EMPA-KIDNEY: the study of heart and kidney protection with empagliflozin

Chronic Kidney Disease (CKD) affects approximately 1 in 10 people in the UK. It is known that people with kidney disease are at risk of their kidney problem worsening and of developing heart problems.

EMPA-KIDNEY was a clinical trial testing whether taking a single pill of empagliflozin every day prevents worsening of kidney disease or deaths from heart disease in people who have chronic kidney disease.

Empagliflozin was developed to treat high blood sugar in people with diabetes, and was shown to have beneficial effects on both the heart and kidney. The drug causes blood sugar and salt to pass into the urine which results in a modest fall in body weight and blood pressure.

This randomised double-blind placebo-controlled trial of empagliflozin versus matching placebo recruited 5,000 people with chronic kidney disease, with or without diabetes to assess whether empagliflozin reduces the risk of kidney disease progression or cardiovascular death. 

The trial was stopped early due to evidence of efficacy and results were reported in November 2022. EMPA-KIDNEY is now in an observational post-trial follow-up phase. These results are expected to be available in late 2024.

results

EMPA-KIDNEY demonstrated that empagliflozin reduced the risk of kidney disease progression or cardiovascular death by 28% when compared with a placebo. The trial also demonstrated a 14% reduction in the risk of hospitalisation for any cause, which may help to relieve the burden on healthcare systems. 

Based on the results of the EMPA-KIDNEY trial, the Medicines and Healthcare products Regulatory Agency (MHRA), granted approval for the use of Jardiance® (empagliflozin) to treat adults with chronic kidney disease.

Treatment with empagliflozin has the potential to advance the standard of care for 7.2 million people in the UK living with chronic kidney disease.