Business Wire

Independent large real-world study comparing NOACs in AF-patients

Jaa

The results from an independent retrospective comparative study, published in January 2019 in the American Journal of Medicine, showed that dabigatran was associated with a more favourable benefit-harm profile than both warfarin and rivaroxaban. The study analysed a database of patients enrolled in US Medicare with non-valvular atrial fibrillation (NVAF) treated with either a standard dose of a non-vitamin K antagonist oral anticoagulants (NOAC, i.e. dabigatran, rivaroxaban or apixaban) or warfarin.1

Recently, the Summary of Product Characteristics (SmPC) for dabigatran in the EU was updated with information from the results of a previous large independent Medicare study, which was published in Circulation in 2015. In the study, dabigatran was associated with reduced risk of ischaemic stroke, intracranial haemorrhage and mortality and increased risk of gastrointestinal bleeding in elderly NVAF patients compared to warfarin. The risk of major bleeding was similar across both study drugs.2

According to the 2019 independent real-world study, compared to warfarin, each NOAC investigated was associated with reduced risk of thromboembolic stroke (20-29% reduction; P=0.002 [dabigatran], P<0.001 [rivaroxaban, apixaban]), intracranial haemorrhage (35-62% reduction; P<0.001 [each NOAC]), and mortality (19-34% reduction; P<0.001 [each NOAC]).1

The most recent study also compared the individual NOACs with each other. According to the results, both dabigatran and apixaban demonstrated decreased risks of intracranial haemorrhage, major extracranial bleeding, and death, compared with rivaroxaban.1

Overall, the authors concluded that among the NOACs, apixaban and dabigatran had a more favourable benefit-harm profile than rivaroxaban.1

“This independent study from 2019 is a positive reminder of dabigatran’s demonstrated safety profile, compared to both warfarin and rivaroxaban,” said Dr Waheed Jamal, Corporate Vice President, Head of Cardiometabolic Medicine, Boehringer Ingelheim. “Also, it is quite unique that a non-interventional study based on a retrospective assessment of a specific database has been accepted by a Health Authority to be added to the product label. Both this and the new comparative data add further credibility to the body of evidence demonstrating the favourable safety and efficacy profile of Pradaxa® in its licensed indications.”

The 2019 study was carried out by independent researchers including David J. Graham, MD, MPHm, and funded by US Food and Drug Administration (FDA). The retrospective, propensity-matched study analysed data from NVAF patients (≥ 65 years old) enrolled in US Medicare between Oct. 2010 and Sept. 2015. Only those initiating on warfarin (183,318) or standard US dose of dabigatran (86,198), rivaroxaban (106,389), or apixaban (73,039) were included.

The 2015 study was also carried out by independent researchers, led by David J. Graham, MD, MPHm, and was funded through an intra-agency agreement between the Centers for Medicare & Medicaid Services and the FDA. The retrospective study analysed data from NVAF patients (≥ 65 years old) initiating dabigatran or warfarin for the treatment of nonvalvular AF, who were enrolled in US Medicare between Oct. 2010 and Dec. 2012. Dabigatran users (67,207) were propensity score matched to warfarin users in a 1:1 ratio. Patients who had received prior treatment with a study medication or rivaroxaban or apixaban were excluded from the study.

Please click on the following link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/press-release/real-world-study-comparing-noacs-af-patients

Intended audiences:
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. It is directed to the international audience outside Germany. 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 we do business.

Contact information

Media Contact
Boehringer Ingelheim
Corporate Communications
Media + PR
Meike Bausinger
55216 Ingelheim/Germany
Phone: +49 6132 77 182085
Mobile: +49 151 44061760
Fax: +49 6132 77 6601
Email: press@boehringer-ingelheim.com

Tietoja julkaisijasta

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

Process Systems Enterprise: gPROMS FormulatedProducts 1.4 Includes Enhanced Capabilities Linking Digital Design to Digital Operations19.4.2019 10:58:00 EESTTiedote

Process Systems Enterprise (PSE), the Advanced Process Modelling company, today released version 1.4 of gPROMS FormulatedProducts, the mechanistic model-based environment for integrated digital design of robust formulated products and their manufacturing processes, and related digital process operation. This release introduces major enhancements to both the gPROMS FormulatedProducts model libraries and the underlying gPROMS platform 6.0, including morphological crystallizer and sensor models to capture particle size and shape evolution, enhanced continuous direct compression models and improved wet granulation models. Platform enhancements include support for cluster computing, to significantly speed up execution of parameter estimation and other complex numerical solutions, and comprehensive global system analysis of dynamic systems for rapid exploration of the time-varying decision space and systematic risk and uncertainty analysis. Version 1.4 also introduces two key usability enhan

LOXAM Contributes to the Reconstruction of Notre Dame De Paris Cathedral19.4.2019 10:44:00 EESTTiedote

In the wake of the Notre Dame de Paris blaze on Monday 15 April, Loxam the leading equipment rental company in Europe is playing its part in the reconstruction project of the partly destroyed cathedral. A rental operator in the construction equipment, LOXAM pledges to provide, free of charge, machines to the companies and tradesmen who will take part in these restoration works for the scheduled duration of five years. “Notre Dame de Paris Cathedral is the legacy of accomplished builders that we ought to preserve. As a committed rental operator, Loxam wishes to contribute to the rehabilitation of this monument by providing equipment for an overall 10-million € value over the upcoming five years” Gérard DEPREZ, President of LOXAM, indicates. With a fleet of over 200,000 machines, Loxam is meeting the needs of all tradesmen operating on this worksite. View source version on businesswire.com: https://www.businesswire.com/news/home/20190419005025/en/ Contact information PRESS : Virginie Ada

IFF to Release First Quarter 2019 Results May 618.4.2019 23:15:00 EESTTiedote

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 EESTTiedote

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 EESTTiedote

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 EESTTiedote

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

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