Background: Within the EMPA-REG OUTCOME trial (BI 10773 [Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Patients) in patients with type 2 diabetes and atherosclerotic coronary disease, in comparison to placebo, empagliflozin reduced the potential risks of three-point major adverse cardiovascular occasions (3-point MACE), cardiovascular and all sorts of-cause dying, and hospitalization for heart failure. We investigated whether these effects varied over the spectrum of baseline cardiovascular risk.
Methods: Cardiovascular dying, all-cause mortality, 3-point MACE, and hospitalization for heart failure within the pooled empagliflozin and placebo groups were examined in subgroups by prior myocardial infarction and stroke at baseline, by believed baseline cardiovascular risk in line with the 10-point TIMI (Thrombolysis In Myocardial Infarction) Risk Score for Secondary Prevention.
Results: Of 7020 patients who received the research drug, 65% were built with a prior myocardial infarction or stroke, and 12%, 40%, 30%, and 18% were at low, intermediate, high, and greatest believed cardiovascular risk based on TIMI Risk Score for Secondary Prevention (?ΓΌ2, 3, 4, and ?Y5 points, correspondingly). Within the placebo group, 3-point MACE happened throughout the trial in 7.3%, 9.4%, 12.6%, and 20.6% of patients at low, intermediate, high, and greatest believed baseline risk, correspondingly. Relative reductions in chance of cardiovascular dying, 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 getting atherosclerotic coronary disease, patients in EMPA-REG OUTCOME shown an extensive risk spectrum for cardiovascular occasions. Reductions in key cardiovascular outcomes and mortality with empagliflozin versus placebo were consistent across the plethora of cardiovascular risk.