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Courier | significantly slow kidney disease progression and cardiovascular death! The blockbuster SGLT2 inhibitor reached phase 3 clinical endpoint


    Today, Boehringer Ingelheim and Eli Lilly and Company announced that Jardiance (empagliflozin) met its primary endpoint in a Phase 3 clinical trial, This drug significantly reduces the risk of kidney disease progression or cardiovascular death in adult patients with chronic kidney disease (CKD). Detailed data was presented at the 2022 ASN Kidney Week and also published in the New England Journal of Medicine.


    Chronic kidney disease is a serious and progressive disease that affects nearly 700 million people worldwide. Patients develop complications related to fluids and electrolytes, as well as waste accumulation in the body, due to kidney damage that prevents them from filtering blood properly. The most common causes of the disease are diabetes, high blood pressure and glomerulonephritis. Chronic kidney disease can progress to kidney failure, and patients are at higher risk for cardiovascular disease, including heart attacks and strokes. In addition, chronic kidney disease is statistically associated with twice the risk of hospitalization.




▲ Results of clinical trial of EMPA-KIDNEY (picture source: Reference [1])



    Englipurified is a highly selective once-daily inhibitor of sodia-glucose cotransporter 2 (SGLT2). In patients with type 2 diabetes with high blood glucose levels, inhibition of SGLT2 prevents the reabsorption of sugar into the kidneys, thereby allowing more sugar to be excreted from the urine. In addition, Englecine prevents salt reabsorption, which increases salt excretion in the body and reduces fluid load on the body's vascular system. Englazine induces changes in the metabolism of sugars, salts and water in the body that may contribute to the reduction of cardiovascular death. It was approved by the FDA last August to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with reduced ejection fraction heart failure.





    The EMPA-KIDNEY trial was presented as a randomized, double-blind, Phase 3 international trial to examine the efficacy of Englipizine in improving kidney disease progression and cardiovascular death in 6,609 patients with chronic kidney disease. Analysis of the data found that, compared with placebo, engliazine reduced the risk of kidney disease progression or cardiovascular death in patients by 28% (HR: 0.72, 95%CI: 0.64-0.82, P<0.000001). EMPA-KIDNEY is also the first trial to show that an SGLT2 inhibitor significantly reduced the risk of hospitalization for any cause in patients with chronic kidney disease compared with a placebo, the press release noted. Engliecin reduced the risk of hospitalization by 14% (HR: 0.86, 95%CI: 0.78-0.95, P<0.0025), which was the intended key secondary endpoint of the trial.
    Safety data from the trial were consistent with past findings and no new safety issues were identified.
    "Boehringer Ingelheim and Lilly were very proud of the results of the EMPA-KIDNEY trial, which provided another key achievement for Engelejin," Carinne Brouillon, PhD, Head of Human Pharmacy and managing director of Boehringer Ingelheim, said, "Today's data add to our clinical development program of more than 700,000 cardiovascular, renal and metabolic patients. The EMPA-KIDNEY trial showed that Engliazine has the potential to transform the treatment of these related diseases."

Reference Materials:

[1] Landmark EMPA-KIDNEY trial showed significant benefit of Jardiance® in reducing kidney disease progression or progression cardiovascular death by 28% vs. placebo in people with chronic kidney disease. Retrieved November 4, 2022 from https://www.boehringer-ingelheim.com/human-health/metabolic-diseases/full-data-chronic-kidney-disease-trial-efficacy

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