Outcomes With Finerenone by Baseline Treatment Goals in Type 2 Diabetes and Chronic Kidney Disease: A FIDELITY Analysis
Abstract
Aims: The American Diabetes Association recommends achieving treatment goals (glycated haemoglobin ≤ 53 mmol/mol [7.0%], blood pressure < 130/80 mmHg, low-density lipoprotein cholesterol < 1.81 mmol/L and use of sodium-glucose cotransporter-2 inhibitors or glucagon-like peptide-1 receptor agonists), to reduce cardiovascular and kidney complications in people with chronic kidney disease and type 2 diabetes. This exploratory study assessed whether treatment effects of finerenone versus placebo were modified by the number of treatment goals met at baseline.
Materials and methods: FIDELITY, a prespecified pooled analysis, combined participant-level data from the randomized, double-blind, multicentre phase III FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049) trials. Participants with type 2 diabetes and chronic kidney disease were randomized 1:1 to finerenone or placebo. Composite cardiovascular and kidney outcomes, hospitalization for heart failure or cardiovascular death, hospitalization for heart failure and treatment-emergent adverse events were assessed by subgroups based on the number of treatment goals achieved.
Results: At baseline, 29%, 40%, 24% and 7% of participants had met 0, 1, 2 and ≥ 3 treatment goals, respectively. Those with more treatment goals met had fewer composite cardiovascular outcomes (events per 100 patient-years in the placebo group: 6.0, 5.1, 4.3 and 3.5 for 0, 1, 2 and ≥ 3 treatment goals, respectively). Similar patterns were observed for other…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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