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Top results for dabigatran

81. Risk of Bleeding With 2 Doses of Dabigatran Compared With Warfarin in Older and Younger Patients With Atrial Fibrillation: An Analysis of the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) Trial. (Full text)

Risk of Bleeding With 2 Doses of Dabigatran Compared With Warfarin in Older and Younger Patients With Atrial Fibrillation: An Analysis of the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) Trial. Dabigatran 150 and 110 mg twice a day and warfarin are effective for stroke prevention in atrial fibrillation. The purpose of this study was to compare their risks of bleeding in the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) trial.The RE-LY trial randomized 18 (...) 113 patients to receive dabigatran 110 or 150 mg twice a day or warfarin dose adjusted to an international normalized ratio of 2.0 to 3.0 for a median follow-up of 2.0 years. Compared with warfarin, dabigatran 110 mg twice a day was associated with a lower risk of major bleeding (2.87% versus 3.57%; P=0.002), whereas dabigatran 150 mg twice a day was associated with a similar risk of major bleeding (3.31% versus 3.57%; P=0.32). There was a significant treatment-by-age interaction

2011 EvidenceUpdates PubMed

82. Dabigatran for atrial fibrillation: Why we can not rely on RE-LY

Dabigatran for atrial fibrillation: Why we can not rely on RE-LY January - March 2011 80 © Tel.: 604 822•0700 Fax: 604 822•0701 E-mail: info@ti.ubc.ca www.ti.ubc.ca Mailing Address: Therapeutics Initiative The University of British Columbia Department of Anesthesiology, Pharmacology & Therapeutics 2176 Health Sciences Mall Vancouver, BC Canada V6T 1Z3 MI RE-LY-able? monitor SAE ? 3x intracranial hemorrhage? non-blinding bias Dabigatran for atrial fibrillation Why we can not rely on RE-LY (...) an estimate of net health benefit; the numerical difference (1.6%) favouring the lower dose bare- ly misses statistical significance. Based on its benefit for stroke, both the FDA and Health Canada approved only the 150 mg BID dose of dabigatran for patients with non-valvular atrial fibrillation 3 ; the European Medicines Agency approved both 150 and 110 mg BID 4 . Alternative interpretations of the data shown in Table 1 are that 110 mg BID provides a net health benefit over 150 mg BID

2011 Therapeutics Letter

83. Anticoagulant Options - Why the FDA Approved a Higher but Not a Lower Dose of Dabigatran. (PubMed)

Anticoagulant Options - Why the FDA Approved a Higher but Not a Lower Dose of Dabigatran. 21488759 2011 06 01 2015 11 19 1533-4406 364 19 2011 May 12 The New England journal of medicine N. Engl. J. Med. Anticoagulant options--why the FDA approved a higher but not a lower dose of dabigatran. 1788-90 10.1056/NEJMp1103050 Beasley B Nhi BN Division of Cardiovascular and Renal Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA (...) . Unger Ellis F EF Temple Robert R eng Journal Article 2011 04 13 United States N Engl J Med 0255562 0028-4793 0 Anticoagulants 0 Benzimidazoles 11P2JDE17B beta-Alanine 5Q7ZVV76EI Warfarin I0VM4M70GC Dabigatran AIM IM Anticoagulants administration & dosage adverse effects Atrial Fibrillation drug therapy Benzimidazoles administration & dosage adverse effects Dabigatran Drug Approval Embolism prevention & control Hemorrhage chemically induced Humans Stroke prevention & control Therapeutic Equivalency

2011 NEJM

84. The Efficacy of Dabigatran versus Warfarin for Stroke Prevention in Patients With Atrial Fibrillation: Systematic Review

The Efficacy of Dabigatran versus Warfarin for Stroke Prevention in Patients With Atrial Fibrillation: Systematic Review "The Efficacy of Dabigatran versus Warfarin for Stroke Prevention in Pa" by Karim Bouferrache < > > > > > Title Author Date of Graduation 4-20-2011 Degree Type Capstone Project Degree Name Master of Science in Physician Assistant Studies Rights . Abstract Background: Patients with atrial fibrillation are at increased risk of experiencing embolic events. Anticoagulation (...) therapy is known to reduce these events. Warfarin, the only oral anticoagulant available, gives inconsistent results, and thus requires frequent laboratory monitoring and adjustment. A newly FDA approved fixed-dosage direct thrombin inhibitor, dabigatran, has shown some promising results in efficacy and safety. Method: An extensive review of the literature search was performed using the following database: Web of Science, MEDLINE and CINHAL. Two studies met the inclusion and exclusion criteria

2011 Pacific University EBM Capstone Project

85. [Dabigatran for the prevention of ischemic stroke in patients with acute or chronic atrial fibrillation]

[Dabigatran for the prevention of ischemic stroke in patients with acute or chronic atrial fibrillation] Dabigatrán en la prevención del accidente cerebrovascular isquémico en pacientes con fibrilación auricular [Dabigatran for the prevention of ischemic stroke in patients with acute or chronic atrial fibrillation] Dabigatrán en la prevención del accidente cerebrovascular isquémico en pacientes con fibrilación auricular [Dabigatran for the prevention of ischemic stroke in patients with acute (...) cerebrovascular isquémico en pacientes con fibrilación auricular. [Dabigatran for the prevention of ischemic stroke in patients with acute or chronic atrial fibrillation] Buenos Aires: Institute for Clinical Effectiveness and Health Policy (IECS). Informe de Respuesta Rápida N°249. 2011 Authors' objectives The purpose of this report is to assess the evidence available on the efficacy, safety and issues related to coverage policies on the use of dabigatran for the prevention of ischemic stroke (IS) in patients

2011 Health Technology Assessment (HTA) Database.

86. [Dabigatran etexilate for the prevention of stroke or systemic embolism in patients with non-vascular atrial fibrillation]

[Dabigatran etexilate for the prevention of stroke or systemic embolism in patients with non-vascular atrial fibrillation] Dabigatran etexilat en la profilaxi de l'accident vascular cerebral i de l'embolisme sistèmic en fibril·lació auricular no valvular [Dabigatran etexilate for the prevention of stroke or systemic embolism in patients with non-vascular atrial fibrillation] Dabigatran etexilat en la profilaxi de l'accident vascular cerebral i de l'embolisme sistèmic en fibril·lació auricular (...) no valvular [Dabigatran etexilate for the prevention of stroke or systemic embolism in patients with non-vascular atrial fibrillation] Gómez D, Paladio N, Almazán C 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 Gómez D, Paladio N, Almazán C. Dabigatran etexilat en la profilaxi de l'accident vascular cerebral i de l'embolisme sistèmic en

2011 Health Technology Assessment (HTA) Database.

87. [Dabigatran to prevent stroke in patients with atrial fibrillation]

[Dabigatran to prevent stroke in patients with atrial fibrillation] Dabigatran för att förebygga stroke vid förmaksflimmer [Dabigatran to prevent stroke in patients with atrial fibrillation] Dabigatran för att förebygga stroke vid förmaksflimmer [Dabigatran to prevent stroke in patients with atrial fibrillation] SBU 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 SBU. Dabigatran för att förebygga stroke vid förmaksflimmer. [Dabigatran to prevent stroke in patients with atrial fibrillation] Stockholm: The Swedish Council on Health Technology Assessment (SBU). SBU Alert 2011-04. 2011 Final publication URL Additional data URL Indexing Status Subject indexing assigned by CRD MeSH Atrial Fibrillations; Benzimidazoles; Pyridines; Stroke Language Published Swedish Country of organisation Sweden English summary An English language summary

2011 Health Technology Assessment (HTA) Database.

88. Cost-Effectiveness of Dabigatran Compared With Warfarin for Stroke Prevention in Atrial Fibrillation. (PubMed)

Cost-Effectiveness of Dabigatran Compared With Warfarin for Stroke Prevention in Atrial Fibrillation. Warfarin reduces the risk for ischemic stroke in patients with atrial fibrillation (AF) but increases the risk for hemorrhage. Dabigatran is a fixed-dose, oral direct thrombin inhibitor with similar or reduced rates of ischemic stroke and intracranial hemorrhage in patients with AF compared with those of warfarin.To estimate the quality-adjusted survival, costs, and cost-effectiveness (...) of dabigatran compared with adjusted-dose warfarin for preventing ischemic stroke in patients 65 years or older with nonvalvular AF.Markov decision model.The RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial and other published studies of anticoagulation. The cost of dabigatran was estimated on the basis of pricing in the United Kingdom.Patients aged 65 years or older with nonvalvular AF and risk factors for stroke (CHADS₂ score ≥1 or equivalent) and no contraindications

2010 Annals of Internal Medicine

89. Oral Dabigatran Etexilate: an Emerging Alternative to Conventional Anticoagulation Therapy

Oral Dabigatran Etexilate: an Emerging Alternative to Conventional Anticoagulation Therapy "Oral Dabigatran Etexilate: an Emerging Alternative to Conventional Ant" by Megan C. Merritt < > > > > > Title Author Date of Graduation 8-14-2010 Degree Type Capstone Project Degree Name Master of Science in Physician Assistant Studies First Advisor James Ferguson PA-C, MPH Second Advisor Annjanette Sommers MS, PAC Third Advisor Rob Rosenow PharmD, OD Rights . Abstract Background: Thromboembolic events (...) of anticoagulation both for patients and prescribers, and would likely increase adherence to prophylactic guidelines. Dabigatran etexilate, an oral direct thrombin inhibitor, is poised to offer this advantage, and has been appraised in several diverse settings of thromboembolic risk. While authorized for use in Europe, it awaits FDA approval in the United States. Methods: An exhaustive search of available medical literature was performed on five databases: MEDLINE, CINAHL, ISI World of Science, the National

2010 Pacific University EBM Capstone Project

90. Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. (PubMed)

Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. Effectiveness and safety of warfarin is associated with the time in therapeutic range (TTR) with an international normalised ratio (INR) of 2·0-3·0. In the Randomised Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial, dabigatran versus warfarin reduced both stroke and haemorrhage. We aimed (...) to investigate the primary and secondary outcomes of the RE-LY trial in relation to each centre's mean TTR (cTTR) in the warfarin population.In the RE-LY trial, 18 113 patients at 951 sites were randomly assigned to 110 mg or 150 mg dabigatran twice daily versus warfarin dose adjusted to INR 2·0-3·0. Median follow-up was 2·0 years. For 18 024 patients at 906 sites, the cTTR was estimated by averaging TTR for individual warfarin-treated patients calculated by the Rosendaal method. We compared the outcomes

2010 Lancet

91. Economic evaluation of dabigatran etexilate for the prevention of venous thromboembolism in patients aged over 75 years or with moderate renal impairment undergoing total knee or hip replacement

Economic evaluation of dabigatran etexilate for the prevention of venous thromboembolism in patients aged over 75 years or with moderate renal impairment undergoing total knee or hip replacement Economic evaluation of dabigatran etexilate for the prevention of venous thromboembolism in patients aged over 75 years or with moderate renal impairment undergoing total knee or hip replacement Economic evaluation of dabigatran etexilate for the prevention of venous thromboembolism in patients aged (...) compared oral dabigatran etexilate with subcutaneous enoxaparin, for patients undergoing total knee or hip replacement, who were over 75 years old or had moderate renal impairment. The authors concluded that dabigatran etexilate was superior to enoxaparin because it produced cost savings, with comparable efficacy and safety. The reporting was variable, but the analysis tends to support the authors' conclusions, based on the evidence available. Type of economic evaluation Cost-effectiveness analysis

2010 NHS Economic Evaluation Database.

92. Treatments for stroke prevention in atrial fibrillation: a network meta-analysis and indirect comparisons versus dabigatran etexilate

Treatments for stroke prevention in atrial fibrillation: a network meta-analysis and indirect comparisons versus dabigatran etexilate 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.

2010 DARE.

93. Dabigatran etexilate - Venous thromboembolism prevention

Dabigatran etexilate - Venous thromboembolism prevention Common Drug Review CEDAC Meeting – November 19, 2008, CEDAC Reconsideration – January 21, 2009 Page 1 of 3 Notice of CEDAC Final Recommendation – January 28, 2009 © 2009 CADTH CEDAC FINAL RECOMMENDATION on RECONSIDERATION and REASONS for RECOMMENDATION DABIGATRAN ETEXILATE (Pradax ® – Boehringer Ingelheim Canada Ltd.) Description: Dabigatran, administered as dabigatran etexilate, is an oral antithrombotic agent. It is a reversible direct (...) thrombin inhibitor indicated for the prevention of venous thromboembolic events (VTE) in patients who have undergone elective total hip replacement (THR) or total knee replacement (TKR) surgery. Dosage Forms: Supplied as 75 mg and 110 mg capsules. The recommended initial dose is 110 mg given one to four hours after surgery, followed by 220 mg once daily thereafter. Recommendation: The Committee recommends that dabigatran not be listed. Reasons for the Recommendation: 1. Non-inferiority compared

2009 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

94. Rivaroxaban and dabigatran for thromboprophylaxis in patients undergoing total hip or knee replacement

Rivaroxaban and dabigatran for thromboprophylaxis in patients undergoing total hip or knee replacement Home - Monash Health Find a Location Latest news Victorian Minister for Health Jenny Mikakos MP meets a patient and researcher leading the world-first safety trial examining stem cells as therapy for acute stroke. Your health Heat kills more people than any natural disaster. Be prepared and survive the heat this summer. Our children’s hospital Monash Children’s Hospital is one of Australia’s

2009 Monash Health Evidence Reviews

95. Dabigatran versus warfarin in patients with atrial fibrillation. (Full text)

Dabigatran versus warfarin in patients with atrial fibrillation. Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor.In this noninferiority trial, we randomly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive, in a blinded fashion, fixed doses of dabigatran--110 mg or 150 mg twice daily--or, in an unblinded fashion, adjusted (...) -dose warfarin. The median duration of the follow-up period was 2.0 years. The primary outcome was stroke or systemic embolism.Rates of the primary outcome were 1.69% per year in the warfarin group, as compared with 1.53% per year in the group that received 110 mg of dabigatran (relative risk with dabigatran, 0.91; 95% confidence interval [CI], 0.74 to 1.11; P<0.001 for noninferiority) and 1.11% per year in the group that received 150 mg of dabigatran (relative risk, 0.66; 95% CI, 0.53 to 0.82; P

2009 NEJM PubMed

96. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. (PubMed)

Dabigatran versus warfarin in the treatment of acute venous thromboembolism. The direct oral thrombin inhibitor dabigatran has a predictable anticoagulant effect and may be an alternative therapy to warfarin for patients who have acute venous thromboembolism.In a randomized, double-blind, noninferiority trial involving patients with acute venous thromboembolism who were initially given parenteral anticoagulation therapy for a median of 9 days (interquartile range, 8 to 11), we compared oral (...) dabigatran, administered at a dose of 150 mg twice daily, with warfarin that was dose-adjusted to achieve an international normalized ratio of 2.0 to 3.0. The primary outcome was the 6-month incidence of recurrent symptomatic, objectively confirmed venous thromboembolism and related deaths. Safety end points included bleeding events, acute coronary syndromes, other adverse events, and results of liver-function tests.A total of 30 of the 1274 patients randomly assigned to receive dabigatran (2.4

2009 NEJM

97. Dabigatran or Rivaroxaban versus other anticoagulants for thromboprophylaxis after major orthopedic surgery: systematic review of comparative clinical-effectiveness and safety

Dabigatran or Rivaroxaban versus other anticoagulants for thromboprophylaxis after major orthopedic surgery: systematic review of comparative clinical-effectiveness and safety Dabigatran or Rivaroxaban versus other anticoagulants for thromboprophylaxis after major orthopedic surgery: systematic review of comparative clinical-effectiveness and safety Dabigatran or Rivaroxaban versus other anticoagulants for thromboprophylaxis after major orthopedic surgery: systematic review of comparative (...) clinical-effectiveness and safety Ndegwa S, Moulton K, Argaez C 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 Ndegwa S, Moulton K, Argaez C. Dabigatran or Rivaroxaban versus other anticoagulants for thromboprophylaxis after major orthopedic surgery: systematic review of comparative clinical-effectiveness and safety . Ottawa: Canadian Agency

2009 Health Technology Assessment (HTA) Database.

98. A cost-effectiveness model comparing rivaroxaban and dabigatran etexilate with enoxaparin sodium as thromboprophylaxis after total hip and total knee replacement in the Irish healthcare setting

A cost-effectiveness model comparing rivaroxaban and dabigatran etexilate with enoxaparin sodium as thromboprophylaxis after total hip and total knee replacement in the Irish healthcare setting A cost-effectiveness model comparing rivaroxaban and dabigatran etexilate with enoxaparin sodium as thromboprophylaxis after total hip and total knee replacement in the Irish healthcare setting A cost-effectiveness model comparing rivaroxaban and dabigatran etexilate with enoxaparin sodium (...) , dabigatran etexilate, and enoxaparin sodium, for the primary prevention of venous thromboembolism in patients undergoing elective total hip or knee replacement. Rivaroxaban was less costly and more effective than dabigatran and enoxaparin, following either hip or knee replacement, but the probabilistic analysis showed uncertainty in rivaroxaban being more cost-effective than dabigatran etexilate, when both were compared with enoxaparin. Methodologically, the study was well conducted and the authors

2009 NHS Economic Evaluation Database.

99. Economic evaluation of dabigatran etexilate for the prevention of venous thromboembolism after total knee and hip replacement surgery

Economic evaluation of dabigatran etexilate for the prevention of venous thromboembolism after total knee and hip replacement surgery Economic evaluation of dabigatran etexilate for the prevention of venous thromboembolism after total knee and hip replacement surgery Economic evaluation of dabigatran etexilate for the prevention of venous thromboembolism after total knee and hip replacement surgery Wolowacz S E, Roskell N S, Maciver F, Beard S M, Robinson P A, Plumb J M, Dolan G, Brenkel I J (...) Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary This study examined the cost-effectiveness of oral dabigatran etexilate (DE) versus subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement

2009 NHS Economic Evaluation Database.

100. Dabigatran etexilate for the prevention of venous thromboembolism after hip or knee replacement surgery in adults (TA157)

Dabigatran etexilate for the prevention of venous thromboembolism after hip or knee replacement surgery in adults (TA157) Overview | Dabigatran etexilate for the prevention of venous thromboembolism after hip or knee replacement surgery in adults | Guidance | NICE Dabigatran etexilate for the prevention of venous thromboembolism after hip or knee replacement surgery in adults Technology appraisal guidance [TA157] Published date: 24 September 2008 Share Guidance on dabigatran etexilate (Pradaxa

2008 National Institute for Health and Clinical Excellence - Technology Appraisals