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A prespecified analysis of FIDELITY details the effects of finerenone against placebo therapy for reducing the risk of cardiovascular events based on history of ASCVD among patients with type 2 diabetes and chronic kidney disease.
A prespecified analysis of the FIDELITY program presented at the American College of Cardiology’s 71st Annual Scientific Sessions suggests the effects of finerenone (Kerendia) on reducing the risk of adverse cardiovascular and kidney events was consistent regardless of whether or not patients had a history of atherosclerotic cardiovascular disease (ASCVD).
With ASCVD placing patients with diabetes at a greater risk of adverse outcomes, results of the respecified analysis provide clinically applicable insight into the magnitude of effect seen with finerenone based on presence of ASCVD among patients with type 2 diabetes and chronic kidney disease.
“In patients with chronic kidney disease associated with type 2 diabetes, cardiovascular complications are among the most frequent causes of death. However, there is limited data on how the risk of cardiovascular events could be reduced in these patients,” said Javed Butler, MD, MPH, MBA, president of the Baylor Scott & White Research Institute and senior vice president for Baylor Scott & White Health, and distinguished professor of medicine at the University of Mississippi, in a press release from Bayer.
Combining data from the FIGARO-DKD and FIDELIO-DKD analyses, FIDELITY represents efforts to pool data from both studies to learn more about the effects of finerenone, including the consistency of benefit across different subgroups of patients. At ACC.22, Gerasimos Filippatos, MD, presented data from a FIDELITY analysis assessing impact of baseline ASCVD on cardiorenal outcomes among patients within both trials using finerenone. Primary analyses of FIDELITY indicated use of finerenone reduced risk of a composite cardiovascular outcome, which included cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure, by 14% and risk of chronic kidney disease progression by 23% (HR, 0.77 [95% CI, 0.67-0.88]) when compared against placebo therapy.
Of the more than 13,000 patients enrolled in FIDELIO-DKD and FIGARO-DKD, 5935 had a history of ASCVD and 7091 had no history of ASCVD. When comparing baseline characteristics of these patient subgroups, investigators pointed out patients with ASCVD had a lower eGFR and UACR than those without, but blood pressure and HbA1c were well-controlled in both groups. Investigators also pointed out patients with ASCVD were more likely to be prescribed beta-blockers, statins, and insulin than their counterparts without ASCVD.
Upon analysis, results indicated patients with a history of ASCVD were at a 2-fold increase in risk of a composite cardiovascular outcome that included time to cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalizations for heart failure compared to those without a history of ASCVD (HR, 2.09 [95% CI, 1.89-2.30]). When assessing the effects of finerenone, use was associated with a 17% (HR, 0.83 [95% CI, 0.74-0.94]) reduction in risk of the composite cardiovascular outcome among those with a history of ASCVD and a 9% (HR, 0.91 [95% CI, 0.78-1.06]) reduction in risk among those without a history of ASCVD when compared against placebo therapy. Analysis of treatment-emergent adverse events indicated the safety profile of finerenone was similar between patients with and without a history of ASCVD.
“In general, overall, the data presented today indicate that finerenone may be used for both primary and secondary cardiovascular disease prevention in these groups of patients with type 2 diabetes and chronic kidney disease as well as protection from worsening kidney disease,” Filippatos said, at the conclusion of his presentation.
This study, “Finerenone and Cardiorenal Outcomes by History of Cardiovascular Disease in Patients with Type 2 Diabetes and Chronic Kidney Disease: Fidelity Analyses,” was presented at ACC.22.