Business Wire

New analysis estimates the positive impact of empagliflozin on prolonging life expectancy in adults with type 2 diabetes and established cardiovascular disease

Jaa

Today, the journal Circulation published novel results based on data from the landmark EMPA-REG OUTCOME® trial, which suggest that treatment with empagliflozin positively impacts life expectancy in adults with type 2 diabetes and established cardiovascular disease. Using actuarial methods*, and assuming that the demonstrated beneficial effects of empagliflozin remain consistent with long-term use, empagliflozin was estimated to extend life expectancy by 1 to 4.5 years on average, depending on age, when compared with placebo.1 This analysis suggests that treatment with empagliflozin could add years of life.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181010005421/en/

In an analysis of data from 7,020 patients included in the EMPA-REG OUTCOME® trial, estimated life expectancy increased across all ages when adults were treated with empagliflozin as compared to those treated with placebo. Specifically, estimated mean survival in people aged 45 years was 32.1 years with empagliflozin versus 27.6 years with placebo, resulting in a mean survival difference of 4.5 years. In people aged 50, 60, 70 and 80 years old, the mean survival difference with empagliflozin compared to placebo was an additional 3.1 years, 2.5 years, 2 years and 1 year, respectively.1

The primary EMPA-REG OUTCOME ® trial results, published in the New England Journal of Medicine in September 2015, demonstrated a 38 percent relative risk reduction in cardiovascular death and a 32 percent relative risk reduction in all-cause mortality with empagliflozin in people with type 2 diabetes and established cardiovascular disease, compared with placebo, over a period of 3.1 years.2 Modelling based on the EMPA-REG OUTCOME ® trial data was used to quantify the potential benefit of empagliflozin on residual life span.

*Actuarial methods refer to the statistical techniques and analysis used to prepare mortality and other analytical tables

“For a 60-year-old living with type 2 diabetes, who has already had a cardiovascular event, previous studies estimate that life expectancy could be reduced by up to 12 years compared with someone of the same age without these conditions,” commented Brian Claggett, Ph.D., Division of Cardiovascular Medicine, Brigham and Women’s Hospital and lead author of the Circulation paper. “This latest analysis estimates that empagliflozin could prolong such a person’s life span by, on average, 2.5 years.”

About Diabetes and Cardiovascular Disease
More than 425 million people worldwide have diabetes, of which over 212 million are estimated to be undiagnosed.3 By 2045, the number of people with diabetes is expected to rise to 629 million people worldwide.3 Type 2 diabetes is the most common form of diabetes, responsible for around 90 percent of diabetes cases in high-income countries.3 Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.3

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.4,5 People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes.5 In 2017, diabetes caused four million deaths worldwide, with cardiovascular disease as the leading cause.3 Approximately 50 percent of deaths in people with type 2 diabetes worldwide are caused by cardiovascular disease.6,7

Having a history of diabetes at age 60 can shorten a person’s life span by as much as six years compared with someone without diabetes. And having both diabetes and a history of heart attack or stroke at age 60 can shorten a person’s life span by as much as 12 years compared with someone without these conditions.8

The American Diabetes Association and Diabetes Canada recommend the use of agents that have been proven to reduce the risk of cardiovascular events for patients with type 2 diabetes and established cardiovascular disease (such as empagliflozin).9,10

About the EMPA-REG OUTCOME trial ®2
The EMPA-REG OUTCOME® trial was a long-term, multicentre, randomised, double-blind, placebo-controlled trial of more than 7,000 people from 42 countries with type 2 diabetes at high risk for cardiovascular events.

The trial 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 for blood pressure and cholesterol). 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 Empagliflozin

Empagliflozin (marketed as Jardiance®) is an oral, once daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes medicine to include cardiovascular death risk reduction data in the label in several countries.11,12,13

Inhibition of SGLT2 with empagliflozin in people with type 2 diabetes and high blood sugar levels leads to excretion of excess sugar in the urine. In addition, initiation of empagliflozin increases excretion of salt from the body and reduces 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.

Empagliflozin is not approved for people with type 1 diabetes.

About Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centres on compounds representing several of the largest diabetes treatment classes. The alliance leverages the strengths of two of the world’s leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of people with diabetes and stand together to focus on patient needs. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributed to the alliance.

About Boehringer Ingelheim
Improving the health and quality of life of patients is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company therefore concentrates on developing innovative therapies that can extend patients’ lives. In animal health, Boehringer Ingelheim stands for advanced prevention.

Family-owned since it was established in 1885, Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2017, Boehringer Ingelheim achieved net sales of nearly 18.1 billion euros. R&D expenditure, exceeding three billion euros, corresponded to 17.0 per cent of net sales.

As a family-owned company, Boehringer Ingelheim plans in generations and focuses on long-term success. The company therefore aims at organic growth from its own resources with simultaneous openness to partnerships and strategic alliances in research. In everything it does, Boehringer Ingelheim naturally adopts responsibility towards mankind and the environment.

More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.

About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a wide range of therapies and a continued determination to provide real solutions—from medicines to support programs and more—we strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com.

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels.

Intended audiences
This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where Boehringer Ingelheim and Eli Lilly and Company do business.

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about empagliflozin and its safety profile, and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that JARDIANCE will receive additional regulatory approvals. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

###

1 Claggett B, et al. Long-Term Benefit of Empagliflozin on Life Expectancy in Patients with Type 2 Diabetes Mellitus and Established Cardiovascular Disease. Circulation. 2018;138:1599-1601.

2 Zinman B. et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015;373:2117-2128.

3 International Diabetes Foundation. Diabetes Atlas 8th Edition. Available at: http://www.diabetesatlas.org. Accessed: March 2018.

4 World Health Organisation. Diabetes: Fact Sheet no. 312. Available at: www.who.int/mediacentre/factsheets/fs312/en/#. Last accessed March 2018.

5 World Heart Federation. Diabetes as a Risk Factor for Cardiovascular Disease. Available at: www.world-heart-federation.org/cardiovascular-health/cardiovascular-disease-risk-factors/diabetes. Last accessed March 2018.

6 Morrish NJ et al. Mortality and Causes of Death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia. 2001;44(2):S14–21.9.

7 Einarson TR, Acs A, Ludwig C, et al. Prevalence of cardiovascular disease in type 2 diabetes: a systematic literature review of scientific evidence from across the world in 2007–2017. Cardiovasc Diabetol. 2018;17:83.

8 The Emerging Risk Factors Collaboration. Association of Cardiometabolic Multimorbidity With Mortality. JAMA. 2015;314(1):52-60.

9 American Diabetes Association. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes – 2018. Diabetes Care. 2018;41 [Suppl.1]:S86-S104.

10 Diabetes Canada Clinical Practice Guidelines Expert Committee. Diabetes Canada 2018 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada. Can J Diabetes. 2018;42(Suppl 1):S1-S325.

11 Jardiance® (empagliflozin) tablets U.S. Prescribing Information. Available at: http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf. Last accessed August 2018.

12 European Summary of Product Characteristics Jardiance®, approved May 2018. Data on file.

13 Jardiance® (Full Prescribing Information). Mexico; Boehringer Ingelheim Pharmaceuticals, Inc; 2017.

Contact information

Boehringer Ingelheim
Dr Petra Kienle

Product Communication Manager
Email: press@boehringer-ingelheim.com
Phone: +49 (6132) 77 143877
or
Lilly Diabetes and Lilly USA
Greg Kueterman

Director of Communications
Email: kueterman_gregory_andrew@lilly.com
Phone: +1 (317) 432-5195

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Vertex Announces European Commission Approval for ORKAMBI® (lumacaftor/ivacaftor) for Treatment of Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease21.1.2019 12:00Tiedote

Vertex Pharmaceuticals (Europe) Limited today announced that the European Commission has granted approval of the label extension for ORKAMBI® (lumacaftor/ivacaftor) for the treatment of children with cystic fibrosis (CF) aged 2 to 5 years old who have two copies of the F508del mutation, the most common form of the disease. “Today’s approval by the European Commission brings us one step closer to our goal of bringing treatment to all people living with CF,” said Reshma Kewalramani, MD, Executive Vice President, Global Medicines Development and Medical Affairs and Chief Medical Officer at Vertex. ‘‘By treating the underlying cause of disease early, we can potentially modify its course and offer patients the chance of improved outcomes.’’ The label update is based on data from a Phase 3 open-label safety study in 60 patients that showed treatment with lumacaftor/ivacaftor was generally well tolerated for 24 weeks, with a safety profile in these pediatric patients generally consistent with

Anticipation Builds as MWC19 Barcelona Approaches21.1.2019 12:00Tiedote

The GSMA today announced final updates for MWC19 Barcelona (formerly Mobile World Congress), including additional keynote speakers, participating companies, programmes and events. Taking place 25-28 February 2019, with events being staged at Fira Gran Via, Fira Montjuïc and La Farga L’Hospitalet, MWC19 Barcelona is set to attract more than 107,000 professionals from over 200 countries and territories. “With the anticipated arrival of 5G, this year’s event is set to be one of the most exciting as the industry convenes to showcase Intelligent Connectivity across new technologies on the brink of reaching millions of people across the world,” said John Hoffman, CEO, GSMA Ltd. “Over the four days of MWC19, attendees will have the opportunity to hear from leaders who are driving innovation and we look forward once again to welcoming the mobile world to Barcelona.” Global Leaders to Keynote The GSMA announced the addition of several new keynote speakers for MWC19 including executives from lea

B2C2 Launches Streaming OTC Pricing with Point-and-Click Execution21.1.2019 12:00Tiedote

B2C2, one of the largest cryptocurrency liquidity providers and the leader in electronic OTC trading, today announced the launch of streaming pricing with point-and-click execution on its OTC platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190121005063/en/ Max Boonen, Founder and CEO of B2C2 (Photo: Business Wire) For the first time, B2C2’s clients will be able to view and execute trades on a real-time two-way market, via the firm’s secure web interface. The new functionality allows market participants to easily monitor live pricing in user-defined quantities and execute with the click of a button, as they would on traditional FX trading platforms. The launch rounds out a number of milestones for B2C2 in 2018, including surpassing 2017 peak volumes; rolling out a completely redesigned front-end; forming integration partnerships with the major liquidity hubs; and launching a research offering. Founded in 2015, B2C2 i

Alnylam Pharmaceuticals and Medison Pharma Partner to Commercialize RNAi Therapeutics in Israel21.1.2019 11:00Tiedote

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, and Medison Pharma, Israel’s leading commercial partner for innovative pharmaceuticals, announced today an exclusive agreement to commercialize ONPATTRO®, the first-ever commercialized RNAi therapeutic, as well as other investigational therapeutics under development in the Alnylam RNAi portfolio. “Our partnership with Medison marks an important step in our global commercial expansion and signals our intent to ensure that patients suffering from serious rare diseases have access to our medicines, regardless of location,” said Theresa Heggie, SVP and Head of Europe, Middle East and Africa, and Canada, Alnylam Pharmaceuticals. “Medison has a strong organization with a proven track record of commercializing orphan products successfully, together with an infrastructure uniquely suited to supporting patients suffering from rare diseases in Israel and providing access to our potentially transformational thera

Gore Introduces GORE® TAG® Conformable Thoracic Stent Graft with Reduced Profiles in Europe21.1.2019 11:00Tiedote

W. L. Gore & Associates, Inc. (Gore) today introduced reduced profiles for the most commonly used diameters of the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System. The reduced profile allows physicians to perform TEVAR in patients with smaller vessels where access is challenging and aortic anatomy is tortuous, expanding the availability of Gore’s thoracic stent graft to a greater population of patients. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190121005042/en/ GORE(R) TAG(R) Conformable Thoracic Stent Graft with ACTIVE CONTROL System (Photo: Business Wire) The GORE® TAG® Conformable Thoracic Stent Graft was modified to reduce the delivery profile of the 31, 37, and 40 mm device diameters by 2 Fr for all lengths. The reduction in profile, through the use of a smaller diameter primary sleeve, is the only change to the device. The stent graft leverages the same predictable outcomes of the time-teste

HCL 2030 Ecosystem Platform to Explore Societal Implications of Emerging Technology at the World Economic Forum21.1.2019 10:26Tiedote

HCL Technologies (HCL), a leading global technology company and the World Economic Forum’s Strategic Partner, today announced its largest presence to date at the side-lines of World Economic Forum’s Annual Meeting in Davos scheduled from 21st January 2019 to 25th January 2019. The company will host a three-day event in a special Pavilion that will feature a technology showcase, thought-leadership programs, as well as a number of high-level networking and social events throughout the tenure of the conference. The overarching theme of the HCL and Fast Company programs will explore how humanity’s relationship with technology will evolve through the next decade of rapid innovation. HCL has partnered with Fast Company to develop a thought-leadership track that includes three panel discussion breakfasts. As part of the theme of Human-Machine Harmony, HCL is launching the HCL 2030 Platform, together with its ecosystem of partners and stakeholders, that will conduct in-depth explorations and d

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme