Finerenone significantly reduces kidney and cardiovascular events in adults with chronic kidney disease and type 2 diabetes

On October 26, 2020, Finerenone's FIDELIO-DKD study, published during Kidney Week 2020 at the American Society of Nephrology, showed that the drug Finerenone delayed progression of chronic kidney disease in patients with chronic kidney disease and type 2 diabetes compared to placebo.
, Finerenone significantly reduced the risk of major compound endpoints by 18% (relative risk reduction, HR 0.82 (95% CI, 0.73-0.93; p-0.0014), the main composite endpoints include the occurrence of kidney failure, at least 4 weeks of continuous reduction of the estimated renal cystic filtration rate to less than 40% of the baseline level, or the time of death from kidney disease, the average follow-up time is 2.6 years.
is an under-recognized fatal disease, the most common complication of diabetics and an independent risk factor for cardiovascular disease.
about 40% of people with type 2 diabetes develop chronic kidney disease.
people with chronic kidney disease and type 2 diabetes are at high risk of chronic kidney disease progression and cardiovascular events, even if treated according to guidelines.
estimates that chronic kidney disease affects more than 160 million people with type 2 diabetes worldwide.
chronic kidney disease combined with type 2 diabetes is the main cause of end-stage kidney disease, patients need dialysis or kidney transplantation to survive.
FIDELIO-DKD study is the first large-scale study in patients with chronic kidney disease and type 2 diabetes to design the main compound endpoint as a result of kidney outcomes and positive results.
FIDELIO-DKD study is also part of the largest Phase III clinical project to date in patients with chronic kidney disease and type 2 diabetes, published in the New England Journal of Medicine. "Existing treatments focus on hemodynamics and metabolic path pathridges, but patients with chronic kidney disease and type 2 diabetes are still at risk of developing kidney disease after receiving these drugs, and the FIDELIO-DKD results provide an important and evidence-backed new treatment strategy for these patients," said lead researcher professor George L. Bakris of the
FIDELIO-DKD study.
overactivation of salt corticosteroids can lead to inflammation and fibrosis in the kidneys and heart, a promising target for new treatments.
new strategy needs to prevent further targeted organ damage and reduce the proportion of patients with reduced kidney function.
Finderenone results are highly consistent with this, showing that improved prognostic effects can be used in patients with limited options for current treatment options.
study showed that Finerenone reduced the risk of major endpoint events, that the results were basically the same across the preset subgroups, and that the therapeutic effect remained maintained throughout the study period.
Compared to placebos, Finerenone also significantly reduced the risk of critical secondary endpoints by 14% (relative risk reduction, HR 0.86 (95% CI, 0.75-0.99; p-0.039) in hospital compound events with cardiovascular death, non-fatal myocardial infarction, or heart failure over a 2.6-year period.
two groups of patients received standard treatment, including sugar-lowering therapy and maximum dose-resistant RAS blocking therapy, such as angiotrophic conversion enzyme (ACE) inhibitors or angiosin II recipient antagonists (ARBs). Dr. Joerg Moeller, Executive Committee Member and Director of Research and Development, Prescription Drug Division,
Bayer, said, "To protect such vulnerable patients, we should find ways to delay dialysis or kidney transplantation and reduce the risk of cardiovascular events in patients with high unsepped medical needs in the field of cardiovascular and kidney disease, and our goal is to help address these issues through research and development."
of renal function in patients with chronic kidney disease and type 2 diabetes, the FIDELIO-DKD study suggests that Finerenone may be a new potential treatment option for these patients.
we are pleased that Finerenone has reached an important research and development milestone, demonstrating that the drug plays a role as a key driver of progression of chronic kidney disease in people with type 2 diabetes.
Finerenone is well-to-do, consistent with the safety observed in previous studies.
two groups of general adverse events and severe adverse events were similar during treatment.
most adverse events are mild or moderate.
the finerenone group had a lower proportion of patients with severe adverse events (31.9%) than in the placebo group (34.3%); The proportion of patients with high potassiumemia-related adverse events in finerenone group was higher than that in the placebo group, at 18.3% and 9%, respectively, while the frequency of severe adverse events related to high potassiumemia was lower, at 1.6% and 0.4%, respectively, and the proportion of discontinued treatment due to high potassiumemia was 2.3% and 0.9%, respectively, and there were no deaths related to high potassiumemia in both groups.
Bayer plans to submit a listing permit application to national drug regulators for the treatment of people with chronic kidney disease and type 2 diabetes.
about Finerenone Finerenone (BAY 94-8862) is a research-in-study, new, nonsteroidal, selective salt corticosteroid-subject antagonist (MRA).
studies have shown that it protects against a variety of damage caused by overactivation of salt corticosteroids.
and fibrosis processes caused by overactivation of salt corticosteroids are important cause of kidney and cardiovascular damage.
Phase III clinical program for the treatment of chronic kidney disease and type 2 diabetes included more than 13,000 patients at critical stages of different diseases, from early kidney damage to late stages of kidney disease.
The project is by far the largest Phase III clinical study in the field of chronic kidney disease and type 2 diabetes, and includes two projects designed to evaluate the kidney and cardiovascular benefits of Finerenone compared to placebos on the basis of standard treatment.
FIDELIO-DKD is a randomized, double-blind, placebo-controlled, parallel control group, multi-center, event-driven Phase III clinical study designed to evaluate the effectiveness and safety of Finerenone in reducing kidney failure and preventing progression of kidney disease on a standard treatment basis compared to placebo.
study included approximately 5,700 people with chronic kidney disease and type 2 diabetes from more than 1,000 clinical centers in 48 countries around the world.
based on standard treatment, oral Finerenone 10 mg or 20 mg per day can significantly reduce the risk of kidney complexity by up to 18% (relative risk reduction, HR 0.82 (95% CI, 0.73-0.93; p-0.0014) ), including the ongoing reduction of the estimated cylindrology rate to less than 40% of the baseline level for at least 4 weeks, or the time of death from kidney disease.
standard treatments include sugar-lowering therapy and maximum dose-resistant RAS blocking therapy, such as angiotrophic conversion enzyme (ACE) inhibitors or angiosin II-ligand antagonists (ARBs).
study follow-up time was 2.6 years.
results for each of the major endpoints were as follows: kidney failure: HR 0.87, 95% CI≥ (0.72-1.05);
In addition, Finerenone significantly reduced the risk of cardiovascular critical secondary compound endpoints by up to 14% (relative risk reduction, HR 0.86 (95% CI, 0.75-0.99; p=0.0339), including cardiovascular death, non-fatal heart attack, non-fatal stroke, or hospitalization for heart failure.
average follow-up time was 2.6 years.
results for each sub-endpoint of the key secondary endpoints are as follows: cardiovascular death: HR 0.86, 95% CI (0.68-1.08); 1.09); Non-fatal stroke: 1.03, 95% CI (0.76-1.38); Hospitalization for heart failure: HR 0.86, CI 95% (0.68-1.08).
FIGARO-DKD study is currently under way to evaluate the effectiveness and safety of Finerenone in reducing cardiovascular morbidity and mortality compared to placebos on a standard treatment basis.
study included about 7,400 people with chronic kidney disease and type 2 diabetes from 47 countries, including Europe, Japan, China and the United States.
Bayer also recently announced the launch of the FINEARTS-HF study, a multi-center, randomized, double-blind, placebo-controlled Phase III clinical study that compared Finerenone to a placebo in more than 5,500 patients with left-cardiac blood test scores ≥40 percent of patients with symptomatic heart failure (New York Heart Association II-IV).
study was primarily aimed at verifying that Finerenone was superior to a placebo in terms of compound endpoints that reduced cardiovascular death and overall (first and relapse) heart failure events (defined as hospitalization or emergency hospitalization for heart failure).
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