Saturday, 11 April 2015 10:03

Anticoagulation news items. Week commencing 6th April 2015

FDA files supplemental New Drug Application for dabigatran (Pradaxa®) for the prophylaxis of DVT and PE following hip replacement surgery

Biospace Inc.

The US FDA has filed an application seeking approval of dabigatran for the prophylaxis of DVT and PE in patients who have had primary elective total hip replacement surgery, based on the results of two Phase III trials (RE-NOVATE and RE-NOVATE II) comparing it to enoxaparin.

 

Investigational anticoagulant reversal agent (PER977) receives FDA Fast Track designation

Biospace Inc.

The FDA has granted Fast Track status for PER977, an investigational anticoagulant reversal agent that directly binds to NOACs, fondaparinux, low molecular weight heparins and unfractionated heparins. It is undergoing development as an IV injection; Phase III studies are planned.

 

Eyes on Evidence: Detecting atrial fibrillation in people who have had a stroke

National Institute for Health and Care Excellence

A commentary is provided on 2 RCTs which reported that long-term ECG monitoring was more effective at detecting AF than 24-hour or intermittent ECG monitoring in people who had experienced apparent cryptogenic stroke or transient ischaemic attack.

 

Antiphospholipid syndrome: A patient’s journey

British Medical Journal

This is last in a series of occasional articles by patients about their experiences that offer lessons to doctors. It illustrates the often long delays
experienced by patients before a diagnosis is made and treatment started.

 

Association Between Perioperative Low-Molecular-Weight Heparin vs Unfractionated Heparin and Clinical Outcomes in Patients With Cancer Undergoing Surgery

Journal of the American Medical Association

Based on 16 trials (n=12 890) there was no difference between LMWH and unfractionated heparin in their associations with mortality, pulmonary embolism, symptomatic DVT, major bleeding, or minor bleeding outcomes in patients with cancer undergoing surgical procedures.

 

Practice Guide for managing a high INR in a patient on warfarin

British Medical Journal

This practice guide, based on a case vignette, outlines the immediate and long-term management of a patient presenting with a high INR whilst on
warfarin.

 

CADTH reviews point-of-care INR testing compared with laboratory INR testing

Canadian Agency for Drugs and Technologies in Health

This review summarises the practical impact of, and cost effectiveness of point-of-care (POC) INR testing compared with lab INR testing concluding that patient self-management (POC INR testing + dose adjustment) may be the most cost-effective option, when feasible, in Canada.

 

 

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