Thursday, March 22, 2018

Jardiance® reduced risk of cardiovascular death in people with type 2 diabetes and established CV disease* independent of background blood sugar control
  SocialTwist Tell-a-Friend  

Date: 13-09-2017 11:17AM
Source: Boehringer Ingelheim
Category: Business/ Finance, Pharmaceutical, General, Science & Research, Healthcare & Biotechnology, Pharmaceutical
Location: Ingelheim, Germany & Indianapolis, United States

Business Wire India

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:

“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."

About Empagliflozin
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).

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.

Intended audiences
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’:

*Adult patients with type 2 diabetes and coronary artery disease, peripheral artery disease, or a history of myocardial infarction or stroke



Boehringer Ingelheim
Dr Petra Kienle
Product Communication Manager
Phone: +49 (6132) 77 143877
Lilly Diabetes
Molly McCully
Phone: +1 (317) 478 5423

More Press Releases

GSMA Advances a Comprehensive Agenda on Digital Inclusion for Women Ahead of G20 Summit

Philip Morris International Shifts Entire Capacity of Its Cigarette Factory in Greece to Smoke-Free Products

Recipients for 12th GATSBY CREATIVE AWARDS Decided

BIRAC and PerkinElmer Sign Letter of Intent to Promote India-Led Startups and Innovations

Gemalto Unveils Two New Enhanced Security Features for ID Documents

Bentley Systems' Year in Infrastructure 2018 Conference and Awards Gala to be Held in London, Oct. 15-18

Dubai Breaks Ground on World’s Biggest CSP Project

DHFL Pramerica AMC Appoints Rajesh Iyer as CEO

Morinaga Milk's New Probiotic Strain, Bifidobacterium breve A1, May Prevent Onset of Alzheimer's Disease

Chitkara University Professor Achieves Honours at Economic Times – Power of Ideas 2018

Accenture Labs and Grameen Foundation India Use Emerging Technologies to Help Increase Adoption of Financial Services Among Low-income Women

Technics Organizes World's First Full Turntable Orchestra

Edgecore Networks Introduces 400G Open Networking

Telangana's Biggest National Rural Technology Festival 'Antahpragnya 2018' kicked off at RGUKT, Basar

Chargebee Closes Series C with $18 Million Investment from Insight Venture Partners

Rolls-Royce Motor Cars Announces the Silver Ghost Collection

FLIR Launches Thermal Traffic Sensor for Vehicle-to-Everything Communication

IDEMIA: Easier Travel with the Biometric Innovations Presented at Passenger Terminal Expo (20–22 March 2018)

Toshiba Memory Corporation Releases Enhanced Data Center SSD Line-up with 64-Layer 3D Flash Memory

MIPAQ™ Pro, the Intelligent Device for Smart Grids

Favorable safety profile of Pradaxa® (dabigatran etexilate) confirmed in large prospective real-world analysis

Louis Chevrolet Watch Company launches the Chrono-Tour Bitcoin Special Edition

Shopping on Instagram Goes Global with Shopify

Prof. Frank Stangnberg-Haverkamp Meets the President of Niger H.E. Mahamadou Issoufou to Discuss Merck Foundation Commitment towards Niger

FAA Approves AerTrakTM to Comply with Automatic Dependent Surveillance-Broadcast (ADS-B) Operations Mandate

Star Union Dai-ichi Life Insurance Co. Ltd. Partners with Manipal Global Education Services for a Customized Talent Development Program

New Documentary Raises Global Water Crisis Awareness As 844 Million People Still Lack Access to Clean Drinking Water

IDEMIA Partnering with Unisys to Provide Biometric Services for Home Affairs Department in Australia

Intuit’s Open Platform Strategy Transforms How QuickBooks Online Accountant Users Serve Their Clients

LEE Launches Spring Summer 2018 BODY OPTIX 360 Collection

New Global Survey Points to Key Issues, Needs and Gaps in Fight to End Smoking

Akshay Kumar Reveals that the Secret to his Son Aarav's Success May be a Very Special Lady!

Badminton Champ and Coach Pullella Gopichand Says he Struggles Between Being a Tough or Lenient Coach

Kent RO Teams Up with Kings XI Punjab as Title Sponsor

Bajaj Electricals Showcases 'Smart Indoors and Connected Outdoors' at Light + Building 2018

Priyadarshni Academy Celebrates 34th Anniversary Literary Awards and Educational Scholarships Program

L&T Technology Services' Industry Academia Skill Building Initiative TECHgium®, Receives Record Breaking Participation

HealthMode.Org Launches Window of Opportunity Drive and Free Public Service Live Chat on Website to Raise Awareness of Risk and Prevention of Chronic Lifestyle Diseases in India

Tripura to brand pineapple international...
Jackfruit declared as Kerala's official ...
Cricket-Thunderstorm helps West Indies t...
Shivpal attend SP dinner for RS Polls...
Shivpal ,Raja Bhaiyya attend SP dinner f...
PM congratulates Angela Merkel on assum...
 Top Stories
Mark Zuckerberg apologises for data... 
US Congress unveils $1.3tn spending... 
'We Are Sikhs' campaign wins top US... 
Mobilise humanity to save rivers: S... 
Eva Mendes scents hair to feel luxu... 
US Fed raises interest rates, signa... 
Russia launches manned spacecraft t... 
China wants to loot our resources: ...