Another new indication for Wegovy?

Novo Nordisk's blockbuster GLP-1 drug improved symptoms and physical function in a trial of patients with obesity, diabetes, and heart failure with preserved ejection fraction. This comes after Novo reported positive results last year in a similar HFpEF trial, but in patients who didn't have diabetes.

With the data from these two new trials, Novo is now seeking regulatory approval for a new indication for Wegovy in HFpEF. The drug is quickly amassing data that shows its benefits beyond weight loss. It just last month got FDA clearance for the use of preventing cardiovascular complications.

Strikingly, patients in this trial lost less weight than people in the first HFpEF trial, but the magnitude of heart failure benefit was around the same across the two studies. That suggests that weight loss was not the only factor driving heart benefit, an observation that was also seen in a recent large cardiovascular trial of Wegovy.

A Jardiance disappointment

SGLT2 inhibitors have shown to improve cardiovascular outcomes in an array of patients — people with diabetes, chronic kidney disease, and heart failure. But it's been unclear if they can help people who just had heart attacks.

In a trial presented today, Boehringer Ingelheim and Eli Lilly's Jardiance did not significantly lower the risk of a first hospitalization for heart failure or death in patients at risk of heart failure after a heart attack. The results, also published in NEJM, showed that patients on the drug had a 10% lower risk than those on placebo, but this was not statistically significant.

This follows a recent trial of AstraZeneca's Farxiga, another SGLT2 inhibitor, which also failed to show a benefit on rates of death or heart failure hospitalization after heart attacks.

telehealth

Promises of remote care

A new study out of the U.K. points to the potential not of drugs, but of telehealth monitoring, to help patient outcomes following heart attacks.

The trial, which enrolled about 300 patients who had acute coronary syndrome, found that those who underwent telehealth monitoring had a 76% lower risk of being readmitted into the hospital and 41% lower risk of visiting an emergency department over six months.

"This simple strategy can potentially free up thousands of hospital beds and doctors' hours across the country whilst keeping patients just as safe." Ramzi Khamis, lead author and a British Heart Foundation research fellow, said in a statement.

The authors noted, though, that the monitoring consisted of a high level of support in which patients could call at any time from 7 a.m. to 11 p.m. on weekdays. That level of attention could be difficult to achieve outside a trial setting.

devices

Mixed results for heart failure device

My colleague Matt Herper brings us the puzzling results of a large study on a new device to treat heart failure.

The device, an intra-atrial shunt developed by privately held VWave Medical, creates a five-millimeter opening between the left and right upper chambers of the heart. That is meant to help compensate for the effects of heart failure.

Unfortunately, the study failed in its main goal of reducing a collection of heart-failure related outcomes. But the results differed depending on patients' left ventricular ejection fraction (LVEF) – a measure of how well the heart pumps blood. In patients with low LVEF, there was a statistically significant 45% reduction in adverse cardiovascular events for those who received the shunt. But in the patients with normal LVEF, there was a 60% increase in adverse cardiovascular events.

"Although further studies are required to confirm our observations, the present results strongly suggest that heart failure patients with reduced LVEF may benefit from these devices," Gregg W. Stone, the lead investigator of the study, said in a prepared statement released by Mount Sinai Health System, where he is a professor.

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