FIDELIO: Type 2 Diabetes & CKD

October 2020 NEJM / July 2021 FDA Approved

Diabetes stands as the leading cause of chronic kidney disease (CKD) and kidney failure in the United States, thereby significantly increasing the risks of cardiovascular disease and mortality. Consequently, the development of medications that can effectively prevent or delay CKD becomes paramount in addressing these health concerns.

The Food and Drug Administration (FDA) has granted approval for Kerendia (Finerenone) oral tablets, specifically designed to mitigate the risk of exacerbating CKD in adults diagnosed with type 2 diabetes. Additionally, Kerendia is indicated for preventing kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization due to heart failure.

Kerendia is an oral non-steroidal mineralocorticoid receptor (MR) antagonist. Excessive activation of mineralocorticoid receptors can result in hypertension, fluid retention, and cardiovascular harm, all of which have been directly linked to the deterioration of kidney function. The evaluation of kidney function primarily relies on the eGFR laboratory test.

Kerendia’s effectiveness in improving kidney and heart outcomes was rigorously assessed in a significant clinical trial known as FIDELIO-DKD. This extensive study involved random assignment of approximately 5,500 patients to either receive Kerendia or a placebo over a duration of about 2.5 years. The results were remarkable, as patients who received Kerendia demonstrated an average reduction of 15% in the occurrence of CKD progression, cardiovascular death, non-fatal heart attacks, non-fatal strokes, and hospitalizations for heart failure.

Due to its mechanism of action as an MR antagonist, Kerendia is associated with certain side effects such as hyperkalemia, hypotension, and hyponatremia, which are anticipated. It is crucial to note that patients with adrenal insufficiency or those concurrently receiving treatment with strong CYP3A4 inhibitors are contraindicated from taking Kerendia. Examples of strong CYP3A4 inhibitors include diltiazem, verapamil, itraconazole, ketoconazole, clarithromycin, erythromycin, ritonavir, goldenseal, and grapefruit.

Kerendia represents a remarkable addition to the array of treatment options for adults with type 2 diabetes who are grappling with CKD. It is crucial to exercise meticulous monitoring of kidney function and electrolyte levels throughout the course of therapy to ensure optimal outcomes.

Dr. Tashko

Dr. Tashko is an ABIM board-certified endocrinologist with additional certifications in lipidology, hypertension, and obesity medicine. He delivers personalized, holistic care to patients in Montgomery County, Maryland.