BOEHRINGER-INGELHEIM
16.5.2019 10:46:03 CEST | Business Wire | Press release
Boehringer Ingelheim today announced full results from the RE-SPECT ESUS® trial, a Phase III randomised, double-blind study investigating the efficacy and safety of Pradaxa® (dabigatran etexilate) versus acetylsalicylic acid (ASA) in preventing recurrent stroke in patients with embolic stroke of undetermined source (ESUS). The results were published in the New England Journal of Medicine (NEJM).1
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190516005334/en/
The trial did not meet its primary endpoint, which was to show a clinically significant difference between dabigatran etexilate and ASA on reducing the risk of a recurrent stroke among post-stroke patients with ESUS. However, a post-hoc analysis showed a treatment effect emerged in favour of dabigatran after one year.1 The safety results from the trial demonstrated that the risk of major bleeding was not significantly different between dabigatran etexilate and ASA.1 A comparable low risk for the most serious bleeding outcomes, such as intracranial haemorrhage, was shown.1
As the first ever comparative trial to investigate dabigatran etexilate versus ASA, the results add to the wealth of evidence supporting the established safety profile of dabigatran etexilate, which has already been demonstrated in its approved indications in the extensive RE-VOLUTION® clinical trial and registry programme.2-24
“The results from RE-SPECT ESUS provide highly interesting information, showing that dabigatran had a similar low risk of major bleeding compared to ASA in this high-risk population of post-stroke patients. This clearly reaffirms the positive risk-benefit profile of dabigatran,” said Dr Waheed Jamal, Corporate Vice President, Head of CardioMetabolic Medicine, Boehringer Ingelheim.
ESUS is a type of cryptogenic stroke, which is when an ischaemic stroke has an unknown cause.25 A stroke is classified as an ESUS when other potential diagnoses have been ruled out.25,26 Overall, one in six ischaemic strokes are classified as ESUS.25 Following an ESUS, most patients are treated with anti-platelet therapy, such as ASA27 ; however, one in three go on to have a recurrent stroke within five years.28
Pradaxa is not approved in any country for patients with ESUS.
Randomised, double-blind, evaluation in secondary stroke prevention comparing the efficacy and safety of the oral thrombin inhibitor dabigatran etexilate vs. acetylsalicylic acid (ASA) in patients with embolic stroke of undetermined source (RE-SPECT ESUS ® ) 1
RE-SPECT ESUS® was a Phase III, double-blind trial of dabigatran vs ASA for secondary stroke prevention in patients with ESUS and involved 5,390 patients from more than 40 countries. Patients were randomised to receive dabigatran etexilate 150 mg BID, adjusted to 110mg BID for patients above 75 years or with impaired renal function, and a placebo matching ASA 100 mg or ASA 100 mg and a placebo matching dabigatran etexilate. The primary endpoint of the trial was to show a clinically significant difference between dabigatran etexilate and ASA on the risk of a recurrent stroke among post-stroke patients with ESUS.1
Please click on the following link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/press-release/noac-vs-asa-esus-trial-results-published-nejm
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190516005334/en/
Contact:
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
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Incyte Announces New Positive 54-Week Late-Breaking Data for Povorcitinib in Hidradenitis Suppurativa at the 2026 American Academy of Dermatology (AAD) Annual Meeting28.3.2026 20:00:00 CET | Press release
Phase 3 data from the STOP-HS program demonstrate povorcitinib’s substantial and durable clinical efficacy through Week 54 in patients with moderate to severe hidradenitis suppurativa (HS). Through Week 54, clinically meaningful and durable responses were observed across all groups in both STOP-HS1 and STOP-HS2, with up to 71.4% of patients achieving HiSCR50. Improvements in clinical responses across high stringent thresholds were observed, with up to 57% of participants achieving HiSCR75 and up to 29% of participants achieving HiSCR100. Povorcitinib treatment led to consistent reductions across key inflammatory lesion types, with full resolution (ANdT=0) achieved in up to 20% of patients. Additionally, clinically meaningful improvements in quality-of-life measures, including skin pain and fatigue, were observed at Week 54. The overall safety profile of povorcitinib through 54 weeks is consistent with previously reported data, and both doses were well tolerated. Incyte (Nasdaq:INCY) to
Takeda’s Zasocitinib Delivered Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill, Affirming Promise to Reshape Psoriasis Care28.3.2026 20:00:00 CET | Press release
About 70% of patients treated with zasocitinib achieved clear or almost clear skin (sPGA 0/1) at week 16 in Phase 3 plaque psoriasis studies A significantly greater PASI 75 response rate versus placebo was observed as early as week 4 Safety profile consistent with Phase 2b studies with no new safety signals identified Takeda(TSE:4502/NYSE:TAK)today announced new data from the two pivotal Phase 3studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).1 Presented as a late-breaking abstract at the 2026 American Academy of Dermatology (AAD) Annual Meeting, these data show that convenient once-daily oral zasocitinib demonstrated rapid and durable skin clearance with a safety profile consistent with Phase 2b studies.1,2 “Our goal in psoriasis treatment is clear or almost clear skin, and previously this has been achieved primarily with injectable therapies,” said Melinda Gooderham,
AAD 2026: Late-Breaking Nemolizumab Data Demonstrate Clinically Meaningful Benefits for Children Aged 2 to 11 With Moderate-to-Severe Atopic Dermatitis28.3.2026 16:00:00 CET | Press release
Pharmacokinetics, safety and efficacy clinical study data show that nemolizumab achieved clinically meaningful reductions in skin lesions and itch through Week 16, which were sustained up to a year in children aged 2 to 11 with moderate-to-severe atopic dermatitis1 These findings reinforce the previously established safety and efficacy of nemolizumab in adults and adolescents with moderate-to-severe atopic dermatitis, for which it is approved by multiple global regulatory authorities2,3 Up to 25% of children are affected by atopic dermatitis, and currently there are limited approved treatment options for children living with moderate-to-severe atopic dermatitis4,5 Galderma (SIX: GALD) today announced new phase II data showing that nemolizumab was well tolerated and effective in children (aged 2 to 11 years) with moderate-to-severe atopic dermatitis, with a clinically meaningful and sustained reduction in skin lesions and itch for up to a year.1 Results will be presented in a late-break
Angelalign Technology (6699.HK)Releases 2025 Results: Passion for Clinical Excellence Drives Worldwide Growth27.3.2026 20:56:00 CET | Press release
Angelalign Technology Inc. (6699.HK) (“Angel” or the “Company”) released its financial results for fiscal year 2025. During the reporting period, the Company continued to do well in both the global and China markets. Total case volume was 532,400, which increased 48.1%, revenue was USD 370.3 million, which increased 37.8%, and adjusted net profit was USD 43.8 million, which increased 63.0%. The results were driven by Angel’s passion for clinical excellence and its open and inclusive culture that empowers talented people to work together to meet customer needs, the Company said. Fox Hu, CEO of Angel, stated: “The clear aligner industry is complex and multidisciplinary. It requires top-tier technical and operational talent along with seamless collaboration among professionals from diverse geographies. Angel’s open and inclusive culture attracts professionals who share a passion for clinical excellence and a dedication to bringing outstanding products and services to customers. This melti
Axway Positioned as a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment27.3.2026 18:46:00 CET | Press release
Axway, a 74Software company (Euronext: 74SW) and global leader in federated API management and enterprise integration, has been named a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment.1 Axway Amplify securely connects, orchestrates, and automates data integration. Organizations in financial services, manufacturing, healthcare, and other industries rely on Amplify to modernize integrations and confidently unlock data to deliver superior digital services faster. The report notes: “The platform benefits from Axway’s long-standing experience in B2B integration, secure file transfer, and legacy connectivity, providing differentiated capabilities for organizations that need to expose and control APIs around core systems that are not cloud-native.”1 This multi-pattern expertise in security, integration, and federated governance — built during the early phases of the API-driven digital transformation — becomes especially critical as enterprises seek to govern dat
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom