Items filtered by date: February 2016

European CHMP issues positive opinion on granting marketing authorisation for eftrenonacog alfa (Alprolix)

European Medicines Agency

Eftrenonacog alfa, an antihaemorrhagic, blood coagulation factor IX, is intended for the treatment and prophylaxis of bleeding in patients with haemophilia B. It will be available as 250 IU, 500 IU, 1000 IU, 2000 IU and 3000 IU powder and solvent for solution for injection.


European CHMP starts review on medicines containing dienogest 2mg and ethinylestradiol 0.03mg used for acne

European Medicines Agency

The review has been requested by MHRA because of concerns that benefits of these agents have not been sufficiently demonstrated in treatment of acne. MHRA was also concerned about venous thromboembolism risk, which has not been sufficiently characterised for this combination.


Non-vitamin K antagonist oral anticoagulants (NOACs) (KTT16)

National Institute for Health and Care Excellence

This document summarises the evidence-base on NOACs. It is a key therapeutic topic which has been identified to support medicines optimisation. It is not formal NICE guidance.


Stopping vs. Continuing Aspirin before Coronary Artery Surgery

New England Journal of Medicine

RCT (n=2100) found that administration of preoperative aspirin resulted in neither a lower risk of death or thrombotic complications (occurred in 202 [19.3%] on aspirin and 215 [20.4%] placebo) nor a higher risk of major haemorrhage leading to reoperation (1.8% vs. 2.1% placebo).


Improving anticoagulation in patients with atrial fibrillation using the GRASP AF audit tool

West Hampshire CCG and Boehringer Ingelheim Ltd

This audit tool (developed by Boehringer Ingelheim and PRIMIS) was used to improve stroke prevention in patients with AF. The project specifically focussed on patients receiving antiplatelet monotherapy and no treatment despite being at high risk of stroke, based on NICE CG180.


FibCLOT (human fibrinogen) obtains first Marketing Authorisations in Europe

Biospace Inc.

EU marketing authorisations for this product to treat patients with a congenital fibrinogen deficiency have been granted in Germany, Denmark and Hungary. Thirteen more marketing authorisations are expected in Europe in the coming months.



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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The impact of atrial fibrillation type on the risk of thromboembolism, mortality, and bleeding: a systematic review and meta-analysis

European Heart Journal

Guidelines recommend decisions on oral anticoagulation be made independently of classification into paroxysmal AF (PAF) or non-PAF. This study suggests NPAF may be linked to increased risk of stroke and mortality vs. PAF, thus AF type may need to be considered.


Boehringer announces that idarucizumab (Praxbind®) is now available to be used commercially in England, Ireland and Wales

Biospace Inc.

According to Boehringer, the Health Technology Appraisal bodies in these countries agreed that idarucizumab, which specifically reverses anticoagulant effect of dabigatran, is eligible for full reimbursment without the need for a full appraisal.


The past and future of haemophilia: diagnosis, treatments, and its complications

The Lancet

In this seminar, the authors provide an overview of the diagnosis of haemophilia and describe the clinical manifestations and treatment (both on-demand and prophylactic). Inhibitor formation as a complication of replacement therapy and its treatment is also discussed.


Rivaroxaban compared with standard thromboprophylaxis after major orthopaedic surgery: co-medication interactions

British Journal of Clinical Pharmacology

This retrospective analysis (n=17,701) found that major bleeding events were more common with NSAID use (vs non-use) in both standard of care (SOC) and rivaroxaban groups. NSAID use had no influence on thromboembolic events in either SOC or rivaroxaban groups.


Biologics License Application for andexanet alfa to reverse anticoagulant activity of direct and indirect Factor Xa inhibitors accepted for review by FDA

Biospace Inc.

Andexanet alfa is being developing as an antidote for use in patients treated with a direct or indirect Factor Xa inhibitor when reversal of anticoagulation is needed, such as in life-threatening or uncontrolled bleeding or for emergency surgery and urgent procedures.



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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Long-term antiplatelet therapy following myocardial infarction: implications of PEGASUS-TIMI 54

European Heart Journal

This review on dual antiplatelet therapy (DAPT) discusses the implications of the PEGASUS-TIMI 54 study which showed that patients with a history of ACS and at high risk of further ischaemic events, may benefit from prolonged ticagrelor-based DAPT.


Oral direct thrombin inhibitors or oral factor Xa inhibitors for the treatment of pulmonary embolism

Cochrane Database of Systematic Reviews

Moderate to high quality evidence suggests that there are no differences between these agents and standard anticoagulation for long-term treatment of PE for the outcomes recurrent PE, recurrent venous thromboembolism, DVT, all-cause mortality and major bleeding.




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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Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial

The Lancet Haematology

Additional catheter-directed thrombolysis resulted in a persistent and increased clinical benefit vs. control during follow-up for up to 5 years, supporting use of this intervention in patients with extensive proximal DVT. However, it did not lead to better quality of life.


Choosing a particular oral anticoagulant and dose for stroke prevention in individual patients with non-valvular atrial fibrillation: part 1

European Heart Journal

The following scenarios are covered: stable CAD/PVD; cardioversion, ablation and anti-arrhythmics; mechanical valves, patients with time in therapeutic range of >70% on warfarin; patients with single stroke risk factor; and patients with a single first episode of paroxysmal AF.


Choosing a particular oral anticoagulant and dose for stroke prevention in individual patients with non-valvular atrial fibrillation: part 2

European Heart Journal

The following scenarios are covered: post CVA/TIA, acute stroke requiring thrombolysis/thrombectomy, initiating/restarting treatment after CVA/TIA, dialysis, the elderly, high risk of GI bleeding, hypertension, adherence and compliance.


Pfizer issues oral anticoagulants toolkit to support delivery of Medicines Use Reviews (MURs) and the New Medicine Service (NMS)

Pharmaceutical Services Negotiating Committee

The PSNC and Pharmacy Voice have endorsed this toolkit, hard copies of which are available to order from the Access Pfizer website (need to register on website and have an Alliance Healthcare account number or Pfizer customer account number).


Nonaspirin Nonsteroidal Anti-Inflammatory Drugs and Risk of Hemorrhagic Stroke: A Systematic Review and Meta-Analysis of Observational Studies


Review of 10 studies did not find link between use of NSAIDs and increased risk of haemorrhagic stroke (pooled RR 1.09; 95% CI, 0.98–1.22), although individually, this risk was modestly elevated in diclofenac and meloxicam users (1.27, 1.02–1.59 and 1.2, 1.08–1.50, respectively).


Summary of antidotes to NOACs (inlcuding those currently in development) which could impact NOAC use in the future

London Medicines Evaluation Network

This briefing aims to provide an update on idarucizumab (launched), andexanet alpha (potential launch 2017), and aripazine (phase 2 studies), including the evidence base underpinning their use as antidotes to NOACs.


Call for independent review of ROCKET-AF trial of rivaroxaban and Bayer’s response

British Medical Journal

There is a call for an independent investigation into the ROCKET-AF trial underpinning use of rivaroxaban to prevent ischaemic stroke in non-valvular AF after a BMJ investigation found defective point of care INR device was used in warfarin arm of trial.


Impact of pharmacy care upon adherence to cardiovascular medicines: a feasibility pilot controlled trial

European Journal of Hospital Pharmacy

This study of 71 patients randomised to receive community pharmacy interviews (face-to-face or phone consultation) for 6 months after discharge following acute treatment for a coronary event showed statistically significantly improved adherence in the intervention group.


Randomized Phase III Trial of Standard Therapy Plus Low Molecular Weight Heparin in Patients With Lung Cancer: FRAGMATIC Trial

Journal of Clinical Oncology

Data from this open-label RCT (n=2,202) show that these heparins do not improve overall survival or metastasis-free survival in lung cancer patients, although there was a statistically significant reduction in VTE (at the cost of increased clinically relevant non-major bleeding).


A review of sex-specific benefits and risks of antithrombotic therapy in acute coronary syndrome (ACS)

European Heart Journal

An overview of current data examining sex differences in the use of, and outcomes related to, antithrombotic therapy for patients with ACS, concludes that antithrombotic therapies for acute MI are similar in efficacy in males & females, but females are at higher risk of bleeding.


Antifibrinolytic therapy for preventing oral bleeding in patients with haemophilia or Von Willebrand disease undergoing minor oral surgery or dental extractions

Cochrane Database of Systematic Reviews

Despite discovery of a beneficial effect of systemically administered tranexamic acid and epsilon aminocaproic acid in preventing postop bleeding, the limited number of RCTs do not provide definite evidence of efficacy of antifibrinolytic therapy in this setting.


Mobile Telephone Text Messaging for Medication Adherence in Chronic Disease A Meta-analysis

JAMA Internal Medicine

According to this meta-analysis, mobile phone text messaging approximately doubles the odds of medication adherence. This increase translates into adherence rates improving from 50% (assuming this baseline rate in patients with chronic disease) to 67.8% (absolute increase 17.8%).


Acute Limb Ischemia and Outcomes With Vorapaxar in Patients with Peripheral Artery Disease: Results From TRA2°P-TIMI 50


This RCT (n=3,787) of patients with symptomatic peripheral artery disease found that vorapaxar reduced total acute limb ischaemia events (ALI) events (94 vs 56, HR=0.59, 95% CI= 0.38-0.93) and first ALI events (HR 0.58, 95% CI= 0.39-0.86).


European CHMP adopts positive opinion for factor X (Coagadex) for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency

European Medicines Agency

Factor X, an antihaemorrhagic, works as replacement therapy and temporarily increases plasma levels of factor X, helping to prevent and control bleeding. Factor X has orphan status and is being reviewed under accelerated assessment.



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:


Published in News