BAYER AG This new subgroup analysis underscores the potential role of finerenone in both primary and secondary CV prevention in these patients.
The prespecified subgroup analysis of FIDELIO-DKD, presented as a late-breaker at the
Of the patients with a history of CVD, the composite CV outcome occurred in 231 (17.7%) patients in the finerenone group and 263 (20.2%) patients in the placebo group (incidence rate per 100 patient-years 7.18 and 8.5, respectively; HR 0.85 [95% CI, 0.71-1.02]).
Of the patients without a history of CVD, the composite CV outcome occurred in 136 (8.9%) patients in the finerenone group and 157 (10.2%) patients in the placebo group (incidence rate per 100 patient-years 3.43 and 3.92, respectively; HR 0.86 [95% CI, 0.68-1.08]).
'Patients with chronic kidney disease and type 2 diabetes are not only at high risk of progression to kidney failure, they are also exposed to a higher risk of cardiovascular events - and face substantial cardiovascular morbidity and mortality,' said
Results were consistent across subgroups of history of myocardial infarction, ischemic stroke, MI and/or ischemic stroke, coronary artery disease and peripheral artery disease. The overall incidence of treatment-emergent adverse events was similar between the finerenone and the placebo arm, irrespective of CVD history. Overall, finerenone was shown to be well-tolerated. The majority of adverse events were mild or moderate. The frequency of serious adverse events was lower in patients treated with finerenone (31.9%) compared to placebo (34.3%). Overall, hyperkalemia-related adverse events occurred more often in patients receiving finerenone compared with placebo (18.3% and 9%, respectively).
'Finerenone could potentially offer a streamlined approach to addressing cardiovascular risk across this vulnerable patient population,' said Dr.
The FIDELIO-DKD data were presented in October at the
About Finerenone
Finerenone (BAY 94-8862) is an investigational novel, non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that has been shown to block many of the harmful effects of mineralocorticoid receptor (MR) overactivation. MR overactivation is a major driver of kidney and cardiovascular damage through inflammatory and fibrotic processes.
The Phase III program with finerenone in CKD and T2D enrolled over 13,000 patients across a broad range of disease severity including those with early kidney damage and more advanced stages of kidney disease. It is the largest Phase III clinical trial program to date in CKD and T2D and comprises two studies, evaluating the effect of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes.
FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study that investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately 5,700 patients with CKD and T2D from more than 1,000 sites across 48 countries worldwide. Patients with a history of heart failure with reduced ejection fraction (NYHA II-IV) were excluded. Finerenone 10 mg or 20 mg orally once daily when added to standard of care, including blood glucose lowering therapies and a maximum tolerated dose of a RAS-blocking therapy such as an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), significantly reduced the combined risk of time to kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) 40% from baseline over a period of at least four weeks, or renal death by 18% (relative risk reduction; HR 0.82 [95% CI, 0.73-0.93; p=0.0014]) over a median duration of follow-up of 2.6 years. Finerenone also significantly reduced the risk of the key secondary endpoint, a composite of time to cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for heart failure compared to placebo by 14% (relative risk reduction, HR 0.86 [95% CI, 0.75-0.99; p=0.0339]) over a median duration of follow-up of 2.6 years.
FIGARO-DKD (FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease) is still ongoing and is investigating the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of cardiovascular morbidity and mortality in approximately 7,400 patients with CKD and T2D across 47 countries including sites in
Bayer also recently announced the initiation of the FINEARTS-HF study, a multicenter, randomized, double-blind, placebo-controlled Phase III study which will investigate finerenone compared to placebo in more than 5,500 symptomatic heart failure patients (
About Chronic Kidney Disease in Type 2 Diabetes
Chronic kidney disease (CKD) is a deadly condition that is underrecognized. CKD is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease. Approximately 40% of all patients with type 2 diabetes develop chronic kidney disease. Despite guideline-directed therapies, patients with CKD and T2D remain at high risk of CKD progression and cardiovascular events. It is estimated that CKD affects more than 160 million people with T2D worldwide. Chronic kidney disease in type 2 diabetes is the main cause of end stage kidney disease which requires dialysis or a kidney transplant to stay alive. MR over-activation is known to trigger detrimental processes (e.g. inflammation and fibrosis) in kidneys and heart in patients with CKD and type 2 diabetes (T2D).
About Bayer's Commitment in Cardiovascular and Kidney Diseases
Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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