Post-hoc analyses from the EMPA-REG OUTCOME study found consistent benefits for the therapy in comorbidities versus placebo.
New post hoc analyses from the EMPA-REG OUTCOME trial reports that empagliflozin (Jardiance) has consistent effects on renal outcomes in patients with established cardiovascular disease (CVD) and type 2 diabetes (T2D), compared to placebo.
Updated results of the landmark trial found that empagliflozin had consistent reduction of new or worsening kidney disease, irrespective of patient control of blood pressure, low-density lipoprotein (LDL) cholesterol or glycated hemoglobin (A1C) levels.
The EMPA-REG OUTCOME study, a long-term, multicenter, randomized, double-blind, placebo-controlled trial of 7000-plus patients from 42 countries with T2D and CVD, assessed 10 mg and 25 mg once-daily empagliflozin versus placebo. Both treatment arms were added to patient standard-of-care: glucose-lowering agents, plus drugs for blood pressure and cholesterol.
Researchers set a primary endpoint of time to first occurrence of cardiovascular-related death, non-fatal heart attack, or non-fatal stroke. Though the EMPA-REG OUTCOME trial was not designed to assess associations between empagliflozin and positive renal outcomes, researchers had previously specified plans to analyze additional kidney assessment endpoints.
In the analysis for renal outcomes, researchers controlled for measures of common cardiovascular risk factors, defined as patient systolic blood pressure below 140 mmHg, LDL cholesterol under 100 mg/dL, and A1C levels below 7.5%.
Researchers also examined the effect of empagliflozin versus placebo on cardiovascular-based outcomes, as examined by patient risk at trial start. Patient risk was gauged at levels of low, intermediate, high, and highest risk, as per the 10-point TIMI Risk Score for Secondary Prevention. The therapy reported consistent reductions in patient risk of cardiovascular death compared to those administered placebo, as well as similar reductions for risk of hospitalization for heart failure.
In an interview with MD Mag at the 2018 American Diabetes Association (ADA) 78th Scientific Sessions in Orlando, FL, Rogelio Braceras, MD, therapeutic area head of Clinical Development and Medical Affairs (Metabolism) for Boehringer Ingelheim, said renal disease remains a major unmet need in patients with diabetes.
In a partnership with Eli Lilly and Company, Boehringer Ingelheim is conducting, planning, or has completed clinical trial programs involving nearly 20,000 patients to understand the potential of empagliflozin in unmet treatment needs — from type 1 diabetes, to CVD, heart failure and chronic kidney disease. This post-hoc analyses gives more merit to the venture.
“(The results are) very reassuring, very informative, because we are doing the CVD outcome studies for heart failure and also for kidney programs through the EMPA-REG,” Braceras said. “So in a way, this is something really relevant for the medical audience.”
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