United StatesHealth

Empagliflozin reduced the risk of first plus recurrent cardiovascular events in adults with type 2 diabetes and established cardiovascular disease in new analysis from the EMPA-REG OUTCOME® trial

Ingelheim, Germany & Indianapolis, United States: 

– In new results published in The Lancet Diabetes & Endocrinology, empagliflozin reduced the risk of total (first plus recurrent) cardiovascular events including 3P-MACE, hospitalization for heart failure and all-cause hospitalization versus placebo in adults with type 2 diabetes and established cardiovascular disease

– Recurrent cardiovascular events in people with type 2 diabetes are responsible for considerable clinical and socioeconomic burdens;1 evaluation of first and recurrent events allows estimation of the total burden of cardiovascular events

Empagliflozin reduced the risk of total (first plus recurrent) cardiovascular events compared with placebo, when both were given on top of standard of care, in adults with type 2 diabetes and established cardiovascular disease over the three years of the EMPA-REG OUTCOME®trial, according to results of a new post-hoc analysis. Total cardiovascular events included 3P-MACE (a composite of non-fatal heart attack, non-fatal stroke and cardiovascular death), hospitalization for heart failure and all-cause hospitalization. The findings, announced by Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY), were published in TheLancet Diabetes & Endocrinology.2

“People with type 2 diabetes and established atherosclerotic cardiovascular disease are at an increased risk of cardiovascular complications often requiring recurrent admissions to hospital, imposing a significant burden on quality of life for patients and on healthcare systems,” said Darren McGuire, M.D., M.H.Sc., lead author of the analysis and Professor of Medicine at the University of Texas Southwestern Medical Center and Parkland Health and Hospital System. “Considering the totality of hospitalization events, as opposed to just the first event that is most commonly analyzed in clinical trials, better reflects the net effect of beneficial therapies. These new findings help us understand the impact of long-term treatment with empagliflozin for adults who may experience recurrent events due to these debilitating conditions.”

Previously,the landmark EMPA-REG OUTCOME® trial showed that, in adults with type 2 diabetes and established cardiovascular disease, empagliflozin reduced the relative risk of 3P-MACE by 14 percent, driven by a 38 percent reduction in the relative risk of cardiovascular death.3

These new exploratory analyses show that, when added to standard of care, empagliflozin reduced the relative risk of the following total (first plus recurrent) events versus placebo:2

  • 3P-MACE by 22 percent
  • Hospitalizations for heart failure by 42 percent
  • All-cause hospitalizations by 17 percent
  • Fatal or non-fatal myocardial infarction, commonly known as heart attack, by 21 percent
  • Coronary heart disease events (a composite of myocardial infarction and coronary revascularization) by 20 percent.

“These new findings add to previous evidence of the ability of empagliflozin to reduce cardiovascular and all-cause mortality, and in fact suggest additional positive effects of empagliflozin on hospitalization and atherosclerosis-related outcomes in people with type 2 diabetes with established cardiovascular disease,” said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim.

“Boehringer Ingelheim and Lilly will continue to explore how empagliflozin can potentially improve health outcomes and fill treatment gaps for adults with type 2 diabetes and heart disease,” said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly. “We look forward to presenting further results from our EMPOWER program, which is one of the largest cardiovascular clinical programs for an SGLT2 inhibitor to date with more than 377,000 adults studied worldwide.”

Disclaimer: This content is distributed by Business Wire India.

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