FIDELITY: Cardiorenal benefits of finerenone, regardless of LVH status

Finerenone demonstrated cardiorenal benefits across the complete spectrum of patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), regardless of left ventricular hypertrophy (LVH) status at baseline. The data of the FIDELITY analysis suggest that patients with LVH may benefit more from the use of finerenone than patients without LVH concerning their risk of heart failure hospitalisation.

Finerenone is a novel, selective, non-steroidal mineralocorticoid receptor antagonist (MRA), which has demonstrated cardiovascular and renal benefits in patients with CKD and T2D in the FIDELIO-DKD (NCT02540993) and FIGARO-DKD trials (NCT02545049) [1,2]. The current FIDELITY analysis included 13,171 patients from both of these trials to assess the efficacy of finerenone on cardiovascular and renal outcomes across a broad spectrum of patients with CKD or T2D [3]. The primary analysis of FIDELITY displayed a 14% and 23% reduction in the risk of adverse cardiovascular outcomes and progression of CKD, respectively, in participants treated with finerenone compared with participants treated with placebo. The current analysis assessed the performance of finerenone according to LVH status, as LVH is a predictor of cardiovascular disease and frequently occurs in patients with CKD and T2D [4,5]. Prof. Gerasimos Filippatos (Attikon University Hospital, Greece) presented the findings of this analysis.

In total, 9.6% of the participants had LVH at baseline. Finerenone outperformed placebo in reducing the risk of cardiovascular adverse events, regardless of LVH status (LVH HR 0.72 vs non-LVH HR 0.89; P_interaction=0.108). Further analysis suggested that finerenone reduced the risk of heart failure hospitalisation particularly prominent in patients with LVH over patients without LVH (HR 0.34 vs HR 0.86; P_interaction=0.002). Furthermore, finerenone was associated with a reduced risk of adverse renal events compared with placebo, irrespective of LVH status (LVH HR 0.56 vs non-LVH HR 0.80; P_interaction=0.178). Finally, although the risk of hyperkalaemia was increased in participants on finerenone, regardless of LVH status, the number of discontinuations due to this adverse event was low (0.2%).

The benefits of finerenone with respect to cardiovascular and renal outcomes were observed across the spectrum of patients with CKD and T2D, regardless of baseline LVH.

1. Bakris GL, et al. N Engl J Med. 2020;383(23):2219–2229.
2. Pitt B, et al. N Engl J Med. 2021;385(24):2252–2263.
3. Filippatos G, et al. FIDELITY: Effect of finerenone by LVH subgroup. LBT Pharmacological treatment II, Heart Failure 2022, 21–24 May, Madrid, Spain.
4. Levy D, et al. N Engl J Med. 1990;322:1561–1566.
5. Dawson A, et al. Diabetologia 2005;48:1971–1979.

 

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Posted on 28 July 202217 May 2024