Items filtered by date: January 2015

Revised SPC: Xarelto (rivaroxaban) – all strengths

electronic Medicines Compendium

A new paragraph on neuraxial (epidural/spinal) anaesthesia has been added to section 4.4 (all strengths), and new information on patients undergoing cardioversion has been added to sections 4.2 and 5.1 (15mg and 20mg strengths).

 

 

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

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Rivaroxaban for acute coronary syndrome: final appraisal determination

National Institute for Health and Care Excellence

In DRAFTguidance, NICE supports use of rivaroxaban, in combination with aspirin plus clopidogrel or aspirin alone, for preventing atherothrombotic events in people who have had an ACS with elevated cardiac biomarkers. Bleeding risk should be assessed before treatment is started.

 

Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update 2014

Journal of Clinical Oncology

An evidence update which included a review of 53 publications, found that the 2014 recommendations are consistent with the 2013 recommendations.

 

Patient Safety Alert (stage one): Harm from using Low Molecular Weight Heparins when contraindicated

NHS England

Consideration of contraindications is a prominent feature of available local and national guidance for prescribing and administering LMWHs. This stage one Patient Safety Alert aims to reinforce the need for reliable systems to ensure that this always occurs.

 

Dabigatran and Rivaroxaban Use in Atrial Fibrillation Patients on Hemodialysis

Circulation

A US report found approx 5.9% of end-stage renal disease patients with AF are started on dabigatran or rivaroxaban despite the drugs being contraindicated in these patients; both were associated with a higher risk of hospitalisation or death from bleeding compared to warfarin.

 

 

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

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Characterizing Major Bleeding in Patients With Nonvalvular Atrial Fibrillation: A Pharmacovigilance Study of 27 467 Patients Taking Rivaroxaban

Clinical Cardiology

In a large observational study of 27,467 patients on rivaroxaban, the major bleeding rate (496 events in 478 patients; incidence of 2.86 per 100 person-years) was generally consistent with the registration trial results, and fatal bleeds were rare (0.08 per 100 person-years).

 

Phase IV study of Factor Xa inhibitor antidote andexanet alfa initiated to support US accelerated approval

Biospace Inc.

A Phase IV study of the investigational Factor Xa inhibitor antidote andexanet alfa in patients receiving apixaban, rivaroxaban or enoxaparin who present with an acute major bleed has been initiated to support its approval by the FDA under an Accelerated Approval pathway.

 

Ultrasound enhanced catheter-directed thrombolysis for pulmonary embolism: consultation

National Institute for Health and Care Excellence

This DRAFT guidance states there is inadequate evidence of any enhancement of thrombolysis with ultrasound-enhanced, catheter-directed thrombolysis (CDT) over CDT alone for PE; it should only be used with special arrangements for clinical governance, consent and audit or research.

 

Is Prophylactic Anticoagulation for Deep Venous Thrombosis Common Practice After Intracerebral Hemorrhage?

Stroke

US analysis (n=32,690 with intracerebral haemorrhage) found <20% receive prophylactic anticoagulation for DVT during hospital stay, even though this is safe to do after cessation of haematoma growth, and when used, time to initiation is <2 days in less than half of patients.

 

 

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

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Anticoagulation during pregnancy in women with prosthetic valves: evidence, guidelines and unanswered questions

Heart

Managementof this patient group remains difficult and controversial. There is no ideal anticoagulation regimen as there are inherent risks and benefits of each approach for both mother and foetus. There are limited data on optimal treatment strategy for an individual patient.

 

FDA approves licensing of edoxaban (Savaysa) tablets

US Food and Drug Administration

The FDA has approved edoxaban, a factor Xa inhibitor, to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

 

d-Dimer Testing to Select Patients With a First Unprovoked Venous Thromboembolism Who Can Stop Anticoagulant Therapy: A Cohort Study

Annals of Internal Medicine

This cohort study found a 6.7% per patient-year (PPY) risk for recurrent VTE in patients with a first unprovoked proximal DVT or PE who had a negative d-dimer test result during anticoagulant therapy and 1 month after withdrawal; the recurrence risk was higher in men (9.7% PPY).

 

Misperceptions of aspirin efficacy and safety may perpetuate anticoagulant underutilization in atrial fibrillation

European Heart Journal

The authors of this discussion conclude it may be necessary to exclude aspirin for stroke prevention in AF (without comorbid conditions requiring its use) from all AF guidelines, as done by NICE, to remove the 'soft option' of prescribing a drug that is neither effective nor safe.

 

 

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