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
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.
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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Product Communication Manager
Phone: +49 (6132) 77 172209
Global Business Communications
Phone: +1 (317) 276 8304
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
Kyowa Kirin Provides Update on Application for Marketing Authorisation of Istradefylline in Europe for the Treatment of ‘OFF’ Episodes in People Living with Parkinson’s23.7.2021 16:05:00 CEST | Press release
Kyowa Kirin Co., Ltd. (TSE:4151, President and CEO: Masashi Miyamoto, “Kyowa Kirin”) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for istradefylline as an add-on treatment to levodopa (L-Dopa) based regimens in adults living with Parkinson’s, experiencing end-of-dose motor fluctuations. Kyowa Kirin International remain committed to istradefylline and people living with Parkinson’s and are currently reviewing the options available, which may include re-examination. “We are disappointed by the CHMP opinion. However, we remain confident in the benefit-risk profile of istradefylline and are committed to making a difference to the lives of people living with Parkinson’s, an area which has had few innovative therapies for decades,” said Abdul Mullick, President of Kyowa Kirin International. “There are currently few new treatment options available to manage end-of-dose motor fluctuations in Parkinson
ForumPay Teams Up with Bambora to Conquer the Crypto-to-Fiat Payments Market23.7.2021 15:16:00 CEST | Press release
ForumPay, an international cryptocurrency-to-fiat payment service provider, has established a partnership with the global payments provider Bambora, a Worldline brand, to bring seamless crypto payment solutions to merchants and online shoppers. The partnership will cater to a large global audience and offer expanded payment options for both shoppers and merchants. ForumPay continues its march to dominate the growing crypto payments ecosystem for merchants around the world. “ForumPay provides merchants with a seamless, secure and instant processing solution to accept payments from the more than 54 million active crypto wallet users around the world. By providing a payments service for processing crypto into fiat that functions as naturally as card payments, ForumPay enables merchants with a familiar feeling payments alternative that also gives them a competitive advantage by tapping into the fastest growing consumer base on the planet.” says Joshua Tate, CEO of ForumPay. “We are very ex
Wipro Recognized as 2021 Microsoft Modernizing Applications Partner of the Year23.7.2021 14:54:00 CEST | Press release
Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced that it has won the 2021 Microsoft Partner of the Year Award in the Modernizing Applications category. In addition, Wipro was also named as a category finalist in the 2021 AI Partner of the Year category, solidifying its reputation as an innovator in multiple sectors. This recognition highlights Wipro’s deep expertise and ability to go above and beyond for its customers, powered by an established partnership with Microsoft. Even when working with complex customer environments, spanning across hundreds of servers with different applications of different versions, Wipro was able to help customers meet their business needs and leverage the power of public cloud in an efficient way. “Global enterprises have embraced modernization at an unprecedented scale and pace, and the demands of the past year show no sign of easing. We are honor
Merck Announces Appointment of Head of China & International for Healthcare23.7.2021 13:45:00 CEST | Press release
Merck, a leading science and technology company, today announced that Hong Chow will join its Healthcare business sector as Head of China & International on October 1. In this role at Merck, Chow will lead China, Japan as well the regions Europe, Latin America, Asia-Pacific and Middle East, Africa and Russia, the franchise of Cardiovascular Metabolism & Endocrinology (CM&E), and the Global Business Innovation team. Chow will report to Peter Guenter, Member of the Executive Board of Merck and CEO Healthcare. She will serve as a member of the Healthcare Executive Committee, and be based in Shanghai, China. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210723005186/en/ Merck Announces Appointment of Head of China & International for Healthcare (Photo: Business Wire) “Hong’s international experience and strong track record of bringing innovative medicines to patients in need across both developed and emerging markets, most nota
H.I.G. WhiteHorse Refinances Grupo Recoletas23.7.2021 13:03:00 CEST | Press release
H.I.G. WhiteHorse, a credit affiliate of global investment firm H.I.G. Capital ("H.I.G.") is pleased to announce that it has arranged a refinancing package for Grupo Hospitalario Recoletas (“Recoletas”), which includes a significant growth capital component. Recoletas is a family-owned Spanish private hospital operator headquartered in Valladolid, Spain, with a leading position in the Castilla y Leon Spanish inland region. It operates 8 hospitals with c. 540 beds and 13 medical centres across 7 regions. H.I.G. WhiteHorse has committed €110 million in unitranche loans to refinance the borrower's existing indebtedness and provide additional capital to finance growth, supporting the Company’s expansion. Recoletas is currently developing ambitious projects to expand its healthcare services provided through hospitals and medical centers, as well as diagnostic imaging centers and radiotherapy units. Amando J. Rodríguez, President and CEO of Grupo Hospitalario Recoletas, said: “We are very ha
Schlumberger Announces Second-Quarter 2021 Results23.7.2021 12:50:00 CEST | Press release
Schlumberger Limited (NYSE: SLB) today reported results for the second-quarter 2021. Second-Quarter Results(Stated in millions, except per share amounts)Three Months EndedChangeJun. 30, 2021Mar. 31, 2021Jun. 30, 2020SequentialYear-on-yearRevenue* $5,634 $5,223 $5,356 8% 5% Income (loss) before taxes - GAAP basis $542 $386 $(3,627) 40% n/m Net income (loss) - GAAP basis $431 $299 $(3,434) 44% n/m Diluted EPS (loss per share) - GAAP basis $0.30 $0.21 $(2.47) 43% n/m Adjusted EBITDA** $1,198 $1,049 $838 14% 43% Adjusted EBITDA margin** 21.3% 20.1% 15.6% 118 bps 561 bps Pretax segment operating income** $807 $664 $396 22% 104% Pretax segment operating margin** 14.3% 12.7% 7.4% 162 bps 694 bps Net income, excluding charges & credits** $431 $299 $69 44% 525% Diluted EPS, excluding charges & credits** $0.30 $0.21 $0.05 43% 500% Revenue by Geography International $4,511 $4,211 $4,224 7% 7% North America* 1,083 972 1,097 11% -1% Other 40 40 35 n/m n/m $5,634 $5,223 $5,356 8% 5% *Schlumberger di
Wyss Center Partners With Artiria Medical to Accelerate a Novel Therapy for Cerebral Vasospasm23.7.2021 11:59:00 CEST | Press release
The Wyss Center and Artiria Medical today announced a new partnership to accelerate the translation of a novel technology that has the potential to reduce deaths and improve quality of life for stroke patients. Artiria Medical, an early-stage medical device company focused on disruptive neurovascular products, has been developing the technology and is now joining forces with the Wyss Center, a non-profit organization dedicated to bringing state-of-the-art therapies to the patient. The team has received support from the Swiss Innovation Agency, Innosuisse, to test and validate the efficacy of the therapy preclinically, in preparation for human clinical studies. Stroke is the third leading cause of disability worldwide with more than 80 million people living with long-term impairments as a result. Some strokes result in bleeding in the brain. Such hemorrhagic strokes can lead to severe cerebral vasospasm - an uncontrolled contraction of brain arteries - in the days that follow, depriving