Business Wire

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

Share

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

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201118005653/en/

“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.”

About EMPA-REG OUTCOME® (NCT01131676)3

EMPA-REG OUTCOME® was a long-term, multicenter, randomized, double-blind, placebo-controlled trial of more than 7,000 patients from 42 countries with type 2 diabetes and established cardiovascular disease.

The study assessed the effect of empagliflozin (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care. Standard of care was comprised of glucose-lowering agents and cardiovascular drugs (including medication for the treatment of hypertension and hypercholesteremia). The primary endpoint was defined as time to first occurrence of cardiovascular death, non-fatal heart attack or non-fatal stroke.

The overall safety profile of empagliflozin was consistent with that of previous trials.

About the EMPOWER program

The Alliance has developed the EMPOWER program to explore the impact of empagliflozin on major clinical cardiovascular and renal outcomes in a spectrum of cardio-renal-metabolic conditions. Cardio-renal-metabolic conditions are the leading cause of mortality worldwide and account for up to 20 million deaths annually.4 Through the EMPOWER program, Boehringer Ingelheim and Lilly are working to advance knowledge of these interconnected systems and create care which offers integrated, multi-organ benefits. Comprised of nine clinical trials and two real-world evidence studies, EMPOWER reinforces the long-term commitment of the Alliance to improve outcomes for people living with cardio-renal-metabolic conditions. With more than 377,000 adults estimated to have enrolled worldwide upon completion of the studies, it is one of the broadest and most comprehensive clinical programs for an SGLT2 inhibitor to date.

The development program encompasses:

  • EMPEROR-Reduced, in adults with chronic heart failure with reduced ejection fraction to reduce the risk of cardiovascular death or hospitalization due to heart failure5
  • EMPEROR-Preserved, in adults with chronic heart failure with preserved ejection fraction to reduce the risk of cardiovascular death or hospitalization due to heart failure6
  • EMPULSE, in adults hospitalized for acute heart failure and stabilized to improve clinical and patient reported outcomes7
  • EMPACT-MI, to evaluate all-cause mortality and hospitalization for heart failure in adults with and without type 2 diabetes who have had an acute myocardial infarction, with the aim to prevent heart failure and improve outcomes8
  • EMPA-KIDNEY, in adults with established chronic kidney disease to reduce the progression of kidney disease and the occurrence of cardiovascular death9
  • EMPERIAL-Reduced, in adults with chronic heart failure with reduced ejection fraction to evaluate functional ability and patient reported outcomes10
  • EMPERIAL-Preserved, in adults with chronic heart failure with preserved ejection fraction to evaluate functional ability and patient-reported outcomes11
  • EMPA-REG OUTCOME®, in adults with type 2 diabetes and established cardiovascular disease to reduce the risk of major adverse cardiovascular events, including cardiovascular death3
  • EMPRISE, two non-interventional studies (U.S. and EU-Asia) of the effectiveness, safety, healthcare utilization and cost of care of empagliflozin in routine clinical practice in adults with type 2 diabetes across the cardiovascular risk continuum12,13

About Type 2 Diabetes and Cardiovascular Disease

Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.14 More than 463 million people worldwide have diabetes, of which 232 million are estimated to be undiagnosed.14 By 2045, the number of people with diabetes is expected to rise to 700 million people worldwide.14 Type 2 diabetes is the most common form of diabetes.14

Due to the complications associated with diabetes, such as high blood sugar, high blood pressure and obesity, cardiovascular disease is a major complication and the leading cause of death associated with diabetes.15 One in two people with type 2 diabetes worldwide die from a cardiovascular event.16

About Cardio-Renal-Metabolic Conditions

Boehringer Ingelheim and Lilly are driven to transform care for people with cardio-renal-metabolic conditions, a group of interconnected disorders that affect more than one billion people worldwide and are a leading cause of death.17,18

The cardiovascular, renal and metabolic systems are interconnected, and share many of the same risk factors and pathological pathways along the disease continuum. Dysfunction in one system may accelerate the onset of others, resulting in progression of interconnected diseases such as type 2 diabetes, cardiovascular disease, heart failure, and kidney disease, which in turn leads to an increased risk of cardiovascular death. Conversely, improving the health of one system can lead to positive effects throughout the others.19,20

Through our research and treatments, our goal is to support people’s health, restoring the balance between the interconnected cardio-renal-metabolic systems and reducing their risk of serious complications. As part of our commitment to those whose health is jeopardized by cardio-renal-metabolic conditions, we will continue embracing a multidisciplinary approach towards care and focusing our resources on filling treatment gaps.

About Empagliflozin

Empagliflozin (marketed as Jardiance®) is an oral, once daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor and the first medicine approved by regulatory authorities to significantly reduce the risk of cardiovascular death or include data on the reduction of the risk of cardiovascular death in the label for adults with type 2 diabetes and established cardiovascular disease.18,19,21

Inhibition of SGLT2 with empagliflozin in people with type 2 diabetes and high blood sugar levels prevents sugar being re-absorbed by the kidneys, leading to the excretion of excess sugar in the urine. In addition, initiation of empagliflozin also prevents salt being re-absorbed, leading to increased excretion of salt from the body and reducing the fluid load of the body’s blood vessel system (i.e. intravascular volume). Empagliflozin induces changes to the sugar, salt and water metabolism in the body that may contribute to the reductions in cardiovascular death observed in the EMPA-REG OUTCOME® trial.20

Please click on the following link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/press-release/empa-reg-outcome-recurrent-events

Contact information

Stefanie Molkenthin
Product Communication Manager
Boehringer Ingelheim
Email: press@boehringer-ingelheim.com
Phone: +49 (6132) 77 172209

Stephan Thalen
Global Business Communications
Lilly Diabetes
Email: stephan.thalen@lilly.com
Phone: +1 (317) 276 8304

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

H.I.G. Capital Closes H.I.G. Europe Capital Partners III at €1.1 Billion24.11.2020 10:00:00 CETPress release

H.I.G. Capital (“H.I.G.”), a leading global alternative asset management firm with $42 billion of equity capital under management, is pleased to announce the closing of its third European Lower Middle Market Fund, H.I.G. Europe Capital Partners III (the “Fund”). The Fund closed with aggregate capital commitments of €1.1 billion, exceeding its target. The Fund will continue the successful strategy of its two predecessor funds, by making private equity investments in lower middle market companies, primarily in Western Europe. Sami Mnaymneh and Tony Tamer, H.I.G. Co-Founders and Co-CEOs, commented: “We are delighted with the continued support from our limited partner base, which reflects their confidence in the capability of our European team and our differentiated investment approach.” Wolfgang Biedermann, Head of H.I.G. Europe Buyouts, added: “The team is excited to build upon H.I.G.’s successful European lower middle market strategy. The current economic environment in Europe leaves us

FERI Group and Target Global Join Forces for New Growth Fund24.11.2020 09:00:00 CETPress release

The Bad Homburg-based FERI Group is cooperating with Target Global in the management and placement of a new growth fund. The two companies will work together in the selection of target investments and the placement of this new alternative investment fund for growth capital. This cooperation between one of the leading investment houses in the German-speaking region and one of the most active European venture capital investment companies is the first of its kind. The new Target Global Growth Fund offers investment opportunities in selected growth companies to semi-professional and professional investors. The fund will invest in start-ups with strong growth potential that offer digital products and services in typical European industries for large and preferably global markets – mainly market platforms, Fintechs and service software providers. The fund's investment focus is on companies in early and mid growth phases with valuations in excess of EUR 50 million. "The fund opens up new inve

Exclusive Networks Acquires Nuaware to Accelerate Cloud and DevOps Opportunities for Channel and Vendor Partners24.11.2020 09:00:00 CETPress release

Exclusive Networks today announced the acquisition of Nuaware, a hyper growth, born-in-the-cloud distributor at the bleeding edge of cloud, DevSecOps and containerisation. The move adds immediate global scale and services capability to the Nuaware proposition and portfolio, while enabling Exclusive Networks, its vendors and partner community with a unique skill set for capitalising on immense demand shifts brought about by digital transformation. Jesper Trolle, CEO at Exclusive Networks said: "DevOps tool chains, containers and the emergence of DevSecOps are specialist areas where Nuaware has carved a truly unique niche in distribution. This acquisition puts us where we want to be in this space, giving our partners a readymade on-ramp into new high-growth opportunities. Large vendors being drawn to these markets are seeking turnkey channel solutions, and their established partner ecosystems have technical skills gaps that demand credible support. We can now meet these kinds of challeng

Aker BP and Cognite Pioneer Robotics Deployment Offshore to Transform Oil and Gas Industry with Autonomous Mission24.11.2020 09:00:00 CETPress release

Cognitea global industrial AI software-as-a-service (SaaS) company supporting the full-scale digital transformation of heavy-asset industries around the world, has partnered with fully-fledged exploration and production company Aker BP to deploy Spot, the quadruped robotic dog, to pioneer the remote controlled offshore mission on the Skarv installation, 210 kilometers offshore in the North Sea. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201124005292/en/ Cognite Data Fusion powers Spot, the Boston Dynamics quadruped robot dog, as it completes autonomous mission onboard Aker BP Skarv installation in the North Sea (Photo: Business Wire) The effort continues to build upon Aker BP and Cognite’s bold digital agenda to transform the industry through digitalization, which will result in improved efficiency, safety, and sustainability offshore. This recent endeavor signals a significant opportunity to transform the oil and gas in

beCloud Selects P.I. Works to Drive Automation of its Nationwide Multi-Operator and Multi-Vendor LTE Network24.11.2020 06:00:00 CETPress release

beCloud, Belarus’ telecommunications infrastructure and service provider, has selected P.I. Works’ cutting-edge network management solutions to drive the automation and proactive monitoring of its multi-operator and multi-vendor 4G network. The deployment has been initiated and will oversee the installation of P.I. Works’ next-generation automation and analytics products, EXA and VantagePM, to enable AI-powered network automation for 24/7 optimization across the operator’s networks. EXA, which runs on the P.I. Works EVO Platform™, will empower beCloud to automatically manage its traffic load, identify cross connection problems without visiting the sites and maximize 4G coverage using existing resources. VantagePM, on the other hand, will enable beCloud to gauge insights into different operator users, monitor individual operator service quality levels, perform rigorous anomaly detection and implement easy-to-use interactive dashboards. To deliver this, P.I. Works utilizes PLMN (network

Global Superstars BTS Team Up With Iconic MapleStory Games in Brand New Collaboration24.11.2020 04:00:00 CETPress release

Nexon America Inc.: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201123006306/en/ MS x BTS Collab Logo (Graphic: Business Wire) WHAT: Today, Nexon announced a collaboration with global record-breaking pop superstars, BTS with the iconic MMORPG IP, MapleStory coming soon. Leading up to the in-game collaboration inMapleStory and MapleStory M, players will be treated to three behind the scenes videos surrounding the MapleStory X BTS collaboration with one new video releasing each week beginning on November 25 via MapleStory’s YouTube channel at youtube.com/MapleStory. The video content will feature BTS sharing their journey growing up with MapleStory through childhood and their fondness for the game. More details on the collaboration will be announced. To stay up to date on the MapleStory X BTS collaboration, visit maplestory.com/maplestoryxbts and follow @maplestory and @playmaplem on Twitter. WHO: MapleStory & MapleStory M

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom