Dr. Ahmed Jardiance CKD approval by the FDA was based on the EMPA-Kidney trial, a multinational trial that demonstrated a 28% relative risk reduction of kidney disease progression and cardiovascular deaths [Ref].
Few drugs have shown promising results in the prevention of disease progression of CKD. These include:
- Drugs acting on the RAAS pathway (Renin-Angiotensin-Aldosterone System) [Ref]
- SGLT2 inhibitors (Sodium-Glucose Co-Transporter 2 Inhibitors) [Ref]
- Nonsteroidal Mineralocorticoid Receptor Antagonist – Finerenone [Ref]
Jardiance CKD approval is the fourth FDA-approved indication. However, it is not recommended for patients on immunosuppressants or prednisolone (in a dose of 45 mg or more per day) treatment for kidney disease.
Jardiance is also not recommended for the treatment of patients with polycystic kidney disease (PKD) and patients with Type 1 diabetes.
Jardiance FDA-approved Indications:
Initially approved for the treatment of Type 2 Diabetes, Jardiance has shown to be effective in a diverse group of patients.
Currently, the FDA has approved Jardiance in the following conditions:
- Type 2 Diabetes: For Glycemic Control
- For Cardiovascular risk reduction in Type 2 Diabetics with established CVD [Ref]
- For treating patients with heart failure to reduce the risk of hospitalization and cardiovascular deaths
- For preventing kidney disease progression, ESRD, cardiovascular deaths, and hospitalizations in adults with chronic kidney disease.
While there were expectations regarding its application in Type 1 Diabetics, it was ultimately not approved due to the elevated risk of euglycemic ketoacidosis.
A Summary of Jardiance CKD Approval Study – The EMPA-KIDNEY Trial:
Jardiance CKD approval was primarily based on The EMPA-KIDNEY trial (Study of Heart and Kidney Protection with Empagliflozin).
EMPA-KIDNEY Trial Study Design:
- An international, randomized, double-blind, placebo-controlled trial
- Total Patients Enrolled: 6609
- Median Follow-up: 2 years
- Medications and Doses: Jardiance 10 mg vs. placebo
Patients who were included in the study:
- Adult patients with or without diabetes,
- Patients with an eGFR of 20 to 45 ml/min/1.73 m2, or
- an eGFR of 45 – 90 ml/min/1.73 m2, plus a urinary albumin-to-creatinine ratio of at least 200, and
- Patients with low levels of proteinuria
Patients who were excluded from the study:
- Type 2 diabetics with a prior atherosclerotic cardiovascular disease
- Type 1 diabetics
- Patients scheduled for kidney transplant or who had a kidney transplant
- Patients on dialysis
- Polycystic kidney disease
- Required or had a recent history of intravenous immunosuppressive therapy or greater than 45 mg of prednisone or equivalent for kidney disease
Results of the EMPA-KIDNEY Trial:
Primary End Point (CKD progression or Cardiovascular death):
- 28% relative risk reduction (absolute risk reduction 3.6% per patient-year at risk) compared with placebo (HR=0.72; 95% CI 0.64 to 0.82; P<0.0001)
Key Secondary Endpoints (Reduction in Hospitalizations):
- 14% relative risk reduction (HR=0.86; 95% CI 0.78 to 0.95; p=0.0025) with Jardiance versus placebo
Weight loss:
- Compared to placebo, a mean weight loss of -0.9 +/- 0.1 kg was noticed in the Jardiance group.
Reduction in Blood pressure:
- The mean difference in systolic blood pressure: -2.6±0.3 mm Hg
- The mean difference in diastolic blood pressure: -0.5±0.2 mm Hg
Reduction in Glycated Hemoglobin:
- -0.39 mmol per mole (95% CI, -0.77 to -0.01 [-0.04%; 95% CI, -0.07 to 0.00])
Safety Concerns:
- Ketoacidosis occurred in 6 patients in the Jardiance group vs. 1 patient in the placebo group.
- Lower limb amputations were observed in 28 patients in the Jardiance group vs. 16 patients in the placebo group.
- No major adverse events including hypoglycemia occurred.
What are the prospects of Jardiance CKD Approval by the FDA:
Jardiance CKD approval by the FDA might help reduce the burden of patients who need advanced kidney care such as dialysis support and kidney transplantation.
There is a pressing need for interventions that can effectively prevent the progression of kidney disease.
This need has become increasingly critical due to the rising number of individuals diagnosed with kidney-related conditions.
Jardiance resulted in a significant 28% risk reduction in preventing CKD progression and slowing down the disease process.
When added early in the treatment course, it may potentially reduce the chances of a person with CKD progressing into ESRD and dialysis needs.
Jardiance may reduce the financial burden and improve the quality of life of patients with CKD.
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