Simultaneous treatment start with Finerenone and SGLT-2-inhibitor demonstrated positive data in patients with CKD associated with type 2 diabetes: Bayer

The CONFIDENCE study showed that simultaneous initiation with finerenone and empagliflozin in patients with CKD associated with T2D led to an early and additive reduction in UACR from baseline of 52% at Day 180. This was a 29% and 32% greater relative reduction in UACR from baseline to Day 180 compared to finerenone alone and empagliflozin alone, respectively. Notably, a reduction of more than 30% in UACR was observed within 14 days of starting both treatments simultaneously – a threshold recommended by the American Diabetes Association (ADA) to slow kidney disease progression in patients with CKD*. Almost 3 out of 4 patients achieved this threshold of a 30% reduction in UACR versus baseline – 20% more than with either treatment alone. The safety profile of simultaneous initiation of finerenone and SGLT-2i was consistent with that of either agent alone, and treatment benefits were seen across all prespecified subgroups enrolled in the study, across a broad spectrum of patient populations with a high comorbidity burden.

“The CONFIDENCE study delivers clinical evidence that simultaneous initiation of finerenone and empagliflozin led to an early and additive reduction in UACR of 52% in patients with chronic kidney disease and type 2 diabetes, which was significantly greater than with either treatment alone,” said Rajiv Agarwal, MD, Professor Emeritus of Medicine, Indiana University School of Medicine and VA Medical Centre, Indianapolis, USA and Chair of the study’s Steering Committee. “Given that UACR is an important mediator of kidney and cardiovascular outcomes, these findings provide key insights to clinicians when considering how to optimize disease management, supporting the early combined use of finerenone and an SGLT-2 inhibitor for a positive impact on patient outcomes.”

Finerenone, a non-steroidal, selective mineralocorticoid receptor (MR) antagonist, has been investigated in a broad patient population with CKD (stages 1-4) associated with T2D across two completed and published Phase III studies, FIDELIO-DKD and FIGARO-DKD, which evaluated the effects of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes. Patients on background therapy with an SGLT2-inhibitor were allowed in those studies. Data from FIDELITY, a prespecified pooled analysis of these Phase III studies, confirm that early albuminuria (UACR) reduction in patients with CKD associated with T2D mediated a large proportion of the treatment effect of finerenone in slowing CKD progression.

“The CONFIDENCE data mark an important milestone in our mission to improve care for people living with chronic kidney disease associated with type 2 diabetes,” said Dr. Michael Devoy, Chief Medical Officer at Bayer’s Pharmaceuticals Division. “The findings suggest that a proactive simultaneous initiation can deliver a substantial early and additive UACR reduction, which is associated with kidney and cardiovascular protection. We are excited to share these important results with physicians, as they demonstrate that early combined use of finerenone and an SGLT2-inhibitor has the potential to improve long-term outcomes for millions of patients worldwide.”

Diabetes continues to be a substantial public health issue, with an estimated 462 million people globally affected by T2D alone. Approximately 40% of people with T2D go on to develop CKD, highlighting a significant unmet medical need for therapies that can better protect kidney function and slow disease progression.