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

electronic Medicines Compendium

Additions include advice on how to reduce the potential bleeding risk associated with concurrent use of rivaroxaban and neuraxial anaesthesia or spinal puncture (section 4.4) and post-marketing adverse events of cholestasis, hepatitis and thrombocytopenia (section 4.8).

Six Months vs Extended Oral Anticoagulation After a First Episode of Pulmonary Embolism: The PADIS-PE Randomized Clinical Trial

Journal of the American Medical Association

This RCT of adults with a first unprovoked PE who had already received 6 months of warfarin found that extended treatment (further 18 months) reduced the composite outcome of recurrent VTE and major bleeding (3.3% v 13.5% placebo).

A practical guideline for the haematological management of major haemorrhage

British Journal of Haematology

This guideline provides recommendations for the haematological management of major haemorrhage in any clinical situation, with practical guidance on the content and delivery of major bleeding protocols, including the use of blood components and transfusion alternatives.

Atrial flutter and thromboembolic risk: a systematic review

Heart

This analysis of 52 studies (observational; no RCTs) confirms clinical thromboembolic events are highly prevalent in atrial flutter. The authors say thromboprophylaxis should strongly be considered in the presence of ≥1 additional stroke risk factors.

Antiplatelet therapy as a modulator of stroke aetiology: a meta-analysis

British Journal of Clinical Pharmacology

This meta-analysis (9 studies; n=5739) evaluating antiplatelet therapy (APT) on incidence of each subtype of stroke: large artery atherosclerosis (LAA), cardioembolic and small vessel occlusion concluded that APT preferentially reduces the incidence of LAA stroke.

Anticoagulant vs. antiplatelet therapy in patients with cryptogenic stroke and patent foramen ovale: an individual participant data meta-analysis

European Heart Journal

This meta-analysis of 804 patients on oral anticoagulants and 1581 patients on antiplatelets did not find a statistically significant difference between the two groups for stroke/TIA or death in patients being treated for cryptogenic stroke or patent foramen ovale.

The clinical effectiveness and cost-effectiveness of point-of-care tests (CoaguChek system, INRatio2 PT/INR monitor and ProTime Microcoagulation system) for the self-monitoring of the coagulation status of people receiving long-term vitamin K antagonists

National Institute for Health Research

An analysis of 26 RCTs found that compared with standard monitoring, self-monitoring appears to be safe and effective, especially for people with artificial heart valves.

FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes

US Food and Drug Administration

Following a comprehensive review of new safety information, the FDA is requiring updates to the drug labels of all prescription NSAIDs, to strengthen an existing label warning that NSAIDs increase the chance of a heart attack or stroke.

Antithrombotic therapy in the elderly: expert position paper of the European Society of Cardiology Working Group on Thrombosis

European Heart Journal

This paper discusses pharmacokinetic and pharmacodynamic variables influencing the efficacy and safety of drugs in elderly subjects and makes recommendations regarding use of oral and IV antiplatelets and anticoagulants and how to prevent and manage bleeding in the elderly.

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