Business Wire

Boehringer Ingelheim and Lilly expand heart failure programme for empagliflozin with new exercise capacity trials

Del

Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced plans to expand their clinical trial programme for empagliflozin in chronic heart failure with the EMPERIAL clinical trials. These trials will evaluate the effect of empagliflozin on exercise ability and heart failure symptoms in people with chronic heart failure independent of whether they have type 2 diabetes. EMPERIAL comprises two Phase III trials that will assess the effect of 12 weeks’ treatment with empagliflozin on the ability of people with heart failure to perform daily exercise.1,2

This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180306005966/en/

The plans for the EMPERIAL trials follow initiation of the EMPEROR trials in March 2017.3,4 While the EMPEROR outcome trials focus on long-term morbidity and mortality outcomes in people with heart failure, the EMPERIAL functional trials will investigate possible benefits on exercise capacity and heart failure symptoms.3,4 These studies are based on data obtained from the landmark EMPA-REG OUTCOME® trial, where the effect of empagliflozin on heart failure outcomes was evaluated.5

“Symptoms of heart failure can have a profound effect on quality of life, with more than three quarters of people with heart failure finding it difficult to carry out routine activities,” said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly Diabetes. “Currently, there are limited treatment options that can help improve the everyday lives of people living with chronic heart failure. We look forward to seeing whether empagliflozin can help address this unmet need.”

Heart failure is a serious condition where the heart is unable to pump enough blood around the body.6 It affects 26 million people worldwide and is associated with high morbidity and mortality.7 Approximately 50 percent of people who develop heart failure die within five years and it is the leading cause of hospitalisation in the United States and Europe.6,8

“In the EMPA-REG OUTCOME® trial, it was encouraging to see a significant reduction in the risk of hospitalisation for heart failure with empagliflozin in people with type 2 diabetes and established cardiovascular disease,” said Prof Dr Martina Brückmann, Global Head of Clinical Development, Therapeutic Area CardioMetabolism, Boehringer Ingelheim. “Boehringer Ingelheim and Lilly will conduct the EMPERIAL trials to investigate whether empagliflozin could also improve daily exercise and quality of life for people with chronic heart failure with or without type 2 diabetes.”

About EMPERIAL

EMPERIAL consists of two Phase III randomised, double-blind trials. The trials evaluate the effect of 12 weeks treatment of once daily empagliflozin 10 mg compared with placebo on exercise ability and heart failure symptoms in patients with chronic heart failure with preserved or reduced ejection fraction.* This will be measured by the 6-minute walk test, a common measure of functional exercise capacity.

  • EMPERIAL-preserved [NCT03448406]: will investigate empagliflozin in patients with chronic heart failure with preserved ejection fraction (HFpEF). The study looks at a functional endpoint: how far patients can walk in 6 minutes and at heart failure symptoms.1
    • Primary endpoint: Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes
    • Anticipated number of patients: approx. 300
    • Estimated completion: 2019
  • EMPERIAL-reduced [NCT03448419]: will investigate empagliflozin in patients with chronic heart failure with reduced ejection fraction (HFrEF). The study looks at a functional endpoint: how far patients can walk in 6 minutes and at heart failure symptoms.2
    • Primary endpoint: Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes
    • Anticipated number of patients: approx. 300
    • Estimated completion: 2019

*Ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. During each heartbeat pumping cycle, the heart contracts and relaxes. When the heart contracts, it ejects blood from the two pumping chambers (ventricles). When the heart relaxes, the ventricles refill with blood.9

HFpEF occurs when the heart muscle contracts normally but the ventricle muscles are stiff. They do not relax as they should when the ventricle fills with blood, so less blood can enter the heart compared to a normally functioning heart.10

HFrEF occurs when the heart muscle does not contract effectively and less blood is pumped out to the body compared to a normally functioning heart.10

Both, HFpEF and HFrEF lead to similar symptoms of heart failure, specifically difficulty breathing, swelling, and fatigue.

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.6 Symptoms of heart failure include difficulty breathing, swelling, and fatigue amongst others.11 Heart failure is a prevalent disease; 26 million people around the world have chronic heart failure.7 There is a high unmet need in the treatment of heart failure, as approximately 50 percent of people diagnosed with heart failure will die within five years.8 Additionally, heart failure represents the most common cause of hospitalisation among individuals aged 65 years and over in the United States and Europe.Heart failure is highly prevalent in people with diabetes;12 however, approximately half of all people with heart failure do not have diabetes.7,13

About Empagliflozin

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 reduction data in the label in several countries.14,15,16

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.

Empagliflozin is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

Please click on the following link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/EMPERIAL-heart-failure

Contact information

Boehringer Ingelheim
Dr Petra Kienle
Product Communication Manager
Email: press@boehringer-ingelheim.com
Phone: +49 (6132) 77 143877
or
Eli Lilly and Company
Grant Smith
Manager, Global Business Communications
Email: grant.smith@lilly.com
Phone: +1 (317) 954 9907

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(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

Announcement by Viking Corp on Tecnotree22.6.2018 11:09Pressemelding

In the interests of stakeholder transparency, this announcement provides background and context to Viking's file bankruptcy proceedings upon Tecnotree: As many of you will now know, Viking Corp was recently forced to file bankruptcy proceedings upon Tecnotree, which were withdrawn on the 19 June. In the interests of stakeholder transparency, we make this Announcement to provide background and context to this action. Firstly, we would reflect on the recent history of our attempts to partner with Tecnotree and all its stakeholders. Viking launched a Tender Offer (TO), having conducted detailed discussions with the Tecnotree Board and our advisors. On the basis of those discussions, we were very confident that the TO price of 10 cents per share provided truly superior value for shareholders. So did the Tecnotree Board as evidenced by their unanimous recommendation of our Offer and of course, further evidenced by the current prevailing market price. This TO was supported in the most vigoro

HeartSciences Named “Start-Up to Watch”22.6.2018 11:00Pressemelding

HeartSciences is delighted to have been highlighted as “Start-Up to Watch” in the June 8, 2018 issue of the MedTech Strategist. The article titled “HEARTSCIENCES: ARTIFICIAL INTELLIGENCE IMPROVES FRONTLINE RISK STRATIFICATION FOR HEART DISEASES” discusses HeartSciences’ role in addressing the current challenges and significant unmet need to identify heart disease at an early stage and reduce the high prevalence of expensive diagnostic testing with low yields. The article highlights the enormous opportunity for HeartSciences’ breakthrough MyoVista® Wavelet ECG (wavECG™) technology to benefit patients and to reduce health system costs and references a recently published study titled “Prediction of Abnormal Myocardial Relaxation From Signal Processed Surface ECG” in the Journal of American College of Cardiology (JACC). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180622005088/en/ MyoVista Wavelet ECG Cardiac Testing Device (P

High-Performance Solutions and Complete Protection for Critical Installations: the Latest Innovations from CNIM and Its Bertin Subsidiary to Be Unveiled at WNE 201822.6.2018 09:39Pressemelding

The third edition of the World Nuclear Exhibition – major event for the global nuclear energy community – will be held at Paris-Villepinte, June 26 th to 28 th , 2018. CNIM and Bertin Technologies , leading players in the fields of nuclear equipment, safe handling and instrumentation for the complete protection of nuclear power plants, will be unveiling their joint offerings at this exhibition (booth D125-Hall 7). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180622005185/en/ CNIM's high safety fuel handling systems (Photo: Business Wire) Based on its long experience of major nuclear projects and its cutting-edge industrial capabilities, CNIM’s offering reflects its ability to innovate and adapt to the most difficult environments. Highlights on its exhibition booth will include: The design and manufacturing of high-safety fuel handling systems (notably the design of three remotely operated spent fuel handling and transferri

Loxam Announces the Acquisition of Italian Powered Access Rental Specialist Nove22.6.2018 07:00Pressemelding

Loxam Group (“Loxam”) announces the acquisition of the Italian powered access rental company No.Ve. S.r.l. (“Nove”) from Haulotte Group S.A. (“Haulotte”). Nove was founded in 1998 and was controlled by Haulotte since 2006. The company is headquartered in Rome and has 45 employees in 6 branches throughout Italy. Following the acquisition of Nacanco last year, this transaction enables Loxam to consolidate its leading position in the Italian powered access rental market. Gérard Déprez, President of Loxam states: “I am delighted to welcome the skilled and experienced Nove team into the Loxam group. Nove is a long-established player in Italy and operates an equipment range very well known to the Loxam Group and we will be able to share our mutual expertise. We will join forces to provide our customers with the best service through an expanded network, and build a reference company in the Italian equipment rental market.” “The divestment of Nove is in line with Haulotte strategic targets and

Wealthify Selects Moody’s Analytics Modeling Technology to Support Its Online Investment Proposition22.6.2018 07:00Pressemelding

Moody’s Analytics, a leading provider of financial intelligence, announced today that its technology has been selected by Wealthify, an innovative provider of digital wealth management services. Wealthify will be using the Moody’s Analytics Wealth Scenario Generator (“WSG”) to assist clients in making informed decisions on their investment plans. The Moody’s Analytics WSG is a modeling engine that supports financial planning and investment decision making. It has been integrated into Wealthify’s online investment proposition to illustrate a likely range of financial outcomes based on the investment style and level of investment a customer selects. This allows investors to better appreciate the balance between risk and return. “Our decision to work with Moody’s Analytics was driven by their comprehensive modeling and technology offering,” said Michelle Pearce, co-founder and Chief Investment Officer at Wealthify. “Their solution provides the robust economic assumptions required for our

OpenGate Capital Completes Sale of NorPaper Group to Gemayel Freres & Chaoui Industriel Group22.6.2018 06:00Pressemelding

OpenGate Capital, a global private equity firm, announced today that it has completed the sale of one of its legacy, pre-fund investments, NorPaper Group (“NorPaper”), to Gemayel Freres & Chaoui Industriel Group, a Lebanon-based business specialized in recycled corrugated cardboard and packaging products. Terms of the transaction were not disclosed. OpenGate Capital acquired NorPaper from Canadian paper conglomerate, Cascades, in 2011. NorPaper is a leading producer of white top testliner paper that is sold to European packaging manufacturers. Realizing an opportunity to increase capacity within NorPaper, OpenGate completed an accretive, add-on acquisition in February of 2015 of DS Smith Packaging Papeterie de Nantes SAS (“Nantes”), a division of DS Smith, Plc (LON: SMDS). Integrated into NorPaper, Nantes broadened the product portfolio and added 50kT per year of production capacity through its white top testliner paper made from 100% recycled fiber with best in class quality and print