Home » News » Drugs in the Pipeline Publish Date November 7, 2022 Empagliflozin Cuts Risk of Kidney Disease Progression, CV Death in CKD Patients Brian Park, PharmD Share on Facebook Share on Twitter Share on LinkedIn Share on Reddit Print Share by Email Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor.
Credit: Getty Images Positive results were announced from a phase 3 trial evaluating the effect of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, on kidney disease progression or cardiovascular (CV) death in patients with pre-existing chronic kidney disease (CKD).
The multicenter, randomized, parallel-group, double-blind, placebo-controlled EMPA-KIDNEY trial (ClinicalTrials.gov Identifier: NCT03594110 ) enrolled more than 6600 patients 18 years of age and older with CKD at risk of kidney disease progression.
The study population included patients with or without diabetes, with mildly to severely reduced eGFR, and with normal and increased levels of albumin.
Patients were randomly assigned to receive empagliflozin 10mg or placebo once daily.
The primary composite endpoint was the time to first occurrence of kidney disease progression (defined as end stage kidney disease with a sustained decline in eGFR <10mL/min/1.73m 2 , renal death, or a sustained decline of ≥40% in eGFR) or CV death.
Results showed that treatment with empagliflozin reduced the risk of kidney disease progression or CV death by 28% compared with placebo (hazard ratio [HR], 0.72; 95% CI, 0.64-0.82; P <.000001).
Additionally, a 14% reduction in all-cause hospitalization (secondary endpoint) was observed with empagliflozin when compared with placebo (HR, 0.86; 95% CI, 0.78-0.95; P =.0025).
Differences in other key secondary endpoints including hospitalization for heart failure or CV death or all-cause death were found not to be statistically significant.
The overall safety profile of empagliflozin was generally consistent with its established profile.
Commenting on the findings, Professor Richard Haynes, co-principal investigator, said: “Previous SGLT2 inhibitor trials focused on certain groups of people living with CKD, such as those with diabetes or high levels of protein in their urine.
Today’s positive trial results across a broad CKD population reflect an opportunity to improve the treatment of this disease and prevent people from needing dialysis.” Empagliflozin is marketed under the brand name Jardiance ® and is currently indicated to improve glycemic control as an adjunct to diet and exercise in adults with type 2 diabetes mellitus (T2DM); to reduce the risk of CV death in adults with T2DM and established CV disease; and to reduce the risk of CV death and hospitalization for heart failure in adults with heart failure independent of left ventricular ejection fraction.
References Landmark EMPA-KIDNEY trial showed significant benefit of Jardiance ® in reducing kidney disease progression or cardiovascular death by 28% vs. placebo in people with chronic kidney disease.
News release.
Boehringer Ingelheim and Eli Lilly and Company.
Accessed November 4, 2022. https://www.businesswire.com/news/home/20221104005412/en/Landmark-EMPA-KIDNEY-trial-showed-significant-benefit-of-Jardiance%C2%AE-in-reducing-kidney-disease-progression-or-cardiovascular-death-by-28-vs.-placebo-in-people-with-chronic-kidney-disease The EMPA-KIDNEY Collaborative Group.
Empagliflozin in patients with chronic kidney disease .
Published online November 4, 2022.
NEJM . doi: 10.1056/NEJMoa2204233.
Topics Cardiovascular Disease Chronic Kidney Disease Kidney Disease Urologic Disorders document.addEventListener( 'DOMContentLoaded', function () {const newsletterAsset = new HMIRegistration({ publicationId: 13, pubName: 'MPR', view: 'newsletter-asset', bootstrap: document.getElementById('newsletter-asset'), formType : "user-initiated",pubType: "medical"});newsletterAsset.mount();}); if ( typeof googletag != 'undefined' ) { googletag.cmd.push(function() { window.hmAds.registerAd( 'div-gpt-ad-box_1' ); }); } if ( typeof googletag != 'undefined' ) { googletag.cmd.push(function() { window.hmAds.registerAd( 'div-gpt-ad-box_2' ); }); } Popular Emailed Recent Loading...
Loading...
Loading... if ( typeof googletag != 'undefined' ) { googletag.cmd.push(function() { window.hmAds.registerAd( 'div-gpt-ad-box_3' ); }); } Want to read more?
Please login or register first to view this content.
Login Register if ( typeof googletag != 'undefined' ) { googletag.cmd.push(function() { window.hmAds.registerAd( 'div-gpt-ad-leaderboard_bottom' ); }); } Back to Top Resources MPR Publications Reprints/Licensing Subscribe Cookie Settings User Center FAQ Customer Service Advertise User Feedback Haymarket Medical Network Cancer Therapy Advisor Clinical Advisor Clinical Pain Advisor Dermatology Advisor Endocrinology Advisor Gastroenterology Advisor Hematology Advisor Infectious Disease Advisor McKnight’s Long Term Care News McKnight’s Senior Living Medical Bag myCME Neurology Advisor Oncology Nurse Advisor Ophthalmology Advisor Optometry Advisor Psychiatry Advisor Pulmonology Advisor Rare Disease Advisor Renal & Urology News Rheumatology Advisor The Cardiology Advisor Copyright © 2022 Haymarket Media, Inc.
All Rights Reserved This material may not be published, broadcast, rewritten or redistributed in any form without prior authorization.
Your use of this website constitutes acceptance of Haymarket Media’s Privacy Policy and Terms & Conditions .
Positive results were announced from a phase 3 trial evaluating the effect of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, on kidney disease progression or cardiovascular (CV) death in patients with pre-existing chronic kidney disease (CKD).
The multicenter, randomized, parallel-group, double-blind, placebo-controlled EMPA-KIDNEY trial (ClinicalTrials.gov Identifier: NCT03594110 ) enrolled more than 6600 patients 18 years of age and older with CKD at risk of kidney disease progression.
The study population included patients with or without diabetes, with mildly to severely reduced eGFR, and with normal and increased levels of albumin.
Patients were randomly assigned to receive empagliflozin 10mg or placebo once daily.
The primary composite endpoint was the time to first occurrence of kidney disease progression (defined as end stage kidney disease with a sustained decline in eGFR <10mL/min/1.73m 2 , renal death, or a sustained decline of ≥40% in eGFR) or CV death.
Results showed that treatment with empagliflozin reduced the risk of kidney disease progression or CV death by 28% compared with placebo (hazard ratio [HR], 0.72; 95% CI, 0.64-0.82; P <.000001).
Additionally, a 14% reduction in all-cause hospitalization (secondary endpoint) was observed with empagliflozin when compared with placebo (HR, 0.86; 95% CI, 0.78-0.95; P =.0025).
Differences in other key secondary endpoints including hospitalization for heart failure or CV death or all-cause death were found not to be statistically significant.
The overall safety profile of empagliflozin was generally consistent with its established profile.
Commenting on the findings, Professor Richard Haynes, co-principal investigator, said: “Previous SGLT2 inhibitor trials focused on certain groups of people living with CKD, such as those with diabetes or high levels of protein in their urine.
Today’s positive trial results across a broad CKD population reflect an opportunity to improve the treatment of this disease and prevent people from needing dialysis.” Empagliflozin is marketed under the brand name Jardiance ® and is currently indicated to improve glycemic control as an adjunct to diet and exercise in adults with type 2 diabetes mellitus (T2DM); to reduce the risk of CV death in adults with T2DM and established CV disease; and to reduce the risk of CV death and hospitalization for heart failure in adults with heart failure independent of left ventricular ejection fraction.
Please login or register first to view this content.
Login Register Copyright © 2022 Haymarket Media, Inc.
All Rights Reserved This material may not be published, broadcast, rewritten or redistributed in any form without prior authorization.
Your use of this website constitutes acceptance of Haymarket Media’s Privacy Policy and Terms & Conditions . source