Результаты исследований: Научные публикации в периодических изданиях › статья › Рецензирование
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 изданиях › статья › Рецензирование
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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