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Drug: Pradaxa
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Total 29 results found since Jan 2013.

Can I use DOAC in a patient with renal disease?
Case A 76-year-old man is diagnosed with non-valvular atrial fibrillation. His comorbid conditions are hypertension, diabetes complicated by neuropathy, and chronic kidney disease stage 3. His current medications include metformin, lisinopril, gabapentin, and aspirin. His most recent laboratories showed a creatinine 1.8, creatinine clearance (CrCl) 35 mL/min, hemoglobin 11g/dL, and international normalized ratio 1.0. His congestive heart failure, hypertension, age, diabetes, stroke, vascular disease, and sex (CHADSVASc) score is 4. Which medication should we use to prevent stroke in this patient?  Brief overview of the is...
Source: The Hospitalist - February 3, 2022 Category: Hospital Management Authors: Ronda Whitaker Tags: Renal & Genitourinary Source Type: research

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

Benefit-Risk Tradeoffs in Assessment of New Drugs and Devices.
Abstract Balancing benefits and risks is a complex task that poses a major challenge, both to the approval of new medicines and devices by regulatory authorities and in therapeutic decision-making in practice. Several analysis methods and visualization tools have been developed to help evaluate and communicate whether the benefit-risk profile is favorable or unfavorable. In this White Paper, we describe approaches to benefit-risk assessment using qualitative approaches such as the Benefit Risk Action Team framework developed by the Pharmaceutical Research and Manufacturers of America, and the Benefit-Risk Framewor...
Source: Circulation - November 17, 2020 Category: Cardiology Authors: Kaul S, Stockbridge N, Butler J Tags: Circulation Source Type: research

All-Cause Mortality and Cardiovascular Outcomes With Non-Vitamin K Oral Anticoagulants Versus Warfarin in Patients With Heart Failure in the Food and Drug Administration Adverse Event Reporting System
Background: Many patients with heart failure (HF) are treated with warfarin or non-vitamin K oral anticoagulants (NOACs). Randomized outcome-driven comparisons of different anticoagulant strategies in HF are lacking. Data from international, government-mandated registries may be useful in understanding the real-life use of various anticoagulants and how they are linked to outcomes. Study Question: To assess 2015 annual all-cause mortality, myocardial infarction, and stroke rates co-reported for warfarin and NOACs in subjects with and without HF in the US Food and Drug Administration Adverse Event Reporting System (FAE...
Source: American Journal of Therapeutics - November 1, 2019 Category: Drugs & Pharmacology Tags: Original Research Source Type: research

Oral anticoagulation in emergency department patients: high rates of off-label doses,no difference in bleeding rates
Patients with oral anticoagulation constitute an increasing proportion in the present medical routine.1 The approval of the first direct oral anticoagulant (DOAC) dabigatran by the U.S. food and drug administration in 2010 for the purpose of stroke prevention in patients with non-valvular atrial fibrillation revolutionized the therapy strategies of this entity since the Vitamin-K antagonists (VKA) warfarin, phenprocoumon and acenocoumarol had been the only available oral anticoagulants for decades.
Source: The American Journal of Medicine - October 23, 2019 Category: General Medicine Authors: Corinne M. Eschler, Bertram K. Woitok, Georg-Christian Funk, Philipp Walter, Volker Maier, Aristomenis K. Exadaktylos, Gregor Lindner Tags: Clinical Research Study Source Type: research

FDA Drug Safety Communication: FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin
[05-13-2014] In its ongoing review of the blood thinner Pradaxa (dabigatran), the U.S. Food and Drug Administration (FDA) recently completed a new study in Medicare patients comparing Pradaxa to an older blood thinner, warfarin, for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death.
Source: FDA Center for Drug Evaluation and Research - What's New - February 26, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: Pradaxa (dabigatran etexilate mesylate) should not be used in patients with mechanical prosthetic heart valves
The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves.
Source: FDA Center for Drug Evaluation and Research - What's New - February 13, 2018 Category: Drugs & Pharmacology Source Type: news

A Review of the Clinical Subgroup Analyses From the RE-LY Trial.
Authors: Kumar R, Rahman AM, Henry BL Abstract Dabigatran was the first direct-acting oral anticoagulant approved by the US Food and Drug Administration for prevention of stroke and systemic embolism in people with atrial fibrillation, based on data from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial. Over 18,000 patients with nonvalvular atrial fibrillation and a moderate-to-high risk of thromboembolic stroke were randomized to warfarin or dabigatran. With respect to the primary endpoints for efficacy and safety, dabigatran was superior to warfarin in the prevention of stroke and thro...
Source: Reviews in Cardiovascular Medicine - September 28, 2016 Category: Cardiology Tags: Rev Cardiovasc Med 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

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

All bleeding stops — but does idarucizumab (Praxbind) make it stop faster?
3.5 out of 5 stars Persistent life-threatening hemorrhage after administration of idarucizumab. Alhashem HM et al. Am J Emerg Med 2016 June 30 [Epub ahead of print] Reference Dabigatran (Pradaxa) is a direct thrombin inhibitor approved for stroke and embolism prophylaxis in patients with non-valve-related atrial fibrillation. When it was first released in 2008, a major disincentive to widespread use was the lack of a reliable reversal agent to treat major bleeds, or to administer before necessary invasive procedures. In October 2015, the U.S. Food and Drug Administration approved idarucizumab (Praxbind), a monoclonal ant...
Source: The Poison Review - July 27, 2016 Category: Toxicology Authors: Leon Gussow Tags: Medical anticoagulant hemorrhage idarucizumab pradaxa praxbind reversal agent Source Type: news

New reversal agent for factor Xa inhibitors shows promise
Commentary on: Siegal DM, Curnette JT, Connolly SJ, et al.. Andexanet alfa for the reversal of Factor Xa inhibitor activity. N Engl J Med 2015;373:2413–24. Context Direct oral anticoagulants (DOACs) have emerged as alternatives to vitamin K-antagonists (eg, warfarin) for the long-term management of stroke prevention for non-valvular atrial fibrillation or venous thromboembolic disease. Favourable side-effect profiles and absence of therapeutic monitoring are important benefits of these newer agents. Warfarin is readily reversed with fresh frozen plasma (FFP) or prothrombin complex concentrates.1 The first reversal ag...
Source: Evidence-Based Medicine - May 22, 2016 Category: Internal Medicine Authors: Ghadimi, K., Welsby, I. J. Tags: Clinical trials (epidemiology), Immunology (including allergy), Drugs: cardiovascular system, Stroke, Venous thromboembolism, Unwanted effects / adverse reactions Therapeutics/Prevention Source Type: research

Reversing the effects of the new anti-clotting drugs
The oral anticoagulant warfarin (Coumadin) became available for prescription in 1954. This anti-clotting drug commanded national attention when President Dwight Eisenhower received the drug as part of his treatment following a heart attack. No other oral anticoagulant was successfully developed and marketed in the United States until 2010. Warfarin is a dangerous drug. Along with insulin, it is responsible for the most emergency hospitalizations due to adverse drug reactions. Whereas insulin causes low blood sugar, warfarin is notorious for the complication of major bleeding. Warfarin is plagued by hundreds of drug-drug an...
Source: New Harvard Health Information - December 9, 2015 Category: Consumer Health News Authors: Samuel Z. Goldhaber, MD Tags: Drugs and Supplements Health Heart Health Hypertension and Stroke anti-clotting coumadin deep-vein-thrombosis DVT Source Type: news

Atrial Fibrillation and Renal Function How High Is the Price of Anticoagulation? ∗
For over a half century, vitamin K antagonists, chiefly warfarin, were the exclusive oral anticoagulants available for long-term anticoagulation. Being “the only game in town,” the emphasis of the accompanying clinical research was focused on determining the most appropriate method to measure anticoagulant effects, define the most efficacious and safe target range for anticoagulation, and identify strategies to maintain and reverse therapeutic anticoagulation. This emphasis came at the expense of turning a blind eye to rare concerns raised about the potential for warfarin to cause or worsen renal dysfunction (1,2). Th...
Source: Journal of the American College of Cardiology - June 8, 2015 Category: Cardiology Source Type: research