Exclusion of patients based on further trial specific criteria
proteinuria, CKD, albuminuria
The application of the full set of inclusion and exclusion criteria to patients actually receiving ACEi/ARBs at baseline left 43.5% of patients who would have been included in the finerenone RCTs. While the selection criteria ensure guideline-consistency, comparability of patients and patients’ safety in the clinical trials, they also exclude many patients that need further treatment in clinical practice. Patients that would have been excluded from the RCTs were slightly older, more often female, had lower eGFR values, substantially lower rates of albuminuria and received less SGLT2-inhibitors than eligible patients. As older people with CKD are also less likely to have albuminuria than younger people [Moreover, we observed and increased cardiovascular and renal risk in the registry population eligible for the clinical trials than in patients not eligible. This was based on a variety of specific risk factors such as systolic blood pressure values, non-HDL cholesterol levels and smoking. Also, the level of proteinuria was, as already outlined above, increased in RCT eligible patients.The pattern of CV and diabetes-related drug therapy differed substantially between the finerenone RCTs and clinical practice, mainly based on the undertreatment with RAS blockers of the registry patients. However, if patients not treated with RAS blockers are excluded from the comparison, treatment patterns did not differ much. Furthermore, there was an apparent undertreatment with SGLT-2i and GLP-1RA despite the available evidence to support their use. It was higher though in the RCT eligible registry patients than in the clinical trials: GLP-1RA 9.7% vs. 7.2% and SGLT-2i 12.4% vs. 6.7%. Several potential factors may contribute to the low prescription rate, including prescriber hesitancy, treatment inertia and increased drug costs [