Abstract: SA-PO481
Interim Results from FINE-REAL: A Prospective Study Providing Insights into the Use of Finerenone in Routine Clinical Settings
Session Information
- Diabetic Kidney Disease: Clinical - II
November 04, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Diabetic Kidney Disease
- 702 Diabetic Kidney Disease: Clinical
Authors
- Nicholas, Susanne B., David Geffen School of Medicine at UCLA, Los Angeles, California, United States
- Correa-Rotter, Ricardo, Department of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutricion Salvador Zubiran, Ciudad de Mexico, Mexico
- Desai, Nihar, Section of Cardiovascular Medicine, Yale School of Medicine, Yale New Haven Hospital, New Haven, Connecticut, United States
- Guo, Lixin, Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Sciences, Beijing, China
- Navaneethan, Sankar D., Section of Nephrology, Baylor College of Medicine, Houston, Texas, United States
- Pantalone, Kevin M., Endocrinology and Metabolism Institute, Cleveland Clinic, Cleveland, Ohio, United States
- Wanner, Christoph, Department of Medicine, Division of Nephrology, University Hospital Würzburg, Würzburg, Germany
- Hamacher, Stefanie, ClinStat GmbH, Huerth, Germany
- Gay, Alain, Medical Affairs & Pharmacovigilance, Pharmaceuticals, Bayer AG, Berlin, Germany
- Wheeler, David C., Department of Renal Medicine, University College London, London, United Kingdom
Background
Finerenone is a selective, nonsteroidal mineralocorticoid receptor antagonist, which improved kidney and cardiovascular outcomes in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in phase 3 trials. Finerenone is approved in the European Union, US, China, and several other countries. FINE-REAL (NCT05348733) aims to provide insights on characteristics and treatment patterns of participants treated with finerenone in clinical practice.
Methods
FINE-REAL is a prospective, single-arm, non-interventional study of patients initiated on finerenone as part of their routine care in accordance with their country-approved label. The study, initiated in June 2022, is expected to be completed by January 2028.
Results
As of April 28, 2023, 574 participants have been enrolled. Baseline median UACR is 1,354 mg/g; however, UACR is unreported for 35% of participants (Table). Mean eGFR (mL/min/1.73 m2 ([SD]) is 53 (23). Uptake of agents acting on the RAAS and of statins is 52% and 24%, respectively. Adverse events have been reported in 72 (12.54%) participants. Hyperkalemia has been reported in 17 (2.96%) participants, with all instances recorded as asymptomatic and none requiring hospitalization. Updated results from a later cut-off date, June 13, 2023, will be presented at the congress.
Conclusion
UACR is not routinely measured in a large proportion of patients in the real-world setting. In general, the uptake of guideline-recommended therapies for CKD associated with T2D is low (RAAS inhibitors and statins). Advocacy for greater adherence to standard of care could improve patient outcomes.
| Baseline demographic and disease characteristics | Total N=574; data cut-off date April 28, 2023 | Baseline medications | Total N=574; data cut-off date April 28, 2023 |
| Age, years (standard deviation [SD]) | 66 (11) | Agents acting on the renin–angiotensin–aldosterone system (RAAS), n (%) | 299 (52) |
| Body mass index, kg/m2 (SD) | 33 (10) | Angiotensin-converting enzyme inhibitor (ACEi), n (%) | 99 (17) |
| Median urinary albumin-to-creatinine ratio (UACR), mg/g | 1,354 | Angiotensin receptor blocker (ARB), n (%) | 200 (35) |
| UACR >300 mg/g, n (%) | 135 (28) | ACEi + ARB, n (%) | 1 (<1) |
| UACR 30–300 mg/g, n (%) | 138 (28) | Insulin, n (%) | 199 (35) |
| UACR <30 mg/g, n (%) | 42 (9) | Sodium–glucose cotransporter 2 inhibitor, n (%) | 199 (35) |
| Individuals without evaluable UACR, n (%) | 171 (35) | Glucagon-like peptide-1 receptor agonist, n (%) | 150 (26) |
| Mean estimated glomerular filtration rate (eGFR), mL/min/1.73 m2 (SD) | 53 (23) | Dipeptidyl peptidase-4 inhibitor, n (%) | 34 (6) |
| eGFR ≥60 mL/min/1.73 m2, n (%) | 151 (31) | Statin, n (%) | 137 (24) |
| eGFR 30–59 mL/min/1.73 m2, n (%) | 273 (57) | Previous mineralocorticoid receptor antagonist, n (%) | 11 (2) |
| eGFR 15–29 mL/min/1.73 m2, n (%) | 58 (12) | ||
Funding
- Commercial Support – The study and this analysis were funded by Bayer AG, Leverkusen, Germany. Medical writing and/or editorial assistance was provided by Moamen Hammad, PhD, and Melissa Ward, BA, both of Scion, London, UK. This assistance was funded by Bayer AG, Wuppertal Germany according to Good Publication Practice guidelines.