Filtered By:
Management: European Medicines Agency (EMA)
This page shows you your search results in order of date.
Order by Relevance | Date
Total 105 results found since Jan 2013.
Modeling the public health impact of voxelotor in the management of sickle cell disease in France
The objective of this study was to estimate the impact of voxelotor on the burden of SCD in France using a modeling approach, accounting for its anticipated adoption and diffusion over the next 5 years. We designed a sequential multi-cohort model to project and compare the cumulative incidence of SCD complications over a 20-year time horizon in a world with and without voxelotor. A distribution of patients was simulated across various levels of Hb response based on the phase 3 HO PE trial results, and relative risk reduction was adjusted using published meta-analysis results that projected risk reduction due to a 1 g/dL in...
Source: PLoS One - September 13, 2023 Category: Biomedical Science Authors: Fr édéric Galacteros 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
Reply: Association between triple therapy and major adverse cardiovascular events in COPD patients
We thank P. Almagro and P. Martinez-Camblor for their interest in our work and for their salient comments. While we agree that there is no universally accepted definition of major adverse cardiovascular event (MACE), the US Food and Drug Administration (FDA) and the European Medicines Agency include nonfatal myocardial infarction and stroke as well as cardiovascular (CV) mortality in their MACE definition [1]. Importantly, this definition includes both haemorrhagic and ischaemic stroke [1–4]. In our study, we followed this classical "three-point" definition of MACE (including haemorrhagic strokes). While this definit...
Source: European Respiratory Journal - March 2, 2023 Category: Respiratory Medicine Authors: Yang, M.-J., Guo, S.-L., Sin, D. D. Tags: Correspondence Source Type: research
EMA: No Bivalent-Stroke Link; Presley's Cause of Death 'Deferred'; Handshakes Return
(MedPage Today) -- Note that some links may require subscriptions.
The European Medicines Agency said it has not seen any signal of a possible stroke risk related to the Pfizer-BioNTech bivalent COVID-19 vaccine. (Reuters)
Funds from pandemic...
Source: MedPage Today Infectious Disease - January 19, 2023 Category: Infectious Diseases Source Type: news
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
