Friday, 03 November 2017 20:46

Anticoagulation news items. Week commencing 30th October 2017

Use of oral anticoagulants in combination with antiplatelet(s) in atrial fibrillation

Heart

Analysis of Danish registry data (n=2946) found that from 2011 to 2016, the use of a NOAC in combination with antiplatelet(s) increased from 10% to 52% in patients with AF following MI/PCI, and exceeded the use of vitamin K antagonist in combination with antiplatelet(s) by 2016.

 

Hospital admissions for bleeding events associated with treatment with apixaban, dabigatran and rivaroxaban

European Journal of Hospital Pharmacy

Retrospective observational study identified 37 hospitalisation episodes for DOAC-induced bleeding in 32 patients (15 rivaroxaban, 9 apixaban, 8 dabigatran), representing incidence rate of 3.44/ 100 person-years. Most common bleeding site was GI. Intracranial bleeding was rare.

 

US FDA approves 10mg dose of rivaroxaban for reduction of continued risk of venous thromboembolism (VTE)

Biospace Inc.

FDA has approved 10 mg dose for reducing continued risk for VTE after completing at least 6-months of initial anticoagulation. Approval is based on data from EINSTEIN CHOICE, which showed superior efficacy in reducing VTE risk and with major bleeding rates similar to aspirin.

 

International Expert Consensus on Switching Platelet P2Y12 Receptor-Inhibiting Therapies

Circulation

This expert consensus provides an overview of the pharmacology of P2Y12 inhibitors, different modalities and definitions of switching, and available literature and recommendations for switching between P2Y12 inhibitors.

 

Bayer files for approval of long-acting haemophilia therapy damoctocog alfa pegol (BAY94-9027) in US

PharmaTimes

BAY94-9027 is engineered to potentially prolong factor VIII activity in the blood while preserving coagulation activity using site-specific PEGylation technology, thus reducing the number of infusions necessary to prevent bleeds in patients with haemophilia A.

 

Revised SPC: Pradaxa (dabigatran) hard capsules (all strengths)

electronic Medicines compendium

Sections 4.2 (Posology and method of administration), 4.4 (Special warnings and precautions for use) and 5.1 (Pharmacodynamic properties) have been updated to include information regarding catheter ablation for atrial fibrillation.

 

Revised SPCs: Xarelto (rivaroxaban) film-coated tablets (all strengths)

electronic Medicines compendium

As with other anticoagulants, the possibility may exist that patients are at increased risk of bleeding in case of concomitant use with SSRIs or SNRIs. When concomitantly used in the clinical program, numerically higher rates of clinically relevant bleeding were observed.

 

The Efficacy and Safety of the Use of Non-Vitamin-K Antagonist Oral Anticoagulants in Patients with Non-Valvular Atrial Fibrillation and Concomitant Aspirin Therapy: A Meta-Analysis of Randomized Trials

Circulation

This analysis of 4 RCTs found that in patients receiving aspirin (n=21,722), NOACs were more effective than vitamin K antagonists (e.g. HR 0.78; 95% CI 0.67-0.91 for stroke/systemic embolism), as safe for major bleeding and safer for intracranial haemorrhage (HR 0.38; 0.26-0.56).

 

Conference report: Three months of dual antiplatelet therapy (DAPT) non-inferior to 12 months DAPT in patients with acute coronary syndrome (ACS) treated with the COMBO Dual Therapy Stent

Biospace Inc.

The overall incidence of the primary endpoint (composite of all-cause mortality, myocardial infarction, stent thrombosis, stroke, target vessel revascularisation, moderate/major bleeding within 360 days) was 8.2% for 3 months v 8.4% for 12 months DAPT; P non-inferiority <0.001).

 

Lower dose of rivaroxaban (Xarelto) for extended prevention of recurrent venous thromboembolism (VTE) approved in Europe

PharmaTimes

The European Commission has approved a 10mg once daily dose for extended prevention of recurrent VTE, for patients who have already received at least six months of initial anticoagulation. The approval is based on data from the EINSTEIN CHOICE study.

 

 

The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:

http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services