Initial results from EMPRISE real-world evidence study shows empagliflozin was associated with reduced risk for hospitalisation for heart failure compared with DPP-4 inhibitors in people with type 2 diabetes with and without cardiovascular disease
Initial effectiveness results from the real-world EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study showed empagliflozin was associated with a 44 percent relative risk reduction in hospitalisation for heart failure (HHF) compared with dipeptidyl peptidase-4 (DPP-4) inhibitors in routine clinical practice in the U.S. The EMPRISE analysis of data from approximately 35,000 people with type 2 diabetes between August 2014 and September 2016 will be presented at the American Heart Association® (AHA) Scientific Sessions 2018 in Chicago, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181105005408/en/
These results support findings from the EMPA-REG OUTCOME® trial, which showed a 35 percent relative risk reduction in HHF (a secondary endpoint) with empagliflozin, compared with placebo, when added to standard of care, in people with type 2 diabetes and established cardiovascular disease.1,2
“With more than a million hospital admissions for heart failure in the U.S. every year, it’s important to understand whether the relative risk reduction in hospitalisation for heart failure seen in the EMPA-REG OUTCOME® trial translates into routine clinical care,” said Elisabetta Patorno, M.D., DrPH, of the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Assistant Professor of Medicine, Harvard Medical School, and study co-investigator. “These first results from the EMPRISE study show that empagliflozin is associated with a reduction in hospitalisation for heart failure, and the effect is consistent in people with type 2 diabetes with and without history of cardiovascular disease.”
The full EMPRISE real-world evidence study will provide a clinical picture of empagliflozin in routine clinical care including comparative effectiveness, safety and healthcare resource utilisation and cost outcomes compared with commonly used DPP-4 inhibitors between 2014 and 2019. Early findings from EMPRISE, which at completion will assess the first five years of empagliflozin use in the U.S. through 2019, represent data collected between August 2014 and September 2016. The effectiveness findings will be updated as more data are gathered. Safety data from EMPRISE are not yet available and will be presented at a future time. EMPRISE was initiated, and is being led by academic partners from the Division of Pharmacoepidemiology at Brigham and Women’s Hospital and Harvard Medical School. The study is part of an academic collaboration between Brigham and Women’s Hospital and Boehringer Ingelheim.
“Insights from the EMPRISE real-world evidence study are critical in today’s healthcare landscape to understand how gold standard clinical trials, such as the EMPA-REG OUTCOME® trial, can reduce the burden of cardiovascular disease in patients seen in everyday clinical practice,” said Waheed Jamal, MD, Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “Initial results from EMPRISE suggest that, compared with DPP-4 inhibitors, empagliflozin provides cardioprotective benefits in people with type 2 diabetes with and without cardiovascular disease.”
By study completion, EMPRISE is expected to have analysed health records of more than 200,000 people with type 2 diabetes from two commercial U.S. healthcare providers and Medicare. From 2019, additional EMPRISE studies including Asia and Europe will provide insights from different regions of the world with an international perspective on the use of empagliflozin in routine clinical care.
“The Boehringer Ingelheim and Lilly Diabetes Alliance is committed to building a comprehensive clinical picture of empagliflozin across the cardiovascular risk continuum in type 2 diabetes,” stated Sherry Martin, M.D., vice president, Medical Affairs, Lilly Diabetes. “Physicians need better options to help their patients avoid hospitalisation for heart failure, and we are encouraged that these findings from EMPRISE complement cardiovascular results from the EMPA-REG OUTCOME® trial. We are committed to further understanding whether empagliflozin may have potential in this area and look forward to sharing the future results of the EMPRISE study.”
As part of their efforts to help address unmet needs, Boehringer Ingelheim and Lilly have initiated two large clinical trial programs focused on improving outcomes and reducing morbidity and mortality for people with heart failure. EMPEROR HF comprises two Phase III outcome trials investigating empagliflozin for the treatment of adults with chronic heart failure. The trials include not only adults with type 2 diabetes who have heart failure, but also people with heart failure who do not have diabetes.3,4 EMPERIAL comprises two Phase III studies evaluating the effect of empagliflozin on exercise ability and heart failure symptoms in people with chronic heart failure with or without type 2 diabetes.5,6
About EMPRISE (NCT03363464, EUPAS20677)
EMPRISE was initiated in 2016 to complement the EMPA-REG OUTCOME trial results by providing data on the comparative effectiveness, safety, healthcare resource utilisation and costs in routine clinical care compared with DPP-4 inhibitors in people with type 2 diabetes with and without cardiovascular disease.
The study will assess the first five years of empagliflozin use in the U.S. between 2014 to 2019. Over 200,000 people with type 2 diabetes from two commercial U.S. healthcare providers and Medicare are projected to be included by study completion. From 2019, additional EMPRISE studies including Asia and Europe will provide insights from different regions of the world with an international perspective on the use of empagliflozin in routine clinical care.
The EMPRISE study was initiated, and is being led, by academic partners from the Division of Pharmacoepidemiology at Brigham and Women’s Hospital and Harvard Medical School, Boston, USA. The study is part of an academic collaboration between Brigham and Women’s Hospital and Boehringer Ingelheim.
About EMPA-REG OUTCOME
EMPA-REG OUTCOME® was a long-term, multicenter, randomised, 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 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 Heart Failure
Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot pump enough blood around the body.7 Symptoms of heart failure include difficulty with breathing, swelling – most commonly in feet, legs and ankles – and fatigue, among others.8 Heart failure is a prevalent disease; 26 million people around the world have chronic heart failure.9 There is a high unmet need in the treatment of heart failure, as upto 45 percent of people diagnosed with heart failure will die within one year.10 Additionally, heart failure represents the most common cause of hospitalisation among individuals aged 65 years and over in the United States and Europe.9 Heart failure is highly prevalent in people with diabetes, but approximately half of all people with heart failure do not have diabetes.9,11,12
About Diabetes and Cardiovascular Disease
More than 425 million people worldwide have diabetes, of which over 212 million are estimated to be undiagnosed.13 By 2045, the number of people with diabetes is expected to rise to 629 million people worldwide.13 Type 2 diabetes is the most common form of diabetes, responsible for around 90 percent of diabetes cases in high-income countries.13 Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.13
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.14,15 People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes.15 In 2017, diabetes caused four million deaths worldwide, with cardiovascular disease as the leading cause.13 Approximately 50 percent of deaths in people with type 2 diabetes worldwide are caused by cardiovascular disease.16,17
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 by age 60 can shorten a person’s life span by as much as 12 years compared with someone without these conditions.18
More than 50 guidelines have been updated to endorse type 2 diabetes agents with proven cardiovascular benefits since 2016, including a recent Consensus Report initiated by the American Diabetes Association® and European Association for the Study of Diabetes, recommending that, in patients with type 2 diabetes and established atherosclerotic cardiovascular disease, SGLT2 inhibitors (such as empagliflozin) or GLP1 receptor agonists with proven cardiovascular benefits are recommended as part of glycaemic management.19,20
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.21,22,23
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.
Please click on the following link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/press-release/initial-results-emprise-real-world-evidence-study
Dr Petra Kienle
Product Communication Manager
Phone: +49 (6132) 77 143877
Director of Communications
Lilly Diabetes and Lilly USA
Phone: +1 (317) 432-5195
Om 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.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Personalis, Inc. to Present at European NeoAG Summit 201923.4.2019 15:00:00 CEST | Pressemelding
Personalis, Inc., a leader in advanced genomics for cancer, today announced that the company will present at European NeoAG Summit 2019 in Amsterdam on April 24th at 2:30 PM CEST. The presentation, entitled “ImmunoID NeXT Platform: Improving Neoantigen Prediction, TME Assessment, and ctDNA Detection for Vaccine Development,” will introduce Personalis’ new universal cancer immunogenomics platform, ImmunoID NeXT™. In addition to an overview, the presentation will highlight innovative genomics methods for more comprehensive assessment of neoantigens, which include improving neoantigen-to-MHC binding prediction and ranking and assessing TME/TCR and tumor escape mechanisms that may impact vaccine response. ImmunoID NeXT is the first platform to provide comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The platform can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays i
Keio Plaza Hotel Tama Opens My Melody, Little Twin Stars Rooms on June 15, 2019 - Sweet Dreams in Our Hello Kitty and Sanrio Character Rooms23.4.2019 14:05:00 CEST | Pressemelding
The Keio Plaza Hotel Co., Ltd., one of Japan’s most prestigious hotel companies operating hotels located in the Shinjuku district of Tokyo and other locations, is proud to announce the strengthening of its collaborative relationship with Sanrio Co., Ltd. (Headquarters: Shinagawa, Tokyo, President and CEO: Shintaro Tsuji) to expand facilities and services featuring “Hello Kitty” and other Sanrio characters at our Keio Plaza Hotel Tama. Our Tama Hotel will renovate a total of four additional rooms, including two rooms each in the themes of “My Melody” and “Little Twin Stars” (Kiki and Lala) who have been adored by fans around the world since their creation in 1975, to be opened on Saturday June 15, 2019, and thereby become the world’s first hotel to operate rooms in these themes on a regular basis. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190423005311/en/ New Sanrio characters rooms, including two rooms each in the theme
Project Management Institute, Inc. (PMI) Delivers Full Suite of Certification Exams in Over 5,000 Locations Through Expanded Testing Agreement with Pearson VUE23.4.2019 14:00:00 CEST | Pressemelding
Project Management Institute, Inc. (PMI), the leading not-for-profit professional membership association for the project management profession, and Pearson VUE, a global leader in the computer-based testing industry, have announced an expanded, multi-year agreement that will offer more testing options for candidates looking to earn PMI certifications at all stages of their career. The new agreement will offer candidates access to even more PMI certification tests as well as more flexibility in their testing location options, thanks to Pearson VUE’s global network of testing centers and online proctoring solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190423005149/en/ Beginning July 1, 2019, seven additional PMI programs, including the Project Management Professional (PMP)® – renowned as the global gold standard for project management professionals – will become available to professionals around the globe through Pe
Andersen Global Marks Growth to 50 Countries with Collaborating Firm in Zambia23.4.2019 13:30:00 CEST | Pressemelding
Andersen Global announced it achieved a new milestone today in its continuing growth with the addition of Mulenga Mundashi Kasonde Legal Practitioners (MMKLP). MMKLP, a law firm in Zambia, has signed a Collaboration Agreement with Andersen Global. The international association now has presence in 50 countries through its member and collaborating firms. Led by five partners, MMK has been advising clients in corporate mergers and acquisitions, tax, litigation, and labor and industrial resolutions since 1999. The firm is now one of the largest law firms in Zambia in its twentieth year. The collaborating firm will be the eleventh location in Africa for Andersen Global. “We’ve had the opportunity to advise on some of the highest profile financial events for Zambia in modern history,” said Micheal Mundashi, MMKLP Managing Partner. “One of the things that keeps us moving forward is the desire to provide even more for our local and international clients. Collaborating with Andersen Global will
Aventri Introduces Uber Vouchers to Deliver New Transportation Options23.4.2019 13:00:00 CEST | Pressemelding
Event management software (EMS) leader Aventri today announces a new partnership with Uber for Business. Aventri is the first EMS provider to launch a partnership with Uber for Business to offer customers the opportunity to utilize Uber Vouchers. Uber Vouchers’ web-based tool allows event organizers to provide VIP treatment to attendees with stress-free, reliable transportation to and from events. “We’re always looking for new partners to help our customers streamline events and add value,” said Brad Langley, vice president of channel and partner management for Aventri. “Uber for Business fits the bill. Using Uber Vouchers, organizers spend less time arranging logistics for moving groups, and their guests can come and go at a time that’s convenient for them.” Using Uber Vouchers, organizers can enhance the journey for themselves and their guests. Some benefits include: Customized Control: Organizers can easily create and manage campaigns online by setting parameters for pickup, drop-of
ECBC Debuts in Japan: Sumitomo Mitsui Banking Corporation Joins the Council23.4.2019 12:50:00 CEST | Pressemelding
The European Covered Bond Council (ECBC) is pleased to announce that Sumitomo Mitsui Banking Corporation, has become the latest member to join the Council, and the first Japanese member. Accordingly, the ECBC now represents 121 members from across more than 30 active covered bond jurisdictions around the world. This significant milestone is the culmination of intensive and constructive dialogue promoted by the ECBC in recent years in relation to covered bonds across the globe. The ECBC has long recognised the potential of this asset class in the Asian market and today’s announcement underlines the significance of a first active issuer in Japan, which paves the way to further development of the covered bond market in Japan and other Asian countries, following the example of South Korea and Singapore. Commenting on Sumitomo Mitsui Banking Corporation’s admission as a member, Luca Bertalot, EMF-ECBC Secretary General said: “We are delighted to welcome Sumitomo Mitsui Banking Corporation a