Impact of the trial‘s additional inclusion and exclusion criteria on patient selection
CKD
Considering the RCT’s requirement for baseline treatment with either ACEi or ARBs, the number of patients for analysis was reduced from 65,168 to 28,359. Overall, 56.5% of the registry patients were not treated with a RAS inhibitor although this is recommended by guidelines and, therefore, needs to be fulfilled by regulatory requirements during clinical trials. As this excluded patients based on clinical practice-specific decisions (e.g., prescription of RAS blockers) rather than on trial determined criteria, we further analyzed 28,359 of the 65,168 patients (43.5%) with ACEi/ARB pre-treatment to assess how all inclusion and exclusion criteria combined affected the representativeness of the trials for patients in clinical practice (Table The RCT-eligible patients were more often male (57.2 vs. 49.1%; p < 0.0001), had higher eGFR values (mean 60.1 vs. 48.6 mL/min/1.73 mTo explore further potential differences in the risk profile between those eligible and non-eligible for the clinical trials, we computed the risk for cardiovascular mortality and progressive CKD as to Levey et al. [