New top-line results from two Phase 3 studies have added to the evidence that sodium–glucose cotransporter 2 (SGLT2) inhibitors have protective effects on the heart and kidneys, both in people with type 2 diabetes and in those with normoglycaemia.
The Phase III DAPA-CKD trial, conducted in 4304 adults with chronic kidney disease, showed that, compared with placebo, dapagliflozin significantly reduced the risk of its primary endpoint, a composite of worsening renal function or risk of death (defined as a composite endpoint of ≥50% sustained decline in estimated glomerular filtration rate, onset of end-stage kidney disease or cardiovascular or renal death). The trial also met all its secondary endpoints (including the time to first occurrence of the composite renal outcome, the composite of cardiovascular death or hospitalisation for heart failure, and death from any cause), both in people with type 2 diabetes and in those without.
In the EMPEROR-Reduced trial, conducted in 3730 adults with chronic heart failure with reduced ejection fraction (with or without comorbid type 2 diabetes), empagliflozin met its primary endpoint, demonstrating superiority over placebo in reducing risk of the composite of cardiovascular death or hospitalisation for heart failure.
The American Diabetes Association and European Association for the Study of Diabetes already recommend SGLT2 inhibitors as the second-line treatment of choice, after metformin, in people with type 2 diabetes and either heart failure or chronic kidney disease. These findings strengthen the evidence behind these recommendations, and may pave the way to using these therapies in people without diabetes.
The full results of the studies will be presented in upcoming scientific meetings.