Jardiance Reduces Risk of Kidney Disease Progression For Patients with Type 2 Who Have CVD

Drug shown to reduce risk of CV death or hospitalization for heart failure in adults with CV disease and type 2 diabetes, irrespective of their CV risk at study start.

Boehringer Ingelheim and Eli Lilly and Company announced findings from two new analyses of the landmark EMPA-REG OUTCOME® trial, presented at the 78th American Diabetes Association (ADA) Scientific Sessions®. Results include a post-hoc analysis demonstrating consistent effects for Jardiance® versus placebo on renal outcomes in patients with established cardiovascular (CV) disease and type 2 diabetes, irrespective of the control of certain CV risk factors.

Thomas Seck, M.D., vice president of Clinical Development and Medical Affairs – Primary Care, Boehringer Ingelheim Pharmaceuticals, Inc, added  that, “Previous EMPA-REG OUTCOME data suggested that Jardiance may reduce the risk of new or worsening kidney disease in adults with cardiovascular disease and type 2 diabetes, which is the number-one cause of kidney failure in the U.S…..In this analysis, the reduced risk of kidney disease progression seen with Jardiance was present whether or not patients had control of common cardiovascular risk factors, such as cholesterol and blood pressure.”

This new post-hoc analysis of the EMPA-REG OUTCOME trial showed Jardiance consistently reduced the risk of new or worsening kidney disease versus placebo irrespective of control of blood pressure, low-density lipoprotein (LDL) cholesterol, or A1C levels, individually or combined. Control of these measures was defined as systolic blood pressure below 140 mmHg, LDL cholesterol under 100 mg/dL, and A1C levels below 7.5 percent.

In a separate presentation, the effect of Jardiance versus placebo on CV outcomes was examined in a post-hoc analysis of sub-groups of EMPA-REG OUTCOME defined by CV risk at trial start – low, intermediate, high, and highest risk (per the 10-point TIMI Risk Score for Secondary Prevention). The study assessed the effect of Jardiance (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care. Standard of care was comprised of glucose-lowering agents and cardiovascular drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of cardiovascular death, non-fatal heart attack, or non-fatal stroke.

Practice Pearls

• The findings demonstrated consistent reductions in the risk of CV death with Jardiance compared with placebo independent of CV risk group.
• Similar consistency in the effects of Jardiance among CV risk groups was seen for reduced risk of hospitalization for heart failure and for the combination of hospitalization for heart failure or CV death.
• This new post-hoc analysis of the EMPA-REG OUTCOME trial showed Jardiance consistently reduced the risk of new or worsening kidney disease versus placebo.

EMPA-REG OUTCOME was a long-term, multicenter, randomized, double-blind, placebo-controlled trial of more than 7,000 patients from 42 countries with type 2 diabetes and established cardiovascular disease.

Reference:

BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME). https://clinicaltrials.gov/ct2/show/NCT01131676.