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Condition: Atrial Fibrillation
Management: Food and Drug Administration (FDA)

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Total 197 results found since Jan 2013.

As some hail new antibody treatment for Alzheimer ’s, safety and benefit questions persist
In a packed San Francisco conference room with a celebratory atmosphere, upbeat company representatives and scientists yesterday presented detailed clinical trial data on the first Alzheimer’s treatment shown to clearly, albeit modestly, slow the disease’s normal cognitive decline. The antibody therapy has buoyed a field marked by decades of failures. Now, it appears to be on the cusp of being greenlit by the U.S. Food and Drug Administration (FDA). Yet other researchers warn of potential risks, including brain swelling and brain hemorrhages that were linked to the recently disclosed deaths of two trial participants wh...
Source: Science of Aging Knowledge Environment - December 1, 2022 Category: Geriatrics Source Type: research

Bayer receives U.S. FDA Fast Track Designation for asundexian atrial fibrillation program
Bayer today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334) as a potential treatment to prevent stroke and systemic embolism in people with atrial fibrillation (AF). This news follows asundexian's first U.S. FDA Fast Track Designation for the prevention of stroke in patients after a non-cardioembolic ischemic stroke, which was granted in 2022.
Source: World Pharma News - May 16, 2023 Category: Pharmaceuticals Tags: Featured Bayer Business and Industry Source Type: news

Dabigatran Use in the Real World: A Multihospital System Experience
Dabigatran etexilate, an oral direct thrombin inhibitor, was approved by the Food and Drug Administration to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation based on the outcomes of the Randomized Evaluation of Long-term anticoagulant therapY (RE-LY) study. Although this study provides robust data on the efficacy and safety of dabigatran, there may be differences in the drug use and outcomes in routine clinical practice following drug approval. In this retrospective chart review study, we describe the use of dabigatran in 160 patients in 4 adult hospitals (1 academic and 3 c...
Source: Journal of Pharmacy Practice - August 4, 2014 Category: Drugs & Pharmacology Authors: Kimmons, L. A., Kabra, R., Davis, M., Segars, B. V., Oliphant, C. S. Tags: Research Articles Source Type: research

Practical aspects of treatment with target specific anticoagulants: initiation, payment and current market, transitions, and venous thromboembolism treatment
Abstract Target specific anticoagulants (TSOACs) have recently been introduced to the US market for multiple indications including venous thromboembolism (VTE) prevention in total hip and knee replacement surgeries, VTE treatment and reduction in the risk of stroke in patients with non-valvular atrial fibrillation (NVAF). Currently, three TSOACs are available including rivaroxaban, apixaban, and dabigatran with edoxaban currently under Food and Drug Administration review for VTE treatment and stroke prevention in NVAF. The introduction of these agents has created a paradigm shift in anticoagulation by considerably...
Source: Journal of Thrombosis and Thrombolysis - January 21, 2015 Category: Hematology Source Type: research

Novel Oral Anticoagulants in Atrial Fibrillation: Update on Apixaban.
Authors: Mezue K, Obiagwu C, John J, Sharma A, Yang F, Shani J Abstract Almost 800,000 new or recurrent strokes happen every year. Atrial fibrillation, the most common cardiac arrhythmia, is a major risk factor for stroke, accounting for 15-20% of ischemic strokes. Apixaban is a direct inhibitor of Factor Xa that was approved in December 2012 by the US Food and Drug Administration (FDA) for the prevention of stroke in patients with non-valvular atrial fibrillation. It is part of a family of novel oral anticoagulants (NOACs) which have the advantage over warfarin of less dosing variability, rapid onset of action and...
Source: Current Cardiology Reviews - July 29, 2016 Category: Cardiology Tags: Curr Cardiol Rev Source Type: research

Idarucizumab: Clinical Role of a Novel Reversal Agent for Dabigatran.
Authors: Teleb M, Salire K, Wardi M, Alkhateeb H, Said S, Mukherjee D Abstract Atrial fibrillation (AF), a common cardiac arrhythmia associated with increased risk of heart failure, thromboembolic phenomena and death, is a leading cause of hospitalization of adults. A major complication of atrial fibrillation is an increased risk of ischemic stroke leading to long-term disability and in severe cases, death. Historically, coumadin has been the drug of choice for chronic anticoagulation and stroke prevention in AF patients however, given the need for constant monitoring and multiple drug interactions, newer anticoagu...
Source: Cardiovascular and Hematological Disorders Drug Targets - August 3, 2016 Category: Drugs & Pharmacology Tags: Cardiovasc Hematol Disord Drug Targets Source Type: research

Percutaneous left atrial appendage closure: current state of the art
Purpose of review: The authors reviewed the seminal and more recent literature surrounding the major modalities for percutaneous left atrial appendage closure used in contemporary practice, with particular emphasis on safety and efficacy, technical challenges, and future developments. Recent findings: Along with the continued practice of surgical left atrial appendage closure, which has evolved substantially with the advent of clipping techniques, a number of percutaneous methods have been developed to close the left atrial appendage with endocardial, epicardial, and hybrid approaches. The last 18 months has seen the Food...
Source: Current Opinion in Cardiology - December 1, 2016 Category: Cardiology Tags: ARRHYTHMIAS: Edited by David H. Birnie Source Type: research

Study: Fish Oil Doesn ’ t Seem To Prevent Heart Problems
This study is consistent with earlier trials. The US Food and Drug Administration approved the fish oil-based drug Vascepa for heart attack and stroke prevention in 2019. Nissen hopes the FDA will take a look at these studies and reconsider that decision. “But it’s hard to get something undone once the genie gets out of the bottle,” he said. An editorial in the journal that accompanies the study written by Dr. Gregory Curfman, assistant professor of medicine at Harvard Medical School, also suggested the FDA should require a postmarketing clinical trial of a high-dose of fish oil, such as Vascepa, vs. corn...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - November 16, 2020 Category: Consumer Health News Authors: CBS Boston Tags: Boston News Health Syndicated CBSN Boston CNN fish oil Source Type: news

Evaluation of Prescribing Practices and Outcomes Using Direct-Acting Oral Anticoagulants After Cardiac Surgery
Clin Ther. 2021 May 30:S0149-2918(21)00203-4. doi: 10.1016/j.clinthera.2021.04.009. Online ahead of print.ABSTRACTPURPOSE: Cardiac surgery patients frequently require anticoagulation. Warfarin remains the preferred agent, and a few trials have reported negative outcomes with the use of direct-acting oral anticoagulants (DOACs) in these patients. Therefore, limited literature exists that supports the dosing, safety, and efficacy of DOACs within the cardiac surgery population.METHODS: This single-center, retrospective analysis was conducted at a tertiary academic medical center. All data were extrapolated from electronic med...
Source: Clinical Therapeutics - June 3, 2021 Category: Drugs & Pharmacology Authors: Dareen M Kanaan Bryan M Cook Julie Kelly Rhynn Malloy Source Type: research

Performing Transcatheter Left Atrial Appendage Closure: Techniques and Challenges
The left atrial appendage (LAA) has been demonstrated to be the major source of thromboemboli in patients with atrial fibrillation (AF).1 The rationale of LAA closure is based on eliminating LAA continuity with the left atrium thereby reducing stroke risk. Indeed, left atrial appendage occlusion (LAAO) procedures play an important role in anticoagulation-intolerant patients at risk for AF-related stroke. Based on the PROTECT-AF2 and PREVAIL3 studies, the Food and Drug Administration (FDA) approved use of the Watchman (Boston Scientific, MA) device in 2015, with an updated generation of device subsequently ratified in 2020 ...
Source: Heart Rhythm - August 6, 2022 Category: Cardiology Authors: Ammar M. Killu, Mohamad A. Alkhouli Source Type: research

Dabigatran, a Cause of Hematologic Emergency.
Abstract ABSTRACT:: Dabigatran etexilate, a direct thrombin inhibitor, has become an alternative to warfarin for stroke prevention in patients with nonvalvular atrial fibrillation. There remains a concern about its overdose and life-threatening hemorrhage because of unavailability of appropriate coagulation tests to monitor and antidotes to reverse its effects. There are no clinical data about its safety in patients with fluctuating renal function. Multiple bleeding events reported with dabigatran have prompted the U.S. Food and Drug Administration to further investigate these reports. Four clinical cases with lif...
Source: The American Journal of the Medical Sciences - December 5, 2012 Category: Journals (General) Authors: Lal Y, Van Heukelom J Tags: Am J Med Sci Source Type: research

Fatal dabigatran toxicity secondary to acute renal failure
We describe the case of a 74-year-old man taking dabigatran 150 mg twice daily for atrial fibrillation who presented to the emergency department after 20 mL of hematemesis at home. Laboratory evaluation revealed a partial thromboplastin time of 99 seconds, international normalized ratio of 11.7, and creatine of 3.1 mg/dL (baseline creatine, 0.9 mg/dL). Upper endoscopy revealed diffuse gastritis and bleeding. Despite treatment with packed red blood cells and fresh frozen plasma, the patient's hematemesis persisted resulting in significant aspiration requiring endotracheal intubation. Per poison control center recommendation...
Source: The American Journal of Emergency Medicine - November 19, 2012 Category: Emergency Medicine Authors: Joseph K. Maddry, Mana Kouros Amir, Daniel Sessions, Kennon Heard Tags: Case Reports Source Type: research

Managing Blunt Trauma in Patients Receiving Dabigatran Etexilate: Case Study and Review of the Literature
The objectives of this article are to present a case of life-threatening bleeding in a patient receiving dabigatran etexilate, followed by a review of the current literature and a suggested reversal guideline.
Source: Journal of Emergency Nursing: JEN - April 1, 2013 Category: Nursing Authors: Peter Eamonn Croft, Katherine P. Cabral, Tania D. Strout, Michael R. Baumann, Michael A. Gibbs, Matthew C. DeLaney Tags: Trauma Notebook Source Type: research

Anticoagulation for non-valvular atrial fibrillation: new anticoagulant agents.
Abstract Atrial fibrillation (AF) is a common cardiac arrhythmia and it is associated with systemic thromboembolism. Until recently, vitamin K antagonists (VKA) such as warfarin were the only available oral anticoagulant therapy for prevention of stroke and systemic embolism in AF. Limitations of VKA therapy have prompted researchers to search for novel anticoagulant drugs, which do not necessitate coagulation monitoring due to their more predictable pharmacokinetic profile. Large-scale phase III trials have been completed for some of these drugs and 'U.S. Food and Drug Administration (FDA)' approved dabigatran an...
Source: The Anatolian Journal of Cardiology - April 11, 2013 Category: Cardiology Authors: Kepez A, Erdoğan O Tags: Anadolu Kardiyol Derg Source Type: research