SGLT2 Inhibitor Empagliflozin Phase 3 Trial in Chronic Kidney Disease Halted Early Due to Positive Efficacy in Interim Analysis

On March 17, Eli Lilly and Company and Boehringer Ingelheim jointly announced that the Phase 3 clinical trial of SGLT2 inhibitor empagliflozin for treating patients with chronic kidney disease (CKD) was terminated early based on the recommendation of the independent data monitoring committee. This trial met the pre-specified positive efficacy criteria in the interim analysis. Detailed results of the trial will be released later this year.

CKD is a serious disease characterized by declining kidney function, affecting nearly 850 million people worldwide, with many patients remaining undiagnosed. One hallmark of CKD is a reduced estimated glomerular filtration rate (eGFR) that persists for at least three months. The most common causes of CKD include diabetes, hypertension, and glomerulonephritis, and the condition is often associated with an increased risk of heart disease or stroke. The most severe form of CKD is end-stage kidney disease (ESKD), though most CKD patients will die from cardiovascular events before reaching ESKD.

Empagliflozin is a once-daily oral, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor. In patients with type 2 diabetes with higher blood glucose levels, inhibiting SGLT2 can prevent the kidneys from reabsorbing sugar, allowing more sugar to be excreted in the urine. Additionally, empagliflozin prevents the reabsorption of salt, thereby increasing salt excretion and reducing fluid load in the body's vascular system. The changes in glucose, salt, and water metabolism induced by empagliflozin may help reduce cardiovascular death. In February this year, it received FDA approval to reduce the risk of cardiovascular death and hospitalization in adult heart failure patients. In 2020, it received Fast Track designation for reducing the risk of kidney disease progression and cardiovascular death in CKD patients.

References:

[1] Jardiance® phase III EMPA-KIDNEY trial will stop early due to clear positive efficacy in people with chronic kidney disease. Retrieved March 16, 2022, from https://investor.lilly.com/news-releases/news-release-details/jardiancer-phase-iii-empa-kidney-trial-will-stop-early-due-clear

(Original text has been abridged)

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