No cardiac remodeling with empagliflozin in people without diabetes, significant HF
Click Here to Manage Email Alerts
CHICAGO — In people without diabetes or significant HF, 6 months of empagliflozin treatment was not associated with any meaningful changes in cardiac remodeling indices compared with placebo, according to data from the EMPA-HEART 2 study.
Data from EMPA-HEART 2 are in contrast with the favorable left ventricular remodeling results reported in the original EMPA-HEART study, which included people with type 2 diabetes and CAD treated with empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) vs. placebo, as well as in those with prevalent HF during a similar treatment duration, Subodh Verma, MD, PhD, FRCSC, professor and the Canada Research Chair in Cardiovascular Surgery at the University of Toronto, said during a featured science presentation at the American Heart Association Scientific Sessions.
Source: Adobe Stock
“The broad benefits [seen] with SGLT2 inhibitors have led to some theories that SGLT2 inhibitors may offer additional benefits if introduced earlier on in the natural history of HF in people without diabetes and without prevalent HF but are at risk of developing HF — so-called stage A or stage B,” Verma said. “But there are really no clinical trials in this space.”
Verma and colleagues analyzed data from 169 adults aged 40 to 80 years without type 2 diabetes or HF, but with at least one of the following major entry criteria: LV mass indexed to baseline body surface area of 96 g/m2 or greater for women and 116 g/m2 or greater for men (assessed via echocardiogram); or LV mass index of 81 g/m2 or greater for women and 85 g/m2 or greater for men; LV hypertrophy (assessed by ECG); structural heart disease; persistent hypertension despite at least three antihypertensive medications. Participants could also have at least two of the minor entry criteria: history of an MI 3 or more months ago, estimated glomerular filtration rate between 30 mL/min/1.73 m2 and 60 mL/min/1.73 m2; and a BMI of 27 kg/m2 or greater. Participants were recruited between April 2021 and January 2022. After undergoing cardiac MRI, participants were randomly assigned to 10 mg daily empagliflozin (n = 85) or placebo (n = 84) for 6 months. The mean age of participants was 59 years; 70% were men; mean BMI was 29 kg/m2.
The primary outcome was cardiac MRI-assessed 6-month change in LV mass index from baseline. Secondary outcomes included 6-month changes in LV end-diastolic volume, LV end-systolic volume, LV ejection fraction, LV wall stress, LV diastolic and systolic function, N-terminal pro-B-type natriuretic peptide, systolic and diastolic BP and hematocrit. The findings were simultaneously published in Circulation.
At 6 months, the mean change in LV mass index from baseline was –1.2 g/m2 with empagliflozin and –1.07 g/m2 with placebo, for an adjusted treatment effect of –0.3 (95% CI, –2.1 to 1.5; P = .74).
Treatment effects of empagliflozin vs. placebo, adjusted for baseline parameters, were –1.26 for LV end-diastolic volume (P = .41), –1.39 for LV end-systolic volume (P = .13) and 2.01 for LVEF (P = .07).
There were also no differences between the groups in 6-month changes in systolic BP (P = .52), diastolic BP (P = .6) or NT-proBNP (P = .7), according to the researchers.
Verma said the study had a small sample size, though adequately powered to detect meaningful changes in LV mass index, as well as a short duration of treatment exposure.
“Our findings do not preclude the possibility that mechanisms other than cardiac remodeling may be responsible for some of the benefits observed with SGLT2 inhibitors,” Verma said.
Reference:
Collapse
Verma S, et al. FS.01: An in-depth look at heart failure trials. Presented at: American Heart Association Scientific Sessions; Nov. 5-7, 2022; Chicago (hybrid meeting).
Read more about
Click Here to Manage Email Alerts