TOPLINE:

Among patients with type 2 diabetes (T2D) and chronic kidney disease (CKD), those who met more American Diabetes Association (ADA)-recommended treatment goals at baseline had a lower risk for adverse cardiovascular (CV) and kidney events. Finerenone reduced these risks compared with placebo, regardless of the number of treatment goals met at baseline.

METHODOLOGY:

• Researchers conducted FIDELITY, a pooled analysis of two randomised phase 3 trials, to assess whether the effect of finerenone varied by the number of ADA-recommended treatment goals achieved at baseline in patients with T2D and CKD.
• A total of 12,990 patients had received oral finerenone (10 or 20 mg once daily) or placebo, on top of maximum tolerated renin-angiotensin system blockade.
• Patients were grouped on the basis of how many ADA-recommended treatment goals they had met at baseline: none (n = 3732; mean age, 63.9 years; 62.4% men), one (n = 5208; mean age, 64.8 years; 70.9% men), two (n = 3091; mean age, 65.6 years; 74% men), and three or more (n = 959; mean age, 65.5 years; 78.1% men).
• Treatment goals used in the analysis were A1c levels ≤ 53 mmol/mol, blood pressure < 130/80 mm Hg, low-density lipoprotein cholesterol levels < 1.81 mmol/L, and the use of SGLT2 inhibitors or GLP-1 receptor agonists.
• Efficacy outcomes were a composite CV outcome (time to CV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalisation for heart failure [HHF]), a composite of HHF or CV death, HHF alone, and a composite kidney outcome (time to kidney failure, sustained at least a 57% decrease in the estimated glomerular filtration rate from baseline over at least 4 weeks, or kidney-related death).

TAKEAWAY:

• In the placebo group, patients who met more goals at baseline had lower rates of composite CV events (6.0, 5.1, 4.3, and 3.5 events per 100 patient-years for those who met no, one, two, and three or more goals, respectively). Similar patterns were seen for other outcomes, and comparable trends were observed for those in the finerenone group.
• Finerenone reduced the risk for a composite CV outcome by 14% compared with placebo overall (hazard ratio [HR], 0.86; 95% CI, 0.78-0.95), with no significant heterogeneity noted among patients who had met no, one, two, and three or more goals at baseline (P for interaction = .75).
• Finerenone reduced the risk for a composite kidney outcome by 24% compared with placebo overall (HR, 0.76; 95% CI, 0.66-0.88), with no significant heterogeneity observed among the groups (P for interaction = .61).
• The safety profile of finerenone vs placebo was similar across the subgroups.

IN PRACTICE:

"The present results suggest that finerenone should be used regardless of the number of treatment goals that have been met. This implies that for people with an indication for finerenone, treatment should not be delayed until risk factors are controlled," the authors wrote.

SOURCE:

This study was led by João Sérgio Neves, Faculty of Medicine of the University of Porto, Porto, Portugal. It was published online on April 24, 2026, in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The current analysis was not prespecified and should be interpreted as exploratory. The randomisation was not stratified by the number of treatment goals met at baseline. Only 7.4% of patients had met three or more treatment goals at baseline, resulting in fewer events in this subgroup and wider CIs. Goal attainment was assessed only at baseline, and changes were not captured during follow-up.

DISCLOSURES:

This study was funded by Bayer AG. Three authors reported being full-time employees of Bayer. Several other authors reported receiving consulting or speaker fees, honoraria, and grants; holding stock or stock options; and having other relationships with multiple pharmaceutical companies, including Bayer AG.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.