The EMPA-KIDNEY clinical trial has demonstrated that empagliflozin, a treatment developed for diabetes, reduces the risk of kidney disease progression or death from cardiovascular disease by 28% in people with chronic kidney disease. The results were announced today at the American Society for Nephrology Conference, “Kidney Week”, and published in the New England Journal of Medicine.
Chronic kidney disease (CKD) is often a progressive condition that can lead to the need for kidney dialysis or a transplant and increases the risk of cardiovascular disease. It affects an estimated 1 in 10 people worldwide and is a leading cause of death globally.
Treatments such as empagliflozin (known as sodium-glucose cotransporter-2 (SGLT2) inhibitors) have been shown to benefit certain types of CKD patients, but it was uncertain whether the treatment would work for patients without diabetes and others at risk of kidney disease progression who had been underrepresented in previous clinical trials.
EMPA-KIDNEY recruited 6,609 participants in eight countries, half of whom were assigned a 10mg daily dose of empagliflozin and half who were assigned a placebo. The mean age of the participants was 63.8 years, 33% of whom were women. Over half of the participants (54%) did not have diabetes. The trial was designed, conducted and analysed by the Medical Research Council Population Health Research Unit at the University of Oxford, part of Oxford Population Health.
- Empagliflozin reduced the risk of the primary outcome of kidney disease progression or cardiovascular death by 28% (HR 0.72; 95% CI 0.64 to 0.82; p<0.0001).
- Kidney disease progression or death from cardiovascular causes occurred in 432 participants (13.1%) in the empagliflozin group and 550 participants (16.9%) in the placebo group during a median follow-up period of two years.
- The effect of empagliflozin on the primary outcome was generally consistent across the different groups of people studied, including those with and without diabetes, and irrespective of age, sex, ethnicity, or level of kidney function.
- No new side effects of empagliflozin were identified, and the benefits of the treatment outweighed the risks.
- There was a 14% reduction in hospitalisations from any cause in the empagliflozin group (HR 0.86; 95% CI 0.78 to 0.95; p=0.003).
- There was no statistically significant effect on hospitalisation for heart failure or cardiovascular death, or on death from any cause, but there were a limited number of these outcomes reducing statistical power to detect a difference. Although not statistically significant, the observed results are consistent with other trials which have shown clear statistical reductions in the risk of these outcomes.
Will Herrington, Associate Professor at the Medical Research Council Population Health Research Unit at the University of Oxford, and co-Principal Investigator for EMPA-KIDNEY, said ‘The majority of people with chronic kidney disease do not have diabetes and so it was important to find out whether empagliflozin would work for these patients and other types of patient who have been underrepresented in previous trials. Thanks to the commitment of the trial participants and our collaborators around the world, we now know that empagliflozin reduces the risk of kidney disease progression or death from cardiovascular disease significantly in patients with, and without, diabetes.
‘Slowing chronic kidney disease progression and avoiding the need for dialysis or a kidney transplant is highly desirable due to the adverse effects on quality of life, and the increased risk of cardiovascular disease.’
Richard Haynes, Professor of Renal Medicine and Clinical Trials at the Medical Research Council Population Health Research Unit at the University of Oxford, and co-Principal Investigator of EMPA-KIDNEY, added ‘The results of EMPA-KIDNEY not only confirm what has been seen in previous trials, but also demonstrate that the benefits extend to a much wider group of patients. We hope that the positive EMPA-KIDNEY results will be used to improve the treatment of a wide range of people with CKD across the world.’
The EMPA-KIDNEY trial was sponsored by Boehringer Ingelheim and funded by Boehringer Ingelheim and Eli Lilly and Company.