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
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
The “Centre Hospitalier de la Côte Basque” in France Has Started the Evaluation of the Biolog-id’s C-LOG® Solution20.6.2019 18:35:00 EEST | Tiedote
The Centre Hospitalier de la Côte Basque (CHCB) in Bayonne has been using Biolog-id's C-LOG® solution since early April 2019. This solution secures and optimizes the circuit of chemotherapy and immunotherapy, from their preparation all the way to the administration to the patient. The C-LOG® solution has been used at the CHCB. "During the last HAS audit, a lack of traceability was revealed in the chemotherapy circuit. In order to close this gap, we decided to install the C-LOG® solution which, in addition to securing the administration to the patient's bed, makes it possible to trace the preparation circuit from the pharmacy to the reception in the nurses station," says Dr. Burtin, Pharmacist at CHCB. The solution will be tested for evaluation for 3 months before final adoption. "The RFID (Radio Frequency Identification) technology is the foundation of our solution. The tag affixed on each preparation contains the product and patient data. This information is updated in real-time and c
CSC Announces Cyber Security Findings for the Media Industry20.6.2019 18:00:00 EEST | Tiedote
Securing a company’s digital infrastructure has become a major concern to corporations worldwide. With leading security companies and other organizations alerting corporations and the public to recent widespread, state-sponsored domain name system (DNS) hijacking, more and more brands are starting to take action. CSC has been issuing Cyber Security Reports since 2017, culling the most important information about security risks, and in particular, risks to brands that are not mitigated by a traditional firewall. The recent research conducted by CSC focuses on the media industry, revealing that 78% of global media brands use a corporate domain registrar, yet only 37% of those have a registrar lock to protect their DNS from hijacking. Recent domain hijacking, unauthorized changes, and deletion of vital domains have shown that effectively managing domain names and DNS must become a critical component for enhancing the security posture of any company with an online presence. More worrisome
Arch Capital Group Names Seamus Fearon EVP, Credit Risk Transfer and Services, Global Mortgage Group20.6.2019 16:00:00 EEST | Tiedote
Arch Capital Group Ltd. (Arch) today announced that Seamus Fearon has been promoted to Executive Vice President, Credit Risk Transfer and Services, Global Mortgage Group. In this role, Fearon will have responsibility for managing Arch’s credit risk transfer (CRT) business and growing its credit risk services offerings. He most recently was Chief Actuary of Arch’s Global Mortgage Group, where he oversaw its capital management framework and the development of its analytics and modeling capabilities. This newly created role highlights Arch’s focus on participating in credit risk transfer programs and supporting customers who would like to enter that growing market. “As the mortgage insurance market in the U.S. becomes even more competitive, it’s important for Arch to diversify its mortgage business to ensure we remain at the forefront of the industry,” said David Gansberg, CEO of Arch’s Global Mortgage Group. “Seamus brings both an analytical perspective and business acumen to these units
Hot Wheels Teams Up With Nintendo to Bring the World of Mario Kart to Fans With New Die-cast Toy Line20.6.2019 16:00:00 EEST | Tiedote
Today Hot Wheels and Nintendo announce the global release of Hot Wheels Mario Kart die-cast vehicles and track sets. With its introduction, the beloved Nintendo characters and iconic karts from the hugely popular Mario Kart franchise have been transformed into authentic, high-performance die-cast toy vehicles. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190620005167/en/ Three Hot Wheels Mario Kart game-inspired track sets will be available this summer. (Photo: Business Wire) The Hot Wheels replica line features 1:64th scale die-cast Mario Kart vehicles that can race, stunt and crash on a variety of Hot Wheels Mario Kart track sets that bring the gameplay to life. The die-cast karts are also compatible with existing Hot Wheels sets. At launch the Hot Wheels Mario Kart Replica Die-cast assortment will include Mario, Yoshi, Luigi and Bowser with many additional characters coming soon such as Princess Peach, Koopa Troopa and
Lumileds Highlights Environmental, Health and Safety Milestones in First Sustainability Report20.6.2019 16:00:00 EEST | Tiedote
Lumileds, a global leader in innovative lighting solutions, today released its 2018 Sustainability Report, which details the company’s progress in supporting the transition to a worldwide low-carbon economy. In the report, Lumileds highlights how its lighting solutions are contributing to positive changes in energy usage, safety, and health and wellness, supporting the company’s commitment to making the world safer, better and more beautiful with light. Lumileds follows a formalized sustainability agenda that identifies specific priorities and tracks progress. For example, in its global LED and automotive lighting operations, the company recently surpassed its 2020 operational goals relative to 2015 including: 41% reduction in emissions (20% goal) 25% reduction in energy consumption (20% goal) 25% reduction in water usage (20% goal) The sustainability objectives are based on creating value for customers through sustainable innovations, reducing the environmental footprint of the compan
Cargo Screening Technology by Smiths Detection at the Mega Tema Port Expansion in Ghana20.6.2019 14:22:00 EEST | Tiedote
Smiths Detection has won a contract with Meridian Port Services Limited (MPS) to provide cargo inspection technology for the major Tema Port Expansion project in Ghana - designed to accommodate the world’s largest container ships, improve cargo handling productivity and increase trade to both Ghana and the rest of Africa. Four Smiths Detection HCVPZ60 scanning portals were selected to deliver the Ghanaian authorities more efficient border security, while safeguarding state revenue derived from duties and taxes on containerised goods. With trade anticipated to grow in Ghana in the coming years, these portals have been selected in part because of their ability to facilitate fast and effective security processing of a high volume of container traffic. The HCVPZ60 can penetrate 9-11.8 inches of steel whilst maintaining a throughput of up to 100 trucks per hour. Smiths Detection’s advanced screening technology, iCMORE will also be deployed, to expose containers falsely declared as empty. Th
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