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Jardiance Meets EMPEROR-Reduced Primary Endpoint

Sep 8, 2020
 
Editor: David L. Joffe, BSPharm, CDE, FACA

Author: Zahra Hashemy, PharmD. Candidate, USF Taneja College of Pharmacy 

Diabetes drug shows benefit for heart failure patients with reduced ejection fraction in the EMPEROR-Reduced trial.

Heart failure is a severe chronic condition that affects 60 million people around the world. In the U.S., heart failure is the leading cause of hospitalization. For heart failure patients, each trip to the hospital increases the risk of death. The chronic disease can affect the amount of blood being pumped to the body. When the heart relaxes, it fills with blood in the ventricle. The ejection fraction is the percentage of blood that fills in the left ventricle during every contraction. In heart failure with reduced ejection fraction (HFrEF), the heart muscle does not contract efficiently, and a smaller percentage of blood is pumped out of the heart than usual. In heart failure with preserved ejection fraction (HFpEF), the heart can contract like normal, but the ventricle fills up with less blood. The heart overall is unable to supply the body with the amount of oxygenated blood it needs, and the heart will then overwork and cause fluid buildup in the lungs and peripheral tissues. Heart failure severely impacts a patient’s quality of life because they have difficulty breathing, acquire edema in the limbs, and become fatigued. Heart failure is common among patients with diabetes. 

Nearly 20 million people die from cardio-renal metabolic conditions a year. The EMPOWER program is an alliance between companies like Boehringer Ingelheim and Lilly that explores Jardiance’s effect on cardio-renal-metabolic conditions. It encompasses nine clinical trials, including 27,000 participants from across the world. The program’s goal is to increase knowledge of the cardio-renal system and generate care that provides multi-organ benefits.   

The diabetes drug  Jardiance (empagliflozin) has been studied for its use in people with heart failure with and without diabetes and reduced ejection fraction (HFrEF). It has recently shown promising results in the EMPagliflozin outcome tRial in patients with chronic heart failure (EMPEROR)-Reduced study. There are two phase III, randomized, double-blind EMPEROR heart failure studies: the EMPEROR-Reduced and EMPEROR-Preserved studies. The EMPEROR-Reduced trial investigated Jardiance’s safety and efficacy in 3,730 individuals with HFrEF. The study’s primary endpoint was time to the first event of adjudicated cardiovascular death or hospitalization for heart failure. The EMPEROR-Preserved study is set to investigate Jardiance safety and efficacy in approximately 5,990 participants and has the same primary endpoint as the EMPEROR-Reduced study. 

The data from the EMPA-REG OUTCOME trial started the Jardiance heart failure program. Currently, Jardiance is used for cardiovascular death reduction in patients with type 2 diabetes (T2D) who have known cardiovascular disease. It is also used along with diet and exercise to aid T2D patients in lowering their blood glucose levels. Those who take Jardiance should be aware of side effects such as dehydration, vaginal yeast infection, yeast infection of the penis, ketoacidosis, kidney problems, severe urinary tract infections, increased cholesterol, necrotizing fasciitis, as well as the possibility of hypoglycemia when taken with insulin or sulfonylurea. 

On July 30, 2020, a press release with Boehringer Ingelheim and Eli Lilly and Company stated that the EMPEROR-Reduced met its primary endpoint, which showed that Jardiance 10 mg, when added to standard of care, was superior to placebo in reducing composite cardiovascular death or hospitalization risk as a result of heart failure. Given that treatment for heart failure can lead to death within five years, there is a substantial unmet need, and Jardiance has great potential to meet that need. According to Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly, “These results build upon the already established cardiovascular benefits of Jardiance in adults living with type 2 diabetes and cardiovascular disease.” The trial’s full results were presented at the European Society of Cardiology (ESC) Congress on August 29, 2020. The Emperor-Preserved trial will be completed in 2021 and provide results regarding an area that has no currently available treatments. The EMPEROR trials have a tremendous potential benefit for heart failure.   

Practice Pearls 

  • There is a great demand for heart failure medication, which can aid in hospitalization and death risk. 
  • New results show that Jardiance can aid in hospitalization and the risk of death in patients with or without diabetes. 
  • The Emperor-Preserved trial can potentially bring to market medication for a disease state with no currently available medications. 

 

The company, Eli Lilly. “Jardiance® Meets Primary Endpoint In Reducing Risk Of Cardiovascular Death Or Hospitalization For Heart Failure In Phase III Trial In Adults With And Without Diabetes.” Prnewswire.Com, 2020, https://www.prnewswire.com/news-releases/jardiance-meets-primary-endpoint-in-reducing-risk-of-cardiovascular-death-or-hospitalization-for-heart-failure-in-phase-iii-trial-in-adults-with-and-without-diabetes-301102692.html. Accessed August 31, 2020. 

 

Zahra Hashemy, PharmD. Candidate, USF Taneja College of Pharmacy

 

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