Safety of apixaban for venous thromboembolism prophylaxis: the evidence to date

Vladimir Trkulja Department of Pharmacology, Zagreb University School of Medicine, Zagreb, Croatia Abstract: Apixaban, a direct orally active anticoagulant (selective, direct factor Xa inhibitor) is approved for (primary) prevention of venous thromboembolism (VTE) in patients undergoing elective total-hip or total-knee arthroplasty, for acute treatment/prevention of recurrent events in patients with VTE, and extended prophylaxis in patients with a history of VTE. Another approved use is prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The present overview focuses on the safety of apixaban specifically in the VTE setting. Apixaban displays favorable pharmacokinetic properties: simple twice-daily dosing, low inter- and intrasubject variability, dose and time linearity, and multiple elimination pathways not critically dependent on either renal or metabolic mechanisms. An extensive nonclinical program and the overall clinical development program (all approved and tested indications) provided no signal that would indicate any particular specific safety concern related to apixaban apart from the increased risk of bleeding. With regard to the approved VTE indications, safety (and efficacy) was assessed in five large pivotal Phase III trials. In comparison to currently recommended standard treatments, apixaban shows superior efficacy, while at the same time no excess risk of bleeding in patients undergoing total-hip or total-knee arthroplas...
Source: Drug, Healthcare and Patient Safety - Category: Drugs & Pharmacology Tags: Drug, Healthcare and Patient Safety Source Type: research

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AbstractThe optimal management of oral anticoagulation (OAC) in the acute phase of non valvular atrial fibrillation (NVAF)-related acute ischemic stroke (AIS) remains controversial, especially in very old patients. Therefore, the aim of our study was to evaluate the practical management of OAC in this context. We conducted an observational retrospective study on patients 85-years old and older admitted to two Italian hospitals for NVAF-related AIS. For each patient, clinical and brain computed tomography data were recorded. Type of OAC (vitamin K antagonists, VKAs or Direct Oral Anticoagulants, DOACs), dosage and starting ...
Source: Journal of Thrombosis and Thrombolysis - Category: Hematology Source Type: research
AbstractPercutaneous left atrial appendage closure (LAAC) may decrease risks of stroke and bleeding in elderly patients with non-valvular atrial fibrillation (NVAF), but it is still lacking of evidence. The present study aimed at evaluating the efficacy and safety of LAAC in patients with NVAF over 75  years. 351 patients with NVAF who underwent LAAC were retrospectively analyzed on the LAAC procedure characteristics and the clinical follow-up according to age (age ≥ 75 years or 
Source: Heart and Vessels - Category: Cardiology Source Type: research
ConclusionsIn our study, DOACs appeared to be as efficacious and safe in CKD IV and V as in CKD III. In addition, DOACs appeared to be more effective than, and as safe as warfarin when compared with reference studies of patients with advanced CKD. Our findings support the use of DOACs for thromboembolism prevention in patients with advanced CKD and AF.This article is protected by copyright. All rights reserved
Source: Pacing and Clinical Electrophysiology : PACE - Category: Cardiology Authors: Tags: ELECTROPHYSIOLOGY Source Type: research
AbstractBackgroundLeft atrial appendage closure (LAAC) with LARIAT has emerged as one of the alternatives to oral anticoagulation (OAC) in patients with non ‐valvular atrial fibrillation (AF). Our aim was to study long‐term outcomes in patients undergoing LARIAT procedure.MethodsWe analyzed patients screened for LARIAT device in 4 centers between December 2009 and June 2012. Out of these, patients who didn't undergo LAAC with the LARIAT device due to unfavorable LAA morphology and other pre ‐procedural contraindications were included in control group. We analyzed thromboembolism, bleeding events and mortality between...
Source: Journal of Cardiovascular Electrophysiology - Category: Cardiology Authors: Tags: ORIGINAL ‐ CLINICAL Source Type: research
Authors: Gumprecht J, Domek M, Lip GY Abstract Introduction: The non-vitamin K antagonist oral anticoagulants (NOACs) are changing the landscape for stroke prevention in atrial fibrillation (AF) and prevention or treatment of venous thromboembolism (VTE). In patients with AF and concomitant acute coronary syndrome (ACS), the treatment regimen of combined NOACs and P2Y12 inhibitors is gaining popularity. Areas covered: The authors conducted a review of studies published in the last 10 years regarding safety evaluation and effectiveness of apixaban for the treatment of AF and ACS, both alone and in combination with d...
Source: Expert Opinion on Drug Safety - Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research
Oral anticoagulants are the preferred therapy for the treatment of venous thromboembolism and for stroke prevention among patients with atrial fibrillation. Given their widespread use, clinicians must balance efficacy of anticoagulation with their associated bleeding risks. Specifically, intracranial hemorrhage (ICH) is the most feared complication as this form of bleeding has the highest mortality and morbidity. To date, clinical trials suggest a lower incidence of ICH and better safety profile among patients prescribed the direct oral anticoagulants (DOACs) compared with traditional vitamin k antagonists (VKAs).
Source: Thrombosis Research - Category: Hematology Authors: Tags: Oral Communications Source Type: research
Abstract Anticoagulation therapy is recommended for preventing, treating, and reducing the recurrence of venous thromboembolism, and preventing stroke in persons with atrial fibrillation. Direct oral anticoagulants are first-line agents for eligible patients for treating venous thromboembolism and preventing stroke in those with nonvalvular atrial fibrillation. Vitamin K antagonists are recommended for patients with mechanical valves and valvular atrial fibrillation. Vitamin K antagonists inhibit the production of vitamin K-related factors and require a minimum of five days overlap with parenteral anticoagulants, ...
Source: American Family Physician - Category: Primary Care Authors: Tags: Am Fam Physician Source Type: research
Conclusions: The Strat-AF study may be an essential step towards the exploration of the role of a combined clinical biomarker or multiple biomarker models in predicting stroke risk in AF, and might sustain the incorporation of such new markers in the existing stroke prediction schemes by the demonstration of a greater incremental value in predicting stroke risk and improvement in clinical outcomes in a cost-effective fashion. PMID: 31548494 [PubMed - in process]
Source: Medicina (Kaunas) - Category: Universities & Medical Training Authors: Tags: Medicina (Kaunas) Source Type: research
This article reviews up to date data about the risk of gastric bleeding on dabigatran, the impact of PPI on the reduction of gastric bleeding, and the interaction between PPI and dabigatran leading to decreased dabigatran plasma levels. [...] Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.Article in Thieme eJournals: Table of contents  |  Abstract  |  Full text
Source: Seminars in Thrombosis and Hemostasis - Category: Hematology Authors: Tags: Review Article Source Type: research
Conclusions The presence of comorbidities was linked to NOAC use over vitamin K antagonist, which is different from prescription factor studies in other countries and requires further study.
Source: International Journal of Clinical Pharmacy - Category: Drugs & Pharmacology Source Type: research
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