Currently Viewing:
Evidence-Based Diabetes Management September 2015
What "Behavioral Change" Looks Like From the Front Lines: Visiting Jefferson Hospital
Mary K. Caffrey
Stumbling Toward Access to Evidence-Based Care for the Chronic Disease of Obesity
Theodore K. Kyle, RPh, MBA: and Fatima Cody Stanford, MD, MPH, MPA
Joslin's Hamdy: Evidence Shows Diet, Exercise Effective Against Diabetes, Obesity Long-Term
Andrew Smith
For Now, PBMs Just Say No to High-Cost PCSK9 Inhibitors
Mary K. Caffrey
From Contrave Saga, Renewed Faith in Trials Built on Trust
Andrew Smith
JAMA: High-Dose Liraglutide Causes Significant Weight Loss in Overweight Persons With T2DM
Mary K. Caffrey
Intarcia Says Phase 3 Results Show Better Control Than Januvia for Type 2 Diabetes Mellitus
Mary K. Caffrey
Another Distinct Link Between Cancer and Obesity: the AEG-1 Protein
Surabhi Dangi-Garimella, PhD
Survey Finds Young Patients With Diabetes Getting Fewer Eye Exams Than Older Patients
Mary K. Caffrey
Fingernail Tests May Offer Cheap, Simple Way to Diagnose Diabetes
Mary K. Caffrey
Currently Reading
Empagliflozin Is First Diabetes Drug to Hit "Holy Grail" of Cutting Heart Attack, Stroke Deaths in Clinical Trial
Mary K. Caffrey
If Beef Is Not Sustainable, Is Growing It the Answer?
Molly Bourg
Synjardy Joins Ranks of Combo Therapies for T2DM
Mary K. Caffrey
Non-Surgical Balloon Device Approved to Treat Obesity
Mary K. Caffrey
Dexcom G5 Mobile CGM System Approved by FDA
Mary K. Caffrey

Empagliflozin Is First Diabetes Drug to Hit "Holy Grail" of Cutting Heart Attack, Stroke Deaths in Clinical Trial

Mary K. Caffrey
The SGLT2 inhibitor empagliflozin, marketed as Jardiance, became the first of the newer diabetes drugs to reduce the risk of heart attacks and stroke deaths in a clinical trial,1 an achievement that a leading researcher recently said would be the “holy grail” of such drugs.
 
Eli Lilly and Company and Boehringer Ingelheim released topline results on August 20, 2015, for the EMPA-REG OUTCOME trial, which will be presented September 17, 2015, at the European Association for the Study of Diabetes in Stockholm, Sweden.1 The results marked the first time that one of the newer class of antidiabetes drugs has been shown to not only have no adverse cardiovascular effects while helping patients achieve glycemic control, but the drug also had a cardioprotective effect.
 
Empagliflozin was approved by the FDA a year ago, after competitors that include Johnson and Johnson’s canagliflozin, sold as Invokana.2,3 The results raise the possibility that other drugs in the sodium glucose cotransporter-2 (SGLT2) class could produce similar benefits. SGLT2 inhibitors work by blocking the SGLT2 protein, which would typically reabsorb glucose. Thus, sugar is expelled through the urine, lowering blood sugar levels in the body.

The drug class is known to have benefits for hypertension, and patients have seen modest weight loss In their announcement, Lilly and Boehringer said the study included 7000 patients with type 2 diabetes mellitus (T2DM) who were considered at high risk for heart attacks or strokes. Those taking the therapy saw significantly fewer cardiac deaths, nonfatal heart attacks, and nonfatal strokes when taking empagliflozin, in combination with standard therapy, than those patients taking standard therapy alone, which included statins and drugs for blood pressure. Patients were followed for an average of 3.1 years.1
 
Since the mid-2000s, the FDA has required newer diabetes therapies to be studied after approval through longer term cardiovascular outcomes trials. This is done to ensure that there are no repeats of the Avandia saga; FDA had to highly restrict sales of this drug after a study in the New England Journal of Medicine indicated it increased heart attack risk.4
 
Two such cardiovascular outcomes trials were presented during the 75th Scientific Sessions of the American Diabetes Association in June. At the presentation of the ELIXA trial on lixisenatide—which found no cardiovascular (CV) risk or benefit—Yale Diabetes Center’s Silvio E. Inzucchi, MD, said that if a therapy were ever developed that actually improved CV outcomes, “then we would have achieved the holy grail.”4
References
 
1. Jardiance demonstrated cardiovascular (CV) risk reduction in people with type 2 diabetes at high risk for CV events [press release]. http://www.prnewswire.com/news-releases/jardiance-demonstrated-cardiovascular-cv-risk-reduction-in-people-with-type-2-diabetes-at-high-risk-for-cv-events-300131117.html. Indianapolis, IN: PRNewswire; August 20, 2015.
 
2. FDA approves Jardiance to treat type 2 diabetes [press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm407637.htm. Silver Spring, MD: FDA newsroom; August 1, 2014.
 
3. FDA approves Invokana to treat type 2 diabetes [press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm345848.htm. Silver Spring, MD: FDA Newsroom; March 29, 2013.
 
4. Caffrey MK. ELIXA trial results find no cardiac benefit, risk for lixisenatide. Conference Coverage, 75th Scientific Sessions of the American Diabetes Association. American Journal of Managed Care website. http://www.ajmc.com/conferences/ADA2015/elixa-trial-results-find-no-cardiac-risk-benefit-for-lixisenatide. Published June 9, 2015. Accessed August 21, 2015.
PDF
 
Copyright AJMC 2006-2020 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
x
Welcome the the new and improved AJMC.com, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up