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Condition: Bleeding
Management: European Medicines Agency (EMA)

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Total 66 results found since Jan 2013.

Janssen to Present the Strength and Promise of its Hematologic Malignancies Portfolio and Pipeline at ASH 2021
RARITAN, N.J., November 4, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 45 company-sponsored abstracts, including 11 oral presentations, plus more than 35 investigator-initiated studies will be featured at the American Society of Hematology (ASH) Annual Meeting and Exposition. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021.“We are committed to advancing the science and treatment of hematologic malignancies and look forward to presenting the latest research from our robust portfolio and pipeline during ASH...
Source: Johnson and Johnson - November 5, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Clinical characteristics and outcomes of COMPASS eligible patients in France. An analysis from the REACH Registry.
CONCLUSION: The COMPASS therapeutic strategy in France appears to be applicable to more than half of CAD or PAD patients. This population appears at high residual risk of atherothrombotic events, and patients with polyvascular disease experienced the highest rate of events. PMID: 32778388 [PubMed - as supplied by publisher]
Source: Annales de Cardiologie et d'Angeiologie - August 6, 2020 Category: Cardiology Authors: Darmon A, Elbez Y, Bhatt DL, Abtan J, Mas JL, Cacoub P, Montalescot G, Billaut-Laden I, Ducrocq G, Steg PG Tags: Ann Cardiol Angeiol (Paris) Source Type: research

Associations of Apixaban Dose With Safety and Effectiveness Outcomes in Patients With Atrial Fibrillation and Severe Chronic Kidney Disease
CONCLUSIONS: Compared with 2.5 mg, use of 5 mg apixaban was associated with a higher risk of bleeding in patients with atrial fibrillation and severe chronic kidney disease, with no difference in the risk of stroke/systemic embolism or death, supporting the apixaban dosing recommendations on the basis of kidney function by the European Medicines Agency, which differ from those issued by the US Food and Drug Administration.PMID:37681341 | DOI:10.1161/CIRCULATIONAHA.123.065614
Source: Circulation - September 8, 2023 Category: Cardiology Authors: Yunwen Xu Alex R Chang Lesley A Inker Mara McAdams-DeMarco Morgan E Grams Jung-Im Shin Source Type: research

Perceived Advantages and Disadvantages of Oral Anticoagulants, and the Trade-offs Patients Make in Choosing Anticoagulant Therapy and Adhering to Their Drug Regimen
Oral anticoagulant therapy (OAT) is proven to be highly effective for stroke prevention in patients suffering from atrial fibrillation (AF) [1,2]. Vitamin K antagonists (VKAs), particularly warfarin, which is the most commonly used VKA, have long been the standard of care to prevent AF-related stroke [3]. However, in recent years the European Medicines Agency has approved a number of direct oral anticoagulants (DOACs) as (possible) alternatives to VKAs. The perceived benefits of DOACs include their high efficacy and low risk of bleeding, the rapid onset/offset of action, fewer food and drug interactions, and predictable ph...
Source: Patient Education and Counseling - July 2, 2018 Category: International Medicine & Public Health Authors: Melissa C.W. Vaanholt, Marieke G.M. Weernink, Clemens von Birgelen, Catharina G.M. Groothuis-Oudshoorn, Maarten J. Ijzerman, Janine A. van Til Source Type: research

Design and rationale of the Edoxaban Treatment in routiNe clinical prActice for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study
This study details the design of the Edoxaban Treatment in routiNe clinical prActice for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study – a postauthorization observational study, which is part of the postapproval plan for edoxaban agreed with the European Medicines Agency. Methods The ETNA-AF-Europe study (Clinicaltrials.gov: NCT02944019) is a multicenter, prospective, observational study that enrolled 13 980 patients with atrial fibrillation treated with edoxaban from 852 sites across 10 European countries (Austria, Belgium, Germany, Ireland, Italy, the Netherlands, Portugal, Spain, Switzerland,...
Source: Journal of Cardiovascular Medicine - January 3, 2019 Category: Cardiology Tags: Research articles: Trial design Source Type: research

Preventable Cases of Oral Anticoagulant-Induced Bleeding: Data From the Spontaneous Reporting System
Conclusion: Our findings describe the most reported risk factors for preventability of oral anticoagulant-induced bleedings. These factors may be useful for targeting interventions to improve pharmacovigilance activities in our regional territory and to reduce the burden of medication errors and inappropriate prescription. Introduction Oral anticoagulant therapy is widely used for the prevention of stroke and systemic embolism in patients with atrial fibrillation, or for the prevention and treatment of deep vein thrombosis and pulmonary embolism (Raj et al., 1994; Monaco et al., 2017). Oral anticoagulants can be di...
Source: Frontiers in Pharmacology - April 29, 2019 Category: Drugs & Pharmacology Source Type: research

Use and safety of aprotinin in routine clinical practice: A European postauthorisation safety study conducted in patients undergoing cardiac surgery
CONCLUSION The data in the NApaR indicated that in this patient population, at high risk of death or blood loss undergoing cardiac surgery, including complex cardiac surgeries other than iCABG, the incidence of adverse events is in line with data from current literature, where aprotinin was not used. TRIAL REGISTRATION EU PAS register number: EUPAS11384.
Source: European Journal of Anaesthesiology - July 19, 2022 Category: Anesthesiology Tags: Cardiac surgery Source Type: research

Andexanet Alfa and its Clinical Application
Heart Int. 2020 Jun 19;14(1):20-23. doi: 10.17925/HI.2020.14.1.20. eCollection 2020.ABSTRACTFactor Xa (FXa) inhibitors are widely used for stroke prevention in patients with nonvalvular atrial fibrillation, and for the treatment and prevention of deep venous thrombosis and pulmonary embolism. Compared with warfarin, individual FXa inhibitors are associated with a lower risk of major bleeding. Nevertheless, bleeding remains a feared complication of any anticoagulant therapy. Despite their demonstrated safety, implementation of FXa inhibitors in clinical practice may have been limited by the lack of a specific antidote. Rece...
Source: Heart International - October 24, 2022 Category: Cardiology Authors: Fauve A Noordergraaf Marco Alings Source Type: research