Business Wire

Boehringer Ingelheim: New sub-analyses to be presented at ESC Congress 2018 further support positive safety profile of Pradaxa® (dabigatran etexilate)

Del

Boehringer Ingelheim today announced that it will present nine sub-analyses from the RE-DUAL PCITM trial and GLORIATM-AF Registry Program at the upcoming ESC Congress 2018, organised by the European Society of Cardiology, taking place in Munich, Germany on the 25-29 August 2018. The primary data from these studies have contributed to a positive label update for dabigatran etexilate (Pradaxa®) in the European Union (EU).

The primary RE-DUAL PCITM trial investigated anticoagulation in patients with non-valvular atrial fibrillation (AF) following percutaneous coronary intervention (PCI) and stent placement. Data showed significantly lower rates of major or clinically relevant non-major bleeding events for dual therapy with dabigatran etexilate when compared to triple therapy with warfarin without compromise on efficacy.1,2

GLORIATM-AF is a large, prospective, observational study program run in over 40 countries worldwide. The primary analysis of nearly 5000 AF patients treated with dabigatran etexilate showed that the rates of stroke, major bleeding and life-threatening bleeding were low, confirming the sustained safety and effectiveness of dabigatran etexilate over two years of follow-up in clinical practice.3 These data are consistent with the long-term safety profile observed in other real-world evidence studies, as well as in randomised clinical trials.3

Both studies have helped to further confirm the safety profile of dabigatran etexilate in high risk patient populations, as well as in a real-world setting. In recognition of this, the European Medicines Agency (EMA) has recently authorised the inclusion of data from both studies within the SmPC for dabigatran etexilate in the EU.4

“Insights from the RE-DUAL PCITM and GLORIATM-AF study data have helped to further inform the positive safety profile of dabigatran etexilate for the treatment of AF patients”, said Waheed Jamal, MD, Corporate Vice President & Head of Cardiometabolic Medicine at Boehringer Ingelheim. “We are pleased to see that the value these studies bring is also acknowledged by the EMA and the medical community. This is reflected by the updates to the EU SmPC and the number of abstracts accepted for presentation at ESC Congress 2018.”

Details of the data presented at ESC Congress 2018 are as follows:

     
Abstract Title  

Details
(Venue: Messe München GmbH, Munich)

RE-DUAL PCI TM
High body mass index and outcomes of dual antithrombotic therapy with dabigatran and a P2Y12 inhibitor in patients with atrial fibrillation undergoing PCI: Results from RE-DUAL PCITM

SPAF-A346 (1160.186)
15:50 – 16:40, 26 Aug 2018, Moderated Poster station- Poster Area

The effect of age on the efficacy and safety of dabigatran dual therapy in atrial fibrillation after PCI: a subgroup analysis from the RE-DUAL PCITM

SPAF-A360 (1160.186)
15:50 – 16:40, 26 Aug 2018, Moderated Poster station- Poster Area

The effect of PCI complexity on the efficacy and safety of dabigatran dual therapy vs warfarin triple therapy in atrial fibrillation: a subgroup analysis from the RE-DUAL PCITM trial

SPAF-A356 (1160.186)
10:05 - 10:55, 27 Aug 2018, Moderated Poster station- Poster Area

Dual antithrombotic therapy with dabigatran vs triple therapy with warfarin after PCI in patients with atrial fibrillation and diabetes mellitus (a RE-DUAL PCITM subgroup analysis)

SPAF-A358 (1160.186)
8:30 - 12:30, 28 Aug 2018, Best Posters screen - Poster Area

GLORIA TM -AF

Two-year outcomes of dabigatran etexilate treatment in patients with co-morbid heart failure and atrial fibrillation: the GLORIATM-AF registry

SPAF-A343 (1160.129/136/171)
14:00 – 18:00, 26 Aug 2018, Posters- Poster Area

Two-year outcomes of dabigatran etexilate in patients with atrial fibrillation with and without a history of coronary artery disease: Data from GLORIATM-AF

SPAF-A354 (1160.129/136/171)
14:00 – 18:00, 26 Aug 2018, Posters- Poster Area

When are Atrial Fibrillation Patients at Risk to Discontinue Anticoagulation Treatment? Results from the GLORIATM-AF Registry

SPAF-A349 (1160.129/136/171)
14:00 – 18:00, 27 Aug 2018, Posters- Poster Area

A prospective global registry on oral antithrombotic treatment in patients with atrial fibrillation: GLORIATM-AF Phase III baseline characteristics; (1160.129/136/171)

SPAF-A347 (1160.129/136/171)
08:30 – 12:30, 27 Aug 2018, Posters- Poster Area

Geographic region, stroke risk and renal function strongly affect treatment choice for stroke prevention in patients with non-valvular AF: results from the GLORIATM-AF registry program

SPAF-A353 (1160.129/136/171)
10:05 – 10:55, 28 Aug 2018, Moderated Poster station- Poster Area

Others
Evaluation of VTE-BLEED for predicting intracranial or fatal bleedings in stable anticoagulated patients with venous thromboembolism

VTE-A72 (Study TBC)
12:35, 25 Aug 2018, Moderated Poster station- Poster Area

Safety and Effectiveness of Dabigatran Relative to Warfarin in Routine Care – Final results from a long-term monitoring program; (1160.207)

SPAF-A357 (1160.207)
12:35 - 13:25, 25 Aug 2018, Moderated Poster station - Poster Area

Trauma victims requiring dabigatran reversal with idarucizumab in RE-VERSE AD

SPAF-A356 (1160.186)
08:30 - 12:30, 27 Aug 2018, Posters- Poster Area

Making sense of real-world evidence: addressing the uncertainties surrounding anticoagulation for stroke prevention in non-valvular atrial fibrillation  

MAPOR-A42
TBC

More information on the Boehringer Ingelheim data due to be presented or published at the ESC Congress 2018 can be found here.

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.

For references and notes to editors, please visit: https://www.boehringer-ingelheim.com/press-release/new-data-at-ESC-supports-Pradaxa-safety-profile

Contact information

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

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

Prominent Coalition of World Class International and Danish Law Firms and ISAF Management Company Proceed with Investor Lawsuit against Danske Bank20.11.2018 23:00Pressemelding

International Securities Associations and Foundations Management Company (“ISAF”) announces the formation of an international coalition of leading American, German and Dutch law firms and the appointment of the preeminent Danish law firm, Németh Sigetty, to proceed with a lawsuit against Danske Bank A/S (“Danske” or the “Bank”) to pursue compensation for damaged investors after revelations of money laundering, financial mismanagement and deficient regulatory disclosures. The lawsuit will be filed in Copenhagen, Denmark on behalf of investors who suffered investment losses in Danske’s share price after various disclosures related to an estimated EUR €200 billion money transfer scheme involving non-resident Eastern European and Russian customers in the Bank’s Estonian Branch. Information about critical lapses in Danske’s ‘know your customer’ and anti-money laundering internal enforcement policies, and its failure to act upon both internal and external warnings of non-compliance, caused a

Saif bin Zayed Witnesses Endorsement of Abu Dhabi Declaration by Religious Leaders at Wahat Al Karama20.11.2018 22:28Pressemelding

Under the patronage of His Highness Sheikh Mohammed bin Zayed Al Nahyan, Crown Prince of Abu Dhabi and Deputy Supreme Commander of the UAE Armed Forces, Lt. General HH Sheikh Saif bin Zayed Al Nahyan, Deputy Prime Minister and Minister of Interior, attended the endorsement of the “Abu Dhabi Declaration.” The declaration, issued by the Interfaith Alliance for Safer Communities: Child Dignity in the Digital World Forum was endorsed and approved by religious and spiritual leaders participating in the two-day assembly, which took place in Abu Dhabi on November 19-20, who pledged to act upon the declaration’s articles and achieve the objectives and obligations outlined by the leaders of the seven major world religions participating in the forum. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181120005775/en/ Saif bin Zayed, Khalifa bin Tahnoun, alongside religious and spiritual leaders in front of a memorial to express commitment

Guy Carpenter Names Ross Howard Vice Chairman20.11.2018 17:46Pressemelding

Guy Carpenter & Company, LLC, a leading global risk and reinsurance specialist and a wholly owned subsidiary of Marsh & McLennan Companies (NYSE: MMC), today announced a new leadership appointment from the Jardine Lloyd Thompson Group plc (JLT) reinsurance organization. Effective upon closing of the transaction between Guy Carpenter’s parent company, Marsh & McLennan Companies and JLT, which remains subject to the receipt of certain antitrust and financial regulatory approvals, Ross Howard, Chairman of JLT Re, will become Vice Chairman of Guy Carpenter, reporting to President & CEO Peter Hearn. Mr. Howard will also become a member of Guy Carpenter’s Executive Committee and will be responsible for developing new business opportunities and assisting with client relationships in order to continue the growth of the combined global reinsurance business. Additionally, Mr. Howard will also play a key role in executing the integration of JLT Re with Guy Carpenter. “We are very excited to take

IDEMIA Will Present Its 2018 Quarterly Financial Results to Investors on November 21, 201820.11.2018 17:31Pressemelding

IDEMIA, the world leader in Augmented Identity, today announced that it will present its Q3 2018 financial results to investors on Wednesday November 21, 2018. Yann Delabrière (CEO), Frédéric Beylier (COO) and Laurent Lemaire (CFO) will be presenting the financial results and taking questions the same day at 1:00 pm CET (12:00 pm London Time / 7:00 am New York Time). For more information, please refer to our website: http://investors.oberthur.com About IDEMIA OT-Morpho is now IDEMIA, the global leader in Augmented Identity, with the ambition to empower citizens and consumers alike to interact, pay, connect, travel and vote in ways that are now possible in a connected environment. Securing our identity has become mission critical in the world we live in today. By standing for Augmented Identity, we reinvent the way we think, produce, use and protect this asset, whether for individuals or for objects. We ensure privacy and trust as well as guarantee secure, authenticated and verifiable t

OCP Announces Date of Third Quarter 2018 Earnings20.11.2018 17:00Pressemelding

OCP S.A. (“OCP” or the “Company”), a global leader in the fertilizer industry, will release its third quarter 2018 results on Thursday, November 29, 2018. The results will be available to holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers on the OCP Intralinks portal from 8:30 a.m. EST, 2:30 p.m. Morocco time (GMT+1), and 1:30 p.m. London time (GMT). OCP senior management will host a conference call to discuss third quarter 2018 results at 9:30 a.m. EST, 3:30 p.m. Morocco time (GMT+1), and 2:30 p.m. London time (GMT) on Thursday, November 29, 2018 for holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers. Eligible parties that have not already registered for access to the Intralinks portal may do so by contacting the Investor Relations Department by emailing g.laraki@ocpgroup.ma About OCP OCP is a global leader in the fertilizer industry, backed by almost a century’s production history. O

Arch Insurance Announces Strategic Leadership Changes20.11.2018 15:50Pressemelding

Arch Insurance (“Arch”) today announced Hugh Sturgess will assume the role of Chief Executive Officer, Arch Insurance International, effective Jan. 1, 2019, subject to regulatory approvals. Arch Insurance International includes Arch’s insurance operations in Europe, Bermuda and Australia. Mr. Sturgess has been with Arch Insurance since 2005 and is currently President and CEO of Arch Insurance Canada Ltd., where he has strategic and operational responsibility for a multi-line underwriting portfolio. Before joining Arch, Mr. Sturgess held various roles in the financial services industry, including tenures with the Royal Bank of Canada and Chubb Insurance Company of Canada. “Arch Insurance International underwrites a diverse portfolio of specialty insurance solutions across a number of geographies, with a key focus on providing value to our distribution partners and customers,” Mr. Sturgess said. “I look forward to the opportunity to work with our team in continuing to expand the value pr