For patients with type 2 diabetes (T2D) and left ventricular hypertrophy, empagliflozin reduced the risk for cardiovascular death vs placebo, according to a post hoc analysis of the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME; NCT01131676) that was published in Diabetes Care.
Researchers analyzed a subgroup of trial patients for risks for cardiovascular death, all-cause mortality, and 3-point major adverse cardiovascular events. Participants were separated into empagliflozin treatment arms (10 mg/day or 25 mg/day) or a placebo arm while also receiving standard of care treatment. All patients completed an electrocardiogram at baseline and were categorized as having left ventricular hypertrophy or not having left ventricular hypertrophy based on electrocardiogram evidence.
Of 5973 patients with usable electrocardiograms, 2008 were in the placebo treatment arm and 3965 were in an empagliflozin treatment arm. Baseline characteristics for age, duration of T2D, body mass index, hypertension, heart failure, and cardiovascular medication usage were similar between patients with and without left ventricular hypertrophy.
For patients in the placebo treatment arm, those with left ventricular hypertrophy had a 4 times greater risk for cardiovascular death (78.9 vs 19.1/1000 patient-years) than patients without left ventricular hypertrophy. Participants with left ventricular hypertrophy also had a 3.5 times greater risk for all-cause mortality (96.4 vs 28.1/1000 patient-years) and 3-point major adverse cardiovascular event (143.7 vs 41.1/1000 patient-years).
For patients in the empagliflozin treatment arms, cardiovascular death (hazard ratios [HRs], 0.4 vs 0.6; P =.40), all-cause mortality (HRs, 0.32 vs 0.67; P =.11), and 3-point major adverse cardiovascular events (HRs, 0.39 vs 0.89; P =.03) were reduced compared with the placebo arm whether left ventricular hypertrophy was present at baseline or not.
The investigators recommended that future studies evaluate the impact empagliflozin has on less stringent definitions of left ventricular hypertrophy and whether the treatment can cause remission in left ventricular mass.
Researchers concluded that for patients with T2D with or without left ventricular hypertrophy, “empagliflozin consistently reduced the risks [for] cardiovascular and all-cause mortality.”
This study was supported by the Boehringer Ingelheim & Eli Lilly and Company Diabetes Alliance. Please refer to reference for a complete list of authors’ disclosures.
Verma S, Mazer CD, Bhatt DL, et al. Empagliflozin and cardiovascular outcomes in patients with type 2 diabetes and left ventricular hypertrophy: a subanalysis of the EMPA-REG OUTCOME trial [published online January 23, 2019]. Diabetes Care. doi: 10.2337/dc18-1959