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
GE’s AffinityTM: The first civil supersonic engine in 55 years – launching a new era of efficient supersonic flight15.10.2018 22:17 | Pressemelding
At a press conference with Aerion Corporation today, GE Aviation announced that it has completed the initial design of the first supersonic engine purpose-built for business jets. This new engine class, revealed today as GE’s AffinityTM turbofan, is optimized with proven GE technology for supersonic flight and timed to meet the Aerion AS2 launch. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181015005961/en/ The name “Affinity” was chosen because it reflects this engine class’ harmonious assemblage of GE’s commercial, non-civil and business aviation propulsion technologies to bring a true step-change in commercial supersonic propulsion. (Photo: Business Wire) The Affinity is a new class of medium bypass ratio engines that provide exceptional and balanced performance across supersonic and subsonic flights. The Affinity integrates a unique blend of proven military supersonic experience, commercial reliability and the most adv
IFF to Release Third Quarter 2018 Results November 515.10.2018 20:15 | Pressemelding
Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF), a leading innovator of scent, taste, and nutrition, announced that it will release its third quarter 2018 earnings results following the market close on Monday, November 5, 2018. The management team will host a live webcast on Tuesday, November 6, 2018 at 10:00 a.m. ET to discuss results and outlook with the investor community. Investors may access the live webcast and accompanying slide presentation on the Company's website at ir.iff.com. For those unable to listen to the live webcast, a recorded version will be made available for replay. Meet IFF International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF) is a leading innovator of scent, taste, and nutrition, with over 110 manufacturing facilities, 100 R&D centers, and 33,000 customers globally. At the heart of our company, we are fueled by a sense of discovery, constantly asking “what if?”. That passion for
Sumitomo SHI FW Wins Contract for Biomass CFB Boiler Island in South Korea15.10.2018 20:00 | Pressemelding
Sumitomo SHI FW (SFW) announces today that it has been awarded a contract by SK Engineering & Construction Co., Ltd. for design and supply of SMG Energy’s SMG Biomass Power Plant to be located in Gunsan City in the Republic of Korea. Commercial operation of the new plant is scheduled for December 2020. SFW will design and supply the 100 MWe CFB steam generator and auxiliary equipment for the boiler island. The CFB steam generator will be designed to burn 100% wood pellets, while meeting applicable environmental regulatory requirements. SFW has supplied over 30 CFB steam generators to South Korea and this is the fourth firing biomass as its primary fuel. Tomas Harju-Jeanty, CEO, Sumitomo SHI FW, said: “Both higher efficiency and the use of biomass in power generation can contribute significantly to reducing emissions of carbon dioxide. SFW’s CFB technology is a perfect solution to meet these market requirements. We are pleased to again be chosen to play a part in helping South Korea mee
AMPLEXOR to Present on Neural Machine Translation Engine at Artificial Intelligence Event: 30 Years of DFKI – 30 Years of AI for Humans15.10.2018 19:09 | Pressemelding
AMPLEXOR: MEDIA ADVISORY: The German Research Center for Artificial Intelligence (DFKI) is one of the largest Artificial Intelligence (AI) centers of excellence globally, and is celebrating the 30th anniversary of its efforts partnering and researching AI for humans with an event, 30 Years of DFKI – 30 Years of AI for Humans. AMPLEXOR is honored to be the only external partner presenting at the event and will join senior researcher from DFKI, Raphael Rubino, to demonstrate AMPLEXOR’s enterprise-grade, neural machine translation (NMT) solution, developed in collaboration with DFKI. The NMT collaboration with DFKI was announced earlier in 2018 to support the translation of content in highly specific and demanding industries, Life Sciences and medical devices. The solution aims to significantly reduce the amount of human intervention to produce professional translation quality and has consistently outperformed customized engines from well-known MT providers. What: AMPLEXOR joins DFKI to c
Lehman Brothers Treasury to Further Explore Strategic Opportunities15.10.2018 16:54 | Pressemelding
Lehman Brothers Treasury Co. B.V. in liquidation (“LBT”) today, through its U.S. counsel Kramer Levin Naftalis & Frankel LLP, announced that the liquidators of LBT are continuing to explore various strategies to, among other things, facilitate the consolidation of the LBT creditor base and the wind-down of the LBT estate. To that end, the liquidators of LBT intend to engage with certain of LBT’s creditors and other market participants regarding potential strategies, including, but not limited to, a potential sale of a portion of LBT’s assets. No assurances can be made that any strategy will be employed, or if one is employed, the timing of its implementation. LBT does not undertake to publicly update its disclosure to reflect developments in this matter. View source version on businesswire.com: https://www.businesswire.com/news/home/20181015005777/en/ Contact information Kramer Levin Naftalis & Frankel LLP Daniel Eggermann, 212-715-9495
SFL – Third-Quarter 2018 Financial Information15.10.2018 16:28 | Pressemelding
Regulatory News: SFL (Paris:FLY): Consolidated revenue by business segment (€000's) 2018 (9 months) 2017 (9 months) Rental income 143,790 147,819 o/w Paris Central Business District 119,038 114,326 Paris Other 22,479 21,526 Western Crescent 2,273 11,967 Other revenue 0 0 Total consolidated revenue 143,790 147,819 At €143.8 million, consolidated rental income for the first nine months of 2018 was down €4.0 million or 2.7% compared to the €147.8 million reported for the same period of 2017. The decline was due to the disposal of the IN/OUT property in September 2017, the effects of which were offset to a significant extent by growth in like-for-like income. On a like-for-like basis (excluding all changes in the portfolio affecting period-on-period comparisons), rental income was €6.0 million (4.6%) higher, reflecting the contribution of new leases signed in 2017 and 2018, mainly in the Washington Plaza, 103 Grenelle, Cézanne Saint-Honoré and 9 Percier properties, as well as an increase i