Surprisingly good results in the cardiovascular safety of empagliflozin (EMPA-REG OUTCOME)

Abstract:

EMPA-REG OUTCOME study is designed to confirm non-inferiority of empagliflozin (all standard therapies with empagliflozin) compared to placebo (all standard therapy except empagliflozin) to the primary objectives of (1. cardiovascular death, 2. nonfatal myocardial infarction, 3. nonfatal stroke) and to the key secondary objectives (primary goals + 4. hospitalization for unstable angina) in patients with type 2 diabetes who are at high risk for cardiovascular disease and death. Patients were randomized into three groups: 1. empagliflozin 10 mg, 2. empagliflozin 25 mg and 3. placebo. Patients’ results randomized to empagliflozin were surprisingly good. The research was only expected to confirm non-inferiority of empagliflozin compared to placebo. Yet, the results obtained excelled and are rarely seen in modern medicine. Oral hypoglycemic medication from the group of inhibitors of SGLT-2 not only reduces the level of HbA1c for >0.6%, but also reduces the risk of cardiovascular death by 38% and the number of hospitalizations due to heart failure by 35%. The research results are superb that they justify considering the possible inclusion of empagliflozin in the treatment of cardiac decompensation with low sodium levels in the serum, even in patients without diabetes mellitus type 2 diabetes.

Key words:
cardiovascular safety; empagliflozin; heart failure; hospitalization; mortality; SGLT-2 inhibitor