Evidence suggests a dose-dependency between LDL cholesterol levels and cardiovascular risk. We analysed the effects of empagliflozin compared to placebo on cardiovascular outcomes according to different LDL-C levels.Design and Method:
In EMPA-REG OUTCOME, patients with T2DM and high cardiovascular risk received empagliflozin 10 mg or 25 mg or placebo in addition to standard of care. All cardiovascular outcomes were independently adjudicated. We investigated the time to (first) 3P-MACE, cardiovascular death, hospitalization for heart failure (HHF) and total mortality for empagliflozin vs placebo between baseline LDL cholesterol categories: < 70, 70-<85, 85-<100, 100 – 115, and > 115 mg/dL by a Cox regression including the interaction of baseline LDL cholesterol category and treatment.Results:
Of the 7,020 patients randomized and treated, 81.0% of patients received lipid lowering therapy (77.0% statins) and the mean (SD) LDL cholesterol was 85.6 (35.7) mg/dL. Baseline characteristics by categories of LDL cholesterol, indicated differences in statin use, diabetes duration, blood pressure, use of antihypertensives, and proportion with albuminuria. The cardiovascular incidence rates varied according to LDL cholesterol levels, however, the impact of empagliflozin on these cardiovascular outcomes were consistent with the overall trial results (interaction p-values: 0.278 3P-MACE, 0.0852 cardiovascular death, 0.5005 HHF and 0.1563 total mortality) (table).Conclusions:
The modulating effects of empagliflozin on cardiovascular outcomes did not differ between the categories of baseline LDL cholesterol levels.