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
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
LivaNova Enters into Binding Letter of Intent to Sell its Cardiac Rhythm Management Business Franchise to MicroPort Scientific Corporation for $190 Million20.11.2017 08:43 | Pressemelding
LivaNova PLC (NASDAQ:LIVN) (“LivaNova”) and MicroPort Scientific Corporation (HK:00853) (“MicroPort”) today announced that the companies have entered into a binding Letter of Intent (“LOI”) for the sale of LivaNova’s Cardiac Rhythm Management (“CRM”) Business Franchise to MicroPort for $190 million in cash. The CRM Business Franchise develops, manufactures and markets products for the diagnosis, treatment and management of heart rhythm disorders and heart failures. CRM products include high-voltage defibrillators, cardiac resynchronization therapy devices and low-voltage pacemakers. The CRM Business Franchise generated approximately $249 million in net sales in fiscal year 2016 and has approximately 900 employees with operations chiefly in Clamart, France; Saluggia, Italy; and Santo Domingo, Dominican Republic. MicroPort is a leading medical device company, focused on innova
Chugai's Bispecific Antibody Emicizumab Meets Primary Endpoint in Phase lll Study20.11.2017 08:29 | Pressemelding
Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that the primary endpoint has been met for the global phase lll HAVEN 3 (NCT02847637) study evaluating emicizumab (ACE910) subcutaneous injection, once a week and once every two weeks, in patients with hemophilia A (12 years of age or older) without inhibitors to factor Vlll. A statistically significant reduction in the number of bleeds was confirmed in patients treated with emicizumab prophylaxis compared to those receiving no prophylactic treatment. The study also met a secondary endpoint that once-weekly emicizumab prophylaxis was superior to factor VIII prophylaxis, as demonstrated by a statistically significant and clinically meaningful reduction in treated bleeds in an intra-patient comparison of patients receiving emicizumab prophylaxis compared to their prior factor VIII prophylaxis. The most common adverse events with em
Fiorano Launches PSD2 Solution for Banks for Seamless Regulatory Compliance20.11.2017 08:00 | Pressemelding
Fiorano Software, a proven global leader in Integration Middleware and API Management, today announced the launch of Fiorano PSD2, a platform solution enabling banks to comply with the European Union’s Revised Payment Service Directive (PSD2) regulations. Fiorano’s end-to-end PSD2 solution is built on the industry's leading banking Integration and API Management infrastructure serving as an onramp for future eDigital Banking initiatives. Banks across Europe need to be PSD2 compliant by January 2018. They are also facing severe competition from FinTechs to improve online payments, customer engagement experiences and making cross-border payments safer. “By building on PSD2 as a solution on top of a tightly integrated API Management and ESB platform, Fiorano masks complex technical details, dramatically simplifies the time and effort for compliance,” said Mr. Atul Saini, CEO of Fio
Synteract Thought Leaders to Speak & Exhibit at Partnerships in Clinical Trials Europe in Amsterdam20.11.2017 08:00 | Pressemelding
(Booth #17) – Thought leaders from Synteract, a full-service, international contract research organization (CRO), will exhibit and present at Partnerships in Clinical Trials Europe (PCT), November 28-29, Amsterdam, Netherlands. With awareness of the shifting CRO landscape and the complexity this represents to biopharma companies as they make critical outsourcing decisions, Synteract invites attendees to “Pause to rethink what matters most from your CRO.” Vice President, Global Medical and Regulatory Affairs at Synteract, Dr. Martine Dehlinger-Kremer, will speak on “The EU Clinical Trials Regulation: Are you prepared for its implementation?” at the event on Tuesday, November 28 at noon. She will address how evolving industry needs are driving momentum towards implementation of a new regulation governing clinical trials, the expected impact on sponsors and necessary steps toward p
Record Attendance at Japan Content Showcase 2017!20.11.2017 03:00 | Pressemelding
Japan Content Showcase 2017 was held October 23-26 at Ikebukuro Sunshine City and the Shibuya Excel Hotel Tokyu. A record 19,549 people participated in sales meetings, excluding the TIMM Showcase Live. Other new records this year were 371 exhibiting groups from 27 countries and regions and 1,549 buyers from 48 countries and regions. There was a significant increase in overseas buyers this year, the 1022 foreign registrations representing an increase of more than 10% over last year. The number of non-Japanese Asian buyers increased by 6%, North Americans by 13%, South Americans by 44%, and Europeans by 49%. The number of Middle Eastern buyers doubled, and there were more than five times the number of Russian buyers as last year. French buyers were up 70%, Italians 60%, British 75%, and Germans 50%. Business matching was a new service offered by the organizers this year. Meeti
Shell, bio-bean and Coffee-Drinkers Collaborate to Help Power London’s Buses20.11.2017 00:01 | Pressemelding
Shell and bio-bean announce that together they are helping to power some of London’s buses using a biofuel made partly from waste coffee grounds. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171119005060/en/ Shell and bio-bean announce that together they are helping to power some of London's buses using a biofuel made partly from waste coffee grounds (Photo: Business Wire) The B20 biofuel contains a 20% bio-component which contains part coffee oil. The biofuel is being added to the London bus fuel supply chain and will help to power some of the buses; without need for modification. Biofuel provides a cleaner, more sustainable energy solution for buses across London’s network by decreasing emissions1. “Our Coffee Logs have already become the fuel of choice for households looking for a
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom