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What are the medications for diabetic nephropathy?

What are the medications for diabetic nephropathy

Kerendia (fenelidone) to treat chronic kidney disease (CKD)

Diabetic Kidney Disease (DKD) is a type of chronic kidney disease (CKD) caused by diabetes. It is typically diagnosed clinically based on elevated urinary albumin levels and/or a decline in the estimated glomerular filtration rate (eGFR), while other causes of CKD are ruled out. The clinical features of DKD include gradually increasing proteinuria, progressive decline in kidney function, and, in advanced stages, severe renal failure. DKD has become the leading cause of CKD, surpassing primary glomerular diseases, and is a major contributor to end-stage renal disease (ESRD) in developed countries.

The clinical diagnosis of DKD is made based on persistent elevation of urine albumin-to-creatinine ratio (UACR) (preferably determined through random urine testing) and/or a decrease in eGFR, while other causes of CKD are excluded. After a confirmed diagnosis, the severity of CKD should be further assessed based on eGFR. The Kidney Disease: Improving Global Outcomes (KDIGO) guidelines recommend evaluating the risk of DKD progression and the frequency of follow-up assessments based on both CKD staging and albuminuria staging. For example, if a diabetic patient has an eGFR of 70 ml/min/1.73m^2 and a UACR of 80 mg/g, they would be classified as having Diabetic Kidney Disease G2A2, with a medium risk of CKD progression, and they should be reevaluated annually.

The treatment strategies for DKD include medication, lifestyle modifications, dietary adjustments, proteinuria control, and intensified glycemic control. Additionally, it is important to manage blood pressure, correct lipid disorders, and improve traditional cardiovascular risk factors. Proper glycemic control can delay the onset and progression of kidney function decline in diabetic patients.

The U.S. Food and Drug Administration (FDA) has approved the company’s “first-in-class” therapy, Kerendia (finerenone) is one of medications for diabetic nephropathy, for the treatment of type 2 diabetes with chronic kidney disease (CKD). It can reduce the risk of kidney failure, slow the decline in estimated glomerular filtration rate (eGFR), and lower the risk of cardiovascular death, non-fatal myocardial infarction, and hospitalization due to heart failure.

Kerendia (finerenone) is a third-generation, highly selective, non-steroidal mineralocorticoid receptor antagonist (MRA). It has higher specificity and affinity for the mineralocorticoid receptor compared to first and second-generation MRAs, allowing it to selectively bind to the mineralocorticoid receptor. Clinical trials (ARTS) have shown that finerenone can reduce urinary albumin in CKD patients, and it has a lower risk of hyperkalemia compared to spironolactone.

In a randomized, multicenter, double-blind study, researchers compared the efficacy of finerenone tablets to a placebo in 5,674 CKD patients. Specifically, with a median follow-up of 2.6 years, compared to the placebo, finerenone significantly reduced the composite risk of first occurrence of kidney failure, a sustained decrease in estimated glomerular filtration rate (eGFR) of ≥40% from baseline for at least 4 weeks, and kidney-related death by 18% (HR=0.82; 95% CI: 0.73-0.93; p=0.0014). In pre-specified subgroups, the impact of finerenone on the primary outcome was broadly consistent, and the treatment effect remained consistent throughout the study period.

FIDELIO⁃DKD Phase III Clinical Trial Main Results

Furthermore, with a median follow-up of 2.6 years, compared to the placebo, finerenone also significantly reduced the risk of key secondary endpoints. It lowered the composite risk of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization due to heart failure by 14% (relative risk reduction, HR=0.86 [95% CI: 0.75-0.99; p=0.0339]).

FIDELIO⁃DKD Phase III Clinical Trial Key Secondary Results

The prevention and treatment of Diabetic Kidney Disease (DKD) primarily focus on strict control of blood sugar and blood pressure. Widely accepted medications with renal protective effects include RAAS inhibitors such as ACEIs/ARBs. However, despite the use of these treatment approaches, the progression of DKD cannot always be entirely avoided, highlighting the need for new therapeutic methods.

Three classes of novel antidiabetic drugs are believed to have renal protective effects independent of their glucose-lowering actions. These include SGLT2 inhibitors, GLP-1 receptor agonists, and DPP-4 inhibitors. Multiple studies have shown that SGLT2 inhibitors can reduce urinary protein levels in DKD patients and can delay the progression of type 2 diabetic kidney disease (T2DKD).

In the field of new drug research for diabetic kidney disease, SER150 by Serodus is in the clinical phase 2/3 and is approaching the market stage. Most other drugs, such as dagaglitazar, CSL346, and MEDI 3506, are in clinical phase 2.

New medicine for treating diabetic nephropathy – LUCIFINE finerenone tablets

LUCIFINE Finerenone Tablets Is a non-steroidal mineralocorticoid receptor antagonist (MRA) indicated to reduce the risk of sustained eGFR decline end stage kidney disease, cardiovascular death non-fatal myocardial infarction, and hospitalization for hear failure in adult patients with chronic kidney disease(CKD) associated with type 2 diabetes T2D)

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of a drug and may not reflect the rates observed in practice.

The safety of LUCIFINE was evaluated in 2 randomized, double-blind, placebo-controlled, multicenter pivotal phase 3 studies, FIDELIO-DKD and FIGARO-DKDin which a total of 6510 patients were treated with 10 or 20 mg once daily over a mean duration of 2.2 and 2.9 years, respectively.

Overall, serious adverse events occurred in 32% of patients receiving LUCIFINE and in 34% of patients receiving placebo in the FIDELIO-DKD study: the findings were similar in the FIGARODKD study. Permanent discontinuations due to adverse events also occurred in a similar proportion of patients in the two studies (6-7% of patients receiving LUCIFINE and in 5-6% of patients receiving placebo).

The most frequently reported (≥10%)adverse reaction in both studies was hyperkalemia [see Warnings and Precautions(5.1)]. Hospitalization due to Hyperkalemia for the LUCIFINE was 0.9% vs 0.2% in the placebo group across both studies. Hyperkalemia led to permanent discontinuation of treatment in 1.7% receiving LUCIFINE versus 0.6% of patients receiving placebo across both studies.

LUCIFINE is a CYP3A4 substrate. Concomitant use with a strong CYP3A4 inhibitor increases Finerenone exposure, which may increase the risk of LUCIFINE adverse reactions. Concomitant Use of LUCIFINE with strong CYP3A4 inhibitors is contraindicated see Contraindications (4) Avoid concomitant intake of grapefruit or grapefruit juice.

Moderate and Weak CYP3A4 Inhibitors LUCIFINE is a CYP3A4 substrate. Concomitant use with a moderate or weak CYP3A4 inhibitor increases Finerenone exposure, which may increase the risk of LUCIFINE adverse reactions. Monitor serum potassium during drug initiation or dosage adjustment of either LUCIFINE or the moderate or weak CYP3A4 inhibitor, and adjust LUCIFINE dosage as appropriate [(see Dosing and Administration (2.3) and Drug interaction (7 .2)]. Strong and Moderate CYP3A4 inducers.

LUCIFINE is a CYP3A4 substrate. Concomitant use of LUCIFINE with a strong or moderate CYP3A4 inducer decreases Finerenone exposure. which may reduce the efficacy of LUCIFINE. Avoid concomitant use of LUCIFINE with strong or moderate CYP3A4 inducers.

LUCIFINE Finerenone Tablets
LUCIFINE Finerenone Tablets

How to find effective and affordable finerenone tablets

Have you suffered from the physical pain of lower backache and abdominal pain due to the renal function deterioration caused by diabetic kidney disease?

Have you experienced fatigue and weakness because of anemia resulting from diabetic kidney disease, making it difficult to carry out daily activities?

Have you felt headaches, dizziness, and difficulty continuing your day due to high blood pressure brought on by diabetic kidney disease?

Have you dealt with anxiety, depression, and emotional instability due to the long-term management of the disease and treatment?

Have you spent a significant amount of money on treating diabetic kidney disease, causing financial strain on your family?

Have you ever been afraid of needing dialysis to sustain life, potentially compromising your dignity?

Are you afraid of death?

If you wish to avoid the aforementioned consequences, it’s essential to undergo early diagnosis, actively manage diabetes, implement medication, dietary and lifestyle adjustments, and engage in regular monitoring. This approach can help slow down the progression of the disease and reduce the risk of related complications.

It’s widely known that the treatment for type 2 diabetes, RYBELSUS® (semaglutide) tablets, comes with a high cost of up to $995 for 30 tablets. Similarly, the medication for treating diabetic kidney disease, Kerendia finerenone tablets, can be as expensive as $670 for 30 tablets. The exorbitant prices of these medications undoubtedly add to the challenges faced by patients in their daily lives.

Is there an equally effective but more affordable medication available? The answer is LUCIFINE finerenone tablets produced by Lucius Pharmaceuticals. LUCIFINE finerenone tablets are a diabetes kidney disease treatment that has received approval from the Laotian Ministry of Health and is manufactured in Lucius Pharmaceuticals’ GMP factory in Laos, as approved by the U.S. FDA.

LUCIFINE finerenone tablets are not only a legitimately authorized medication but also come at a very affordable price, being only one-third the cost of Kerendia finerenone tablets while delivering the same efficacy.

DKD Care Center serves as the authoritative global distributor for LUCIFINE finerenone tablets, and we possess the necessary authorization certificates from Lucius Pharmaceuticals. The introduction of this new medication comes with significant discounts. If you have been suffering from diabetic kidney disease for an extended period, please don’t hesitate to contact us promptly:

Phone: +852 6993858

Whatsapp: +856 2099383722

Email: service@finerenonediabeticnephropathy.com

Website: finerenonediabeticnephropathy.com

Other drugs to treat diabetic nephropathy

The prevention and treatment of DKD mainly focuses on strict blood sugar and blood pressure control. Widely accepted drugs with renal protection include RAAS inhibitors, such as ACEI/ARB. However, despite the use of the above treatments, DKD disease progression cannot be completely avoided, and there is an urgent need to find new treatments. Three new classes of antidiabetic drugs are believed to have renoprotective effects independent of hypoglycemic effects, including SGLT2 inhibitors, GLP-1 receptor agonists, and DPP-4 inhibitors. Multiple studies have shown that SGLT2 inhibitors can reduce urinary protein levels in DKD patients and delay the progression of T2DKD. In terms of new drugs under development for diabetic nephropathy, Serodus’ SER150 is in clinical phase 2/3 and is about to be launched. Most other drugs such as dapagliflozin, CSL346, and MEDI 3506 are in clinical phase 2.

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