scholarly journals Individualising Anticoagulant Therapy in Atrial Fibrillation Patients

2016 ◽  
Vol 5 (2) ◽  
pp. 102 ◽  
Author(s):  
Marco Alings ◽  
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
The Other ◽  
Phase Iii ◽  
European Medicines Agency ◽  
Efficacy And Safety ◽  
Pivotal Phase ◽  
Phase Iii Clinical Trials ◽  
Dosing Regimens

Non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) have emerged as alternatives to VKAs for the prevention of stroke in patients with non-valvular atrial fibrillation. Four NOACs: dabigatran, apixaban, rivaroxaban and edoxaban, have received regulatory approval in Europe from the European Medicines Agency. Numerous factors can influence the decision to prescribe a NOAC, the most important of which are assessment of stroke and bleeding risks. Given the variation in design of the pivotal phase III clinical trials investigating the efficacy and safety of NOACs, and in the absence of head-to-head comparative data, it is impossible to recommend one NOAC over the other. However, NOACs offer the opportunity for individualised therapy based on factors such as renal function, age or patient/doctor preference for once- or twice-daily dosing regimens. Dose reduction of some NOACs should be considered in at-risk patient populations.

Individualising Anticoagulant Therapy in Atrial Fibrillation Patients

2016 ◽  
Vol 5 (2) ◽  
pp. 1
Author(s):  
Marco Ailings ◽  
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
The Other ◽  
Phase Iii ◽  
European Medicines Agency ◽  
Efficacy And Safety ◽  
Pivotal Phase ◽  
Phase Iii Clinical Trials ◽  
Dosing Regimens

Non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) have emerged as alternatives to VKAs for the prevention of stroke in patients with non-valvular atrial fibrillation. Four NOACs: dabigatran, apixaban, rivaroxaban and edoxaban, have received regulatory approval in Europe from the European Medicines Agency. Numerous factors can influence the decision to prescribe a NOAC, the most important of which are assessment of stroke and bleeding risks. Given the variation in design of the pivotal phase III clinical trials investigating the efficacy and safety of NOACs, and in the absence of head-to-head comparative data, it is impossible to recommend one NOAC over the other. However, NOACs offer the opportunity for individualised therapy based on factors such as renal function, age or patient/doctor preference for once- or twice-daily dosing regimens. Dose reduction of some NOACs should be considered in at-risk patient populations.

The NOACs: clinical pharmacology

ESC CardioMed ◽  
2018 ◽  
pp. 268-272
Author(s):  
Jeffrey Weitz
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Active Site ◽  
Randomized Clinical Trials ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Factor Xa ◽  
Vitamin K Antagonist ◽  
Phase Iii ◽  
High Affinity

The limitations of vitamin K antagonists prompted the development of new oral anticoagulants that could be administered in fixed doses without routine coagulation monitoring. Focusing on thrombin and factor Xa because of their prominent roles in coagulation, structure-based design led to the development of small molecules that bind to the active site pockets of these enzymes with high affinity and specificity. Four non-vitamin K antagonist oral anticoagulants are now licensed: dabigatran, which inhibits thrombin, and rivaroxaban, apixaban, and edoxaban, which inhibit factor Xa. In phase III randomized clinical trials that included over 100,000 patients these agents have proven to be at least as effective as vitamin K antagonists for prevention of stroke in patients with non-valvular atrial fibrillation and for treatment of venous thromboembolism, and to produce less bleeding, particularly less intracranial bleeding.

scholarly journals Efficacy and Safety of Non-Vitamin K Antagonist Oral Anticoagulants vs. Warfarin in Japanese Patients With Atrial Fibrillation

2015 ◽  
Vol 79 (2) ◽  
pp. 339-345 ◽  
Author(s):  
Keitaro Senoo ◽  
Yee Cheng Lau ◽  
Mikhail Dzeshka ◽  
Deirdre Lane ◽  
Ken Okumura ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Oral Anticoagulants ◽  
Japanese Patients ◽  
Vitamin K Antagonist ◽  
Efficacy And Safety

scholarly journals Direct Oral Anticoagulants in Patients with Obesity and Atrial Fibrillation: Position Paper of Italian National Association of Hospital Cardiologists (ANMCO)

2021 ◽  
Vol 10 (18) ◽  
pp. 4185
Author(s):  
David Mocini ◽  
Stefania Angela Di Fusco ◽  
Edoardo Mocini ◽  
Lorenzo Maria Donini ◽  
Carlo Lavalle ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
High Body Mass Index ◽  
Normal Weight ◽  
Phase Iii ◽  
Fixed Dose ◽  
Pivotal Phase ◽  
Phase Iii Trials

The use of the direct oral anticoagulants dabigatran, rivaroxaban, apixaban and edoxaban (DOACs) offers some major advantages over warfarin and other vitamin K antagonists (VKAs). One advantage is the possibility to use a fixed dose in normal-weight patients, overweight patients and patients with obesity. However, the “one size fits all” strategy raised a concern regarding the possibility to undertreat patients with a high body mass index. No randomized controlled trials (RCTs) have ever compared VKAs and DOACs in this population. We analyzed data from the literature on DOAC pharmacokinetics and pharmacodynamics, results from the four pivotal phase III trials on non-valvular atrial fibrillation, retrospective observational studies and metanalyses. While we are aware of the limitation imposed by the absence of specific RCTs, we propose the position of the Italian Association of Hospital Cardiologists (ANMCO) on the use of DOACs in patients with obesity based on the existing evidence.

P4783Treatment persistence of patients with atrial fibrillation on VKA or NOAC: Data from GLORIA-AF Phase III 1-year interim analysis

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
G Y H Lip ◽  
H.-C Diener ◽  
S J Dubner ◽  
J L Halperin ◽  
K J Rothman ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Interim Analysis ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Phase Iii ◽  
Treatment Persistence ◽  
Geographical Regions ◽  
Dosing Regimens ◽  
The Impact

Abstract Background Oral anticoagulation (OAC) persistence is important for optimizing stroke prevention in patients with atrial fibrillation (AF); non-vitamin K oral anticoagulants (NOACs) generally show better persistence than vitamin K antagonists (VKAs), while the impact of dosing regimens remains unclear. We compared treatment persistence of NOACs and VKAs, and of NOAC dosing regimens in the prospective GLORIA-AF registry program. Methods Patients newly diagnosed with AF were enrolled in Phase III of GLORIA-AF (2014–2016) from 4 geographical regions (North America [NA], Europe, Asia and Latin America). Treatment persistence after 1 year for i) NOAC (dabigatran, rivaroxaban, apixaban, edoxaban) vs VKA, and ii) twice daily (bid, dabigatran, apixaban) vs once daily (od; rivaroxaban, edoxaban) NOAC treatment was analysed using multivariable Cox analysis; propensity score trimming was used to reduce bias due to unmeasured confounders. Missing data was handled by multiple imputation. Results Overall, 21,592 patients were enrolled (4970 [23%] patients on VKAs, 12,797 [59%] on NOACs, 2391 [11%] on antiplatelets, and 1426 [6.6%] received no therapy; 8 [0.04%] received other treatment). After trimming, 11,935 and 4484 patients treated with NOACs and VKAs, respectively, were compared. NOACs had better treatment persistence than VKAs (discontinuation hazard ratio [HR]=0.75, 95% confidence interval [CI] 0.69–0.81). Other relevant associations were decreased OAC persistence for symptomatic AF, NA and Asia regions (Table). There was no difference in treatment persistence for patients on a bid (N=7842) vs od (N=4098) NOAC (discontinuation HR=0.94, 95% CI 0.86–1.02). Conclusion In this 1-year interim analysis of GLORIA-AF Phase III, treatment persistence was improved with NOACs vs VKAs, whereas for NOACs, dosing regimen (bid vs od) had no impact on treatment persistence. Acknowledgement/Funding The GLORIA-AF Registry program was funded by Boehringer-Ingelheim

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