Items filtered by date: November 2017

Revised SPC: Xarelto (rivaroxaban) film-coated tablets (10mg, 15mg and 20mg)

electronic Medicines compendium

SPC now states when 'extended prevention of recurrent DVT and PE' is indicated (after ≥6 months therapy for DVT/PE), recommended dose is 10mg daily; 20mg should be considered in those at high risk of recurrent DVT/PE. Duration/dose should be based on benefit vs. bleeding risk.
Section 4.5 now advises that as with other anticoagulants the possibility may exist that patients are at increased risk of bleeding in case of concomitant use with SSRIs or SNRIs due to their reported effect on platelets.


Low-dose aspirin and risk of intracranial bleeds: An observational study in UK general practice


Population-based cohort study of 398,158 users and non-users of prophylactic low-dose aspirin (followed over a median of 5.4 years) reports low-dose aspirin is not associated with an increased risk of any type of intracranial bleeds (1,611 cases of intracranial bleeds identified).


Resumption of oral anticoagulation following traumatic injury and risk of stroke and bleeding in patients with atrial fibrillation: a nationwide cohort study

European Heart Journal

Danish cohort study (n=4541) reported that AF patients resuming oral anticoagulation following traumatic injury have lower hazard of all-cause mortality and ischaemic stroke, increased hazard of major bleeding but without additional hazards of recurrent traumatic injury.


Clopidogrel non-responsiveness in patients undergoing percutaneous coronary intervention using the VerifyNow test: frequency and predictors

European Journal of Hospital Pharmacy

In this Iraqi case series (n=115; mean age: 58 years; male sex: 73.9%) of whom 18.3% were clopidogrel non-responders, the major independent predictive factors for non-responsiveness were diabetes mellitus, hypertension, obesity and male sex.



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Pulmonary embolism rule-out criteria (PERC) rule in European patients with low implicit clinical probability (PERCEPIC): a multicentre, prospective, observational study

The Lancet Haematology

Study (n=1757) found of 1052 (60%) patients with low clinical probability of PE, 49 (4.7%) had venous thromboembolism. In patients with low implicit clinical probability, 337 (32%) had negative PERC, of whom 4 (1.2%) had PE, suggesting PERC can exclude PE with few false-negatives.


Boehringer Ingelheim's presents subgroup analyses of RE-VERSE AD on impact of idarucizumab in patients on dabigatran with gastrointestinal bleeding or needing emergency surgery

Biospace Inc.

Of the 137 patients enrolled with a GI bleed, complete reversal of anticoagulant effect was observed in over 95% patients. Idarucizumab also rapidly and completely reversed the anticoagulant effect of dabigatran in approximately 98% patients requiring an urgent procedure.


Shortage of tranexamic acid tablets 500mg (all brands)

Specialist Pharmacy Service

There are limited supplies of generic tranexamic acid (TA) 500mg tablets due to difficulty sourcing raw material. Branded TA (Cyklokapron), OTC product (Cyklo-f) and some generics continue to be remain available, but there may be intermittent supplies issues until at least 2018.


Outcomes of Dabigatran and Warfarin for Atrial Fibrillation in Contemporary Practice: A Retrospective Cohort Study

Annals of Internal Medicine

Retrospective analysis of 50,578 started on dabigatran or warfarin showed no significant difference in rates of ischaemic stroke, or extracranial haemorrhage between the 2 groups, but those on dabigatran were less likely to have intracranial bleeding and more likely to suffer MI.


European CHMP issues positive opinion for paediatric license extension of Nplate (romiplostim) for chronic immune (idiopathic) thrombocytopenic purpura

European Medicines Agency

The additional indication is for patients aged one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).


US FDA approves emicizumab-kxwh (Hemlibra) for prophylaxis in adult and paediatric patients with haemophilia A with inhibitors

Biospace Inc.

In the Phase III HAVEN 1 and 2 studies, prophylaxis with emicizumab was associated with a reduction in treated bleeds in adults and children with haemophilia A and factor VIII inhibitors. It will have a boxed warning regarding risk of severe blood clots.



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An update on the bleeding risks associated with DOACs

Drug and Therapeutics Bulletin

There is uncertainty on optimal lab monitoring of anticoagulation, perioperative management and treatment of bleeding with DOACs, and currently only one licensed reversal agent in UK. Review discusses DOAC-related bleeding and role of drugs to reverse their anticoagulant action.


Mechanical or Biologic Prostheses for Aortic-Valve and Mitral-Valve Replacement

New England Journal of Medicine

Study (n=25,445) found mechanical (MC) mitral valves were linked to lower mortality than biologic valves in patients up to 70 years of age, whereas benefit of MC aortic valve disappeared by 55 years of age. In both cases, MC prosthesis was linked to lower risk of reoperation.


Effect of treatment delay on the effectiveness and safety of antifibrinolytics in acute severe haemorrhage: a meta-analysis of individual patient-level data from 40 138 bleeding patients

The Lancet
Tranexamic acid (TA) increased survival from bleeding (OR 1.20, 95% CI 1.08–1.33; p=0.001). Immediate TA improved survival by > 70% (1.72; 1.42–2.10; p<0.0001) vs later treatment. Thereafter, benefit decreased by 10% for every 15 min delay until 3 h after onset of bleeding.


Association of Warfarin Use With Lower Overall Cancer Incidence Among Patients Older Than 50 Years

JAMA Internal Medicine

A lower incidence of cancer associated with warfarin was noted in a Norweigian population-level study (n=1,256 725), which was reinforced by a subgroup analysis of patients with AF. Further studies are required to fully elucidate mechanisms underpinning these observations.


Bayer files for approval of low-dose rivaroxaban-aspirin combination therapy in EU

Bayer is seeking approval for a low-dose formulation of rivaroxaban 2.5mg administered twice daily alongside aspirin 100mg once daily for reduction of cardiovascular events in patients with coronary or peripheral artery disease. Submission is based on data from Compass study.



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Use of oral anticoagulants in combination with antiplatelet(s) in atrial fibrillation


Analysis of Danish registry data (n=2946) found that from 2011 to 2016, the use of a NOAC in combination with antiplatelet(s) increased from 10% to 52% in patients with AF following MI/PCI, and exceeded the use of vitamin K antagonist in combination with antiplatelet(s) by 2016.


Hospital admissions for bleeding events associated with treatment with apixaban, dabigatran and rivaroxaban

European Journal of Hospital Pharmacy

Retrospective observational study identified 37 hospitalisation episodes for DOAC-induced bleeding in 32 patients (15 rivaroxaban, 9 apixaban, 8 dabigatran), representing incidence rate of 3.44/ 100 person-years. Most common bleeding site was GI. Intracranial bleeding was rare.


US FDA approves 10mg dose of rivaroxaban for reduction of continued risk of venous thromboembolism (VTE)

Biospace Inc.

FDA has approved 10 mg dose for reducing continued risk for VTE after completing at least 6-months of initial anticoagulation. Approval is based on data from EINSTEIN CHOICE, which showed superior efficacy in reducing VTE risk and with major bleeding rates similar to aspirin.


International Expert Consensus on Switching Platelet P2Y12 Receptor-Inhibiting Therapies


This expert consensus provides an overview of the pharmacology of P2Y12 inhibitors, different modalities and definitions of switching, and available literature and recommendations for switching between P2Y12 inhibitors.


Bayer files for approval of long-acting haemophilia therapy damoctocog alfa pegol (BAY94-9027) in US


BAY94-9027 is engineered to potentially prolong factor VIII activity in the blood while preserving coagulation activity using site-specific PEGylation technology, thus reducing the number of infusions necessary to prevent bleeds in patients with haemophilia A.


Revised SPC: Pradaxa (dabigatran) hard capsules (all strengths)

electronic Medicines compendium

Sections 4.2 (Posology and method of administration), 4.4 (Special warnings and precautions for use) and 5.1 (Pharmacodynamic properties) have been updated to include information regarding catheter ablation for atrial fibrillation.


Revised SPCs: Xarelto (rivaroxaban) film-coated tablets (all strengths)

electronic Medicines compendium

As with other anticoagulants, the possibility may exist that patients are at increased risk of bleeding in case of concomitant use with SSRIs or SNRIs. When concomitantly used in the clinical program, numerically higher rates of clinically relevant bleeding were observed.


The Efficacy and Safety of the Use of Non-Vitamin-K Antagonist Oral Anticoagulants in Patients with Non-Valvular Atrial Fibrillation and Concomitant Aspirin Therapy: A Meta-Analysis of Randomized Trials


This analysis of 4 RCTs found that in patients receiving aspirin (n=21,722), NOACs were more effective than vitamin K antagonists (e.g. HR 0.78; 95% CI 0.67-0.91 for stroke/systemic embolism), as safe for major bleeding and safer for intracranial haemorrhage (HR 0.38; 0.26-0.56).


Conference report: Three months of dual antiplatelet therapy (DAPT) non-inferior to 12 months DAPT in patients with acute coronary syndrome (ACS) treated with the COMBO Dual Therapy Stent

Biospace Inc.

The overall incidence of the primary endpoint (composite of all-cause mortality, myocardial infarction, stent thrombosis, stroke, target vessel revascularisation, moderate/major bleeding within 360 days) was 8.2% for 3 months v 8.4% for 12 months DAPT; P non-inferiority <0.001).


Lower dose of rivaroxaban (Xarelto) for extended prevention of recurrent venous thromboembolism (VTE) approved in Europe


The European Commission has approved a 10mg once daily dose for extended prevention of recurrent VTE, for patients who have already received at least six months of initial anticoagulation. The approval is based on data from the EINSTEIN CHOICE study.



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:


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