Latest & greatest articles for dabigatran

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Top results for dabigatran

41. Ischemic stroke in an obese patient receiving dabigatran. (Abstract)

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

2013 NEJM

42. Dabigatran and Postmarketing Reports of Bleeding. Full Text available with Trip Pro

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

2013 NEJM

43. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. Full Text available with Trip Pro

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

2013 NEJM Controlled trial quality: predicted high

44. Pradaxa (dabigatran etexilate mesylate)

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

2013 FDA - Drug Approval Package

45. Dabigatran: Does it increase the risk of MI?

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

2013 RxFiles

46. RE?LY: Dabigatran versus Warfarin in Patients with Atrial Fibrillation

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

2013 RxFiles

47. Dabigatran associated with increased risk of acute coronary events

Dabigatran associated with increased risk of acute coronary events Dabigatran associated with increased risk of acute coronary events | BMJ Evidence-Based Medicine We use cookies to improve our service and to tailor our content and advertising to you. You can manage your cookie settings via your browser at any time. To learn more about how we use cookies, please see our . Log in using your username and password For personal accounts OR managers of institutional accounts Username * Password (...) * your user name or password? Search for this keyword Search for this keyword Main menu Log in using your username and password For personal accounts OR managers of institutional accounts Username * Password * your user name or password? You are here Dabigatran associated with increased risk of acute coronary events Article Text Electronic pages Dabigatran associated with increased risk of acute coronary events Payal Kohli 1 , Christopher Paul Cannon 2 Statistics from Altmetric.com Commentary

2013 Evidence-Based Medicine

48. Dabigatran (Pradaxa): contraindicated in patients with prosthetic heart valve(s) requiring anti-coagulant treatment

Dabigatran (Pradaxa): contraindicated in patients with prosthetic heart valve(s) requiring anti-coagulant treatment Dabigatran (Pradaxa): contraindicated in patients with prosthetic heart valve(s) requiring anti-coagulant treatment - GOV.UK GOV.UK uses cookies to make the site simpler. or Search Dabigatran (Pradaxa): contraindicated in patients with prosthetic heart valve(s) requiring anti-coagulant treatment Risk of thrombosis and haemorrhage in patients with prosthetic heart valve(s (...) ) requiring anti-coagulant treatment. Published 11 December 2014 From: Therapeutic area: , Contents Article date: March 2013 Dabigatran (Pradaxa) is a reversible inhibitor of free thrombin, fibrin-bound thrombin, and thrombin-induced platelet aggregation. It is licensed for primary prevention of venous thromboembolic events in adults who have had elective total hip or knee replacement surgery (at 220 mg/day), and for prevention of stroke and systemic embolism in adults with non-valvular atrial

2013 MHRA Drug Safety Update

49. New oral anticoagulants apixaban (Eliquis?), dabigatran (Pradaxa) and rivaroxaban (Xarelto?)

New oral anticoagulants apixaban (Eliquis?), dabigatran (Pradaxa) and rivaroxaban (Xarelto?) New oral anticoagulants apixaban (Eliquis▼), dabigatran (Pradaxa) and rivaroxaban (Xarelto▼) - GOV.UK GOV.UK uses cookies to make the site simpler. or Search New oral anticoagulants apixaban (Eliquis▼), dabigatran (Pradaxa) and rivaroxaban (Xarelto▼) Risk of serious haemorrhage—clarified contraindications apply to all 3 medicines. Published 11 December 2014 From: Therapeutic area: Contents Article (...) update September 2016: In November 2015, idarucizumab (Praxbind▼) was granted a European licence as a specific reversal agent for dabigatran. Idarucizumab is indicated for adults treated with dabigatran when rapid reversal of its anticoagulant effects is required for emergency surgery/urgent procedures, or in life-threatening or uncontrolled bleeding. Further information about this medicine is available on the website of the Article date: October 2013 Dabigatran (Pradaxa) is a potent, orally active

2013 MHRA Drug Safety Update

50. Cost-effectiveness of dabigatran compared with warfarin for stroke prevention in patients with atrial fibrillation and prior stroke or transient ischemic attack

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.

2013 NHS Economic Evaluation Database.

51. Dabigatran versus Warfarin in Patients with Mechanical Heart Valves. Full Text available with Trip Pro

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

2013 NEJM Controlled trial quality: uncertain

52. Dabigatran in Atrial Fibrillation Question and Answers document to inform commissioners

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

2013 West Midlands Clinical Support Unit

53. 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 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

2012 Health Technology Assessment (HTA) Database.

54. Periprocedural Bleeding and Thromboembolic Events With Dabigatran Compared With Warfarin: Results From the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) Randomized Trial Full Text available with Trip Pro

Periprocedural Bleeding and Thromboembolic Events With Dabigatran Compared With Warfarin: Results From the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) Randomized Trial Dabigatran reduces ischemic stroke in comparison with warfarin; however, given the lack of antidote, there is concern that it might increase bleeding when surgery or invasive procedures are required.The current analysis was undertaken to compare the periprocedural bleeding risk of patients in the Randomized (...) Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial treated with dabigatran and warfarin. Bleeding rates were evaluated from 7 days before until 30 days after invasive procedures, considering only the first procedure for each patient. A total of 4591 patients underwent at least 1 invasive procedure: 24.7% of patients received dabigatran 110 mg, 25.4% received dabigatran 150 mg, and 25.9% received warfarin, P=0.34. Procedures included: pacemaker/defibrillator insertion (10.3%), dental procedures

2012 EvidenceUpdates Controlled trial quality: uncertain

55. Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in UK patients with atrial fibrillation

Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in UK patients with atrial fibrillation 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.

2012 NHS Economic Evaluation Database.

56. 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 Disclaimer: The Rapid Response Service is an information service for those involved in planning and providing health care in Canada. Rapid responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources and a summary of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed (...) to CADTH. Links: This report may contain links to other information available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners’ own terms and conditions. TITLE: Dabigatran for Stroke Prevention in Atrial Fibrillation: A Review of the Evidence on Safety DATE: 06 March 2012 CONTEXT AND POLICY ISSUES Atrial fibrillation (AF) is a type of cardiac dysrhythmia that is estimated to affect between

2012 Canadian Agency for Drugs and Technologies in Health - Rapid Review

57. Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation: a Canadian payer perspective Full Text available with Trip Pro

Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation: a Canadian payer perspective Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation: a Canadian payer perspective Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation: a Canadian payer perspective Sorensen SV, Kansal AR, Connolly S, Peng S, Linnehan J (...) , Bradley-Kennedy C, Plumb JM 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 investigated the cost-effectiveness of dabigatran etexilate versus warfarin (trial data) or usual care (warfarin, aspirin, or no treatment) for stroke

2012 NHS Economic Evaluation Database.

58. Dabigatran etexilate versus warfarin in management of non-valvular atrial fibrillation in UK context: quantitative benefit-harm and economic analyses

Dabigatran etexilate versus warfarin in management of non-valvular atrial fibrillation in UK context: quantitative benefit-harm and economic analyses Dabigatran etexilate versus warfarin in management of non-valvular atrial fibrillation in UK context: quantitative benefit-harm and economic analyses Dabigatran etexilate versus warfarin in management of non-valvular atrial fibrillation in UK context: quantitative benefit-harm and economic analyses Pink J, Lane S, Pirmohamed M, Hughes DA 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 assessed the cost-effectiveness of dabigatran etexilate and warfarin in patients with non-valvular atrial fibrillation and a moderate-to-high risk of stroke. Dabigatran 110mg

2012 NHS Economic Evaluation Database.

59. Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation (TA249)

Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation (TA249) Overview | Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation | Guidance | NICE Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation Technology appraisal guidance [TA249] Published date: 15 March 2012 Share Guidance on dabigatran etexilate (Pradaxa) for preventing stroke and systemic embolism in adults

2012 National Institute for Health and Clinical Excellence - Technology Appraisals

60. Meta-analysis of efficacy and safety of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus warfarin in patients with atrial fibrillation

Meta-analysis of efficacy and safety of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus warfarin in patients with atrial fibrillation 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.

2012 DARE.