU - Mattheus, Michaela

AU - Devins, Theresa

AU - Johansen, Odd Erik

AU - Woerle, Hans J.

AU - Broedl, Uli C.

AU - Inzucchi, Silvio E.

AU - Aizenberg, D.

AU - Ulla, M.

AU - Waitman, J.

AU - De Loredo, L.

AU - Farías, J.

AU - Fideleff, H.

AU - Lagrutta, M.

AU - Maldonado, N.

AU - Colombo, H.

AU - Ferre Pacora, F.

AU - Wasserman, A.

AU - Maffei, L.

AU - Lehman, R.

AU - Selvanayagam, J.

AU - d’Emden, M.

AU - Fasching, P.

AU - Paulweber, B.

AU - Toplak, H.

AU - Luger, A.

AU - Drexel, H.

AU - Prager, R.

AU - Schnack, C.

AU - Schernthaner, G.

AU - Fliesser-Görzer, E.

AU - Kaser, S.

AU - Scheen, A.

AU - Van Gaal, L.

AU - Hollanders, G.

AU - Kockaerts, Y.

AU - Capiau, L.

AU - Chachati, A.

AU - Persu, A.

AU - Hermans, M.

AU - Vantroyen, D.

AU - Vercammen, C.

AU - Van de Borne, P.

AU - Gupta, S.

AU - Obrezan, A.

PY - 2015/11/26

Y1 - 2015/11/26

N2 - BACKGROUND The effects of empagliflozin, an inhibitor of sodium-glucose cotransporter 2, in addition to standard care, on cardiovascular morbidity and mortality in patients with type 2 diabetes at high cardiovascular risk are not known. METHODS We randomly assigned patients to receive 10 mg or 25 mg of empagliflozin or placebo once daily. The primary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, as analyzed in the pooled empagliflozin group versus the placebo group. The key secondary composite outcome was the primary outcome plus hospitalization for unstable angina. RESULTS A total of 7020 patients were treated (median observation time, 3.1 years). The primary outcome occurred in 490 of 4687 patients (10.5%) in the pooled empagliflozin group and in 282 of 2333 patients (12.1%) in the placebo group (hazard ratio in the empagliflozin group, 0.86; 95.02% confidence interval, 0.74 to 0.99; P = 0.04 for superiority). There were no significant between-group differences in the rates of myocardial infarction or stroke, but in the empagliflozin group there were significantly lower rates of death from cardiovascular causes (3.7%, vs. 5.9% in the placebo group; 38% relative risk reduction), hospitalization for heart failure (2.7% and 4.1%, respectively; 35% relative risk reduction), and death from any cause (5.7% and 8.3%, respectively; 32% relative risk reduction). There was no significant between-group difference in the key secondary outcome (P = 0.08 for superiority). Among patients receiving empagliflozin, there was an increased rate of genital infection but no increase in other adverse events. CONCLUSIONS Patients with type 2 diabetes at high risk for cardiovascular events who received empagliflozin, as compared with placebo, had a lower rate of the primary composite cardiovascular outcome and of death from any cause when the study drug was added to standard care.

AB - BACKGROUND The effects of empagliflozin, an inhibitor of sodium-glucose cotransporter 2, in addition to standard care, on cardiovascular morbidity and mortality in patients with type 2 diabetes at high cardiovascular risk are not known. METHODS We randomly assigned patients to receive 10 mg or 25 mg of empagliflozin or placebo once daily. The primary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, as analyzed in the pooled empagliflozin group versus the placebo group. The key secondary composite outcome was the primary outcome plus hospitalization for unstable angina. RESULTS A total of 7020 patients were treated (median observation time, 3.1 years). The primary outcome occurred in 490 of 4687 patients (10.5%) in the pooled empagliflozin group and in 282 of 2333 patients (12.1%) in the placebo group (hazard ratio in the empagliflozin group, 0.86; 95.02% confidence interval, 0.74 to 0.99; P = 0.04 for superiority). There were no significant between-group differences in the rates of myocardial infarction or stroke, but in the empagliflozin group there were significantly lower rates of death from cardiovascular causes (3.7%, vs. 5.9% in the placebo group; 38% relative risk reduction), hospitalization for heart failure (2.7% and 4.1%, respectively; 35% relative risk reduction), and death from any cause (5.7% and 8.3%, respectively; 32% relative risk reduction). There was no significant between-group difference in the key secondary outcome (P = 0.08 for superiority). Among patients receiving empagliflozin, there was an increased rate of genital infection but no increase in other adverse events. CONCLUSIONS Patients with type 2 diabetes at high risk for cardiovascular events who received empagliflozin, as compared with placebo, had a lower rate of the primary composite cardiovascular outcome and of death from any cause when the study drug was added to standard care.

UR - http://www.scopus.com/inward/record.url?scp=84944800184&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa1504720

DO - 10.1056/NEJMoa1504720

M3 - Article

C2 - 26378978

AN - SCOPUS:84944800184

VL - 373

SP - 2117

EP - 2128

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 22

ER -

ID: 53265209