Discussion
comorbid CV disease, CKD, normoalbuminuric, albuminuria
The principal findings of this analysis are as follows:1) As expected, there was a noteworthy difference between patients included into the combined RCTs and those seen and treated in clinical practice; in particular with respect to a higher age, more female patients being treated, the comorbid CV disease profile, the lower rate of albuminuria, and the rate of appropriate ACEi/ARB drug use, which was rather low in clinical practice.2) More specifically, based on the focus on CKD grade 1/2 to 4 with albuminuria in the RCTs, more than half of the patients with CKD in clinical practice (59.2%), namely normoalbuminuric patients, patients with severely impaired kidney function (eGFR < 25 ml/min/1.73m3) Many of the patients in clinical practice with CKD (56.5%) were not pre-treated with ACEi or ARBs, although guidelines clearly recommend such treatment. For the RCTs, a run-in phase was conducted to adjust all patients to the individually highest tolerated in-label dose of ACEi or ARB. At baseline, all RCT-patients were treated with either an ACEi or an ARB. Therefore, the registry patients without RAS-inhibition were not covered by the RCTs. The application of the full set of inclusion and exclusion criteria to patients actually receiving ACEi/ARBs at baseline left 43.5% of patients that would have been included in the finerenone RCTs. Patients that would have been excluded from the RCTs were more often female, had lower eGFR values, lower rates of albuminuria and received less metformin/less SGLT2-inhibitors than RCT-eligible patients.4) As a side-result, there was a clear undertreatment of CKD patients in clinical practice compared to the guideline recommendations.