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Management: European Medicines Agency (EMA)
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Total 105 results found since Jan 2013.
Severe ischemic stroke: Too severe for thrombolysis?
Twenty years after the introduction of IV thrombolysis with recombinant tissue plasminogen activator (rtPA), only a small proportion of stroke patients are treated with rtPA.1 The strict inclusion and exclusion criteria in the stroke guidelines, based on criteria used in the rtPA trials, partially explains the low number of treated patients. Fear of intracranial hemorrhage after rtPA also drives the strict selection of patients, despite evidence of the safety and potential effectiveness of rtPA treatment in an off-label setting.2,3 According to the European Medicines Agency, very severe stroke, defined as an NIH Stroke Sca...
Source: Neurology - December 14, 2015 Category: Neurology Authors: Uyttenboogaart, M., Fink, J. N. Tags: Stroke in young adults, Class III, Infarction, Intracerebral hemorrhage EDITORIALS Source Type: research
The Burden of Diabetes and the Chance of a Previous Stroke: Thrombolysis for Recurrent Stroke in Diabetics
Intravenous thrombolysis with recombinant tissue plasminogen activator is still not approved by the European Medicines Agency for patients with diabetes mellitus and previous stroke. We assessed functional benefit and potential risk of thrombolysis in patients with diabetes and previous stroke and the influence of age, preexisting diabetic damage, as well as acute and chronic hyperglycemia on outcome, symptomatic intracranial hemorrhage, and in-hospital mortality.
Source: Journal of Stroke and Cerebrovascular Diseases - February 3, 2018 Category: Neurology Authors: Alexandra Filipov, Anne D. Ebert, Eva Neumaier-Probst, Angelika Alonso Source Type: research
Citicoline for treating people with acute ischemic stroke.
CONCLUSIONS: This review assessed the clinical benefits and harms of citicoline compared with placebo or any other standard treatment for people with acute ischemic stroke. The findings of the review suggest there may be little to no difference between citicoline and its controls regarding all-cause mortality, disability or dependence in daily activities, severe adverse events, functional recovery and the assessment of the neurological function, based on low-certainty evidence. None of the included trials assessed quality of life and the safety profile of citicoline remains unknown. The available evidence is of low quality...
Source: Cochrane Database of Systematic Reviews - August 28, 2020 Category: General Medicine Authors: Martí-Carvajal AJ, Valli C, Martí-Amarista CE, Solà I, Martí-Fàbregas J, Bonfill Cosp X Tags: Cochrane Database Syst Rev Source Type: research
Practical use of dabigatran etexilate for stroke prevention in atrial fibrillation
Summary
Atrial fibrillation (AF) is associated with an increased risk of thromboembolism, and is the most prevalent factor for cardioembolic stroke. Vitamin K antagonists (VKAs) have been the standard of care for stroke prevention in patients with AF since the early 1990s. They are very effective for the prevention of cardioembolic stroke, but are limited by factors such as drug–drug interactions, food interactions, slow onset and offset of action, haemorrhage and need for routine anticoagulation monitoring to maintain a therapeutic international normalised ratio (INR). Multiple new oral anticoagulants have been develope...
Source: International Journal of Clinical Practice - April 5, 2013 Category: Internal Medicine Authors: K. Huber, S. J. Connolly, A. Kher, F. Christory, G.‐A. Dan, R. Hatala, R. G. Kiss, B. Meier, B. Merkely, B. Pieske, T. Potpara, J. Stępińska, N. Vene Klun, D. Vinereanu, P. Widimský Tags: Consensus Source Type: research
Ischemic stroke and dose adjustment of oral Factor Xa inhibitors in patients with atrial fibrillation
ConclusionOne in three patients with ischemic stroke during treatment with oral Xa inhibitors used inappropriate dose regimens. Underdosing was associated with lower functional plasma levels, higher clinical stroke severity and worse functional outcome.
Source: Journal of Neurology - March 22, 2020 Category: Neurology Source Type: research
Cost-effectiveness analysis of apixaban compared to other direct oral anticoagulants for prevention of stroke in Austrian atrial fibrillation patients.
CONCLUSION: In patients with AF and an increased risk of stroke, prophylaxis with apixaban was highly cost-effective from the perspective of the Austrian health care system.
PMID: 32700584 [PubMed - as supplied by publisher]
Source: Expert Review of Pharmacoeconomics and Outcomes Research - July 24, 2020 Category: Health Management Tags: Expert Rev Pharmacoecon Outcomes Res 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
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
Cardiovascular Morbidity and Pure Red Cell Aplasia Associated With Epoetin Theta Therapy in Patients With Chronic Kidney Disease: A Prospective, Noninterventional, Multicenter Cohort Study.
Abstract
PURPOSE: The European Medicines Agency recommends limiting the hemoglobin (Hb) concentration to 10 to 12 g/dL in adults with chronic kidney disease (CKD) receiving erythropoiesis-stimulating agents such as epoetin theta. This postauthorization study assessed the incidence and intensity of cardiovascular events, including ischemic stroke, in patients receiving epoetin theta for anemia associated with CKD. A secondary end point was adverse drug reactions, including pure red cell aplasia.
METHODS: In this prospective, noninterventional, multinational cohort study, consecutive patients with advanced or e...
Source: Clinical Therapeutics - December 18, 2015 Category: Drugs & Pharmacology Authors: Lammerich A, Balcke P, Bias P, Mangold S, Wiesholzer M Tags: Clin Ther Source Type: research
Janssen Announces U.S. FDA Approval of PONVORY ™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio® (teriflunomide) in Reducing Annual Relapses and Brain Lesions
TITUSVILLE, N.J. – (March 19, 2021) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) approved PONVORY™ (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.1,2,3 PONVORY™ offers MS patients superior efficacy in reducing annualized relapse rates compared to an established oral therapy and a proven safety profile backed by ove...
Source: Johnson and Johnson - March 19, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news
Author reply
Beaumont et al and Ueta raise concerns about the systemic safety of aflibercept for intravitreal injection, particularly regarding cerebrovascular risk and stroke, based on their analysis of safety data from the VIEW studies comparing aflibercept to ranibizumab. They acknowledge similar rates of serious adverse events (SAEs) overall between aflibercept and ranibizumab, as well as similar rates of myocardial infarction, stroke, and vascular death as confirmed by masked adjudication using the strict and well-accepted Antiplatelet Trialists' Collaboration (APTC) criteria. However, they focus on numerical imbalances in certai...
Source: Ophthalmology - November 19, 2013 Category: Opthalmology Authors: Jeffrey S. Heier, David M. Brown, Victor Chong, Jean-Francois Korobelnik, Peter K. Kaiser, Quan Dong Nguyen, Bernd Kirchhof, Allen Ho, Yuichiro Ogura, Ursula Schmidt-Erfurth Tags: Correspondence Source Type: research
New strategies for osteoporosis patients previously managed with strontium ranelate
The aim of this article is to describe potential alternatives to patients no longer eligible for management with strontium ranelate for osteoporosis according to the recommendations by the European Medicines Agency. A systematic search of Pubmed was done for papers on fracture efficacy of various treatments for osteoporosis, and potential harms especially in terms of cardiovascular events and stroke. The results showed that drugs more efficacious in terms of relative risk reduction of fractures than strontium ranelate were alendronate, risedronate, zoledronate, and denosumab. Raloxifene, as for strontium, may be associated...
Source: Therapeutic Advances in Musculoskeletal Disease - November 19, 2014 Category: Orthopaedics Authors: Vestergaard, P. Tags: Reviews Source Type: research
A Post-Authorization Safety Study of Quetiapine as Antidepressant Treatment in Sweden: Nested Case –Control Analyses of Select Outcomes
ConclusionRisks for all-cause mortality, self-harm and suicide, and stroke in older patients may be higher among patients treated with quetiapine and antidepressant combination therapy.
Source: Drug Safety - December 16, 2019 Category: Drugs & Pharmacology Source Type: research
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
