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Latest & greatest articles for dabigatran
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Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source. Cryptogenic strokes constitute 20 to 30% of ischemic strokes, and most cryptogenic strokes are considered to be embolic and of undetermined source. An earlier randomized trial showed that rivaroxaban is no more effective than aspirin in preventing recurrent stroke after a presumed embolic stroke from an undetermined source. Whether dabigatran would be effective in preventing recurrent strokes after this type (...) of stroke was unclear.We conducted a multicenter, randomized, double-blind trial of dabigatran at a dose of 150 mg or 110 mg twice daily as compared with aspirin at a dose of 100 mg once daily in patients who had had an embolic stroke of undetermined source. The primary outcome was recurrent stroke. The primary safety outcome was major bleeding.A total of 5390 patients were enrolled at 564 sites and were randomly assigned to receive dabigatran (2695 patients) or aspirin (2695 patients). During a median
Safety and Efficacy of Minimally Interrupted Dabigatran vs Uninterrupted Warfarin Therapy in Adults Undergoing Atrial Fibrillation Catheter Ablation: A Randomized Clinical Trial Uninterrupted dabigatran therapy reduces stroke risk in patients with nonvalvular atrial fibrillation (NVAF) undergoing ablation and is associated with a lower bleeding risk than uninterrupted warfarin therapy. Minimally interrupted direct oral anticoagulant therapy is widely used, but data from controlled studies (...) are insufficient.To compare the safety and efficacy of minimally interrupted dabigatran vs uninterrupted warfarin therapy in patients undergoing catheter ablation for NVAF.The ABRIDGE-J (ABlation peRIoperative DabiGatran in use Envisioning in Japan) trial is a open-label, randomized clinical trial performed in 28 Japanese treatment centers. A total of 504 patients scheduled for NVAF ablation were enrolled; 500 were randomized to the study treatments; 499 received at least 1 dose of dabigatran etexilate (n = 248
Dabigatran dual therapy with ticagrelor or clopidogrel after percutaneous coronary intervention in atrial fibrillation patients with or without acute coronary syndrome: a subgroup analysis from the RE-DUAL PCI trial After percutaneous coronary intervention (PCI) in patients with atrial fibrillation, safety and efficacy with dabigatran dual therapy were evaluated in pre-specified subgroups of patients undergoing PCI due to acute coronary syndrome (ACS) or elective PCI, and those receiving (...) ticagrelor or clopidogrel treatment.In the RE-DUAL PCI trial, 2725 patients were randomized to dabigatran 110 mg or 150 mg with P2Y12 inhibitor, or warfarin with P2Y12 inhibitor and aspirin. Mean follow-up was 14 months, 50.5% had ACS, and 12% received ticagrelor. The risk of the primary endpoint, major or clinically relevant non-major bleeding event, was reduced with both dabigatran dual therapies vs. warfarin triple therapy in patients with ACS [hazard ratio (95% confidence interval), 0.47 (0.35-0.63
Effects of rivaroxaban, dabigatran, apixaban and edoxaban compared to enoxaparin for thromboprophylaxis after hip or knee arthroplasty: systematic review and meta-analysis Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. The registrant confirms that the information supplied for this submission is accurate and complete. CRD bears no responsibility or liability
Effectiveness and safety of dabigatran (110 or 150 mg/day) compared to vitamin K antagonist (warfarin and acenocumarol) in patients with non valvular atrial fibrillation Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. The registrant confirms that the information supplied for this submission is accurate and complete. CRD bears no responsibility or liability
Less abnormal uterine bleeding with dabigatran than warfarin in women treated for acute venous thromboembolism Essentials Factor Xa inhibitors cause more abnormal menstrual bleeding (AUB) than vitamin-K antagonists (VKA). We analyzed data of AUB in women, evaluating dabigatran versus VKA. We observed a 41% lower risk of AUB in women on dabigatran compared to those on VKA. Our findings of lower AUB risk on dabigatran should be corroborated in future studies.Introduction Although direct oral (...) anticoagulants (DOACs) are associated with a better safety profile than warfarin in patients with acute venous thromboembolism (VTE), direct factor Xa inhibitors involve a higher risk of abnormal uterine bleeding (AUB). We aimed to determine the risk of AUB during anticoagulation with dabigatran compared with warfarin. Methods Post-hoc analysis of the pooled RE-COVER studies and the RE-MEDY trial. Incidences of AUB, based on a defined preferred terms search for adverse events, in female patients aged 18-50
Idarucizumab (PRAXBIND) - antidote, specific for dabigatran Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written for approved after
Dabigatran Top results for dabigatran - Trip Database or use your Google+ account Liberating the literature ALL of these words: Title only Anywhere in the document ANY of these words: Title only Anywhere in the document This EXACT phrase: Title only Anywhere in the document EXCLUDING words: Title only Anywhere in the document Timeframe: to: Combine searches by placing the search numbers in the top search box and pressing the search button. An example search might look like (#1 or #2) and (#3 (...) or #4) Loading history... Population: Intervention: Comparison: Outcome: Population: Intervention: Latest & greatest articles for dabigatran The Trip Database is a leading resource to help health professionals find trustworthy answers to their clinical questions. Users can access the latest research evidence and guidance to answer their clinical questions. We have a large collection of systematic reviews, clinical guidelines, regulatory guidance, clinical trials and many other forms of evidence
Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE): an international, randomised, placebo-controlled trial. Myocardial injury after non-cardiac surgery (MINS) increases the risk of cardiovascular events and deaths, which anticoagulation therapy could prevent. Dabigatran prevents perioperative venous thromboembolism, but whether this drug can prevent a broader range of vascular complications in patients with MINS is unknown. The MANAGE trial assessed the potential (...) of dabigatran to prevent major vascular complications among such patients.In this international, randomised, placebo-controlled trial, we recruited patients from 84 hospitals in 19 countries. Eligible patients were aged at least 45 years, had undergone non-cardiac surgery, and were within 35 days of MINS. Patients were randomly assigned (1:1) to receive dabigatran 110 mg orally twice daily or matched placebo for a maximum of 2 years or until termination of the trial and, using a partial 2-by-2 factorial
2018LancetControlled trial quality: predicted high
Dabigatran versus Warfarin for Acute Venous Thromboembolism in Elderly or Impaired Renal Function Patients: Pooled Analysis of RE-COVER and RE-COVER II Management of acute venous thromboembolism (VTE) with anticoagulants in elderly patients and those with chronic kidney disease poses special challenges. The RE-COVER and RE-COVER II trials showed that dabigatran 150 mg twice daily was as effective as warfarin over 6 months in preventing recurrent VTE, with a lower bleeding risk. We now assess (...) and moderate RI, respectively (23 patients with severe RI and 49 with missing creatinine clearance data were not included). For dabigatran, VTE/VTE-related death decreased from 3.1% (normal renal function) to 1.9% for mild RI and to 0.0% for moderate RI. For warfarin, the event rates were 2.6, 1.6 and 4.1%, respectively. Overall, major bleeding increased with increasing RI (p = 0.0037) and with age (p = 0.4350), with no apparent difference between the dabigatran and warfarin patients. Dabigatran shows
Systematic review of the management strategies and outcomes of major or severe bleeding in patients receiving a direct oral anticoagulant (dabigatran, rivaroxaban, apixaban or edoxaban) Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites
Increased risk of myocardial infarction with dabigatran etexilate: fact or fiction? A critical meta-analysis from integrating randomized controlled trials and real-world studies Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites. Email
Meta-Analysis of the Safety and Efficacy of the Oral Anticoagulant Agents (Apixaban, Rivaroxaban, Dabigatran) in Patients With Acute Coronary Syndrome The significance of adding new oral anticoagulants (NOACs) to antiplatelet therapy in patients with acute coronary syndrome (ACS) is unclear. We conducted a meta-analysis to assess the safety and efficacy of adding NOACs (apixaban, rivaroxaban, and dabigatran) to single antiplatelet agent (SAP) or dual antiplatelet therapy (DAPT) in patients
Outcomes of Dabigatran and Warfarin for Atrial Fibrillation in Contemporary Practice: A Retrospective Cohort Study. Dabigatran (150 mg twice daily) has been associated with lower rates of stroke than warfarin in trials of atrial fibrillation, but large-scale evaluations in clinical practice are limited.To compare incidence of stroke, bleeding, and myocardial infarction in patients receiving dabigatran versus warfarin in practice.Retrospective cohort.National U.S. Food and Drug Administration (...) Sentinel network.Adults with atrial fibrillation initiating dabigatran or warfarin therapy between November 2010 and May 2014.Ischemic stroke, intracranial hemorrhage, extracranial bleeding, and myocardial infarction identified from hospital claims among propensity score-matched patients starting treatment with dabigatran or warfarin.Among 25 289 patients starting dabigatran therapy and 25 289 propensity score-matched patients starting warfarin therapy, those receiving dabigatran did not have
Bleeding-related hospital admissions and 30-day readmissions in patients with non-valvular atrial fibrillation treated with dabigatran versus warfarin Essentials Bleeding is a common cause of hospital admission and readmission in oral anticoagulant users. Patients with dabigatran and warfarin were included to assess hospital admission risk. Dabigatran users had a higher risk of 30-day readmission with bleeding than warfarin users. Close monitoring following hospital discharge for dabigatran (...) -related bleeding is warranted.Background Reducing 30-day hospital readmission is a policy priority worldwide. Warfarin-related bleeding is among the most common cause of hospital admissions as a result of adverse drug events. Compared with warfarin, dabigatran achieves a full anticoagulation effect more quickly following its initiation; hence it may lead to early-onset bleeds. Objectives To compare the incidence of bleeding-related hospital admissions and 30-day readmissions with dabigatran vs
Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. Triple antithrombotic therapy with warfarin plus two antiplatelet agents is the standard of care after percutaneous coronary intervention (PCI) for patients with atrial fibrillation, but this therapy is associated with a high risk of bleeding.In this multicenter trial, we randomly assigned 2725 patients with atrial fibrillation who had undergone PCI to triple therapy with warfarin plus a P2Y12 inhibitor (clopidogrel (...) or ticagrelor) and aspirin (for 1 to 3 months) (triple-therapy group) or dual therapy with dabigatran (110 mg or 150 mg twice daily) plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and no aspirin (110-mg and 150-mg dual-therapy groups). Outside the United States, elderly patients (≥80 years of age; ≥70 years of age in Japan) were randomly assigned to the 110-mg dual-therapy group or the triple-therapy group. The primary end point was a major or clinically relevant nonmajor bleeding event during follow-up
Idarucizumab for Dabigatran Reversal - Full Cohort Analysis. Idarucizumab, a monoclonal antibody fragment, was developed to reverse the anticoagulant effect of dabigatran.We performed a multicenter, prospective, open-label study to determine whether 5 g of intravenous idarucizumab would be able to reverse the anticoagulant effect of dabigatran in patients who had uncontrolled bleeding (group A) or were about to undergo an urgent procedure (group B). The primary end point was the maximum (...) percentage reversal of the anticoagulant effect of dabigatran within 4 hours after the administration of idarucizumab, on the basis of the diluted thrombin time or ecarin clotting time. Secondary end points included the restoration of hemostasis and safety measures.A total of 503 patients were enrolled: 301 in group A, and 202 in group B. The median maximum percentage reversal of dabigatran was 100% (95% confidence interval, 100 to 100), on the basis of either the diluted thrombin time or the ecarin
Patient Characteristics and Clinical Outcomes with Low-Dose DabigatranDabigatran, an oral direct thrombin inhibitor, is used in patients with non-valvular atrial fibrillation to reduce thromboembolic events. Whereas the 150 mg dosing regimen has been extensively studied in clinical setting, to date, there is no clinical data on the 75 mg (low dose, "LD") regimen. In this study, we evaluated patient characteristics and clinical outcomes in 49 patients treated with LD dabigatran.Electronic (...) medical records were utilized to compare patients from one medical center treated with LD dabigatran to those from the warfarin arm of the RE-LY trial.Compared to those from the warfarin arm of the RE-LY trial, the LD dabigatran patients were significantly older (82.6 vs. 71.6 years, p < 0.001), had higher prevalence of diabetes (42.9 vs. 23%, p < 0.001), were predominantly male (100 vs. 63.3%, p < 0.001), and had higher CHADS2 score (2.8 vs. 2.1, p < 0.001). Only 9 (18%) patients had creatinine
Association Between Dabigatran vs Warfarin and Risk of Osteoporotic Fractures Among Patients With Nonvalvular Atrial Fibrillation. The risk of osteoporotic fracture with dabigatran use in patients with nonvalvular atrial fibrillation (NVAF) is unknown.To investigate the risk of osteoporotic fracture with dabigatran vs warfarin in patients with NVAF.Retrospective cohort study using a population-wide database managed by the Hong Kong Hospital Authority. Patients newly diagnosed with NVAF from (...) 2010 through 2014 and prescribed dabigatran or warfarin were matched by propensity score at a 1:2 ratio with follow-up until July 31, 2016.Dabigatran or warfarin use during the study period.Risk of osteoporotic hip fracture and vertebral fracture was compared between dabigatran and warfarin users using Poisson regression. The corresponding incidence rate ratio (IRR) and absolute risk difference (ARD) with 95% CIs were calculated.Among 51 496 patients newly diagnosed with NVAF, 8152 new users