ECEESPE2025 Rapid Communications Rapid Communications 8: Diabetes and Insulin Part 2 (6 abstracts)
Efficacy and safety of finerenone in people with chronic kidney disease and type 2 diabetes by treatment goal attainment: A FIDELITY analysis
Joao Sergio Neves 1,2 , Ana Rita Leite 1,2 , Francisco Vasques-Nóvoa 1 , Bertram Pitt 3 , Gerasimos Filippatos 4 , Luis M. Ruilope 5,6,7 , peter rossing 8,9 , Stefan D. Anker 10 , Charlie Scott 11 , Andrea Lage 12 & João Pedro Ferreira 1
1RISE-Health, Faculty of Medicine of the University of Porto, Department of Surgery and Physiology, Porto, Portugal; 2ULS São João, Diabetes and Metabolism, Department of Endocrinology, Porto, Portugal; 3University of Michigan School of Medicine, Department of Medicine, Ann Arbor, United States; 4National and Kapodistrian University of Athens, School of Medicine, Attikon University Hospital, Department of Cardiology, Athens, Greece; 5Institute of Research imas12, Cardiorenal Translational Laboratory and Hypertension Unit, Madrid, Spain; 6Hospital Universitario 12 de Octubre, CIBER-CV, Madrid, Spain; 7European University of Madrid, Faculty of Sport Sciences, Madrid, Spain; 8University of Copenhagen, Department of Clinical Medicine, Copenhagen, Denmark; 9Steno Diabetes Center Copenhagen, Copenhagen, Denmark; 10Charité Universitätsmedizin, German Centre for Cardiovascular Research (DZHK) partner site Berlin, Department of Cardiology (CVK) of German Heart Center Charité, Berlin, Germany; 11Bayer Corporation, Clinical Statistics and Analytics, Texas, United States; 12Bayer SA, Cardiology and Nephrology Clinical Development, São Paulo, Brazil
JOINT142
Background: Finerenone significantly reduced cardiovascular and kidney risk versus placebo in patients with chronic kidney disease and type 2 diabetes in FIDELITY, a prespecified pooled analysis of the FIDELIO-DKD and FIGARO-DKD trials. Whether the benefits of finerenone on cardiovascular and kidney outcomes are observed independently of the number of American Diabetes Association-recommended treatment goals (HbA1c ≤7.0%, SBP <130 mmHg and DBP <80 mmHg, LDL cholesterol <70 mg/dl, and use of SGLT-2is or GLP-1RAs) achieved by patients at baseline remains to be determined.
Methods: Patients included in FIDELITY were on optimised RASi and were randomised 1:1 to finerenone or placebo. Composite cardiovascular (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for heart failure) and kidney (kidney failure, sustained ≥57% estimated glomerular filtration rate [eGFR] decrease from baseline over ≥4 weeks, or kidney-related death) outcomes, and treatment-emergent adverse events (TEAEs) were assessed according to the number of treatment goals achieved at baseline.
Results: At baseline, 29%, 40%, 24% and 7% of patients achieved 0, 1, 2 and ≥3 goals, respectively. Larger proportions of patients achieved a higher number of goals in Asia and Western Europe versus other regions. Median urine albumin-to-creatinine ratio and mean eGFR at baseline decreased with an increasing number of goals achieved. No significant heterogeneity in the effect of finerenone versus placebo on the composite cardiovascular or kidney outcomes was observed between treatment goal achievement subgroups (P interaction of 0.75 and 0.61, respectively; Table). The safety profile of finerenone (versus placebo) was generally similar across treatment goal attainment subgroups, although patients who achieved a higher number of treatment goals tended to have slightly higher TEAE rates.
| Treatment goals (n) | |||||
| 0 (n=3732) | 1 (n=5208) | 2 (n=3091) | ≥3 (n=959) | ||
| Composite cardiovascular outcome | |||||
| Incidence (n/N) | Finerenone | 295/1905 | 299/2534 | 182/1568 | 47/491 |
| Placebo | 307/1827 | 388/2674 | 194/1523 | 49/468 | |
| HR (95%CI) | 0.90 (0.76–1.05) | 0.79 (0.68–0.92) | 0.88 (0.72–1.08) | 0.89 (0.59–1.37) | |
| P interaction | 0.75 | ||||
| Composite kidney outcome | |||||
| Incidence (n/N) | Finerenone | 128/1905 | 144/2534 | 63/1568 | 21/491 |
| Placebo | 155/1827 | 202/2674 | 89/1523 | 19/468 | |
| HR (95%CI) | 0.77 (0.60–0.97) | 0.71 (0.57–0.88) | 0.70 (0.50–0.97) | 1.11 (0.56–2.18) | |
| P interaction | 0.61 | ||||
| CI, confidence interval; HR, hazard ratio. | |||||
Conclusion: Overall, the beneficial effect of finerenone on the composite cardiovascular and kidney outcomes was observed irrespective of the number of treatment goals achieved by patients at baseline.
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