Dr Jennifer Green Discusses Positive Efficacy of Empagliflozin Among Patients With CKD in the EMPA-KIDNEY Trial

The results of EMPA-KIDNEY (NCT03594110) showed largely consistent efficacy and safety of empagliflozin in different patient subgroups with chronic kidney disease (CKD), including people across the range of estimated glomerular filtration rate (eGFR), those of both sexes, and around the world as well, said Jennifer Green, MD, professor of medicine at Duke University School of Medicine, member of Duke Clinical Research Institute, and EMPA-KIDNEY collaborator.

Transcript

Why was it important for EMPA-KIDNEY to include such a broad range of patients—those with and without diabetes and with different levels of CKD severity?

EMPA-KIDNEY enrolled a very, very large population of people with CKD, with and without diabetes, kidney disease from a variety of different causes, and really across the spectrum of eGFR and urine albumin to creatinine ratio levels. So, it helps to both strengthen and expand our understanding of the benefits of SGLT-2 [sodium-glucose cotransporter 2] inhibitor therapy across a very wide array of people with kidney disease.

Can you describe the findings for specific patient subgroups? Were the effects greater for some patients with certain clinical characteristics compared with others in EMPA-KIDNEY?

Reassuringly, the results of EMPA-KIDNEY, the effects on the primary outcome related to empagliflozin therapy were largely consistent across many key subgroups of interest. There were, in particular, significant reductions in the risk of the primary efficacy outcome in people across the range of eGFR, people of both sexes, and around the world, as well.

So, there was a suggestion that the relative reduction in risk of the primary outcome was greater in people with higher levels of albuminuria at baseline. And that may be for a variety of reasons, but it is very likely due to the very small number of primary outcome events that occurred in people with very low levels of albuminuria at baseline or even normal albuminuria.

So, that really limits the number of events that occur and the ability to detect a statistically significant reduction in risk during the trial. However, numerically, there were fewer events in the patients who received empagliflozin who were in that category. And of course, there was a clear benefit seen across all categories of eGFR, which would apply to all of the enrolled individuals.

Empagliflozin was previously granted fast track designation for CKD and is already approved for the treatment of type 2 diabetes and heart failure. What are the next steps now for empagliflozin for CKD?

Well, I would have to refer those questions to the company. However, the results of EMPA-KIDNEY in reducing the risk of progressive kidney disease and cardiovascular death is important enough that I think we can certainly, with confidence, implement these therapies now in at-risk individuals and certainly look forward to what future indications may hold.