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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

Corrigendum to “Effectiveness and Safety of Oral Anticoagulants in Adults with Non-valvular Atrial Fibrillation Patients and Concomitant Coronary/Peripheral Artery Disease” American Journal of Medicine 131:09 (2018): 1074-1085.e4
There were 33,269 apixaban-warfarin, 9,345 dabigatran-warfarin, and 42,156 rivaroxaban-warfarin matched pairs, with a median follow-up of 4-5 months. Compared with warfarin, apixaban was associated with lower rates of stroke/systemic embolism (hazard ratio [HR] 0.52; 95% confidence interval [95% CI], 0.43-0.62), major bleeding (HR 0.60; 95% CI, 0.55-0.66) and stroke/myocardial infarction/all-cause mortality (HR 0.70; 95%CI, 0.66-0.74); dabigatran was associated with lower rates of major bleeding (HR: 0.73; 95% CI, 0.62-0.85); dabigatran and rivaroxaban were associated with lower rates of stroke/myocardial infarction/all-ca...
Source: The American Journal of Medicine - August 4, 2020 Category: General Medicine Authors: Renato D. Lopes, Jan Steffel, Manuela Di Fusco, Allison Keshishian, Xuemei Luo, Xiaoyan Li, Cristina Masseria, Melissa Hamilton, Keith Friend, Kiran Gupta, Jack Mardekian, Xianying Pan, Onur Baser, W. Schuyler Jones Tags: Corrigendum Source Type: research

Long-term comparative effectiveness and safety of dabigatran, rivaroxaban, apixaban and edoxaban in patients with atrial fibrillation: A nationwide cohort study
Conclusion: NOACs had better long-term risk-benefit profiles than VKAs. While effectiveness was comparable, apixaban was overall associated with a more favorable safety profile followed by dabigatran.
Source: Frontiers in Pharmacology - February 2, 2023 Category: Drugs & Pharmacology Source Type: research

Dabigatran and Acute Coronary Syndromes
There has been considerable interest in the utility of newer oral anticoagulants for the secondary prevention of myocardial infarction (MI) and acute coronary syndromes (ACS). The direct thrombin inhibitor dabigatran has been approved for stroke prevention in patients with atrial fibrillation. However, as Verheugt discussed, when combined with dual antiplatelet therapy for secondary prevention in patients with ACS, no difference was found between the placebo and dabigatran groups for the composite end point of cardiovascular death, nonfatal MI, or stroke. However, it should also be noted that recent reports have actually ...
Source: The American Journal of Cardiology - May 1, 2013 Category: Cardiology Authors: John R. Kapoor Tags: Readers' Comments Source Type: research

Abstract 211: Association of Patient Characteristics With the Initiation of Dabigatran Versus Warfarin Among Anticoagulant Naive Patients With Non-valvular Atrial Fibrillation Poster Session II
Conclusions: Patients who are younger, male, Caucasian, and recently diagnosed with NVAF were significantly more likely to be initiated by their physician on DE vs. warfarin. These findings should be considered when doing comparative analyses of outcomes between patients on DE vs. warfarin.
Source: Circulation: Cardiovascular Quality and Outcomes - May 15, 2013 Category: Cardiology Authors: Walker, D. R., Ivanova, J., Betts, K. A., Rao, S., Wu, E. Q. Tags: Poster Session II Source Type: research

Efficacy and Safety of Dabigatran Etexilate and Warfarin in “Real-World” Patients With Atrial Fibrillation: A Prospective Nationwide Cohort Study
Conclusions: In this “everyday clinical practice” post-approval nationwide clinical cohort, there were similar stroke/systemic embolism and major bleeding rates with dabigatran (both doses) compared with warfarin. Mortality, intracranial bleeding, pulmonary embolism, and MI were lower with dabigatran, compared with warfarin. We found no evidence of an excess of bleeding events or MI among dabigatran-treated patients in this propensity-matched comparison against warfarin, even in the subgroup with ≥1-year follow-up.
Source: Journal of the American College of Cardiology - April 4, 2013 Category: Cardiology Authors: Torben Bjerregaard Larsen, Lars Hvilsted Rasmussen, Flemming Skjøth, Karen Margrete Due, Torbjörn Callréus, Mary Rosenzweig, Gregory Y.H. Lip Tags: Atrial Fibrillation Source Type: research

Causes of Death and Influencing Factors in Patients with Atrial Fibrillation: A Competing Risk Analysis from the Randomized Evaluation of Long-Term Anticoagulant Therapy Study.
CONCLUSIONS: The majority of deaths are not related to stroke in a contemporary anticoagulated AF population. These results emphasize the need to identify interventions beyond effective anticoagulation, in order to further reduce mortality in AF. CLINICAL TRIAL REGISTRATION INFORMATION: http://www.clinicaltrials.gov. Identifier: NCT00262600. PMID: 24016454 [PubMed - as supplied by publisher]
Source: Circulation - September 9, 2013 Category: Cardiology Authors: Marijon E, Le Heuzey JY, Connolly S, Yang S, Pogue J, Brueckmann M, Eikelboom JW, Themeles E, Ezekowitz MD, Wallentin L, Yusuf S Tags: Circulation Source Type: research

Perioperative management and therapy of bleeding complications.
Abstract The new oral anticoagulants directly inhibit either thrombin (Dabigatran, Pradaxa®,) or activated Factor X (rivaroxaban, Xarelto®, and apixaban, Eliquis®) and have been approved for thromboprophylaxis after hip and knee replacement surgery and stroke prevention in non-valvular atrial fibrillation. Moreover, rivaroxaban has been approved for the treatment of deep venous thrombosis, prevention of pulmonary embolism and anticoagulation after acute myocardial infarction. The direct FXa-inhibitor edoxaban (Lixiana®) expects approval for the prevention of stroke in atrial fibrillation in Germany in 2014. Th...
Source: Anasthesiologie, Intensivmedizin, Notfallmedizin, Schmerztherapie : AINS - March 1, 2014 Category: Intensive Care Authors: von Heymann C, Kaufner L, Körber M Tags: Anasthesiol Intensivmed Notfallmed Schmerzther Source Type: research

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

Cardiovascular, Bleeding, and Mortality Risks in Elderly Medicare Patients Treated with Dabigatran or Warfarin for Non-Valvular Atrial Fibrillation.
CONCLUSIONS: -In general practice settings, dabigatran was associated with reduced risk of ischemic stroke, intracranial hemorrhage, and death, and increased risk of major gastrointestinal hemorrhage compared with warfarin in elderly patients with non-valvular AF. These associations were most pronounced in patients treated with dabigatran 150 mg twice daily, whereas the association of 75 mg twice daily with study outcomes was indistinguishable from warfarin except for a lower risk of intracranial hemorrhage with dabigatran. PMID: 25359164 [PubMed - as supplied by publisher]
Source: Circulation - October 30, 2014 Category: Cardiology Authors: Graham DJ, Reichman ME, Wernecke M, Zhang R, Southworth MR, Levenson M, Sheu TC, Mott K, Goulding MR, Houstoun M, MaCurdy TE, Worrall C, Kelman JA Tags: Circulation Source Type: research

Non-vitamin K antagonist oral anticoagulants in the cardioversion of patients with atrial fibrillation: systematic review and meta-analysis
Conclusions This systematic review and meta-analysis suggests that NOACs may be as safe as VKAs in the setting of AF cardioversion.
Source: Clinical Research in Cardiology - February 3, 2015 Category: Cardiology Source Type: research

Anemia predicts thromboembolic events, bleeding complications and mortality in patients with atrial fibrillation: Insights form the RE‐LY trial
ConclusionsAnemia is associated with a raised risk of thromboembolic events, bleeding complications and mortality in anticoagulated patients with AF. These findings suggest that patients with anemia should be monitored closely during all types of anticoagulant treatment.This article is protected by copyright. All rights reserved.
Source: Journal of Thrombosis and Haemostasis - February 1, 2015 Category: Hematology Authors: B. Daan Westenbrink, Marco Alings, Stuart J. Connolly, John Eikelboom, Michael D. Ezekowitz, Jonas Oldgren, Sean Yang, Janice Pongue, Salim Yusuf, Lars Wallentin, W.H. Gilst Tags: Original Article ‐ Cardiovascular Medicine Source Type: research

Anemia predicts thromboembolic events, bleeding complications and mortality in patients with atrial fibrillation: Insights form the RE-LY trial.
CONCLUSIONS: Anemia is associated with a raised risk of thromboembolic events, bleeding complications and mortality in anticoagulated patients with AF. These findings suggest that patients with anemia should be monitored closely during all types of anticoagulant treatment. This article is protected by copyright. All rights reserved. PMID: 25683276 [PubMed - as supplied by publisher]
Source: Thrombosis and Haemostasis - February 13, 2015 Category: Hematology Authors: Westenbrink BD, Alings M, Connolly SJ, Eikelboom J, Ezekowitz MD, Oldgren J, Yang S, Pongue J, Yusuf S, Wallentin L, van Gilst WH Tags: J Thromb Haemost Source Type: research

Clinical and economic consequences of using dabigatran or rivaroxaban in patients with non-valvular atrial fibrillation
Conclusions The results show that dabigatran is a dominant alternative, i.e., it produces better clinical results at a lower cost. Sensitivity analysis demonstrates that the results are robust even considering the uncertainty inherent in an indirect comparison. It can thus be concluded that in clinical practice in Portugal the use of dabigatran is to be preferred to the use of rivaroxaban.
Source: Revista Portuguesa de Cardiologia - March 4, 2016 Category: Cardiology Source Type: research

Dabigatran in real-world atrial fibrillation. Meta-analysis of observational comparison studies with vitamin K antagonists.
Abstract In the RE-LY clinical trial, dabigatran presented a better effectiveness/safety profile when compared to warfarin. However, clinical trials are not very representative of the real-world setting. We aimed to assess the performance of dabigatran in real-world patients with atrial fibrillation (AF) by means of a systematic review and meta-analysis of observational comparison studies with vitamin K antagonists (VKA). We searched PubMed, Embase and Scopus databases until November 2015 and selected studies according to the following criteria: observational study performed with nonvalvular AF patients; reporting...
Source: Thrombosis and Haemostasis - July 27, 2016 Category: Hematology Authors: Carmo J, Moscoso Costa F, Ferreira J, Mendes M Tags: Thromb Haemost Source Type: research

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