An analysis of DPV and DIVE registry patients with chronic kidney disease according to the finerenone phase III clinical trial selection criteria
Authors' conclusion
Certain patient subgroups, especially non-albuminuric CKD-patients, were not included in the RCTs. Although recommended by guidelines, there was an undertreatment of CKD-patients with renin-angiotensin system (RAS) blockers. Further research into patients with normoalbuminuric CKD and a wider prescription of RAS blocking agents for CKD patients in clinical practice appears warranted.
Study context
- Population
- German patients aged ≥18 years with T2D and chronic kidney disease (CKD) (eGFR <60 mL/min/1.73 m², or eGFR ≥60 mL/min/1.73m2 with albuminuria ≥30 mg/g), DPV/DIVE registries
- Participants
- 65,168 patients
- Exposure
- Registry patients vs FIDELIO-DKD/FIGARO-DKD RCT populations
- Outcome
- Coverage of registry patients by finerenone RCT criteria
Methodological detailsapplication of RCT inclusion and exclusion criteria to registry patients
- Application of RCT inclusion and exclusion criteria to registry patients
Main finding
As reported in the abstract
- Normoalbuminuric registry patients not covered by randomized clinical trials (RCTs)
- 28,147 (43.2%)
- Albuminuric patients with eGFR <25 not covered
- 4,519 (6.9%)
- Microalbuminuria with normal GFR (≥90 ml/min) not covered
- 6,565 (10.1%)
- Comparable registry patients after requiring baseline ACEi or ARB
- 28,359
- Registry patients fulfilling all trial inclusion and exclusion criteria
- 12,322 (43.5%)
Observational data: associations, not effects.
Further findings
Registry vs RCT patient characteristics
- Registry patients older, less often male, lower eGFR, more often normoalbuminuric vs RCTs
- CVD burden higher in RCTs; diabetic neuropathy, lipid metabolism disorders and peripheral arterial disease more frequent in registry
- ACEi and ARBs used less often in clinical practice
Eligible vs non-eligible registry patients
- Eligible patients more often male, higher eGFR, more albuminuria, more metformin and SGLT2 inhibitor use
Original publication
An analysis of DPV and DIVE registry patients with chronic kidney disease according to the finerenone phase III clinical trial selection criteria. Cardiovasc Diabetol. Published 8 May 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →