Research output: Contribution to journal › Article › peer-review
Empagliflozin and Cerebrovascular Events in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk. / EMPA-REG OUTCOME Investigators.
In: Stroke, Vol. 48, No. 5, 05.2017, p. 1218-+.Research output: Contribution to journal › Article › peer-review
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TY - JOUR
T1 - Empagliflozin and Cerebrovascular Events in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk
AU - EMPA-REG OUTCOME Trial
AU - Zinman, Bernard
AU - Inzucchi, Silvio E.
AU - Lachin, John M.
AU - Wanner, Christoph
AU - Fitchett, David
AU - Kohler, Sven
AU - Mattheus, Michaela
AU - Biomath, Dipl
AU - Woerle, Hans J.
AU - Broedl, Uli C.
AU - Johansen, Odd Erik
AU - Albers, Gregory W.
AU - Diener, Hans Christoph
AU - Aizenberg, D.
AU - Ulla, M.
AU - Waitman, J.
AU - De Loredo, L.
AU - Farias, 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 - Tiburcio, A.
AU - Gupta, S.
AU - Park, S.
AU - Kim, Y.
AU - Yang, J.
AU - Kim, D.
AU - Lee, S.
AU - Petrov, A.
AU - Nikolaev, K.
AU - Potemkin, V.
AU - Bystrova, A.
AU - Tarasov, N.
AU - Obrezan, A.
AU - Khokhlov, A.
AU - Huang, C.
AU - Chen, J.
AU - Wang, J.
AU - Zotov, S.
PY - 2017/5
Y1 - 2017/5
N2 - Background and Purpose-In the EMPA-REG OUTCOME trial (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients), empagliflozin added to standard of care in patients with type 2 diabetes mellitus and high cardiovascular risk reduced the risk of 3-point major adverse cardiovascular events, driven by a reduction in cardiovascular mortality, with no significant difference between empagliflozin and placebo in risk of myocardial infarction or stroke. In a modified intent-to-treat analysis, the hazard ratio for stroke was 1.18 (95% confidence interval, 0.89-1.56; P= 0.26). We further investigated cerebrovascular events.Methods-Patients were randomized to empagliflozin 10 mg, empagliflozin 25 mg, or placebo; 7020 patients were treated. Median observation time was 3.1 years.Results-The numeric difference in stroke between empagliflozin and placebo in the modified intent-to-treat analysis was primarily because of 18 patients in the empagliflozin group with a first event > 90 days after last intake of study drug (versus 3 on placebo). In a sensitivity analysis based on events during treatment orConclusions-In patients with type 2 diabetes mellitus and high cardiovascular risk, there was no significant difference in the risk of cerebrovascular events with empagliflozin versus placebo.
AB - Background and Purpose-In the EMPA-REG OUTCOME trial (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients), empagliflozin added to standard of care in patients with type 2 diabetes mellitus and high cardiovascular risk reduced the risk of 3-point major adverse cardiovascular events, driven by a reduction in cardiovascular mortality, with no significant difference between empagliflozin and placebo in risk of myocardial infarction or stroke. In a modified intent-to-treat analysis, the hazard ratio for stroke was 1.18 (95% confidence interval, 0.89-1.56; P= 0.26). We further investigated cerebrovascular events.Methods-Patients were randomized to empagliflozin 10 mg, empagliflozin 25 mg, or placebo; 7020 patients were treated. Median observation time was 3.1 years.Results-The numeric difference in stroke between empagliflozin and placebo in the modified intent-to-treat analysis was primarily because of 18 patients in the empagliflozin group with a first event > 90 days after last intake of study drug (versus 3 on placebo). In a sensitivity analysis based on events during treatment orConclusions-In patients with type 2 diabetes mellitus and high cardiovascular risk, there was no significant difference in the risk of cerebrovascular events with empagliflozin versus placebo.
KW - blood pressure
KW - cardiovascular diseases
KW - hematocrit
KW - stroke
KW - type 2 diabetes mellitus
KW - ISCHEMIC-STROKE
KW - FOLLOW-UP
KW - METAANALYSIS
KW - MORTALITY
KW - OUTCOMES
KW - TRIAL
U2 - 10.1161/STROKEAHA.116.015756
DO - 10.1161/STROKEAHA.116.015756
M3 - статья
VL - 48
SP - 1218-+
JO - Stroke
JF - Stroke
SN - 0039-2499
IS - 5
ER -
ID: 87876488