medwireNews: Empagliflozin treatment significantly reduces pulmonary artery (PA) blood pressure in patients with heart failure (HF), show findings from the randomized EMBRACE-HF trial.
Mikhail Kosiborod (Saint Luke’s Mid America Heart Institute, Kansas City, Missouri, USA) and study co-authors say theirs is the first trial to demonstrate a “decongestion effect” of sodium-glucose cotransporter (SGLT)2 inhibition in people with HF via the direct measurement of PA hemodynamics.
Direct measurement of PA pressure is “arguably […] one of the most (if not the most) important intermediate measures in HF,” they say, because it directly reflects left ventricular filling hemodynamics, and strongly predicts clinical outcomes.
To achieve these measurements, the researchers recruited patients with established HF, with reduced or preserved ejection fraction, who already had an implanted PA pressure monitoring system (CardioMEMS). They describe this cohort as “a vulnerable, difficult-to-manage population,” with more severe symptoms than seen in other trials of SGLT2 inhibitors in HF.
In total, 31 of these participants were randomly assigned to receive empagliflozin 10 mg/day for 12 weeks and completed the trial, as did 28 of those given placebo.
PA diastolic pressure was numerically lower in the empagliflozin group than the placebo group from week 1, and this difference increased over time to attain statistical significance during weeks 8–12.
By 12 weeks, which was the primary endpoint, diastolic pressure was an average of 1.7 mmHg lower in the empagliflozin versus placebo group, and the difference persisted 1 week after the patients ceased taking the trial medications, at a still significant 1.9 mmHg.
The researchers describe these differences as “modest,” but stress that small declines in blood pressure can equate to considerably larger reductions in cardiovascular risk.
Moreover, “the curves for PA diastolic pressure continued to separate between empagliflozin and placebo, with no evidence of plateau at the end of the treatment period,” they write in Circulation.
“[I]t is, therefore, possible that the effect on PA pressure would have been even greater if patients were followed for a longer time period.”
The same pattern was observed for systolic and mean PA pressure, and the team highlights that it occurred “in the absence of any difference in loop diuretic management between the treatment groups,” implying that mechanisms other than diuresis were responsible for the PA pressure reduction.
The beneficial effect of empagliflozin on diastolic PA pressure was consistent in participants with reduced and preserved ejection fraction but appeared greater in those with type 2 diabetes (approximately half of the cohort), at an average 2.8 mmHg decrease versus a 0.1 mmHg increase in those without.
But Kosiborod and team stress that “[t]hese analyses should be interpreted with caution, since subgroups of this modestly sized trial were quite small (as few as 15 patients), and therefore substantially underpowered.”
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