Revised SPC: Xarelto (rivaroxaban) 10mg film-coated tablets

electronic Medicines Compendium
Details of an open-label cohort study (XAMOS) have been added to section 5.1; the results of this were consistent with the results of the pivotal randomised studies.

 

Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation

European Heart Journal

This descriptive study in patients with AF undergoing elective cardioversion reports that rivaroxaban is similar to warfarin in terms of efficacy (stroke, TIA, peripheral embolism, MI or CV death in 0.51% and 1.02%, respectively) and safety (major bleeding in 0.6% and 0.8%).

 

Prehospital Ticagrelor in ST-Segment Elevation Myocardial Infarction

New England Journal of Medicine

This international double-blind study found that pre-hospital administration of ticagrelor (in the ambulance) appeared to be safe, but did not improve outcomes when compared to later administration in hospital in patients with ST-segment elevation myocardial infarction.

 

2014 ESC Guidelines on the diagnosis and management of acute pulmonary embolism

European Heart Journal

These updated guidelines on the clinical management of PE consider new data that have extended or modified knowledge in respect of optimal diagnosis, assessment and treatment. New aspects covered include new oral anticoagulants and outpatient treatment, among others.

 

Prognosis and treatment of atrial fibrillation patients by European cardiologists: One Year Follow-up of the EURObservational Research Programme-Atrial Fibrillation General Registry Pilot Phase (EORP-AF Pilot registry)

European Heart Journal

This analysis of a contemporary European registry of AF patients (n=3119) found overall oral anticoagulant use remains high (around 78% at one year). One-year mortality however remains high (5.7%; 70% cardiovascular deaths), and hospital readmissions were common.

 

Management of venous thrombo-embolism: an update

European Heart Journal

This article reviews recent advances in the management of venous thromboembolism, including risk stratification, use of new oral anticoagulants in treatment and secondary prophylaxis, and the potential transition of acute VTE to chronic thromboembolic pulmonary hypertension.

 

One year data from the PREFER in AF European registry show changes in management and implementation of guidelines

Biospace

The results of a multinational disease registry designed to explore AF management in clinical practice show 80% were receiving oral anticoagulants after one year, with an increase in the proportion prescribed new oral anticoagulants (12.6%; up from 6.1% the previous year).


Risk of ischaemic stroke according to pattern of atrial fibrillation: analysis of 6563 aspirin-treated patients in ACTIVE-A and AVERROES

European Heart Journal

In large population of non-anticoagulated AF patients, the pattern of AF (paroxysmal, persistent, or permanent) was a strong independent predictor of stroke risk and may be helpful to assess risk/benefit for anticoagulant therapy, especially in lower risk patients.

 

 

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

 

 

Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary or valve interventions: a European consensus document

European Heart Journal
This updated joint consensus document discusses the optimal antithrombotic therapy management in AF patients presenting with ACS and/or undergoing percutaneous coronary or valve interventions and provides recommendations for use in clinical practice.

 

Aspirin for the Prevention of Recurrent Venous Thromboembolism: The INSPIRE Collaboration

Circulation
This individual-patient-data analysis of the WARFASA and ASPIRE trials found low-dose aspirin for extended treatment of VTE reduced recurrent VTE (5.1% vs. 7.5%/yr with placebo) and major vascular events (5.7% vs. 8.7%/yr). The rate of major bleeding was low (0.5% vs. 0.4%/yr).

 

Symptomatic Hepatocellular Liver Injury With Hyperbilirubinemia in Two Patients Treated With Rivaroxaban

JAMA Internal Medicine
This article reports on two patients with predominantly hepatocellular liver injury that occurred during treatment with rivaroxaban. Both had massively elevated transaminase activity levels and hyperbilirubinaemia, and fulfilled the criteria of Hy's law.

 

MHRA responds to article in the Lancet that questions the authorisation of alteplase for acute ischaemic stroke

Medicines and Healthcare products Regulatory Agency
MHRA has responded to an article raising concerns about trial data for alteplase in ischaemic stroke. Although European regulators have concluded the benefit: risk balance is favourable, an expert working group will be set up to ensure all relevant evidence has been considered.

 

 

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

PLATO study of ticagrelor for ACS gets all clear from US

PharmaTimes
The US Department of Justice has closed its investigation into the phase III PLATO trial which formed the basis for regulatory approval of ticagrelor (Brilique™ in UK) for acute coronary syndrome.

 

Hospital Performance for Pharmacologic Venous Thromboembolism Prophylaxis and Rate of Venous Thromboembolism: A Cohort Study

JAMA Internal Medicine
This US retrospective study found no statistically significant difference in VTE rates within 90 days of admission in medical patients between hospitals with low, moderate or high use of pharmacological VTE prophylaxis.

 

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

electronic Medicines Compendium

Information on converting from parenteral anticoagulants to rivaroxaban has been added to section 4.2 (posology and method of administration).

 

 

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

What is the evidence for the use of Low Molecular Weight Heparins for the prophylaxis of travel-related thrombosis?

UKMi

This Medicines Q&A evaluates the evidence for using low molecular weight heparins for the prevention of travel-related venous thromboembolism

 

Update on Chronic Thromboembolic Pulmonary Hypertension

Circulation
This review on thromboembolic pulmonary hypertension covers epidemiology and definition, mechanisms of disease, clinical characteristics, diagnostic procedures, and treatment.

 

MHRA launches learning module on oral anticoagulants

Medicines and Healthcare products Regulatory Agency
The MHRA has launched an online learning module for healthcare professionals outlining the key risks of oral anticoagulants. The module includes a description of important adverse effects, factors that increase their risk, how risk can be reduced, and specific treatments.

 

Effect of treatment delay, age, and stroke severity on the effects of intravenous thrombolysis with alteplase for acute ischaemic stroke: a meta-analysis of individual patient data from randomised trials

The Lancet
This meta-analysis of individual patient data from 9 RCTs of alteplase for acute ischaemic stroke found that it improved the odds of a good stroke outcome versus control when given within 4.5 hours, with proportional treatment benefits similar regardless of age or stroke severity.

 

Frequent and possibly inappropriate use of combination therapy with an oral anticoagulant and antiplatelet agents in patients with atrial fibrillation in Europe

Heart
This analysis of European registry data found that 10.9% of patients with AF were treated with a combination of oral anticoagulant and one or two antiplatelets. The majority of those on dual (95%) or triple (64%) combination therapy did not have an accepted indication.

 

Perioperative Atrial Fibrillation and the Long-term Risk of Ischemic Stroke

Journal of the American Medical Association
Among patients hospitalised for surgery, perioperative AF was linked to increased long-term risk of ischaemic stroke. More studies are needed to better delineate the risk and determine optimal antithrombotic strategies in such patients with other risk factors for stroke.

 

 

 

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

Comparative Outcomes of Catheter-Directed Thrombolysis Plus Anticoagulation vs. Anticoagulation Alone to Treat Lower-Extremity Proximal Deep Vein Thrombosis

JAMA Internal Medicine

Among 90,618 patients hospitalised for DVT, 3649 underwent catheter-directed thrombolysis (CDT). No difference was found in mortality between CDT and anticoagulation groups (1.2% vs. 0.9%; OR, 1.40; 95% CI, 0.88-2.25; p=0.15).but more adverse events noted in the CDT group.

 

Predicting risk of upper gastrointestinal bleed and intracranial bleed with anticoagulants: cohort study to derive and validate the QBleed scores

British Medical Journal
The QBleed risk algorithms were found to provide valid measures of absolute upper gastrointestinal and intracranial bleed risk in new users of anticoagulants (versus non-users), and were validated by a separate validation cohort, with some advantages over other scoring methods.

 

Symptomatic Intracerebral Hemorrhage in Acute Ischemic Stroke After Thrombolysis With Intravenous Recombinant Tissue Plasminogen Activator: A Review of Natural History and Treatment

JAMA Neurology
This article reviews the definitions and epidemiologic characteristics of symptomatic intracerebral haemorrhage, with a focus on the rationale and options for treatment.

 

Revised SPC: Eliquis (apixaban) 2.5mg and 5 mg film-coated tablets

electronic Medicines Compendium
Apixban is now also licensed for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

 

 

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

Antepartum dalteparin versus no antepartum dalteparin for the prevention of pregnancy complications in pregnant women with thrombophilia (TIPPS): a multinational open-label randomised trial

The Lancet
Antepartum prophylactic dalteparin did not reduce occurrence of VTE, pregnancy loss, or placenta-mediated pregnancy complications in pregnant women with thrombophilia at high risk of these complications and was associated with an increased risk of minor bleeding (n=289).

 

BMJ investigation alleges that Boehringer Ingelheim withheld safety analyses of dabigatran

British Medical Journal
According to an investigation by the BMJ, Boehringer Ingelheim withheld from doctors and drug regulators the fact that monitoring the blood level of dabigatran and adjusting the dose could substantially reduce major bleeds associated with it.

 

Prasugrel with percutaneous coronary intervention for treating acute coronary syndromes (review of technology appraisal guidance 182) – guidance (TA317)

National Institute for Health and Care Excellence
Prasugrel in combination with aspirin is recommended as an option for preventing atherothrombotic events in adults with acute coronary syndrome (unstable angina, non-ST or ST segment elevation myocardial infarction) having primary or delayed percutaneous coronary intervention.

 

Catheter ablation of atrial fibrillation: an update

European Heart Journal
Recent clinical trial data have demonstrated the superiority of catheter ablation of AF to antiarrhythmic drug therapy in controlling AF. However, it is a challenging and complex procedure and therefore not used as a first line treatment option in clinical practice.

 

Antiplatelet therapy for secondary prevention of coronary artery disease

Heart
This review summarizes the currently available evidence on choice, combination and duration of antiplatelet agents in stable coronary artery disease and acute coronary syndrome.

 

 

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

Dual-antiplatelet treatment beyond 1 year after drug-eluting stent implantation (ARCTIC-Interruption): a randomised trial

The Lancet
Results of this planned extension of a previously published study suggest that dual antiplatelet therapy beyond 1 year post stenting with a drug eluting stent provided no apparent benefit but increased harm (bleeding events).

 

Platelet function and long-term antiplatelet therapy in women: is there a gender-specificity? A ‘state-of-the-art’ paper

European Heart Journal
This review attempts to bring together current evidence, clinical practices and gaps in the knowledge on gender-specific platelet function and antiplatelet therapy.

 

Burden of Changes in Pill Appearance for Patients Receiving Generic Cardiovascular Medications After Myocardial Infarction: Cohort and Nested Case–Control Studies

Annals of Internal Medicine
This study found that changes in the appearance of generic medicines among patients receiving cardiovascular medicines following MI increased the odds of non-persistence. Prescribers and pharmacists need to take steps to warn patients about this possible variation in appearance.

 

Hospital Variation in Thrombolysis Times Among Patients With Acute Ischemic Stroke: The Contributions of Door-to-Imaging Time and Imaging-to-Needle Time

JAMA Neurology
This research suggests that imaging-to-needle (ITN) time is a greater source of variability than door-to-imaging time for door-to-needle times in acute ischaemic stroke. The authors conclude that more attention is needed to determine systems changes that can decrease ITN time.

 

 

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

 

Revised SPCs: Pradaxa (dabigatran) 150mg, 110mg and 75mg hard capsules

Electronic Medicines Compendium
The SPCs have been extensively revised following addition of a new indication for use of dabigatran in the treatment of DVT and PE and prevention of recurrent DVT and PE in adults. Wording for the interaction with verapamil has been strengthened in view of bleeding risk.

 

Long-Acting clotting Factor VIIa-CTP receives positive opinion for three orphan drug designations in Europe

Biospace Inc.
This positive opinion recommends approval of orphan drug designation for long-acting version of clotting Factor VIIa (IV or SC route) for treatment of bleeding episodes in patients with haemophilia A or B with inhibitors to Factor VIII or IX and congenital Factor VII deficiency.

 

Antipsychotic drugs and risks of myocardial infarction: a self-controlled case series study

European Heart Journal
This study suggests an increased MI risk during the 30 days after first prescription of an antipsychotic. Although the small absolute risk is unlikely to alter risk/benefit balance in licensed conditions, it is likely to be less favourable for unlicensed uses (e.g. dementia).

 

Quadrivalent Human Papillomavirus Vaccine and the Risk of Venous Thromboembolism

Journal of the American Medical Association
This self-controlled case-series found no evidence for an increased risk of venous thromboembolism during the 42 days after quadrivalent HPV vaccination. The lack of association was apparent in subgroup analyses according to age, and after adjustment for oral contraceptive use.

 

Low molecular weight heparin versus unfractionated heparin for perioperative thromboprophylaxis in patients with cancer

Cochrane Database of Systematic Reviews
No evidence was found between perioperative thromboprophylaxis with LMWH versus UFH in their effects on mortality, thromboembolic outcomes, major or minor bleeding in patients with cancer. Further trials are needed to evaluate different heparin thromboprophylaxis strategies.

 

Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI): an open-label, single centre, randomised controlled trial

The Lancet
This pragmatic study in patients undergoing primary PCI found that the incidence of major cardiac adverse events (MACE) at 28 days was lower with heparin than with bivalirudin (5.7% vs. 8.7%, respectively; p=0.01), with no difference between groups in bleeding complications.

 

 

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

Anticoagulation therapy versus placebo for pulmonary hypertension

Cochrane Database of Systematic Reviews
No randomised evidence is available. The results of other studies (non-RCTs) provide only poor quality evidence of effectiveness of this intervention, and the results should be interpreted with caution. This review therefore highlights need for appropriately designed RCTs.

 

Desmoteplase fails to meet primary endpoint in Phase III study of acute ischaemic stroke

Biospace Inc.

The first of two Phase III studies of desmoteplase in the treatment of acute stroke within 3-9 hours after onset (DIAS-3) has failed to meet its primary endpoint (proportion of patients with a favourable outcome at day 90 compared to placebo; 51.3% v 49.8%, respectively).

 

European CHMP recommends approval of apixaban for treatment of DVT and PE and prevention of recurrence

European Medicines Agency

The CHMP has recommended a license extension for apixaban (Eliquis®) to include its use for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults.

 

Point-of-Care Testing of International Normalized Ratio for Patients on Oral Anticoagulant Therapy: Systematic Review and Economic Analysis

Canadian Agency for Drugs and Technologies in Health
Point of care (POC) INR technologies were found to be generally precise and accurate when INR values are in commonly targeted therapeutic range. There was no significant difference in risk of hemorrhagic/thromboembolic events between POC and standard laboratory testing methods.

 

Preconception low-dose aspirin and pregnancy outcomes: results from the EAGeR randomised trial

The Lancet
RCT (n=1228) found preconception-initiated low-dose aspirin not significantly linked to livebirth or pregnancy loss (PL) in women with 1/2 previous losses vs. placebo, and is thus not recommended for prevention of PL. Increased vaginal bleeding with aspirin was not linked to PL.

 

CMC Biologics announces development plans for first-in-class factor Xa inhibitor antidote Andexanet Alfa

Biospace Inc.
CMC Biologics, Inc. has entered in to a commercial supply agreement with Portola Pharmaceuticals, for the development of andexanet alfa, a potential first-in class factor Xa inhibitor antidote, for use in patients with a major bleed/who require emergency surgery.

 

Supporting local implementation of NICE guidance on use of the non Vitamin K antagonist oral anticoagulants (NOACs) in non-valvular atrial fibrillation

National Institute for Health and Care Excellence
This consensus report was developed following a workshop meeting discussing barriers to use of non-Vitamin K antagonist oral anticoagulants for reducing stroke risk in non-valvular AF and how these barriers might be overcome locally to facilitate appropriate use of the drugs.

 

 

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

Prophylaxis against Venous Thromboembolism in Ambulatory Patients with Cancer

New England Journal of Medicine
This article outlines the risks and rates of VTE from trial data, discusses US guidance which overall does not endorse routine prophylaxis, and concludes that further studies on morbidity, mortality, and cost for this patient population are required.

 

NICE issues Final Appraisal Determination on prasugrel with PCI for treating ACS

National Institute for Health and Care Excellence
NICE has issued DRAFT guidance (FAD) recommending the use of prasugrel 10mg in combination with aspirin as an option for preventing atherothrombotic events in adults with acute coronary syndrome having primary or delayed percutaneous coronary intervention.

 

Boehringer Ingelheim announces new study to evaluate dabigatran for patients with AF undergoing ablation

Biospace Inc.
A new study (RE-CIRCUIT™) will investigate the safety and efficacy of uninterrupted anticoagulant treatment with dabigatran (Pradaxa®) in patients with atrial fibrillation who undergo ablation. Results of the study are expected in 2016.

 

 

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