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Medicine Matters diabetes

We studied 4,744 patients from 20 different countries worldwide who had heart failure with a reduced ejection fraction. But very importantly, 55% of those patients did not have type 2 diabetes. They were all very well-treated with standard heart failure therapies.



And we randomized those patients to receive either dapagliflozin, 10 milligrams once daily, or matching placebo. We followed them for a median of 18.2 months, and we had a primary endpoint, which was a composite of a worsening heart failure event or cardiovascular death. That was reduced by 26%, a highly statistically significant benefit.


Each of the components were reduced significantly so worsening heart failure by 30%, cardiovascular death by 18%. And maybe most importantly of all, the benefit of dapagliflozin was consistent in patients with and without diabetes. So what we really find was that dapagliflozin, an SGLT2 inhibitor, appears to be a new effective treatment for patients with heart failure reducing hospital admission, reducing death, and also improving symptoms.



What is the mechanism of benefit in people without diabetes?

These drugs obviously protect the kidneys, and kidneys are what cause sodium and water retention [and] cause the symptoms and signs of heart failure. They may also have beneficial effects on the metabolism of the heart. That's abnormal when the heart fails.

And they have postulated additional benefits potentially in heart failure. For example, they may influence some of the ion channels in the cardiomyocytes. And they have many other different benefits that have been speculated about. The SGLT2 inhibitors as a class have shown pretty consistent benefits in terms of preventing the development of heart failure and improving renal function. And I would expect the same will be true when we look at more of these agents for treating patients with established heart failure.



What are the next steps?

There are probably several next steps. So one of them is that we need to look into the DAPA-HF database further and in particular that large subset of patients with type 2 diabetes. We need to see whether SGLT2 inhibitors are beneficial in the other major type of heart failure, heart failure with preserved ejection fraction. And there are two large trials currently underway looking at that type of heart failure. And then this whole amazing finding of a benefit in patients with type 2 diabetes, we need to see whether that might also be the case in other conditions. And two of the ongoing chronic kidney disease trials, DAPA CKD and EMPA-KIDNEY, are also enrolling patients who don't have type 2 diabetes.