scholarly journals Characteristics of patients with atrial fibrillation prescribed edoxaban in Belgium and the Netherlands: insights from the ETNA-AF-Europe study

2021 ◽  
Author(s):  
T. A. C. de Vries ◽  
◽  
M. E. W. Hemels ◽  
F. Cools ◽  
H. J. G. M. Crijns ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
The Netherlands ◽  
Dose Reduction ◽  
Clinical Characteristics ◽  
Prospective Observational Study ◽  
Oral Anticoagulants ◽  
Local Implementation ◽  
Reduced Dose ◽  
P Glycoprotein ◽  
Glycoprotein Inhibitors

Abstract Background Studies on the use of non-vitamin K antagonist oral anticoagulants in unselected patients with atrial fibrillation (AF) show that clinical characteristics and dosing practices differ per region, but lack data on edoxaban. Methods With data from Edoxaban Treatment in routiNe clinical prActice for patients with AF in Europe (ETNA-AF-Europe), a large prospective observational study, we compared clinical characteristics (including the dose reduction criteria for edoxaban: creatinine clearance 15–50 ml/min, weight ≤60 kg, and/or use of strong p‑glycoprotein inhibitors) of patients from Belgium and the Netherlands (BeNe) with those from other European countries (OEC). Results Of all 13,639 patients in ETNA-AF-Europe, 2579 were from BeNe. BeNe patients were younger than OEC patients (mean age: 72.3 vs 73.9 years), and had lower CHA2DS2-VASc (mean: 2.8 vs 3.2) and HAS-BLED scores (mean: 2.4 vs 2.6). Patients from BeNe less often had hypertension (61.6% vs 80.4%), and/or diabetes mellitus (17.3% vs 23.1%) than patients from OEC. Moreover, relatively fewer patients in BeNe were prescribed the reduced dose of 30 mg edoxaban (14.8%) than in OEC (25.4%). Overall, edoxaban was dosed according to label in 83.1% of patients. Yet, 30 mg edoxaban was prescribed in the absence of any dose reduction criteria in 36.9% of 30 mg users (5.5% of all patients) in BeNe compared with 35.5% (9.0% of all patients) in OEC. Conclusion There were several notable differences between BeNe and OEC regarding clinical characteristics and dosing practices in patients prescribed edoxaban, which are relevant for the local implementation of dose evaluation and optimisation. Trial registration NCT02944019; Date of registration 24 October 2016

Dose reduction of edoxaban preserves efficacy and safety for the treatment of venous thromboembolism

2016 ◽  
Vol 116 (10) ◽  
pp. 747-753 ◽  
Author(s):  
Philip S. Wells ◽  
Annelise Segers ◽  
Walter Ageno ◽  
Marjolein P. A. Brekelmans ◽  
Alexander T. Cohen ◽  
...  
Keyword(s):  
Body Weight ◽  
Venous Thromboembolism ◽  
Dose Reduction ◽  
Drug Exposure ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Efficacy And Safety ◽  
P Glycoprotein ◽  
Recurrent Vte ◽  
Glycoprotein Inhibitors

SummaryDirect oral anticoagulants simplify venous thromboembolism (VTE) treatment by obviating the need for coagulation monitoring. Nonetheless, renal function, body weight and P-glycoprotein inhibitors influence drug levels. The objective of this analysis was to determine whether reduction in edoxaban dose based on clinical criteria avoids excess drug exposure and preserves efficacy and safety in the Hokusai-VTE study. After initial heparin, patients received edoxaban or warfarin for 3-12 months. Edoxaban was given once daily at a dose of 60 mg, which was reduced to 30 mg in patients with a creatinine clearance of 30–50 ml/minute, body weight ≤60 kg or receiving certain P-glycoprotein inhibitors. The primary efficacy outcome was recurrent VTE and the principal safety outcome was major or clinically relevant non-major bleeding. A total of 8292 patients with acute VTE were randomised, 733 and 719 patients in the edoxaban and warfarin groups met the criteria for dose reduction. These patients were older, more often female or Asian and had more extensive VTE. Edoxaban levels were lower in the 30 mg edoxaban group. Rates of recurrent VTE and bleeding with the 30 mg and 60 mg edoxaban dose were comparable: VTE rates were 3.0 % and 3.2 % and clinically relevant bleeding rates were 7.9 % and 8.6 %, respectively. Rates of recurrent VTE and bleeding in the warfarin-treated patients meeting the criteria for dose reduction were 4.2 % and 12.8 %, respectively. The reduced dose edoxaban regimen maintained efficacy and safety compared with the 60 mg dose but was safer than warfarin in patients meeting the criteria for dose reduction.Supplementary Material to this article is available online at www.thrombosis-online.com.

P4743Inappropriate dosing of non-vitamin K oral anticoagulants (NOACs) in atrial fibrillation patients in Europe

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
I Palau ◽  
S Heinz ◽  
B Y Cheng ◽  
S Brown
Keyword(s):  
Atrial Fibrillation ◽  
Dose Reduction ◽  
Vitamin K ◽  
Oral Anticoagulants ◽  
Standard Of Care ◽  
Considerable Proportion ◽  
Sufficient Data ◽  
Product Label ◽  
Reduced Dose ◽  
Correct Dose

Abstract Background Prescription of Non-vitamin K oral anticoagulants (NOACs) has increased since the first therapies were launched in Europe in 2011, and they are becoming the standard of care in prevention of stroke in patients with non-valvular atrial fibrillation (NVAF). There are concerns about inappropriate NOAC dosing in clinical practice. Purpose This paper examines the extent of inappropriate dose prescription among NOAC patients in Germany, Italy, Spain and United Kingdom. Inappropriate dosing refers to patients who do not meet the criteria for dose reduction (under-dose) or patients who should be on the reduced dose as they meet the criteria for dose reduction (overdose). Methods Ipsos' Stroke Prevention in Atrial Fibrillation Therapy Monitor was fielded for 6 weeks between January 2017 to February 2017 and 6 weeks between January 2018 to March 2018, with 450 treating doctors in 2017 and 509 in 2018 providing data from 5,692 (2017: n=2,497, 2018: n=3,195) patients with non-valvular atrial fibrillation in Europe. We analysed the results for the 3,477 patients with a NOAC prescription that had sufficient data to decide on the appropriate dose. Results Overall, 23.4% of patients (n=813) were receiving an inappropriate dose of dabigatran, rivaroxaban, apixaban or edoxaban. Receiving an under-dose was more common than an overdose (19.2% vs 4.2%). Ipsos data indicate 32.8% of NOAC patients in EU4 (n=1,139) were prescribed a reduced dose, and Italy had a higher proportion of patients who received a reduced dosed; Italy: 41.0% (n=345), Germany: 30.2% (n=402), Spain: 30.6% (n=216) and UK: 29.4% (n=176). Among these patients, a considerable proportion did not meet the criteria for dose reduction in EU4 (58.6%). This suggests that reduced dose is frequently prescribed to patients when not indicated. Conclusion Overall, the majority of patients were prescribed a correct dose according to the product label. However, we see evidence that nearly half of patients receiving a reduced dose were not indicated for a dose reduction. Further research is needed to identify reasons prompting the over-use of reduced dose.

scholarly journals Prediction-Determining Outcomes and Their Predictors in Atrial Fibrillation Patients Receiving Multicomponent Antithrombotic Therapy in Real Clinical Practice

Kardiologiia ◽  
2020 ◽  
Vol 60 (8) ◽  
pp. 33-45
Author(s):  
E. N. Krivosheeva ◽  
E. P. Panchenko ◽  
E. S. Kropacheva ◽  
A. B. Dobrovolsky ◽  
E. V. Titaeva ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Antithrombotic Therapy ◽  
Coronary Occlusion ◽  
Oral Anticoagulants ◽  
Coronary Syndrome ◽  
Reduced Dose ◽  
Chronic Coronary Occlusion ◽  
Coronary Events ◽  
Pai 1

Aim      Searching for clinical, angiographic, and biochemical predictors of cardiovascular complications (CVC) and hemorrhagic complications in patients with atrial fibrillation (AF) receiving a multicomponent antithrombotic therapy (MAT) for an elective percutaneous coronary intervention (PCI). Patients with ischemic heart disease (IHD) and AF who require MAT for PCI are at a high risk of thrombotic complications (stroke, systemic embolism, coronary events) and hemorrhage. This warrants searching for new risk factors determining prediction of the outcome.Materials and methods This study included 207 patients (146 males aged 70.1±8.3 years) with IHD and AF who received direct oral anticoagulants (DOAC) as a part of their MAT therapy. Median duration of the follow-up was 12 [8.0; 12.0] months. The efficacy endpoint was a sum of CVCs combining cardiovascular death, ischemic stroke, venous thromboembolic complications, acute coronary syndrome (ACS), and requirement for an unscheduled PCI. “Coronary events”, including ACS and requirement for an unscheduled PCI were analyzed separately. The safety endpoint was BARC type 2-5 bleeding. Upon admission, biomarkers (growth-differentiation factor 15 (GDF-15), D-dimer, thrombin-activated fibrinolysis inhibitor (TAFI), and plasminogen activator inhibitor-1 (PAI-1)) were measured for all patients. Searching for prognostically significant indexes was performed with the Cox proportional hazards regression.Results Incidence of all CVCs was 16.4 %. Independent predictors of CVC included the DOAC treatment at a reduced dose (odds ratio (OR) 2.5 at 95 % confidence interval (CI) 1.02-6.15; p=0.0454), GDF-15 >1191 pg /ml (OR 3.76 at 95 % CI, 1.26-11.18; p=0.0172), PAI-1 >13.2 U/ml (OR 2.67 at 95 % CI, 1.13-6,26; p=0.0245). Incidence of coronary complications was 9.2 %. Independent predictors of coronary complications included a SYNTAX index >26.5 (OR 4.5 at 95 % CI, 1.45-13.60; p=0.0090), PCI for chronic coronary occlusion (OR 3.21 at 95 % CI, 1.10-9.33; p=0.0326), a GDF-15 >1191 pg/ml (ОR 4.70 at 95 % CI, 1.32-16.81; p=0.0172). Incidence of BARC type 2-5 bleeding was 26.1 %. The only independent predictor for hemorrhage complications was the total PRECISE-DAPT score >30 (ОR 3.22; 95 % CI, 1.89-5.51; р<0.0001).Conclusion      Three independent predictors of CVC were identified for patients with IHD and AF treated with MAT following an elective PCI: treatment with a reduced dose of DOAC, GDF-15 >1191 pg /ml, and PAI-1>13.2 U/ml. Independent predictors of coronary complications included a SYNTAX index >26.5, PCI for chronic coronary occlusion, and GDF-15 >1191 pg/ml. The factor associated with a risk of bleeding was the total PRECISE-DAPT score >30. 

scholarly journals Secondary adherence to non-vitamin-K antagonist oral anticoagulants in patients with atrial fibrillation in Sweden and the Netherlands

2018 ◽  
Vol 34 (10) ◽  
pp. 1839-1847 ◽  
Author(s):  
Maartje S. Jacobs ◽  
Jeroen F. Schouten ◽  
Pieter T. de Boer ◽  
Mikael Hoffmann ◽  
Lars-Åke Levin ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
The Netherlands ◽  
Vitamin K ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist

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.

Evaluation of indications for reduced-dose non-vitamin K antagonist oral anticoagulants in hospitalised patients with atrial fibrillation

2018 ◽  
pp. 1073-1080 ◽  
Author(s):  
Olga Jelonek ◽  
Iwona Gorczyca ◽  
Michał Bączek ◽  
Paweł Kośmider ◽  
Beata Wożakowska-Kapłon
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Reduced Dose ◽  
Hospitalised Patients
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