SGLT2 inhibitor results a ‘huge win’ for HFpEF patients

Cardiologists may gain benefits with SGLT2 inhibitors in patients with heart failure with preserved ejection fraction (HFpEF), according to research released at ESC Congress 2021.

The EMPEROR-Preserved trial reviewed cardiovascular outcomes in 5988 heart failure patients with >40% ejection fraction who were on empagliflozin or placebo over median 26.2 months.

Empagliflozin patients were significantly less likely to experience cardiovascular death or hospitalisation for heart failure than those on placebo (13.8% vs 17.1%, hazard ratio [HR]: 0.79, 95% CI: 0.69–0.90, P < 0.001), Australia’s national study coordinator, Professor Stephen Nicholls and his team wrote in the New England Journal of Medicine.

The drug was particularly effective in reducing hospitalisations for heart failure, with just 407 events on empagliflozin versus 541 on placebo (HR: 0.73, 95% CI: 0.61–0.88, P < 0.001) and consistently benefited diabetic and non-diabetic patients, the study found.

Serious adverse events (47.9% versus 51.6%) and discontinuation rates (19.1% versus 18.4%) were similar across empagliflozin and placebo patients, respectively, though empagliflozin users were more likely to experience uncomplicated genital and urinary tract infections and hypotension, they noted.

Professor Nicholls told the limbic the findings broke ground in a “Holy Grail area” and were “a huge win” for HFpEF patients, adding that previous clinical trials had only ever shown benefit in heart failure with reduced ejection fraction (HFrEF).

“We’ve conducted a lot of trials for many years and we’ve failed to demonstrate that any therapy effectively reduces the likelihood that you’ll die or be hospitalised for heart failure [with preserved ejection fraction] and so really, for the first time, we have a really big clinical trial that shows that a medical therapy does actually benefit patients from that perspective,” he said.

HFpEF “has a significant impact in terms of symptoms and quality of life, we know these patients tend to bounce in and out of hospital and there’s an association with increased mortality,” he said

“So I think that our ability to bring effective therapies to a setting which has bad outcomes and to date, not had standalone therapies show benefit, is a huge win for patients. And that’s why I think, once they’re available for use in Australia, I think you’ll find many patients with HFpEF will be treated with these agents”.

Further work is needed to determine how cardiologists can choose the right combination of SGLT2 inhibitor and standard of care therapies, once more HFpEF drugs are released, he added. Nevertheless, Professor Nicholls said he expected to see “an increasing emphasis for the use of these agents for all forms of heart failure in treatment guidelines that will ultimately flow on to the way we use them in the clinic.”

A clinical trial testing dapagliflozin’s effect in HFpEF is currently underway, and given its success in HFrEF, Professor Nicholls said he hoped to see similar results to empagliflozin.

While he’s “anxiously awaiting TGA approval for use of these drugs in all forms of heart failure”,  regardless of diabetes status, Professor Nicholls said cardiologists should “keep in mind that we already have these agents approved for the management of type 2 diabetes” and using them in these patients “is a no brainer”.

Disclosure: The study was funded by Boehringer Ingelheim and Eli Lilly

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