HOMEPRODUCTSCOMPANYCONTACTFAQResearchDictionaryPharmaSign Up FREE or Login

Empagliflozin Reduced Mortality and Hospitalization for Heart Failure Across the Spectrum of Cardiovascular Risk in the EMPA-REG OUTCOME Trial.

AbstractBACKGROUND:
In the EMPA-REG OUTCOME trial (BI 10773 [Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) in patients with type 2 diabetes mellitus and atherosclerotic cardiovascular disease, in comparison with placebo, empagliflozin reduced the risks of 3-point major adverse cardiovascular events (3-point MACE), cardiovascular and all-cause death, and hospitalization for heart failure. We investigated whether these effects varied across the spectrum of baseline cardiovascular risk.
METHODS:
Cardiovascular death, all-cause mortality, 3-point MACE, and hospitalization for heart failure in the pooled empagliflozin and placebo groups were analyzed in subgroups by prior myocardial infarction and stroke at baseline, and by estimated baseline cardiovascular risk based on the 10-point TIMI (Thrombolysis In Myocardial Infarction) Risk Score for Secondary Prevention.
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.
AuthorsDavid 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
JournalCirculation (Circulation) Vol. 139 Issue 11 Pg. 1384-1395 (03 12 2019) ISSN: 1524-4539 [Electronic] United States
PMID30586757 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Benzhydryl Compounds
  • Glucosides
  • Sodium-Glucose Transporter 2 Inhibitors
  • empagliflozin
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

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!


Choose Username:
Email:
Password:
Verify Password:
Enter Code Shown: