Experience of using idarucizumab, specific antagonist of dabigatran, in Russia

2020 ◽  
Vol 1 (19) ◽  
pp. 29-38
Author(s):  
T. B. Pecherina ◽  
M. V. Larionov ◽  
D. S. Khan ◽  
L. A. Shpagina ◽  
E. V. Pudov ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Dabigatran Etexilate ◽  
Oral Anticoagulants ◽  
Clotting Factors ◽  
Nonvalvular Atrial Fibrillation ◽  
The Past ◽  
Life Threatening ◽  
Specific Antagonist ◽  
Selection Of

Atrial fibrillation (AF) is the most common type of arrhythmias in clinical practice. It has been proven that the presence of AF increases the risk of stroke by five times relative to the population of people without AF. One of the important issues in the management of patients with atrial fibrillation is the management of the risk of thromboembolic complications, namely the optimal selection of anticoagulant therapy. Most oral anticoagulants (dabigatran, apixaban, rivaroxaban) are the most effective and safest drug in patients with nonvalvular AF compared to warfarin. However, even with the use of new oral anticoagulants, there is a proven risk of bleeding, which ranges from minor to life-threatening. Currently, there are approved non-specific strategies for reversing and replenishing clotting factors associated with the use of oral anticoagulants, with certain indications in a patient with severe or life-threatening bleeding, emergency surgery, or before thrombolytic therapy. Over the past few years, specific oral anticoagulants antagonists have been actively studied. Of the specific oral anticoagulants antagonists, only idarucizumab has been approved in Russia (registration of the drug in Russia since September 2018), which makes it safer to use dabigatran in real clinical practice. The article presents clinical cases illustrating the effectiveness of the use of a specific antagonist dabigatran etexilate (idarucizumab) in patients with nonvalvular atrial fibrillation. Clinical examples illustrate the difficulties of managing patients with atrial fibrillation and hemorrhagic complications while taking oral anticoagulants.

scholarly journals The Comparison of Therapeutic Efficacy Between Dabigatran Versus Warfarin in Patients With Nonvalvular Atrial Fibrillation

2021 ◽  
Vol 27 ◽  
pp. 107602962110447
Author(s):  
Hongxia Li ◽  
Lei Zhang ◽  
Ming Xia ◽  
Chi Zhang ◽  
Tingbo Jiang
Keyword(s):  
Atrial Fibrillation ◽  
Dabigatran Etexilate ◽  
Oral Anticoagulants ◽  
International Normalized Ratio ◽  
Thrombin Time ◽  
Nonvalvular Atrial Fibrillation ◽  
Coagulation Assays ◽  
Warfarin Group ◽  
Dose Warfarin ◽  
Coagulation Status

Background Novel oral anticoagulants and warfarin are widely used for stroke prevention in patients with atrial fibrillation. The anticoagulation status of patients receiving warfarin or rivaroxaban has been studied. In this study, we aimed to evaluate the effect of dabigatran and warfarin on preventing thrombin generation (TG). Methods This retrospective study enrolled 237 nonvalvular atrial fibrillation (NVAF) subjects treated with 110 mg dabigatran etexilate twice daily and 224 NVAF patients received adjusted-dose warfarin (international normalized ratio [INR] of 2 to 3)). Coagulation assays, prothrombin fragment 1  +  2 (F1+2), calibrated automated thrombogram, and thrombin–antithrombin complex (TAT) were detected at the steady state. Results Activated partial thromboplastin time (APTT), antithrombin III activity, fibrinogen, and lag time showed no difference between the two groups. Compared to the dabigatran group, prothrombin time and INR values were higher in the warfarin group (all P < .001). Thrombin time, endogenous thrombin potential, peak TG (Cmax), F1+2, and TAT were lower in the warfarin group. The inhibition of TG was still stronger in the warfarin group when the patients were divided into subgroups. Conclusion Conventional coagulation assays are suboptimal for assessing the coagulation status of dabigatran. TG could be used as supplementary assays to evaluate the anticoagulation effect of oral anticoagulants. Our results suggest that warfarin may inhibit TG more aggressively than dabigatran in patients regardless of age and kidney function.

scholarly journals The role of edoxaban in preventing thromboembolic complications in patients with atrial fibrillation

2020 ◽  
pp. 28-43
Author(s):  
O. O. Shakhmatova
Keyword(s):  
Atrial Fibrillation ◽  
Drug Interactions ◽  
Dose Reduction ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Factor Xa ◽  
Extensive Study ◽  
Thromboembolic Complications ◽  
Nonvalvular Atrial Fibrillation ◽  
Life Threatening

Edoxaban is a selective direct factor Xa inhibitor. Edoxaban in a dose of 60 mg per day is an effective and safe option in the prevention of thromboembolic complications in patients with nonvalvular atrial fibrillation, including in combination therapy in patients after percutaneous coronary interventions. ENGAGE AF-TIMI 48 is currently the most extensive study comparing direct oral anticoagulants and warfarin in patients with atrial fibrillation, both in terms of number of participants and duration of observation. For edoxaban, an adequate approach to dose reduction has been developed in patients with alikely increase in plasma concentration due to renal impairment, low body weight or inter-drug interactions. Such dose reduction does notlead to an increase in the frequency of ischemic complications.Edoxaban is characterized by an optimal safety profile in patients with chronic moderate kidney disease, a small number of drug interactions and a convenient mode of administration. In patients with atrial fibrillation and concomitant ischemic heart disease, the use of Edoxaban is associated with a decrease in the frequency of myocardial infarctions, as well as strokes and episodes of systemic thromboembolism in comparison with warfarin. The drug can be successfully used as anticoagulant support for cardioversion and catheter ablation for atrial fibrillation.Edoxaban intake does not require routinelaboratory control. In case of unexpected situations (life-threatening bleeding, urgent surgical intervention) in patients receiving edoxaban, to assess the degree of anticoagulation should use the determination of anti-Xa activity. Clinical studies of a specific antidote of edoxaban - andexanet alfa are ongoing. Before approval of the specific antidote in severe andlife-threatening bleedings against the background of edoxaban administration, the use of prothrombin complex concentrate should be considered. Data on the effective and safe use of edoxaban in routine clinical practice have been accumulated.

Approved Uses of Dabigatran Etexilate as an Anticoagulant

2011 ◽  
Vol 27 (6) ◽  
pp. 258-265
Author(s):  
Joshua B Darnell ◽  
Erika L Kleppinger
Keyword(s):  
Atrial Fibrillation ◽  
Data Extraction ◽  
Dabigatran Etexilate ◽  
Anticoagulation Therapy ◽  
Minor Bleeding ◽  
Systemic Embolism ◽  
Nonvalvular Atrial Fibrillation ◽  
Phase 3 ◽  
Study Selection ◽  
Life Threatening

Objective: To review, analyze, and critique dabigatran etexilate's approved uses as an anticoagulant. Data Sources: Literature searches were performed via MEDLINE, International Pharmaceutical Abstracts, and Google Scholar through February 2011, using the term dabigatran. Additional data were obtained from tertiary sources and prescribing information. Study Selection and Data Extraction: All published Phase 3 anticoagulation trials investigating dabigatran for currently approved indications were selected. Information from other anticoagulation trials investigating dabigatran was used for critiquing Phase 3 studies. Data Synthesis: Dabigatran etexilate has been evaluated in multiple clinical trials as an alternative to enoxaparin for prevention of venous thromboembolism in total hip and knee replacement surgeries. It has also been evaluated as an alternative to warfarin in stroke and systemic embolism prevention in patients with atrial fibrillation. Results have generally been positive, with few exceptions. The standard adult dose of dabigatran 150 mg twice daily, approved for use in the US for stroke prevention in nonvalvular atrial fibrillation, was found to be superior to warfarin in regard to occurrence rates of stroke or systemic embolism and hemorrhagic stroke. The occurrence rates of intracranial bleeding, life-threatening bleeding, and major or minor bleeding were lower with dabigatran 150 mg twice daily than with warfarin; however, the occurrence of gastrointestinal bleeding was significantly higher. Conclusions: With its numerous benefits, and despite its drawbacks, dabigatran remains a promising option for oral anticoagulation therapy.

scholarly journals Factors associated with inappropriate reduced doses of non-vita-min K antagonist oral anticoagulants in patients with atrial fibrillation

2021 ◽  
Vol 28 (1) ◽  
pp. 52-61
Author(s):  
V. A. Ionin ◽  
O. I. Bliznuk ◽  
V. A. Pavlova ◽  
E. I. Baranova
Keyword(s):  
Atrial Fibrillation ◽  
Dabigatran Etexilate ◽  
Oral Anticoagulants ◽  
Bleeding Risk ◽  
Case Histories ◽  
Prehospital Treatment ◽  
Factors Associated ◽  
The Past ◽  
Outpatient Practice ◽  
The University

The objective was to study the factors associated with inappropriate reduced doses of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with non-valvular atrial fibrillation (AF) in real outpatient practice.Methods and materials. 10663 case histories of patients hospitalized to the therapeutic clinic of the university for 5 years (2014 — 2018) were studied, 1307/10663 (12,3 %) case histories of patients with AF were selected. Factors associated with inappropriate low doses of anticoagulant therapy (ACT) with NOACs at prehospital treatment were studied.Results. NOACs received 57.7 % (384/665) of patients with AF at the outpatient stage: rivaroxaban — 180/384 (46.9 %) patients, dabigatran etexilate — 110/384 (28.6 %) patients, apixaban — 94/384 (24.5 %) patients. Inappropriate reduced doses of NOACs were revealed in 68/384 (17.7 %) patients: apixaban — 22/94 (23.4 %), dabigatran — 18/110 (16,4 %) and rivaroxaban — 28/180 (15.6 %) (p>0,05). Patients who received inappropriate reduced doses of NOACs as compared to those who received standard doses of NOACs had higher frequency of major bleedings in the past (7.4 and 1.0 %; p=0.014) and had higher risk of bleedings (HAS-BLED 1.7±1,1 and 1.2±1.0; p = 0.0002). Proportion of patients who had HAS-BLED≥3 in these groups were 19.1 % and 8.6 % (p=0.033). All patients who received inappropriate reduced doses of NOACs had modifiable risk factors of bleedings. 85.3 % of patients with AF who received inappropriate reduced doses of NOACs had high risk of stroke according to CHA2DS2-VASc scale.Conclusion. In real outpatient practice, NOACs were recommended to 57.7 % of patients with AF. 17.7 % of patients received NOACs s in inappropriate reduced doses. Frequency of major bleedings in the past and bleeding risk in AF patients with inappropriate reduced doses was higher than in patients with standard doses.

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