Business Wire

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

Jaa

New data from one of the largest prospective ongoing global studies examining the use of oral antithrombotics for stroke prevention in atrial fibrillation (AF) in clinical practice, GLORIATM-AF, were presented at the EHRA 2018, the annual congress of the European Heart Rhythm Association (EHRA).1,2 The registry examined two-year safety and effectiveness outcomes of nearly 5,000 AF patients treated with dabigatran (marketed as Pradaxa®). Results of the completed Phase II of GLORIATM-AF,1 presented during the ‘Late-breaking science – Registries’ session, showed low rates of major bleeding (0.97%) and stroke (0.65%). These findings confirm the sustained safety and effectiveness of dabigatran and are highly consistent with the long-term safety profile observed in other real-world evidence, as well as in randomised clinical trials.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180320005661/en/

“Long-term, ‘real-world’ data are important to cardiologists as they help build a bigger picture of how an antithrombotic medication works in daily clinical practice,” commented Gregory Y H Lip, MD, Co-Chair of the GLORIATM-AF Steering Committee. “The results from the second phase of GLORIATM-AF underline the safety and effectiveness of dabigatran, which is reassuring for physicians treating patients with atrial fibrillation.”

In an additional analysis from GLORIATM-AF2 the safety of uninterrupted dabigatran for patients undergoing cardiovascular (CV) interventions was evaluated. The rates of major bleeding and stroke/ systemic embolism were very low, i.e. one major bleed and one systemic embolic event occurred in 412 CV interventions that were performed with uninterrupted dabigatran.

“From the first clinical trials such as RE-LY® and RELY-ABLE®, through to numerous real-world studies, both supported by and independent from Boehringer Ingelheim, we get an absolute, consistent picture of the favorable safety of dabigatran,” commented Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “Recent clinical trials in specific settings like RE-CIRCUITTM,3 with dabigatran in AF patients undergoing cardio ablation, again demonstrated the superior safety of Pradaxa® compared to standard-of-care. The prospective, long-term data for dabigatran from GLORIATM-AF now add one further piece to complete this picture with profound real-world evidence.”

AF is the most common cardiac rhythm disorder worldwide, with numbers expected to rise in the coming years.4 Overall, people diagnosed with AF have a five-fold increased risk of stroke,5 which occurs when a blood clot blocks a vessel in the brain. Each year three million patients suffer AF-related strokes.6,7

~ENDS~

Please click on the link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/EHRA-Congress-2018

For more information, please visit:  www.boehringer-ingelheim.com

Further Media Channels

www.facebook.com/boehringeringelheim

www.twitter.com/Boehringer

Contact information

Boehringer Ingelheim GmbH
Corporate Communications
Media + PR
Friederike Middeke, +49 6132 – 77 141575
Fax: +49 6132 – 77 6601
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

AURAK Gains SACSCOC Accreditation15.12.2018 13:49Tiedote

The Southern Association of Colleges and Schools Commission on Colleges (SACSCOC) officially announced the accreditation of the American University of Ras Al Khaimah (AURAK) at its 2018 Annual Meeting which was held in New Orleans, Louisiana, in the United States of America. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181215005017/en/ AURAK delegation during the SACSCOC conference in New Orleans” (Photo: AETOSWire) SACSCOC, the regional body for the accreditation of degree-granting higher education institutions in the Southern United States, has a membership of more than 800 institutions in the Southern states and other international sites approved by SACSCOC that award associate, baccalaureate, master’s, and/or doctoral degrees. SACSCOC also awards accreditation to other international institutions of higher education that satisfy all its requirements and demonstrate compliance with its accreditation standards. AURAK now

Lehman Brothers Treasury Announces Plans for Partial Wind-Down14.12.2018 20:41Tiedote

Lehman Brothers Treasury Co. B.V. in liquidation (“LBT”) today, through its U.S. counsel Kramer Levin Naftalis & Frankel LLP, announced that LBT is planning a final cash distribution to its creditors. Professional holders of eligible notes will have the option to retain their investment by electing to receive substitute notes of one (or a few) series. Such election shall take place through a solicitation process. As a consequence, LBT will be able to reduce the number of series of notes outstanding from more than 3,700 to one or a few. Noteholders electing to receive substitute notes will be afforded the same economic entitlement to distributions received by LBT from Lehman Brothers Holdings Inc. (“LBHI”) through the substitute notes. The substitute notes will be denominated in U.S. dollars and future distributions will be made in U.S. dollars only. Noteholders who are not professional investors, or hold notes that are not eligible for substitution, or do not elect to receive substitut

Takeda Receives Positive CHMP Opinion for ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage IV Hodgkin Lymphoma in Combination with AVD14.12.2018 20:00Tiedote

Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the extension of the marketing authorization of ADCETRIS (brentuximab vedotin) and recommended its approval in combination with AVD in adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma. ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30, a defining marker of Hodgkin lymphoma. ADCETRIS is currently not approved as a therapy for previously untreated Hodgkin lymphoma in Europe. “For a large number of previously untreated Hodgkin lymphoma patients diagnosed with Stage IV disease, progression will occur with current treatments, highlighting a true unmet need in this population,” said Anna Sureda, M.D., Ph.D., Head of the Hematology Department and Hematopoietic Stem Cell Transplant Programme, Institut Català d'Oncologia - Hospital Duran i Reynals. “In the ECHELON-1 cl

Diamond CBD, POTN Subsidiary, Enters the $46 Billion Coffee Market With the Release of Premium Line of CBD-Infused Coffee & Tea K-Kup Capsules14.12.2018 18:42Tiedote

Diamond CBD Inc., wholly owned subsidiary of PotNetwork Holdings, Inc. (OTC Pink: POTN), a leader in hemp extraction and innovative CBD products for the wellness market, enters the Coffee segment, an industry expected to reach revenues of $46 Billion in 2018. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181214005308/en/ Experience a cup of Chill (Photo: Business Wire) Produced in accordance with a universal K-Cup design, these pods fit in almost all modern single cup coffee makers, making it an easily integrated enhancement to any environment, delivering 25mgs of CBD in a tasty favorite beverage at less than $5 per cup. This new line of premium Chill Coffee Capsules was recently added to the Company’s broad range of cannabinoid and natural hemp products. Each box comes with 4 individual capsules in original chill coffee, decaf chill coffee, chill black tea, and chill green tea flavors. The unit price for each box is $10.00

Henley & Partners Enlarges Executive Committee to Manage Expansion and Growth14.12.2018 17:00Tiedote

Residence- and citizenship-by-investment programs have firmly established themselves over the past few years as the new frontier in terms of freedom, flexibility, and future-readiness, both for the countries issuing these programs and for the individual investors participating in them. The societal and economic value these programs generate is undisputed. The investment migration industry as a whole is currently grossing roughly USD 18 billion per year, with an expectation that it will hit the USD 20 billion mark very soon. Foreign direct investment (FDI) is now considered the lifeblood of economic growth for many developing and recovering smaller countries around the world. As such, the number of investment migration programs has been increasing rapidly, from just a handful of programs in the 1980s and 1990s to over 100 countries that now have investment migration provisions in their laws. There are more than 60 active programs today, with Moldova and Montenegro — both fast-growing Eu

Vargatef® plus docetaxel could be an option after failure of immunotherapy in lung cancer14.12.2018 12:07Tiedote

Boehringer Ingelheim announced today the first interim results of VARGADO, an ongoing non-interventional study in routine clinical practice in Germany evaluating the efficacy and safety of Vargatef® (nintedanib) and docetaxel in patients with stage III/IV locally advanced or metastatic non-small cell lung cancer (NSCLC) of adenocarcinoma histology. The study consists of three cohorts, two of which allow for prior treatment with immune checkpoint inhibitors (ICIs) either in combination with chemotherapy in the first-line or as monotherapy in the second-line of treatment. The interim results from Cohort B (first-line chemotherapy, second-line immune checkpoint inhibitors, third-line Vargatef® plus docetaxel) were presented today at ESMO Immuno-Oncology Congress 2018 in Geneva.1 Despite a limited sample size, the VARGADO study adds to the body of evidence for nintedanib in lung adenocarcinoma following pre-treatment with chemotherapy and ICIs.1,3 The addition of nintedanib to docetaxel ha

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