SAN FRANCISCO — Empagliflozin has a consistent cardioprotective effect in patients with type 2 diabetes (T2D) and cardiovascular disease (CVD), regardless of the number of CV risk factors that are controlled, according to research presented at the 79th Scientific Sessions of the American Diabetes Association, held June 7 to 11, 2019, in San Francisco.
Researchers conducted a post hoc analysis of the EMPA-REG OUTCOME (BI 10773 [Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients; ClinicalTrials.gov Identifier: NCT01131676) trial, which included 7020 patients with T2D and CVD. Empagliflozin significantly reduced the risk for major adverse cardiovascular events (MACE), which was defined as CV death, nonfatal myocardial infarction, and nonfatal stroke. In addition, the risk for hospitalization for heart failure was reduced.
In this analysis, the trial outcomes were explored in subgroups of patients based on the following CV risk factor goals at baseline: hemoglobin A1c <7.5%, low-density lipoprotein cholesterol <100 mg/dL, or statin use; systolic blood pressure <140 mm Hg or diastolic blood pressure <90 mm Hg; angiotensin converting enzyme inhibitor or angiotensin receptor blocker use; normoalbuminuria; aspirin use; and nonsmoking status.
The hazard ratio (HR) for MACE was 2.21 (95% CI, 1.53-3.19) and 1.42 (95% CI, 1.06-1.89) in patients who achieved 0 to 3 or 4 to 5 CV goals, respectively, at baseline compared with those who achieved 6 or 7 goals . In addition, patients who achieved 0 to 3 or 4 to 5 goals had an increased risk for CV death (HR, 4.00; 95% CI, 2.26-7.11 and HR, 2.48; 95% CI, 1.52-4.06, respectively), hospitalization for heart failure or CV death (HR, 2.89; 95% CI, 1.82-4.57 and HR, 1.90; 95% CI, 1.31-2.78, respectively) as well as an increased point estimate for heart failure hospitalization (HR, 1.91; 95% CI, 0.96-3.79 and HR, 1.67; 95% CI, 1.00-2.80, respectively) compared with those who achieved 6 to 7 goals.
Although CV risk increased with fewer risk factors controlled, empagliflozin’s cardioprotective effect was consistent regardless of the number of factors controlled when compared with placebo.
Disclosures: Several authors disclosed financial relationships to various pharmaceutical companies, including Boehringer Ingelheim, which sponsored the EMPA-REG OUTCOME trial.
Inzucchi SE, Khunti K, Fitchett DH, et al. Consistent cardiovascular (CV) benefits from empagliflozin across the spectrum of CV risk factor control: post hoc analysis from EMPA-REG OUTCOME. Presented at: American Diabetes Association 79th Scientific Sessions; June 7-11, 2019; San Francisco, CA. Poster 19-LB.