EMPRISE data complement the landmark EMPA-REG OUTCOME trial

Mon, Jun 28, 2021
By editor


THE first data from Europe, Israel and East Asia in the EMPRISE real-world evidence study have been presented, revealing a risk reduction in cardiovascular outcomes associated with empagliflozin compared to DPP-4 inhibitors.

Boehringer Ingelheim and Eli Lilly and Company announced the study results today, which included over 130,000 adults with type 2 diabetes, with or without cardiovascular disease, showing a:

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  • 45 percent relative risk reduction, RRR, in all-cause mortality;
  • 29 percent RRR in hospitalization for heart failure;
  • 33 percent RRR in a composite endpoint including heart attack, stroke and all-cause mortality.

These results were consistent in people with or without cardiovascular disease. The European,

Israeli and East Asian results were presented at the 81 st American Diabetes Association, ADA,

Scientific Sessions, with further European analyses to be revealed at the European Society of Cardiology, ESC, Heart Failure Congress in June–July 2021, and the ESC Congress in August 2021.

The EMPRISE findings confirmed empagliflozin’s well-established safety profile. Empagliflozin was not associated with a risk of acute kidney injury – analyses showed a 51 percent RRR in acute kidney injury requiring dialysis.

There was a similar risk of lower limb amputation and bone fractures as with DPP-4 inhibitors. In addition, there was an increased risk of diabetic ketoacidosis, which is consistent with empagliflozin’s known safety information.

“The risk of hospitalization for heart failure is up to five times higher if you have type 2 diabetes.

Heart failure has a considerable impact on a person’s quality of life and prognosis, plus associated healthcare costs,” commented EMPRISE EU investigator Professor Avraham Karasik, Professor and Vice Dean, Sackler School of Medicine, Tel-Aviv University.

“These latest EMPRISE findings demonstrate the impact of empagliflozin in the real-world across Europe, Israel and East Asia, supporting its role in reducing cardiovascular complications in people with

type 2 diabetes.”

Type 2 diabetes significantly increases the risk of cardiovascular morbidity and mortality. One in two people with type 2 diabetes die from a cardiovascular event globally, and US data show that those with diabetes are twice as likely to develop heart failure than those without. 2,3.

“The EMPRISE study evaluates extensive endpoints in a broad patient population, providing valuable insights into empagliflozin’s cardiovascular risk reduction potential in the treatment of type 2 diabetes,” said Waheed Jamal, MD, Corporate Vice President and Head of Cardiometabolic Medicine, Boehringer Ingelheim.

“These results are positive and encouraging for patients, who will benefit from our continued focus on improving the outcomes for people with cardio-renal-metabolic diseases, like type 2 diabetes and heart failure.”

Findings from the EMPRISE real-world evidence study complement insights from the EMPA-REG OUTCOME ® trial, which showed that empagliflozin provides cardiovascular and renal benefits, in addition to metabolic effects, in people with type 2 diabetes and established cardiovascular disease.

The EMPA-REG OUTCOME ® trial found that empagliflozin reduced the relative risk of hospitalization for heart failure by 35 percent, all-cause mortality by 32 percent and incident or worsening kidney disease by 39 percent, compared to placebo.

“The evidence seen in the EMPRISE analysis provides reassurance supporting empagliflozin’s safety profile,” added Leonard Glass, Vice President of Medical Affairs, Lilly.

“It is five years since the landmark EMPA-REG OUTCOME study and these latest EMPRISE findings add to the wealth of robust, real-world data demonstrating empagliflozin’s effectiveness and safety in routine clinical practice worldwide.”

– June 28, 2021 @ 19:20 GMT