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CKD News Digest

October 27, 2022 – The Kidney Disease: Improving Global Outcomes (KDIGO) and the American Diabetes Association (ADA) released a joint recommendation on the management of diabetes in patients with chronic kidney disease. Based on the updated evidence, recommendations include comprehensive care including the utilization of pharmacotherapy that has been shown to decrease cardiovascular and renal adverse events, in addition to optimizing lifestyle. Such therapies, such as SGLT-2 inhibitors, RAS blockade, GLP-1 RAs and finerenone are now part of the holistic approach to improve outcomes in patients with diabetes and CKD. Additionally, other life-saving therapies such as moderate-or high-intensity statins, antiplalet agents, and newer lipid-lowering therapies also form part of this approach.

You can read the full consensus statement here.

August 29, 2022 – An additional analysis from the FIDELITY study was presented at the 2022 European Society of Cardiology (ESC) meeting. The mortality analysis from FIDELITY showed that finerenone did not reduce the risk of all-cause mortality in patients with T2DM and CKD, but it lowered the likelihood of sudden cardiac death, and the effect of finerenone on all-cause mortality, cardiovascular mortality, and sudden cardiac death was consistent despite eGFR or UACR at baseline, but seemingly more pronounced in patients with a higher baseline eGFR.  During the presentation of this data, Gerasimos Filippatos, MD, one of the authors of the study suggested that this data indicate the need for an earlier initiation of finerenone to maximize its cardiorenal benefits in this setting.

More information on this study can be found here.

June 5, 2022 – A study presented at the 2022 American Diabetes Association (ADA) Scientific Sessions by Dr. Janet McGill showed that the cardiorenal benefits of finerenone were independent of baseline HbA1c, HbA1c variability, or duration of diabetes. The study authors found that HbA1c variability was associated with increased risk of cardiorenal outcomes, and patients with higher baseline HbA1c had longer diabetes duration and more diabetes-related complications. A total of 13,026 patients were included in the analysis, with a mean baseline HbA1c of 7.7% and mean diabetes duration of 15.4 years.

The full results of this study can be accessed here.

March 2, 2022 – A study presented at the 2022 International Society of Nephrology meeting suggested a potential additive benefit from the concomitant use of finerenone and a sodium-glucose cotransporter 2 (SGLT2) inhibitor in patients with type 2 diabetes and chronic kidney disease. This data comes from a sub-analysis of the FIDELITY analysis, which combined the data from the FIDELIO-DKD and FIGARO-DKD trials. In these trials, 877 patients (6.7%) received an SGLT-2 inhibitor at baseline, and the preliminary analysis suggest an additive benefit from this approach in both the reduction of albuminuria as well as the primary composite outcomes of cardiovascular and renal benefits. The increased benefits with this dual approach can be explained by the fact that finerenone and SGLT-2 inhibitors have different mechanisms of action, however, the authors stressed that this was not a trial of finerenone and SGLT-2i combination therapy, and the efficacy and safety of this combination will be determined in future trials and analysis.

Click here to read the full publication of the FIDELITY analysis.

January 1, 2022 – Based on the data from the FIGARO-DKD and FIDELIO-DKD trials, and subsequent FDA approval in 2021, the 2022 American Diabetes Association Standards of Care recently recommended treatment with finerenone to reduce the risk of CKD progression and cardiovascular events in patients at an increased risk of events or if unable to use an SGLT-2 inhibitor. This language potentially suggests an important role for finerenone and how it would fit in with SGLT-2 inhibitors, a role that now is beginning to be clearer, since both agents seem to have additive effects, also based on the data cited above.  Furthermore, inclusion of finerenone in other guidelines (cardiovascular or renal) is also expected in the near future. 

For more info on updated ADA Standards of Care, click here.

November 13, 2021 – An analysis from the FIGARO-DKD trial showed that finerenone reduced the incidence of heart failure in patients with DKD, as well as improved other heart failure outcomes, such as first or subsequent hospitalizations for heart failure. What was more striking is that the FIGARO-DKD did not enroll patients with symptomatic heart failure at baseline, suggesting a benefit of finerenone in patients at high-risk for developing HF, such as those with type 2 diabetes and CKD.

The full results of this study can be viewed here.

September 28, 2021 – A subgroup analysis from the FIDELIO-DKD trial showed that the effects on finerenone on kidney and cardiovascular outcomes are consistent in patients with DKD regardless of GLP-1 RA use. In this trial, 6.9% of participants (394 patients out of the total 5674 analyzed) received a GLP-1 RA at baseline. In addition, finerenone reduced urine albumin-to-creatinine ratio (UACR) regardless of baseline GLP-1 RA use. The analysis suggests that finerenone and GLP-1 RAs can be administered simultaneously in DKD patients, however, the small subgroup of patients receiving a GLP-1 RA limits the extrapolation of these results to patient care.

Click Here for more information »

August 28, 2021 – FIGARO-DKD trial was presented at ESC congress 2021. This trial investigated the impact of finerenone treatment on cardiovascular and renal outcomes in patients with CKD and type 2 diabetes, treated with optimized RAS blockade, and well-controlled blood pressure and diabetes. The results have shown that finerenone reduces the risk of cardiovascular morbidity and mortality in patients with T2DM and CKD.

For more information »

August 28, 2021 – At ESC 2021, results from FIDELITY, a prespecified meta-analysis combining individual patient data from FIDELIO-DKD and FIGARO-DKD, were presented. It was demonstrated that finerenone is an effective treatment option for cardiovascular (CV) and renal protection in patients with mild-to-severe CKD and type 2 diabetes. The CV benefits were uniform across eGFR and UACR categories, indicating the need to initiate this treatment in the early stages of kidney disease.

For more information »
July 9, 2021 – The efficacy of finerenone in improving renal and cardiovascular outcomes in patients with diabetic kidney disease was established in the landmark FIDELIO-DKD trial, with more potential cardiovascular benefits to be announced from the FIGARO-DKD trial, which will be presented at ESC at the end of August. One of the key questions for clinicians is how to integrate this new therapy with existing agents that have carved an important place in treating type 2 diabetes patients with concomitant CKD, HF, or ASCVD, such as GLP-1 RAs and SGLT-2 inhibitors. An important answer to this question came out of two sub-analyses of the FIDELIO-DKD trial presented at the 2021 ADA Scientific Sessions, which showed that the benefits of finerenone were consistent regardless of background use of GLP-1 RAs or SGLT-2i, suggesting that finerenone can be used simultaneously with either agent when indicated. Of note, hyperkalemia events were lower with SGLT-2i vs. no SGLT-2i, and there was a potential additive benefit for urine albumin-to-creatinine ratio (UACR) reduction with the addition of a GLP-1 RA.

More info on the GLP-1 abstract can be found here »

More info on the SGLT-2i abstract can be found here »

July 9, 2021 – The FDA announced that finerenone is now approved to reduce the risk of sustained eGFR decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in patients with chronic kidney disease and type 2 diabetes. This is the first non-steroidal mineralocorticoid receptor antagonist (MRA) approved for this indication, with the approval based on the results of the phase 3 FIDELIO-DKD trial, which showed efficacy in both cardiovascular and renal endpoints.

More information is available in the FDA press release here

The full prescribing label for finerenone can be found here

May 18, 2021 – A secondary analysis of the FIDELIO-DKD trial presented at the 2021 American College of Cardiology (ACC) virtual scientific sessions, showed that finerenone reduce the risk of new-onset atrial fibrillation (AF) in patients with DKD. New-onset AFF (atrial fibrillation or atrial flutter) occurred in 82 (3.2%) patients on finerenone and 117 (4.5%) on placebo (hazard ratio: 0.71; 95% confidence interval: 0.53 to 0.94; p = 0.016). The authors mentioned that although this was only an exploratory analysis, it suggests potential beneficial effects of finerenone on AF, which continues to be a growing concern in patients with heart failure, type 2 diabetes, and chronic kidney disease. However, results should be interpreted with caution and additional studies in this area are needed, much of which will be answered by ongoing trials with finerenone.

The full results of this study can be accessed here.

May 12, 2021 – The manufacturer announced that finerenone met its primary outcome (composite of cardiovascular death and non-fatal CV events, including myocardial infarction, stroke, or hospitalization for heart failure) in the recently-completed FIGARO-DKD trial. The full results of this study are expected to be presented at a major meeting later this year.
January 13, 2021 – The FDA recently accepted a Priority Review for the New Drug Application (NDA) for finerenone for the treatment of chronic kidney disease (CKD) in patients with type 2 diabetes. The NDA submission is based on the results of the FIDELIO-DKD trial, which were published in late 2020 and showed that finerenone decreased the risk of CKD progression and adverse CVD events in this patient population. The priority designation means that the FDA will make a decision on the application within 6 months, as opposed to the 10 months under the standard review process.

December 3, 2020 – Results from the FIDELIO-DKD with finerenone were published in the New England Journal of Medicine. During this trial, which enrolled patients with advanced CKD and T2D, treatment with finerenone reduced the risk of CKD progression (defined as the composite of kidney failure, sustained ≥40% decrease in eGFR from baseline, or renal death) compared to placebo. All patients across groups were treated with optimized renin-angiotensin-aldosterone system (RAAS) inhibitors, and finerenone demonstrated to reduce the risk of DKD progression by an additional 18% over optimal RAAS inhibitor therapy. Additionally, finerenone reduced the risk for adverse cardiovascular events (composite of CV death, non-fatal MI, non-fatal stroke, or hospitalization for heart failure) by an additional 14% in a key secondary outcome of the study

The full prescribing label for finerenone can be found here

November 16, 2020 – An analysis on the effects of finerenone on the individual components of CVD in the FIDELIO-DKD trial was presented at the 2020 American Heart Association Scientific Sessions, and subsequently published in Circulation. The full results of the FIDELIO-DKD trial showed that finerenone decreased the risk of CKD progression and adverse cardiovascular events, and this publication showed that the cardiovascular benefits with finerenone were consistent in patients with or without a history of cardiovascular disease at baseline, suggesting that it can be potentially be used for both primary and secondary cardiovascular prevention in patients with DKD. Patients with finerenone had a lower incidence of the individual CVD components compared to placebo, including CV death, non-fatal MI, and hospitalization for heart failure, however, there was no difference in stroke events between groups.

The full prescribing label for finerenone can be found here

Expert Highlights and Perspectives
Rajiv Agarwal, MD

Interpreting New Evidence with Novel Non-Steroidal MRA's for Cardiorenal Risk Reduction

Rajiv Agarwal,
MD

George L. Bakris,
MD

Bertram Pitt,
MD

Watch the experts share some highlights including:

New and ongoing studies with novel non-steroidal MRAs in addressing cardiorenal risk, including in patients with heart failure and in those with non-diabetic kidney disease. 

Janet B. McGill, MD

Interview #1

Evaluating the Risk For DKD Progression

Janet McGill,
MD

George L. Bakris,
MD

Watch the experts share some highlights including:

  • Early recognition and screening for DKD
  • Monitoring kidney function
  • Risk factors for DKD progression
Rajiv Agarwal, MD
Interview #2

The Rationale For Non-Steroidal MRAS In DKD

Rajiv Agarwal,
MD

George L. Bakris,
MD

Watch the experts share some highlights including:

  • Differentiating between steroidal and non-steroidal MRAs
  • Adverse events and limitations with steroidal MRAs in DKD
  • Advantages of finerenone in DKD
  • The overview of kidney results of the FIDELIO trial
Rajiv Agarwal, MD

Interview #3

The Cardiovascular Benefits of Finerenone

Rajiv Agarwal,
MD

George L. Bakris,
MD

Watch the experts share some highlights including:

  • The interplay between the kidney and heart
  • CVD benefits of finerenone: analysis from the FIDELIO trial and ongoing CVD studies with finere none
  • How does finerenone fit within the context of SGLT-2is

Interview #4

Finerenone: Putting the Data Into Context

George L. Bakris,
MD

Watch the experts share some highlights including:

  • Finerenone in the context of existing treatments
  • Clinical pearls for incorporating finerenone to the DKD treatment armamentarium in the near future
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