In EMPA-REG OUTCOME, empagliflozin (EMPA) reduced the risk of major adverse cardiovascular (CV) events (MACE), CV mortality and hospitalization for heart failure (HHF) in analyses of first events in patients with type 2 diabetes (T2D) and atherosclerotic CV disease (ASCVD). We assessed the effect of EMPA on the total burden of CV events.
Patients were randomized to EMPA 10 mg, EMPA 25 mg, or placebo. We assessed the effects of EMPA pooled vs placebo on any (first plus recurrent) adjudicated CV event (composite of myocardial infarction (MI), stroke, coronary revascularization (CR), hospitalization for unstable angina, transient ischemic attack, HHF, and CV death) using a negative binomial model.
Among 7,020 treated patients (mean [SD] age 63  years), there were 2,142 total adjudicated CV events, most frequently CR (585), MI (421), and HHF (321). EMPA reduced the risk of total adjudicated CV events by 24% vs placebo (event rate ratio (95% CI): 0.76 (0.67, 0.87), p < 0.0001). Risk reductions were driven predominantly by reductions in HHF (0.58 (0.42, 0.81), p=0.0012), MI (0.79 (0.620, 0.998), p=0.0486), and CV death (0.62 (0.50, 0.78), p < 0.0001). The estimated number of total CV events prevented with EMPA was 414.4, and the number of patients needed to treat over 3 years to prevent one event was 10.2 (6.6, 22.7).
EMPA produced a sizeable risk reduction in the total burden of any adjudicated CV outcome, including HHF, MI and CV death, in patients with T2D and ASCVD.