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Heart Failure Needs More Attention in Diabetes Drug Trials, Expert Says

Mary Caffrey and Angelia Szwed
At a symposium at the 77th Scientific Sessions of the American Diabetes Association, experts suggested that the relationship between heart failure and diabetes is finally getting the attention it deserves.
The effect of drugs to treat diabetes on heart failure should be front and center in clinical trials, according to an expert at a symposium on the relationship between the 2 conditions at the 77th Scientific Sessions of the American Diabetes Association (ADA), held Saturday in San Diego, California.

Ten years ago this week, the New England Journal of Medicine’s article on rosiglitazone stunned the diabetes and cardiovascular treatment communities alike, when it connected a blockbuster glucose-lowering therapy with deaths from heart attacks. The incident led to an FDA guidance requiring pharmaceutical companies to study the effects of all new diabetes and obesity therapies for their effects on cardiovascular events and mortality.

In a sign of how much the fields are overlapping, 3 months ago leading researchers in diabetes attended the American College of Cardiology (ACC) to discuss plans for EMPEROR HF, which will study emagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, in heart failure patients, including those without diabetes. And yesterday, at the symposium, “Diabetes, Drugs, and Heart Failure,” leading cardiologists took the podium, led by Darren K. McGuire, MD, MHSc, of the University of Texas Southwestern.

The cardiologists speaking at ADA asserted that heart failure, perhaps, is finally getting its due, given its $31 billion footprint on the healthcare system and its rising cost to Medicare. While 25% of those newly diagnosed with heart failure have diabetes, according to Shannon Dunlay, MD, MS, of Mayo Clinic, they tend to be sicker, accounting for 46% of heart failure hospitalizations. “This is an area we need to learn more about,” she said.

Eldrin F. Lewis, MD, MPH, of Brigham and Women’s Hospital, was more blunt in his talk that called for making heart failure a primary endpoint in cardiovascular outcomes trials, not a “secondary, or exploratory, or not even looked at endpoint.”

When scrutinizing heart failure hospitalization rates in drug trials, he said it’s essential to examine what happens to these patients afterward—death rates can be high. Looking at data for saxagliptin, which had shown a heart failure hospitalization signal that FDA examined, Lewis said, “I would rather not be joining the heart failure club.”

While Dunlay said studies have linked diabetes and heart failure for decades—going back to the Framingham Heart Study in 1974—there’s still much that isn’t known. The pathway from diabetes to heart failure “is circuitous and still ill-defined,” she said.

What is known: “If you have diabetes in the presence of heart failure, you do worse,” Dunlay said.” Diabetes increases death from heart failure by 50%; although patients with diabetes ultimately die of the same causes as other heart failure patients, she said, they die earlier.

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