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Dabigatran and Mechanical Heart Valves - Not as Easy as We Hoped. 23991659 2013 10 17 2018 12 02 1533-4406 369 13 2013 Sep 26 The New England journal of medicine N. Engl. J. Med. Dabigatran and mechanical heart valves--not as easy as we hoped. 1264-6 10.1056/NEJMe1310399 Hylek Elaine M EM eng Editorial Comment 2013 08 31 United States N Engl J Med 0255562 0028-4793 0 Anticoagulants 0 Benzimidazoles 11P2JDE17B beta-Alanine 5Q7ZVV76EI Warfarin I0VM4M70GC Dabigatran AIM IM N Engl J Med. 2013 Sep (...) 26;369(13):1206-14 23991661 Anticoagulants administration & dosage Atrial Fibrillation drug therapy Benzimidazoles administration & dosage Dabigatran Female Heart Valve Prosthesis Humans Male Stroke prevention & control Thromboembolism prevention & control Warfarin administration & dosage beta-Alanine administration & dosage analogs & derivatives 2013 9 3 6 0 2013 9 3 6 0 2013 10 18 6 0 ppublish 23991659 10.1056/NEJMe1310399
Cost-effectiveness of apixaban, dabigatran, rivaroxaban, and warfarin for stroke prevention in atrial fibrillation Cost-effectiveness of apixaban, dabigatran, rivaroxaban, and warfarin for stroke prevention in atrial fibrillation Cost-effectiveness of apixaban, dabigatran, rivaroxaban, and warfarin for stroke prevention in atrial fibrillation Harrington AR, Armstrong EP, Nolan PE, Malone DC Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion (...) . Interventions The four interventions were warfarin, apixaban 5mg twice daily, dabigatran 150mg twice daily, and rivaroxaban 20mg once daily. Warfarin dose was assumed to be adjusted to achieve the patient's target international normalised ratio (INR). Location/setting USA/in-patient and out-patient care. Methods Analytical approach: A Markov model, with one-month cycles, combined the published data. The time horizon was 30 years and the authors stated that the perspective was societal. Effectiveness data
Ischemic stroke in an obese patient receiving dabigatran. 23782198 2013 06 28 2015 11 19 1533-4406 368 25 2013 Jun 20 The New England journal of medicine N. Engl. J. Med. Ischemic stroke in an obese patient receiving dabigatran. 2440-2 10.1056/NEJMc1215900 Breuer Lorenz L Ringwald Jürgen J Schwab Stefan S Köhrmann Martin M eng Case Reports Letter United States N Engl J Med 0255562 0028-4793 0 Antithrombins 0 Benzimidazoles 0 Proton Pump Inhibitors 11P2JDE17B beta-Alanine I0VM4M70GC Dabigatran (...) AIM IM Antithrombins adverse effects pharmacokinetics Benzimidazoles adverse effects pharmacokinetics Dabigatran Humans Male Middle Aged Obesity complications Proton Pump Inhibitors therapeutic use Stroke chemically induced beta-Alanine adverse effects analogs & derivatives pharmacokinetics 2013 6 21 6 0 2013 6 21 6 0 2013 7 3 6 0 ppublish 23782198 10.1056/NEJMc1215900
Dabigatran and Postmarketing Reports of Bleeding. 23484796 2013 04 11 2015 11 19 1533-4406 368 14 2013 Apr 04 The New England journal of medicine N. Engl. J. Med. Dabigatran and postmarketing reports of bleeding. 1272-4 10.1056/NEJMp1302834 Southworth Mary Ross MR Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA. Reichman Marsha E ME Unger Ellis F EF eng Journal Article 2013 03 13 United States N Engl J Med 0255562 0028-4793 0 Anticoagulants 0 (...) Antithrombins 0 Benzimidazoles 11P2JDE17B beta-Alanine 5Q7ZVV76EI Warfarin I0VM4M70GC Dabigatran AIM IM Anticoagulants adverse effects Antithrombins adverse effects Benzimidazoles adverse effects Dabigatran Gastrointestinal Hemorrhage chemically induced Hemorrhage chemically induced Humans Intracranial Hemorrhages chemically induced Product Surveillance, Postmarketing Randomized Controlled Trials as Topic United States United States Food and Drug Administration Warfarin adverse effects beta-Alanine adverse
Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. Dabigatran, which is administered in a fixed dose and does not require laboratory monitoring, may be suitable for extended treatment of venous thromboembolism.In two double-blind, randomized trials, we compared dabigatran at a dose of 150 mg twice daily with warfarin (active-control study) or with placebo (placebo-control study) in patients with venous thromboembolism who had completed at least 3 initial months (...) of therapy.In the active-control study, recurrent venous thromboembolism occurred in 26 of 1430 patients in the dabigatran group (1.8%) and 18 of 1426 patients in the warfarin group (1.3%) (hazard ratio with dabigatran, 1.44; 95% confidence interval [CI], 0.78 to 2.64; P=0.01 for noninferiority). Major bleeding occurred in 13 patients in the dabigatran group (0.9%) and 25 patients in the warfarin group (1.8%) (hazard ratio, 0.52; 95% CI, 0.27 to 1.02). Major or clinically relevant bleeding was less frequent
Dabigatran Compared to Warfarin in the Reduction of Stroke Risk in Patients With Atrial Fibrillation "Dabigatran Compared to Warfarin in the Reduction of Stroke Risk in Pat" by Thomas S. Haslam < > > > > > Title Author Date of Graduation Summer 8-10-2013 Degree Type Capstone Project Degree Name Master of Science in Physician Assistant Studies First Advisor James Ferguson, PA-C Second Advisor Annjanette Sommers, PA-C Rights . Abstract Background: Atrial fibrillation (AF) is the most common (...) been available for over 60 years. Warfarin is effective, but dated compared to newer drugs of its class and associated with inherent difficulties in treatment. Dabigatran, a new anticoagulant that promises to be easier to administer, may reduce the risk of stroke even further than warfarin. Is dabigatran a better option than warfarin in reducing stroke in patients with AF? Method: Exhaustive search of available medical literature was done using CINAHL, Medline-OVID, and Academic Research Premiere
The Effectiveness of Prothrombin Complex Concentrate in Reversing the Anticoagulant Activity of the Oral Director Thrombin Inhibitor Dabigatran (Pradaxa®): A Review of Human Studies "The Effectiveness of Prothrombin Complex Concentrate in Reversing the " by Bridget Barron < > > > > > Title Author Date of Graduation 8-10-2013 Degree Type Capstone Project Degree Name Master of Science in Physician Assistant Studies First Advisor Annjanette Sommers Rights . Abstract Dabigatran is an oral direct (...) thrombin inhibitor approved by the US FDA for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Dabigatran is rapidly replacing traditional anticoagulants, such as warfarin, despite the fact that clinicians have very little experience with dabigatran induced bleeding and no reliable therapeutic agent to reverse its effects. Prothrombin complex concentrate is effective at reversing traditional anticoagulants as it contains clotting factors, including
Dabigatran: Does it increase the risk of MI? Page 1 of 3 RxFiles: Q&A Summary www.RxFiles.ca - updated June 2013 Lynette Kosar, BSP, MSc Does Dabigatran PRADAX Increase the Risk of Myocardial Infarction? BOTTOM LINE 1,2,3,5,6,7 • It all depends. The data available has been analyzed in various ways resulting in conflicting conclusions. • Factors that impact analysis include 1) combining or separating the two dabigatran doses studied, 2) combining silent myocardial infarction (MI) & clinical MI (...) , and 3) excluding trials of = 1 month duration. • All analyses resulted in an MI risk that hovers just above or below the accepted threshold for statistical significance (e.g. p 6 days). • Fatal MI within 30 days of drug discontinuation was not statistically significant. • CONCLUSION pertaining to MI risk: when the newly identified clinical & silent MI was combined with the original data, dabigatran no longer had a statistically significant ? risk of MI compared to warfarin; however, the p-value
RE?LY: Dabigatran versus Warfarin in Patients with Atrial Fibrillation RXFILES TRIAL SUMMARY ORIGINALLY PREPARED BY: Z.DUMONT, D.BUNKA. REVISED BY L.KOSAR – UPDATED AUG 2013 – WWW.RXFILES.CA Page 1 of 5 RE-LY: Dabigatran versus Warfarin in Patients with Atrial Fibrillation 1 Randomized Evaluation of Long-term anticoagulation therapY in patients with atrial fibrillation & who were at increased risk of stroke BOTTOM LINE In RE-LY, patients with atrial fibrillation (AF) (mean CHADS 2 score 2.1 (...) ): ? Dabigatran both doses had less hemorrhagic strokes & intracranial bleeds. ? Dabigatran 150mg po bid had: - less stroke/systemic embolism 1 ? endpoint, but more gastrointestinal (GI) bleeds compared to warfarin & dabigatran 110mg po bid - a better net clinical benefit compared to warfarin - more major bleeding than dabigatran 110mg po bid but similar to warfarin ? Dabigatran 110mg po bid was similar to warfarin for stroke & systemic embolism, but had less major bleeding than warfarin. - consider
Pradaxa (dabigatran etexilate mesylate) Drug Approval Package: PRADAXA (dabigatran etexilate mesylate) NDA #022512 Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - PRADAXA (dabigatran etexilate mesylate) Capsules Company: Boehringer Ingelheim Pharmaceuticals, Inc. Application No.: 022512 Approval Date: 10/19/2010 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. (PDF) (PDF) (PDF) (PDF) (PDF
Dabigatran in Atrial Fibrillation Question and Answers document to inform commissioners 1 Dabigatran in Atrial Fibrillation Question and Answers document to inform commissioners West Midlands Commissioning Support Unit, Birmingham University /New Medicines Evaluation Unit, Keele University Introduction and background Dabigatran is a new oral anticoagulant which was licensed in 2011 for atrial fibrillation. INR monitoring is not required though renal function should be assessed before initiation (...) and annually in patients over 75 years or those with suspected renal function decline. It has fewer interactions with other drugs and foodstuffs than warfarin. There is a considerable cost impact associated with the new drug Issues for Commissioners: 1. In March 2012 NICE issued a Technology Appraisal (TA249) 1 • previous stroke, transient ischaemic attack or systemic embolism which states:“Dabigatran etexilate is recommended as an option for the prevention of stroke and systemic embolism within its
Dabigatran versus Warfarin in Patients with Mechanical Heart Valves. Dabigatran is an oral direct thrombin inhibitor that has been shown to be an effective alternative to warfarin in patients with atrial fibrillation. We evaluated the use of dabigatran in patients with mechanical heart valves.In this phase 2 dose-validation study, we studied two populations of patients: those who had undergone aortic- or mitral-valve replacement within the past 7 days and those who had undergone (...) such replacement at least 3 months earlier. Patients were randomly assigned in a 2:1 ratio to receive either dabigatran or warfarin. The selection of the initial dabigatran dose (150, 220, or 300 mg twice daily) was based on kidney function. Doses were adjusted to obtain a trough plasma level of at least 50 ng per milliliter. The warfarin dose was adjusted to obtain an international normalized ratio of 2 to 3 or 2.5 to 3.5 on the basis of thromboembolic risk. The primary end point was the trough plasma level
Cost-effectiveness of dabigatran compared with warfarin for stroke prevention in patients with atrial fibrillation and prior stroke or transient ischemic attack Untitled Document The CRD Databases will not be available from 08:00 BST on Friday 4th October until 08:00 BST on Monday 7th October for essential maintenance. We apologise for any inconvenience.
Dabigatran for stroke prevention in atrial fibrillation: a review of the evidence on safety Dabigatran for stroke prevention in atrial fibrillation: a review of the evidence on safety Dabigatran for stroke prevention in atrial fibrillation: a review of the evidence on safety CADTH Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation CADTH (...) . Dabigatran for stroke prevention in atrial fibrillation: a review of the evidence on safety. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). 2012 Authors' conclusions Bleeding is typically the main safety issue of concern with all anticoagulants, including dabigatran. In RE-LY, the major randomized controlled trial (RCT) comparing dabigatran with warfarin, the risk of severe bleeding was reduced with the lower 110-mg dose of dabigatran compared with adjusted-dose warfarin
Dabigatran or rivaroxaban versus other anticoagulants for thromboprophylaxis after major orthopedic surgery: systematic review of comparative clinical-effectiveness and safety. 22977402 2012 09 18 2018 11 13 1481-4501 1 2 2010 CADTH technology overviews CADTH Technol Overv Dabigatran or rivaroxaban versus other anticoagulants for thromboprophylaxis after major orthopedic surgery: systematic review of comparative clinical-effectiveness and safety. e0111 Canadian Agency for Drugs and Technologies
Dabigatran, rivaroxaban, or apixaban versus enoxaparin for thromboprophylaxis after total hip or knee replacement: systematic review, meta-analysis, and indirect treatment comparisons Dabigatran, rivaroxaban, or apixaban versus enoxaparin for thromboprophylaxis after total hip or knee replacement: systematic review, meta-analysis, and indirect treatment comparisons Dabigatran, rivaroxaban, or apixaban versus enoxaparin for thromboprophylaxis after total hip or knee replacement: systematic (...) ), dabigatran (220mg or 150mg) or apixaban (5mg) with enoxaparin in patients who underwent total hip or knee replacement were eligible for inclusion. Trials were required to assess an approved regimen for enoxaparin: 40mg once daily from 12 hours before surgery (Europe) or 30mg twice daily from 12 to 24 hours after surgery (North America). The primary outcome was symptomatic venous thromboembolism defined as deep vein thrombosis (DVT) or pulmonary embolism. Secondary outcomes were composites of total venous