Saturday, 27 June 2015 10:50

Anticoagulation news items. Week commencing 22nd June 2015

High-dose ibuprofen (≥2400mg/day): small increase in cardiovascular risk

Medicines and Healthcare products Regulatory Agency

EU review confirms that CV risk of high-dose ibuprofen (≥2400mg/day) is similar to COX 2 inhibitors and diclofenac. Clinicians are advised that naproxen and low-dose ibuprofen (≤1200mg per day) are considered to have most favourable thrombotic CV safety profiles of all NSAIDs.

 

Meta-analysis of Comparison of the Newer Oral P2Y12 Inhibitors (Prasugrel or Ticagrelor) to Clopidogrel in Patients with Non-ST-elevation Acute Coronary Syndrome

American Journal of Cardiology

Review of 4 RCTs (n=31,470 with NSTE-ACS) found newer oral P2Y12 inhibitors decrease major cardiovascular events (MACEs) and MI at expense of significant increase in bleeding risk. Treatment of 1000 patients will prevent 16 MACEs at expense of increase in 6 major bleeds.

 

Is self-monitoring an effective option for people receiving long-term vitamin K antagonist therapy? A systematic review and economic evaluation

BMJ Open

Review of 26 RCTs (n=8763) suggests self-monitoring (SM) appears to be a safe and cost-effective option. It found that both SM and self-testing were as safe as standard care (SC) in terms of major bleeding events. SM was also linked to fewer thromboembolic events vs. SC.

 

Prevalence, Clinical Features, and Prognosis of Acute Myocardial Infarction Due to Coronary Artery Embolism

Circulation

Of 1776 Japanese patients who presented with de novo AMI between 2001 and 2013, prevalence of coronary artery embolism (CE) was 2.9% (n=52). AF was the most common cause (n=38, 73%). Only 39% of patients with CE were treated with vitamin K antagonists, and median INR was 1.42.

 

Association of Rivaroxaban Anticoagulation and Spontaneous Vitreous Hemorrhage

JAMA Opthalmology

This report describes 3 patients who developed spontaneous vitreous haemorrhage after initiating rivaroxaban. All 3 patients were taking an additional antithrombotic agent (2 warfarin, 1 clopidogrel) at the time of haemorrhage.

 

CHMP adopts positive opinion on licence extension of Voncento (human coagulation factor VIII / von Willebrand factor) in EU

European Medicines Agency

The licence extension will be for prophylaxis and treatment of haemorrhage or surgical bleeding in patients with von Willebrand Disease, when desmopressin treatment alone is ineffective or contraindicated.

 

Revised SPC: Konakion (phytomenadione) MM (10mg/ml and Paediatric 2 mg/0.2 ml)

electronic Medicines Compendium

SPC notes reports of anaphylactoid reactions after IV injection. Local irritation may occur at injection site but is unlikely due to the small injection volume. Rarely, injection site reactions may occur which may be severe, including inflammation, atrophy and necrosis.

 

Apixaban Compared with Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease: Findings From the ARISTOTLE Trial

Circulation

Analysis (n=18,201 of which 4808 had valvular heart disease [VHD]) or prior valve surgery found no evidence of differential effect of apixaban over warfarin in patients with and without VHD in reducing stroke and systemic embolis, causing less bleeding, and reducing death.

 

Characterising and predicting bleeding in high-risk patients with an acute coronary syndrome

Heart

Analysis of APPRAISE-2 study (n=7392) found that when compared with placebo, use of apixaban is linked to an important short-term and long-term risk of bleeding in high-risk post-ACS patients, with GI bleeding being most common source of major bleeding.

 

Superficial thrombophlebitis (superficial venous thrombosis)

British Medical Journal

This reviews covers epidemiology, diagnosis, causes, types of superficial thrombophlebitis, complications, investigations, treatment (hosiery, NSAIDs, anticoagulation, antibiotics, surgery), and when to refer.

 

Edoxaban (Lixiana) approved in EU for stroke prophylaxis and prevention and treatment of venous thromboembolism

PharmaTimes

Edoxaban is a once-daily selective factor Xa-inhibitor which has been licensed for prevention of stroke and systemic embolism in patients with nonvalvular AF with one or more risk factors; and treatment and prevention of DVT and pulmonary embolism.

 

Venous thromboembolism in adults admitted to hospital: reducing the risk - guideline (CG92)

National Institute for Health and Care Excellence

This guidance is about the care and treatment of adults who are at risk of developing deep vein thrombosis (DVT) while in hospital in the NHS in England and Wales. It should be read in conjunction with TA 245 (published in January 2012).

 

Preliminary findings from the GARFIELD-AF registry show poor anticoagulation control and high risk scores increase mortality and strokes in newly diagnosed AF patients

Biospace Inc.

Preliminary results from GARFIELD-AF study (n=17,200) presented at the International Society on Thrombosis and Haemostasis conference have shown that fewer patients diagnosed at a hospital have good anticoagulant control vs patients diagnosed at an office/anticoagulation clinic.

 

Idarucizumab for Dabigatran Reversal

New England Journal of Medicine

Interim results of the RE-VERSE AD cohort study (n=90) show that idarucizumab (5g IV) rapidly and completely reversed the anticoagulant activity of dabigatran in 88 to 98% of those with elevated clotting times at baseline.

 

Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation

New England Journal of Medicine

In AF patients requiring warfarin interruption for an elective procedure, no bridging (placebo) was non-inferior to dalteparin bridging for the prevention of arterial thromboembolism (incidence of 0.4% v 0.3%) and decreased the risk of major bleeding (1.3% v 3.2%).

 

Positive Phase III data for anticoagulant antidote andexanet alfa

PharmaTimes

In Phase III ANNEXA-A trial, andexanet alfa rapidly reversed the anticoagulant effect of apixaban by 93.5%, and sustained a high level of efficacy across the two-hour infusion period. No serious adverse events were reported.

 

 

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