Jardiance® reduced risk of cardiovascular death in people with type 2 diabetes and established CV disease* independent of background blood sugar control
New analyses of the landmark EMPA-REG OUTCOME® trial showed that Jardiance® (empagliflozin) reduced the risk of cardiovascular death in patients with type 2 diabetes and established cardiovascular (CV) disease*, independent of blood sugar control at the start of the study.1 A reduction in cardiovascular death was also seen when Jardiance® was added to common first and second-line diabetes medications, such as metformin or sulphonylurea.2,3 These results from post-hoc analyses were presented by Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) at the 53rd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Lisbon, Portugal.
This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170912005928/en/
“Now that we have a new option for reducing the risk of cardiovascular death among people with type 2 diabetes, we are striving to better understand if there are differences in how patients can benefit,” said Prof. Silvio Inzucchi, Section of Endocrinology, Yale School of Medicine, New Haven, USA, who presented the data today. “These new analyses of the EMPA-REG OUTCOME® trial showed empagliflozin was effective in reducing the risk of cardiovascular death in patients with type 2 diabetes and established cardiovascular disease, no matter what the blood sugar levels at the start of the study were or if empagliflozin was added to commonly used oral blood sugar lowering treatments.”
In all four blood sugar level groups at study start (HbA1c levels of <7.0%, 7.0% to <8.0%, 8.0% to <9.0% and ≥9.0%), patients receiving Jardiance® demonstrated a reduction in the risk of cardiovascular death compared with placebo. This was consistent with the risk reduction seen in the overall trial population* and seen irrespective of whether blood sugar control was improved following introduction of the study treatment (as measured by a decrease in HbA1c level of ≥ 0.5% at week 12).1
Additional post-hoc analyses showed that when Jardiance® was added to metformin or sulphonylurea, the reduction of cardiovascular death compared to placebo was consistent with the overall trial population*. These analyses also showed the proportion of patients with hypoglycaemic adverse events were similar between the placebo and Jardiance® groups in the EMPA-REG OUTCOME® trial.2,3
The 7,020-patient EMPA-REG OUTCOME® trial results, first published in the New England Journal of Medicine in 2015, had shown that Jardiance® reduced the relative risk of cardiovascular death by 38 percent compared to placebo in patients with type 2 diabetes and established cardiovascular disease* on top of standard of care (including glucose-lowering agents and cardiovascular drugs). The overall safety profile of Jardiance® was consistent with that of previous clinical trials and current label information.4,5
“Cardiovascular disease is the primary cause of death in people with type 2 diabetes," said David Kendall, M.D., Distinguished Medical Fellow, Lilly Diabetes. “The results presented at EASD provide further evidence of the benefit empagliflozin can provide to patients with different background blood sugar control.”
“The Boehringer Ingelheim and Eli Lilly Diabetes Alliance leads the paradigm shift in the treatment of people with type 2 diabetes”, said Dr Georg van Husen, Corporate Senior Vice President, Head of the Therapeutic Area CardioMetabolism, Boehringer Ingelheim. “The EMPA-REG OUTCOME® trial showed a remarkable reduction in CV death by 38% and the new data indicates that this effect is independent of the blood sugar control."
Empagliflozin (marketed as Jardiance®) is an oral, once daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor approved for use in Europe, the United States and other markets around the world for the treatment of adults with type 2 diabetes.
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 (i.e. sodium) and reduces the fluid load of the body’s blood vessel system (i.e. intravascular volume). The glucosuria, natriuresis and osmotic diuresis observed with empagliflozin may contribute to the improvement in cardiovascular outcomes.5
Empagliflozin is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
About EMPA-REG OUTCOME
EMPA-REG OUTCOME® 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 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.
Over a median of 3.1 years, Jardiance® significantly reduced the risk of CV death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo. The risk of CV death was reduced by 38 percent, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. The overall safety profile of empagliflozin was consistent with that of previous trials.
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 Jardiance 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.
Please click on the link below for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/EASD-2017
*Adult patients with type 2 diabetes and coronary artery disease, peripheral artery disease, or a history of myocardial infarction or stroke
Dr Petra Kienle
Product Communication Manager
Phone: +49 (6132) 77 143877
Phone: +1 (317) 478 5423
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
Versum Materials Celebrates the Grand Opening of Its Research and Development Facility in Hometown, PA19.4.2018 20:37 | Pressemelding
Versum Materials, Inc. (NYSE: VSM), a leading materials supplier to the semiconductor industry, announced today the grand opening of its new research and development (R&D) facility at its semiconductor materials manufacturing site in Hometown, Pennsylvania. The ribbon-cutting ceremony took place April 10, 2018. Versum employees, members of the community, local government, customers and strategic partners attended the event. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180419006305/en/ Versum Materials ribbon-cutting ceremony at the company's new R&D facility in Hometown, PA. (Photo: Business Wire) The state-of-the-art R&D laboratory is dedicated to new materials used in the manufacture of semiconductors. Scientists in the facility will synthesize and purify new molecules down to parts per billion impurity levels and below using the latest technologies available in the industry. The researchers can assess the applications f
Pharnext to Showcase PLEOTHERAPY™ R&D Platform at the 8th Annual Global Orphan Drug Conference19.4.2018 15:45 | Pressemelding
Regulatory News: Pharnext SA (Paris:ALPHA) (FR0011191287 - ALPHA), a biopharmaceutical company pioneering a new approach to the development of innovative drug combinations based on big data genomics and artificial intelligence, today announced that Rodolphe Hajj, Ph.D., the Company’s Chief Pharmacology Officer, will present at the 8th Annual Global Orphan Drug Conference. The presentation will take place as follows: Date & Time: Wednesday April 25th at 4:40 pm EST Title: “Next generation drug repurposing using network pharmacology to develop new therapeutic entities for rare diseases” Venue: Gaylord National Harbor Hotel, Oxon Hill, MD, U.S. Pharnext’s team will also attend the 2018 American Academy of Neurology Annual Meeting as a first-time exhibitor (booth 908). The meeting will take place on April 21-27, 2018 in Los Angeles, CA, U.S. If you are interested in meeting the Pharnext management team during these events, please send an email to email@example.com. About Pharnext Pharne
New Study Investigates the Utility of Masimo SpHb® in Post-operative Red Blood Cell (RBC) Transfusion Best Practices19.4.2018 15:01 | Pressemelding
Masimo (NASDAQ: MASI) announced today the findings of an abstract presented at the 2018 Annual Meeting of the Network for the Advancement of Patient Blood Management, Haemostatis and Thrombosis (NATA), in which researchers investigated the utility of Masimo noninvasive and continuous hemoglobin (SpHb®) in supporting and enhancing red blood cell (RBC) transfusion best practices as part of post-operative patient blood management (PBM).1 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180419005949/en/ Masimo Radical-7® with SpHb® and RD rainbow SET™ Sensor (Photo: Business Wire) In the study, Prof. Baricchi and colleagues in the Transfusion Medicine Unit, AUSL-IRCCS of Reggio Emilia and at the Department of Medicine and Surgery at the University of Parma, Italy, sought to evaluate the appropriateness of post-operative RBC transfusion over a three-year period (2013-2015), before and after implementation of a patient blood managem
Synteract Repositions Itself with Centers of Therapeutic Development and Unveils Updated Brand Platform19.4.2018 14:06 | Pressemelding
Synteract, an innovative contract research organization (CRO) providing full-service, Phase I-IV services to biopharma companies bringing new medicines to market, has enhanced its focus. The CRO today announced the creation of therapeutic centers of development that include some of the most progressive in the biopharma industry: oncology, especially leading edge immunotherapy studies, neuro-degenerative disorders, pediatrics, and rare and orphan disease. In addition, Synteract revealed its new market positioning with an updated logo, tagline, and website to reinforce its core capabilities. Synteract’s leadership has been proven in these core development areas, over its nearly 30-year history, through its contributions to more than 240 product approvals. Formal establishment of its new centers of development bring more visibility to Synteract’s longstanding, specialized expertise in these complex areas of clinical research. Synteract CEO Steve Powell says, “By aligning operational excel
Nel ASA: Receives Additional Purchase Order from Nikola19.4.2018 14:00 | Pressemelding
Nel ASA (Nel, OSE: NEL) has received a USD 5.5 million purchase order from Nikola Motor Company (Nikola), as part of the previously announced hydrogen stations. “We are very proud to announce that we have received an additional order from Nikola related to the electrolyzer and fueling solution for their prototype trucks. The order marks a strengthening of our partnership and is a recognition of the level of competence our team and hydrogen solutions can offer. We look forward to supplying the demo stations, which will lay the groundwork for the world’s largest, most efficient network of low-cost hydrogen production and fueling sites,” says Jon André Løkke, Chief Executive Officer of Nel. On November 15, 2017, Nikola and Nel announced the exclusive partnership and a purchase order for two so-called demo hydrogen refueling stations for Nikola's fleet of prototype hydrogen trucks. The partnership aims at developing low-cost, renewable hydrogen production and fueling sites for the potentia
Voith and Franka Emika Form a Strategic Partnership19.4.2018 13:39 | Pressemelding
The technology company Voith and the Munich-based robotics company Franka Emika have entered into a strategic partnership. Part of the strategic partnership is the establishment of a new joint venture called Voith Robotics – A Voith and Franka Emika Company. The company, with headquarters in Munich, is to become a global system supplier for robot-assisted automation in the digital age. Voith Robotics will offer self-teaching lightweight robots made by Franka Emika, along with software solutions, apps, services and process consulting, to customers in various industries and markets throughout the world. As part of the strategic partnership Voith will also have a direct stake in Franka Emika, thus emphasizing the long-term and strategic commitment by the two companies to cooperation. Martin Scherrer, formerly a member of the Board of Management of Voith Paper, will be the new chief executive officer of Voith Robotics, which is to be managed by Voith. The still very young market for collab