Empagliflozin Reduced Mortality and Hospitalization for Heart Failure Across the Spectrum of Cardiovascular Risk in the EMPA-REG OUTCOME Trial.
Abstract | BACKGROUND: METHODS: RESULTS: Of 7020 patients who received the study drug, 65% had a prior myocardial infarction or stroke, and 12%, 40%, 30%, and 18% were at low, intermediate, high, and highest estimated cardiovascular risk according to TIMI Risk Score for Secondary Prevention (≤2, 3, 4, and ≥5 points, respectively). In the placebo group, 3-point MACE occurred during the trial in 7.3%, 9.4%, 12.6%, and 20.6% of patients at low, intermediate, high, and highest estimated baseline risk, respectively. Relative reductions in risk of cardiovascular death, all-cause mortality, 3-point MACE and hospitalization for heart failure with empagliflozin versus placebo were consistent in patients with and without prior myocardial infarction and/or stroke and across subgroups by TIMI Risk Score for Secondary Prevention at baseline ( P>0.05 for randomized group-by-subgroup interactions). CONCLUSIONS: Despite all patients having atherosclerotic cardiovascular disease, patients in EMPA-REG OUTCOME demonstrated a broad risk spectrum for cardiovascular events. Reductions in key cardiovascular outcomes and mortality with empagliflozin versus placebo were consistent across the range of cardiovascular risk. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01131676.
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Authors | David Fitchett, Silvio E Inzucchi, Christopher P Cannon, Darren K McGuire, Benjamin M Scirica, Odd Erik Johansen, Steven Sambevski, Stefan Kaspers, Egon Pfarr, Jyothis T George, Bernard Zinman |
Journal | Circulation
(Circulation)
Vol. 139
Issue 11
Pg. 1384-1395
(03 12 2019)
ISSN: 1524-4539 [Electronic] United States |
PMID | 30586757
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Benzhydryl Compounds
- Glucosides
- Sodium-Glucose Transporter 2 Inhibitors
- empagliflozin
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Topics |
- Aged
- Atherosclerosis
(diagnosis, drug therapy, mortality)
- Benzhydryl Compounds
(adverse effects, therapeutic use)
- Cause of Death
- Diabetes Mellitus, Type 2
(blood, diagnosis, drug therapy, mortality)
- Female
- Glucosides
(adverse effects, therapeutic use)
- Heart Failure
(diagnosis, mortality, physiopathology, prevention & control)
- Humans
- Male
- Middle Aged
- Patient Admission
- Risk Assessment
- Risk Factors
- Sodium-Glucose Transporter 2 Inhibitors
(adverse effects, therapeutic use)
- Time Factors
- Treatment Outcome
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