Real-World Effectiveness and Safety of Finerenone in People With Type 2 Diabetes and Chronic Kidney Disease: A Spanish Multicentre Retrospective Observational Study (MEDFINE-RWD).

内容摘要

Although finerenone has shown efficacy in randomized trials, evidence from routine clinical practice remains limited. We aimed to assess the real-world effectiveness and safety of finerenone in people with type 2 diabetes (PWT2D) and chronic kidney disease (CKD), with a particular focus on residual cardiorenal risk as reflected by changes in urinary albumin-to-creatinine ratio (UACR). MEDFINE-RWD was a multicentre, retrospective study across eight Spanish centres, enrolling patients initiating finerenone (June 2024-December 2025). The primary endpoint was a &#x2265;&#x2009;30% reduction in UACR. Multivariable logistic regression identified response predictors. Secondary outcomes included safety (hyperkalaemia &#x2265;&#x2009;5.5&#x2009;mmol/L, major kidney [MAKE] and cardiovascular events [MACE]). Among 844 participants (median age 72&#x2009;years; median follow-up 184&#x2009;days; 76.8% male; baseline eGFR 49&#x2009;mL/min/1.73&#x2009;m2; UACR 285&#x2009;mg/g; 77.8% were at high/very high KDIGO risk), finerenone was associated with a 34.5% median UACR reduction at 6&#x2009;months (p&#x2009;<&#x2009;0.001), despite intensive SGLT2 inhibitors (88.4%) and GLP-1 receptor agonists (35.7%) use. The primary endpoint was achieved by 52.7%, consistently across background renoprotection or baseline KDIGO risk strata. Predictors of response were age&#x2009;&#x2265;&#x2009;70 (aOR 2.12), baseline UACR >&#x2009;245&#x2009;mg/g (aOR 1.94), and BMI >&#x2009;27&#x2009;kg/m2 (aOR 1.84), while insulin use was associated with lower response odds. Treatment persistence was 89.5%, with low incidences of hyperkalaemia (4.8%), MAKE (0.9%), and MACE (1.1%). In real-world practice, finerenone was associated with a substantial reduction in albuminuria. Finerenone demonstrated high persistence and a favourable safety profile, irrespective of baseline renoprotective regimens or KDIGO risk.