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Comparison of the Ecarin Chromogenic Assay and Diluted Thrombin Time for Quantification of Dabigatran Concentrations.
CONCLUSIONS: For detection of levels below 50 ng/mL both tests have specificities of at least 96%, suggesting that they accurately detect even low levels of drug. Therefore, regardless of whether a chromogenic or clot-based platform is preferred, the STA-ECA-II and dTT are useful tests for measuring dabigatran concentrations. Unfortunately, neither test is licensed by the United States Food and Drug Administration. Although approved in other jurisdictions, the dTT and STA-ECA-II are not widely or rapidly available in most hospitals. Therefore, cooperation between regulators and hospitals is urgently needed to render these ...
Source: Thrombosis and Haemostasis - October 4, 2017 Category: Hematology Authors: Jaffer IH, Chan N, Roberts R, Fredenburgh JC, Eikelboom JW, Weitz JI Tags: J Thromb Haemost Source Type: research

Stop Bleeding! Oral  Anticoagulation and Options for Reversal
Direct oral anticoagulants (DOACs) are widely used medications for stroke prevention in nonvalvular atrial fibrillation (AF), and for deep vein thrombosis treatment and prevention. The IMS Institute for Healthcare Informatics analyzed outpatient anticoagulant use in the United States between 2009 and 2014 and found that there has been a steady increase in DOAC use following their initial approval in 2010.1 DOACs include the direct thrombin inhibitor dabigatran, and the factor Xa inhibitors rivaroxaban, apixaban, and edoxaban, and recently approved betrixaban.
Source: The Journal for Nurse Practitioners - November 29, 2017 Category: Nursing Authors: Archna Jariwala, Kori Hamman Tags: Prescription Pad Source Type: research

A Review of the Use of Direct Oral Anticoagulant Use in Orthotopic Heart Transplantation Recipients
Over 60 years ago, the vitamin K antagonist (VKA) warfarin was approved and remained the only oral anticoagulation agent until recently [1]. Currently, within North America and Europe there are four DOACs available. Dabigatran, first approved in Europe and Canada in 2008, then in the United States of America in 2010, followed by rivaroxaban, apixaban, and most recently edoxaban. The introduction of direct oral anticoagulants (DOACs) has been a major advancement and these agents are the preferred to VKAs for many indications [2 –5], including stroke prevention in nonvalvular atrial fibrillation (NVAF), acute treatment and...
Source: Transplantation Reviews - April 16, 2018 Category: Transplant Surgery Authors: Rosaleen Boswell, Glen J. Pearson Tags: Review article Source Type: research

Variation in the Use of Warfarin and Direct Oral Anticoagulants in Atrial Fibrillation and Associated Cost Implications
Atrial fibrillation is the most common arrhythmia in the United States and affects between 2.7 million and 6.1 million adults in the United States, with a lifetime risk of up to 1 in 4 adults over age 40 and a prevalence that is projected to double over the next 25 years.1,2 Though warfarin has long been the cornerstone of therapy to reduce the risk of stroke, several new direct oral anticoagulants (DOACs) have recently become available, beginning with FDA approval of dabigatran in October 2010, and followed by rivaroxaban in 2011, apixaban in 2014, and most recently edoxaban in 2015.
Source: The American Journal of Medicine - October 3, 2018 Category: General Medicine Authors: Benjamin A. Rodwin, Joseph A. Salami, Erica S. Spatz, Javier Valero-Elizondo, Salim S. Virani, Ron Blankstein, Michael J. Blaha, Khurram Nasir, Nihar R. Desai Tags: Clinical Research Study Source Type: research

Clinical Outcome Following Reinstitution of Anticoagulation after Major Gastrointestinal Bleed: A Single Institutional Analysis
Conclusion: Given the rising national trend on the use of anticoagulants for various medical necessities, it is imperative that a safe and efficient process be devised on reinstitution of anticoagulation post MGIB to guide Clinicians. Although our study represents a single institutional analysis, it concurs with recent studies that early resumption of anticoagulant following stabilization of MGIB is associated with lower thromboembolic events. Timing for resumption depends largely on the medical reason for anticoagulation; reinstitution by day 7 appear safe for patients on mechanical valve whereas after day 12 maybe approp...
Source: Blood - November 21, 2018 Category: Hematology Authors: Ezekwudo, D. E., Gaikazian, S., Anusim, N., Konde, A. S., Zakalik, D., Huben, M. T., Stender, M., Anderson, J., Jaiyesimi, I. Tags: 332. Antithrombotic Therapy: Poster I Source Type: research

Comparison of Drug Switching and Discontinuation Rates in Patients with Nonvalvular Atrial Fibrillation Treated with Direct Oral Anticoagulants in the United States
ConclusionIn the real-world setting, patients with NVAF newly treated with apixaban were less likely to switch or discontinue treatment compared to patients treated with rivaroxaban or dabigatran.FundingPfizer and Bristol-Myers Squibb.
Source: Advances in Therapy - November 29, 2018 Category: Drugs & Pharmacology 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

Comparison of Dabigatran Versus Warfarin Treatment for the Prevention of New Cerebral Lesions in Valvular Atrial Fibrillation
Atrial fibrillation is one of the most common arrhythmias in the United States and is associated with an increased risk of thromboembolic events.1 The American Heart Association/American College of Cardiology/Heart Rhythm Society guidelines recommend oral anticoagulation with either warfarin or oral non-vitamin K antagonists for patients diagnosed with atrial fibrillation with a high risk for ischemic stroke based on the CHA2DS2-VASc score.2 The recently published article “Comparison of Dabigatran Versus Warfarin Treatment for Prevention of New Cerebral Lesions in Valvular Atrial Fibrillation” discussed the efficacy of...
Source: The American Journal of Cardiology - October 7, 2022 Category: Cardiology Authors: Marwa S.H. Abrahim, Olufemi Sofola-James, Zeina Bani Hani Source Type: research

A Real-World Evaluation of Primary Medication Nonadherence in Patients with Nonvalvular Atrial Fibrillation Prescribed Oral Anticoagulants in the United States
ConclusionsMore than one-quarter of patients experienced PMN within 30 days of their initial prescription order. This rate decreased over a longer period, suggesting a delay in fills. Understanding the factors associated with PMN is warranted to develop effective interventions for improving OAC treatment rates in NVAF.
Source: American Journal of Cardiovascular Drugs - June 10, 2023 Category: Cardiology Source Type: research

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