Transcript
Welcome to DataPulse from ERA 2025. This activity, titled “The CONFIDENCE Trial: Data Insights” is provided by Medcon International.
Dr. Heerspink:
Hello, everyone. This is Hiddo Heerspink, affiliated with the University Medical Center Groningen in the Netherlands. I'm here at the European Renal Association meeting in Vienna, where we presented the results of the CONFIDENCE trial.
The CONFIDENCE trial tested the combined use of an SGLT2 inhibitor, empagliflozin, and a mineralocorticoid receptor antagonist, finerenone, in patients with type 2 diabetes and chronic kidney disease. We know already that SGLT2 inhibitors and finerenone protect the kidney. We don't know whether combined use of finerenone with an SGLT2 inhibitor can augment kidney protection and can also be safely initiated.
Therefore, we designed the CONFIDENCE trial, an active-controlled, randomized, clinical trial in patients with type 2 diabetes and chronic kidney disease who were randomized to empagliflozin, finerenone, and their combination. These patients were followed for 180 days, and we assessed the change in albuminuria as the primary endpoint.
At the end of the 180-day treatment period, we saw that empagliflozin and finerenone reduced albuminuria by about 30%. The combination reduced albuminuria by 53%, a significant larger reduction compared to either empagliflozin or finerenone.
The initiation of combined treatment was also safe. Hyperkalemia was reported by investigators in 30% of patients assigned to finerenone. Hyperkalemia was reported in 9% of patients who were assigned to combination treatment, and about 3% of patients who were randomized to empagliflozin. Orthostatic hypotension, acute kidney injury were rare adverse events.
So the trial demonstrated that combined initiation causes a significant reduction and clinically meaningful reduction in albuminuria of 53%, which should translate into long-term kidney protection. The combined initiation of finerenone and empagliflozin is also safe. So these results demonstrate now that you can initiate a combined use of empagliflozin and finerenone and that you don't have to necessarily sequence the 2 drugs.
If you are interested in the results of this trial, I recommend to read the publication, and the results are published in The New England Journal of Medicine.
Thank you very much for listening. This was Hiddo Heerspink from the European Renal Association meeting in Vienna.
Thank you for listening to this DataPulse from ERA 2025. This activity is provided by Medcon International Thank you for listening.