Items filtered by date: August 2018

Revised SPC: NovoEight (human coagulation factor VIII) powder and solvent for solution for injection (all strengths)

electronic Medicines compendium

Information has been added on weight based dosing as has warning that in patients with existing CV risk factors, substitiution therapy with FVIII may increase CV risk. ADR data from trial in treatment naïve patients, aged 0 to 6 years have been added.

 

Revised SPC: Xarelto (rivaroxaban) 2.5 mg film-coated tablets

electronic Medicines compendium

DRESS syndrome and anaphylactic reactions have been added to SPC as adverse effects. SPC has been amended to advise interaction with fluconazole/erythromycin/clarythromycin is likely not clinically relevant in most patients but can be potentially significant in high-risk patients.

 

Association of Intracranial Hemorrhage Risk With Non–Vitamin K Antagonist Oral Anticoagulant Use vs Aspirin Use: A Systematic Review and Meta-Analysis

JAMA Neurology

Review of 5 RCTS (n=39,398) found 15 to 20mg dose of rivaroxaban (RV) once daily is linked to increased risks of intracranial haemorrhage vs. aspirin (2 trials; OR, 3.31; 95% CI, 1.42-7.72), while smaller daily doses of RV and apixaban were not, suggesting dose dependent risk.

 

Revised SPC: Eliquis (apixaban) 2.5 mg film-coated tablets

electronic Medicines compendium

The SPC has been updated to advise that care should be taken if patients are treated concomitantly with SSRIs or SNRIs, due to the increased bleeding risk.

 

Effect of aspirin in vascular surgery in patients from a randomized clinical trial (POISE‐2)

British Journal of Surgery

RCT (n=10,010) found that perioperative withdrawal of chronic aspirin therapy did not increase cardiovascular or vascular occlusive complications (HR for death or MI = 1.48, 95% CI 0.71-3.09 for aneurysm repair and 1.16, 0.62-2.17 for surgery for occlusive vascular disease).

 

 

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

 

Published in News

Revised SPC: Brilique (ticagrelor) products

electronic Medicines compendium

Timing of discontinuation of ticagrelor prior to elective surgery has been changed from 7 to 5 days.

 

Management of Intraprocedural Anticoagulation in Patients on Non-Vitamin K Antagonist Oral Anticoagulants Undergoing Catheter Ablation for Atrial Fibrillation

Circulation

This review aims to provide a brief summary on physiology of haemostasis, review key studies on DOAC safety and efficacy in AF catheter ablation, and identify current gaps in knowledge on intraprocedural anticoagulation and monitoring.

 

 

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

Published in News

A systematic review of the efficacy of aspirin monotherapy versus other antiplatelet therapy regimens in peripheral arterial disease

Journal of Vascular Surgery

Review of 14 studies (10 RCTs) found that dual antiplatelet therapy (DAPT) reduces rates of major adverse cardiac events, major adverse cardiac and cerebrovascular events, and mortality compared with use of mono APT after revascularisation in peripheral arterial disease.

 

Rates of Overtreatment and Treatment-Related Adverse Effects Among Patients With Subsegmental Pulmonary Embolism

JAMA Internal Medicine

Restrospective review (single centre, n=1,408) found that almost all isolated subsegmental pulmonary embolisms (SSPEs) were anticoagulated with a similar frequency to more proximal embolisms and that treatment was associated with harm (e.g. bleeding).

 

Antithrombotic Therapy in Patients With Atrial Fibrillation Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention: A North American Perspective–2018 Update

Circulation

On the basis of pivotal clinical trials this group recommended that a DOAC be preferred over a vitamin K antagonist as the oral anticoagulant of choice. This document provides a focused update on the rationale for the new expert consensus–derived recommendations.

 

CHMP negative opinion: Dexxience (betrixaban) for the prevention of venous thromboembolism

European Medicines Agency

A previous negative opinion was confirmed after re-examination. The CHMP considered that the study did not satisfactorily show efficacy when used for preventing blood clots in patients admitted to hospital for recent medical illness. Also, those given betrixaban had more bleeding.

 

CHMP positive opinion: Xarelto (rivaroxaban) licence extension

European Medicines Agency

The license extension is for use (as 2.5mg tablets in combination with aspirin) for the prevention of atherothrombotic events in adult patients with coronary artery disease or symptomatic peripheral artery disease at high risk of ischaemic events.

 

 

 

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

Published in News