Lack of Interaction Observed For Treatment Effect of Empagliflozin By Region, Race

Vijay Chopra MD

New research suggested a consistent risk reduction of empagliflozin may be postulated independent of region or race in patients with heart failure and preserved ejection fraction (HFpEF).

Subgroup analyses of the EMPEROR-Preserved by race and region did not indicate a significant effect modified for the primary endpoint of cardiovascular death (CV death) or hospitalization for heart failure.

These findings were presented at the 2022 American College of Cardiology (ACC) 71st Annual Scientific Session & Expo.

Previous reporting on the EMPEROR-Preserved showed that empagliflozin on top of standard of care therapy reduced the risk of the primary endpoint. Thus, the current analysis aimed to explore the influence of region and race/ethnicity on the effects of empagliflozin within the study.

A total of 5988 patients were randomized in EMPEROR-Preserved. Demographic data show 686 (11.5%) were enrolled in Asia, 2689 (44.9%) in Europe, 1515 (25.3%) in Latin America, 719 (12.0%) in North America, and 379 (6.3%) in other countries, including Australia, India, and South Africa.

Further, the study noted 824 (13.8%) were Asian, 258 (4.3%) were Black, 4542 (75.9%) were White, and 362 (6.0%) were classified in other categories, including mixed race.

Investigators observed no interaction for the treatment effect of empagliflozin on the primary outcome by region or race. In addition, there was no interaction seen for the treatment effect of empagliflozin on time to first hospitalization for heart failure or time to CV death.

Overall, 415 of 2997 patients treated with empagliflozin 10 mg had an event, compared to 511 of 2991 treated with placebo (hazard ratio [HR], 0.79; 95% CI, 0.69 - 0.90).

In North America, data show CV death or HHF occured in 64 of 360 patients treated with empagliflozin, compared to 63 of 359 patients in the placebo group (HR, 0.72; 95% CI, 0.52 - 1.00).

Additionally, in Europe, data show CV death or HHF was reported in 165 of 1346 patients treated with empagliflozin 10 mg, compared to 202 of 1343 patients treated with placebo (HR, 0.80; 95% CI, 0.65 - 0.98).

By race, data show CV death or HHF occurred in 310 of 2286 White patients treated with empagliflozin 10 mg, compared to 370 of 2256 treated with placebo (HR, 0.81; 95% CI, 0.69 - 0.94).

In comparison, CV death or HHF was reported in 24 of 133 Black patients treated with empagliflozin 10 mg, compared to 28 of 125 patients treated with placebo (HR, 0.73; 95% CI, 0.42 - 1.25).

“For total [hospitalizations for heart failure], the exploratory analysis by region indicates heterogeneity, but the analysis by race does not,” wrote study author Vijay Chopra MD, EMPEROR-Preserved Committees and Investigators, Max Super Speciality Hospital, New Delhi, India.

The abstract, “Regional and Ethnic Influences on the Response to Empaglifzloin in Patients with Heart Failure and A Preserved Ejection Fraction - Results From The Emperor-Preserved Trial,” was presented at ACC 2022.