New post-hoc analysis of EMPA-REG OUTCOME® examined cost-effectiveness of empagliflozin versus standard of care in a subgroup of people with type 2 diabetes and diabetic kidney disease
Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) today announced results from a new cost-effectiveness analysis of the EMPA-REG OUTCOME® trial in a subgroup of 2,250 people with type 2 diabetes and established cardiovascular disease who also have diabetic kidney disease.1 Results suggest that treatment with empagliflozin, in addition to standard of care, leads to fewer cardiovascular and renal events, and has the potential to be a cost-effective treatment option for people with type 2 diabetes and diabetic kidney disease from the perspective of payers in the US.1 The results were presented at the ISN World Congress of Nephrology 2019 on 13 April in Melbourne, Australia.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190414005012/en/
Currently, there are more than 425 million people living with diabetes worldwide, 30-40 percent of whom are at risk of developing diabetic kidney disease.2,3 Furthermore, one third of people with diabetic kidney disease are at risk of progressing to end-stage kidney disease.3 Type 2 diabetes and diabetic kidney disease independently increase the risk of developing cardiovascular disease, with up to 1.2 million deaths from cardiovascular disease attributed to impaired kidney function.4 This progression of diabetic kidney disease among people with type 2 diabetes imposes substantial medical care costs.4 Typically, high-income countries spend more than 2-3 percent of their annual healthcare budget on the treatment of end-stage kidney disease.4
“Diabetic kidney disease occurs in up to 40 percent of people living with type 2 diabetes, many of whom are at substantial risk of experiencing kidney failure. This places a huge burden, not only on the patient’s life and the lives of their loved ones, but also on healthcare systems,” said Waheed Jamal, MD, Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “We are encouraged by this latest analysis of the EMPA-REG OUTCOME® trial, which suggests that empagliflozin has the potential to be a cost-effective treatment option for people with type 2 diabetes and diabetic kidney disease.”
Empagliflozin is not indicated for the prevention of kidney disease.
Cost effectiveness analysis is a conventional method of evaluating the economic impact of a treatment. The results were garnered using a simulation economic model to predict clinical events and estimated costs for the EMPA-REG OUTCOME® trial subgroup of patients with type 2 diabetes and established cardiovascular disease who also have diabetic kidney disease receiving empagliflozin with standard of care versus standard of care alone.1 The modeling and simulation of cost effectiveness was performed using the cost per episode of certain diabetes-related clinical events and health utilities in the US associated with these events. Patients receiving empagliflozin were predicted to experience fewer of these clinical events, including progression of albuminuria (presence of the protein albumin in the urine), composite renal outcomes, hospitalisation for heart failure and cardiovascular deaths. Additionally, patients taking empagliflozin with standard of care were projected to survive 1.37 years longer compared to standard of care alone. This sensitivity analyses showed that, from a US perspective, empagliflozin could be a cost effective option for 99 percent of people with type 2 diabetes and cardiovascular disease at a threshold of $100,000/quality-adjusted life years (QALYs).1*†
“Boehringer Ingelheim and Eli Lilly and Company are committed to addressing the high, unmet clinical need for additional therapies to reduce the risk of kidney disease progression and cardiovascular disease in people with kidney disease, irrespective of whether or not they have diabetes,” said Sherry Martin, M.D., Vice President, Medical Affairs, Lilly Diabetes. “We are looking forward to validating the results presented today with the patient outcomes in EMPA-KIDNEY, which investigates whether empagliflozin could help improve the lives of people living with kidney disease.”
In the landmark EMPA-REG OUTCOME® trial, empagliflozin showed promising results related to the reduction in the relative risk of new onset or worsening kidney disease.5 Based on these insights, Boehringer Ingelheim and Lilly have initiated an academic collaboration with the Medical Research Council Population Health Research Unit at the University of Oxford (MRC PHRU) to conduct EMPA-KIDNEY.6 The study investigates the effects of empagliflozin on the progression of kidney disease and the occurrence of cardiovascular death in people with established chronic kidney disease with and without diabetes. Recruitment for the trial started in 2019 with the first results expected in 2022.6
About diabetic kidney disease
Diabetic kidney disease is a progressive decline of kidney function over time that occurs in 30-40 percent of all people with diabetes.3 One third of people with diabetic kidney disease may develop end-stage kidney disease, also known as kidney failure.3 Once end-stage kidney disease is reached, affected individuals have to undergo kidney replacement treatments, such as chronic dialysis or kidney transplantation.7 Since there is currently no approved treatment available to specifically reduce kidney disease progression and cardiovascular death, the overarching unmet medical need for new treatment options for people with kidney disease is evident.
About EMPA-KIDNEY: The study of heart and kidney protection with
EMPA-KIDNEY is a multinational randomised, double-blind, placebo-controlled clinical trial. It is designed to evaluate the effect of empagliflozin on clinically relevant outcomes: kidney disease progression and cardiovascular mortality risk. The primary outcome is defined as time to a first event of either a cardiovascular death or kidney disease progression, defined as end-stage kidney disease (the need for kidney replacement therapy such as, dialysis or kidney transplantation), a sustained decline in eGFR to <10mL/min/1.73m2, renal death or a sustained decline of ≥40 percent in eGFR from randomisation. EMPA-KIDNEY includes people with established chronic kidney disease both with and without diabetes receiving current standard of care.
The study is conducted in selected countries representing a global footprint and aims to randomise approximately 5,000 participants to receive either empagliflozin 10mg once daily or placebo, on top of standard of care.
About EMPA-REG OUTCOME
EMPA-REG OUTCOME® was a long-term, multicenter, randomised, double-blind, placebo-controlled trial of more than 7,000 patients from 42 countries with type 2 diabetes and established cardiovascular disease.
The study assessed the effect of empagliflozin (10mg or 25mg 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.
The overall safety profile of empagliflozin was consistent with that of previous trials.
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 risk reduction data in the label in several countries.8,9,10
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 and reduces the fluid load of the body’s blood vessel system (i.e. intravascular volume). Empagliflozin induces changes to the sugar, salt and water metabolism in the body that may contribute to the reductions in cardiovascular death observed in the EMPA-REG OUTCOME® trial.
Please click on the following link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/press-release/effectiveness-analysis-in-diabetic-kidney-disease-and-type-2-diabetes
* Quality-adjusted life years (QALYs) reflect a patient’s health by weighting life years lived with a health-related utility score, which puts a value on the reduction in a patient’s quality of life
† $100,000/QALY is the threshold for cost-effectiveness analysis in the US. This figure is based on an estimate of the cost-effectiveness of dialysis for chronic kidney disease
Dr Petra Kienle
Product Communication Manager
Phone: +49 (6132) 77 143877
Global Business Communications
Phone: +1 (317) 276 8304
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
IFF to Release First Quarter 2019 Results May 618.4.2019 23:15:00 EEST | Tiedote
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 first quarter 2019 earnings results following the market close on Monday, May 6, 2019. The management team will host a live webcast on Tuesday, May 7, 2019 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 97 manufacturing facilities, 105 R&D centers, and 39,000 customers globally. At the heart of our company, we are fueled by a sense of discovery, constantly asking “what if?”. That passion for exploration dri
Gilead Sciences to Release First Quarter 2019 Financial Results on Thursday, May 2, 201918.4.2019 23:05:00 EEST | Tiedote
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its first quarter 2019 financial results will be released on Thursday, May 2, after the market closes. At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s financial results for the first quarter 2019 and provide a business update. The live webcast of the call can be accessed at the company’s Investors page at http://investors.gilead.com/. Please connect to the company’s website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 5259422 to access the call. Telephone replay will be available approximately two hours after the call through 8:00 p.m. Eastern Time, May 4, 2019. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (international) and dial the conference ID
Andersen Global Expands Africa Presence; Signs Collaboration Agreement in Economic Hub of South Africa18.4.2019 16:30:00 EEST | Tiedote
Andersen Global is excited to announce the addition of its first collaborating firm in South Africa. Tabacks Attorneys and Corporate Law Advisors, headquartered in Johannesburg, South Africa, has signed a Collaboration Agreement with Andersen Global, an international association of member and collaborating firms. South Africa marks the tenth country in Africa in which Andersen Global has a presence. Led by Chairman David Woodhouse, Tabacks has a team of 27 lawyers who offer legal assistance and commercial advice to a diverse clientele in construction, manufacturing, energy, mining, explosives, retail, hospitality, logistics, pharmaceutical, property and banking industries. The firm is considered a leading law firm in South Africa, and its practice areas include competition law, commercial law, mining, employment law, environmental health & safety law, tax and litigation. “The global economy is rapidly changing, which brings unique challenges to corporate and commercial law,” said David
Amazon and Google Announce Official YouTube Apps to Launch on Fire TV; Prime Video App Coming to Chromecast and Android TV18.4.2019 16:00:00 EEST | Tiedote
Today, Amazon (NASDAQ: AMZN) and Google (NASDAQ: GOOGL) announced that in the coming months, the two companies will launch the official YouTube app on Amazon Fire TV devices and Fire TV Edition smart TVs, as well as the Prime Video app for streaming to Chromecast and Chromecast built-in devices. In addition, Prime Video will be broadly available across Android TV device partners, and the YouTube TV and YouTube Kids apps will also come to Fire TV later this year. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190418005212/en/ “We are excited to work with Amazon to launch the official YouTube apps on Fire TV devices worldwide,” said Heather Rivera, Global Head of Product Partnerships at YouTube. “Bringing our flagship YouTube experience to Amazon Fire TV gives our users even more ways to watch the videos and creators they love.” “We’re excited to bring the Prime Video app to Chromecast and Android TV devices, and to give our c
KCI Files Registration Statement for Proposed Initial Public Offering18.4.2019 16:00:00 EEST | Tiedote
Acelity announced today that its affiliate, KCI Holdings, Inc. (“KCI”), filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (“SEC”), relating to a proposed initial public offering of KCI’s common stock. Prior to the effectiveness of the registration statement, there will be a restructuring as a result of which KCI will become the holding company of the businesses currently conducted by Acelity L.P. Inc. and its subsidiaries. The number of shares to be offered and the price range for the proposed offering have not yet been determined. J.P. Morgan, Goldman Sachs & Co. LLC and BofA Merrill Lynch are acting as joint book-running managers for the proposed offering. The offering will be made only by means of a prospectus. When available, a copy of the preliminary prospectus related to the offering may be obtained from: J.P. Morgan, Attention: Prospectus Department c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, via tele
Strasbourg Approves the Covered Bond Legislative Package: a Milestone for the Future of the Industry and the Capital Markets Union18.4.2019 15:06:00 EEST | Tiedote
Following the trilogue negotiations with the Council and the European Commission on the proposal for a Covered Bond Legislative Package, the European Parliament’s Plenary adopted today in Strasbourg the text which had been approved by the Council (Coreper) on 20 March and then by the European Parliament’s Economic and Monetary Affairs (ECON) Committee on 1 April 2019. In this context, the European Mortgage Federation - European Covered Bond Council (EMF-ECBC ) welcomes the adoption of the Covered Bond Legislative Package, which aims at completing the Capital Markets Union (CMU) in Europe. The Package provides a basis for enhanced harmonisation of the European covered bond market, in line with the objectives of the CMU, reinforcing a European common qualitative benchmark for international investors and respecting well-functioning traditional markets. It moreover paves the way for the smooth introduction of this asset class in newer and emerging covered bond markets in the Union, such as
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme