Anticoagulation news items. Week commencing 3rd November 2014
Use of PER977 to Reverse the Anticoagulant Effect of Edoxaban
New England Journal of Medicine
In double-blind, placebo-controlled dose escalation trial in 80 healthy people given 60mg edoxaban, baseline haemostasis was restored from anticoagulated state in 10-30 minutes after administration of 100-300 mg of PER977 and was sustained for 24 hours. Phase 2 studies underway.
NHS Improving Quality
53.6% suitable patients (pts) in England are on anticoagulants. If warfarin prescribed for all of above with CHA2DS2-VASc ≥2, further 11,600 AF-related CVAs would be averted/year, with additional 1500 excess bleeds, and decrease in number of deaths in AF pts over 1-year by 3500.
JAMA Internal Medicine
The authors of this viewpoint article discuss the risks and benefits of vorapaxar and conclude that although it has a potential role in the secondary prevention of cardiovascular disease, they remain sceptical of its widespread use as part of a 3-drug antiplatelet regimen.
National Institute for Health and Care Excellence
A systematic review and meta-analysis of observational studies found that there was a statistically significantly increased risk of venous thromboembolism (VTE) among users of NSAIDs compared to non-users of NSAIDs. However, the meta-analysis has a number of important limitations.
European Heart Journal
This study reports a relatively low risk of VTE beyond 3 months after radiofrequency ablation for AF. The authors suggest the risk of bleeding with oral anticoagulation may outweigh benefits in this setting, but randomised studies are required to confirm their findings.
Risk of Bleeding With Dabigatran in Atrial Fibrillation
JAMA Internal Medicine
This analysis of Medicare patients who started warfarin (n=8102) or dabigatran (n=1302) within 60 days of AF diagnosis reports that dabigatran was associated with a higher risk of overall, major and GI bleeding (HR 1.30, 1.58 and 1.85 v warfarin) but lower risk of ICH (HR 0.32).
Biospace Inc.
The EMA has validated an application seeking approval of Elocta™, a recombinant factor VIII Fc fusion protein product candidate for the treatment of haemophilia A. The application includes results from the A-LONG and Kids A-LONG Phase III studies.
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 news items. Week commencing 27th October 2014
Circulation
Retrospective cohort study in general practice found dabigatran linked to reduced risk of ischaemic stroke, intracranial bleed, and death, and increased risk of major GI bleed vs. warfarin in elderly patients with non-valvular AF. These links more pronounced with 150mg BD dose.
The Lancet Neurology
RCT (n=2876) found despite previously reported decrease proximal DVT risk at 30 days (primary endpoint), there were no significant differences in disability, living circumstances, or health-related QoL in patients using or not using intermittent pneumatic compression.
National Institute for Health and Care Excellence
DRAFT guidance recommends dabigatran etexilate, within its marketing authorisation, as an option for treating and for preventing recurrent deep vein thrombosis and pulmonary embolism in adults.
UKMi
This document highlights key factors influencing anticoagulant choice, identification of patients taking anticoagulants, when might warfarin be the preferred option, and active swapping from warfarin to novel agents.
FDA advisory panel recommends approval of edoxaban 60mg in selected AF patients
Reuters
Advisory panel to FDA has recommended approval of 60 mg dose of edoxaban, a once-daily anticoagulant that inhibits Factor Xa, for use in patients with AF, but only in those with mild renal impairment, as outcomes vs. warfarin were worse in those with normal renal function.
US Food and Drug Administration
The US FDA has approved Obizur (Antihaemophilic Factor (Recombinant), Porcine Sequence) for the treatment of bleeding episodes in adults with acquired haemophilia A.
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 news items. Week commencing 20th October 2014
Acute coronary syndrome - rivaroxaban [ID532]: consultation document
National Institute for Health and Care Excellence
DRAFT guidance recommends rivaroxaban as option, in combination with aspirin plus clopidogrel/aspirin alone, for preventing atherothrombotic events in people who have had an ACS with elevated cardiac biomarkers. Risk of bleeding should be assessed before treatment is started.
Heart
In patients with STEMI treated with primary PCI, chronic use of vitamin K antagonist (VKA) was associated with an increased risk of in-hospital major bleed (17.0% v 10.1% in those not on VKA). In those on VKA, glycoprotein inhibitors were associated with increased bleeding risk.
New product: Nuwiq (human coagulation factor VIII, simoctocog alfa)
electronic Medicines Compendium
Nuwiq is licensed for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Dose and duration depend on the severity of the factor VIII deficiency, location and extent of the bleeding and the patient's clinical condition.
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 news items. Week commencing 13th October 2014
New product: Xarelto (rivaroxaban) 2.5 mg film-coated tablets
electronic Medicines Compendium
Rivaroxaban co-administered with aspirin alone or with aspirin plus clopidogrel or ticlopidine, is indicated for prevention of atherothrombotic events in adult patients after an ACS with elevated cardiac biomarkers.
Guideline for the diagnosis and management of the rare coagulation disorders
British Journal of Haematology
This guideline covers the diagnosis and management of patients with rare coagulation disorders, defined as monogenic bleeding disorders caused by deficiency of a soluble coagulation factor or factors, other than von Willebrand disease, Haemophilia A or Haemophilia B.
dabigatran etexilate (Pradaxa)
Scottish Medicines Consortium
The SMC has accepted dabigatran etexilate (Pradaxa®) for use within NHS Scotland for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Cost-effectiveness of longer-term use (>18 months) is uncertain.
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 news items. Week commencing 6th October 2014
Anticoagulation in adults with congenital heart disease: The who, the when and the how?
Heart
This article reviews the current use of anticoagulation in patients with congenital heart disease. It discusses treatment and monitoring with warfarin, heparin and the new oral anticoagulants, and who and when to treat.
National Institute for Health and Care Excellence
A randomised controlled trial reported that continuing dual antiplatelet therapy beyond a year after stent implantation did not statistically significantly reduce the risk of the combined outcome of death or cardiovascular events compared with continuing aspirin monotherapy....
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 news items. Week commencing 29th September 2014
JAMA Internal Medicine
The authors of this research letter report that women, elderly patients, and those of non-white racial backgrounds are underrepresented in the RCTs of US (ACC/AHA) guidelines for AF, HF, and ACS, raising concerns about their applicability in these populations.
Journal of Clinical Oncology
The results of this study suggest that in patients with cancer treated with LMWH for 6 months for a first DVT, continuation for a further 6 months in those with residual vein thrombosis did not reduce the rate of recurrent VTE. Those without RVT at 6 months are a low risk group.
JAMA Internal Medicine
This meta-analysis of observational studies suggests that women with STEMI treated with primary PCI have a higher risk of in-hospital mortality than men; this association is likely however to be confounded by baseline CV risk factors and differences in clinical profile.
Ministry of Health, Labour and Welfare in Japan approves edoxaban for additional indications
Biospace Inc.
The oral factor Xa inhibitor edoxaban has been approved in Japan for the prevention of ischaemic stroke and systemic embolism in patients with non-valvular AF and for treatment and secondary prevention of VTE. It is currently under regulatory review in the EU for these indications.
Canadian Agency for Drugs and Technologies in Health
This article reviews current evidence of comparative efficacy and safety of monotherapy or combination medical interventions for patients with chronic thromboembolic pulmonary hypertension. Studies of riociguat, bosentan and sildenafil are summarised.
Non-adherence to cardiovascular medications
European Heart Journal
The authors of this review on non-adherence to cardiovascular medications, which is increasingly recognised, conclude that in the face of a rapidly expanding population at risk for CHD, effective means of ensuring patient adherence to evidence-based therapy are urgently needed.
All Wales Advice on the Role of Oral Anticoagulants
All Wales Medicines Strategy Group
This updated document covers the safe and effective use of oral anticoagulants for the prevention of stroke and systemic embolism in people with non-valvular AF. It considers assessment, drug choice, review, prescribing responsibility, and INR monitoring for warfarin.
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 news items. Week commencing 22nd September 2014
Rheumatology
Meta-analysis of 6 observational studies (21,401 VTE events) noted statistically significant increased VTE risk among NSAID users (pooled risk ratio 1.80; 95% CI, 1.28, 2.52). Results should be interpreted with caution due to observational nature of studies and other limitations.
Circulation
Analysis of data on 44,410 patients with ischaemic stroke treated with IV tPA found those with CKD had higher risk of symptomatic intracranial or serious systemic haemorrhage, but presence of renal impairment not independently linked to these major complications of IV tPA use.
National Institute for Health and Care Excellence
In this guidance, NICE recommends the use of two point-of care coagulometers (CoaguChek XS and InRatio2 PT/INR) for patients on long term vitamin K antagonist therapy who have AF or heart valve disease, provided they or their carer are able to self monitor effectively.
Electronic Medication Packaging Devices and Medication Adherence: A Systematic Review
Journal of the American Medical Association
This review of 37 studies of electronic medication packaging devices (adherence-monitoring devices incorporated into the packaging of a prescription medication) concluded that higher quality evidence is needed to determine the effects of these interventions on non-adherence.
2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes
Circulation
This is a full revision of the 2007 guideline for the management of unstable angina and NSTEMI. It incorporates both established and new evidence from published clinical trials, as well as information from basic science and comprehensive review articles.
Circulation
This scientific statement provides an overview of the post-thrombotic syndrome, a frequent, chronic complication of deep venous thrombosis, and offers practical recommendations for its optimal prevention, diagnosis, and management.
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 news items. Week commencing 15th September 2014
Journal of the American Medical Association
Analysis found no differences in efficacy/safety with most treatment strategies used to treat VTE compared with the LMWH–vitamin K antagonist, except UFH–vitamin K antagonist which was associated with an increased rate of recurrent VTE.
National Institute for Health and Care Excellence
A Danish observational study found that adding antiplatelet therapy (aspirin, clopidogrel or both) to anticoagulant treatment with a vitamin K antagonist such as warfarin, was not associated with a reduced risk of recurrent coronary events or of thromboembolism, but was associated with increased bleeding.
National Institute for Health and Care Excellence
A Spanish study found a wide range of views among patients and physicians on the acceptable trade-off between a reduction in risk of stroke and an increased risk of bleeding in atrial fibrillation.
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 news items. Week commencing 8th September 2014
European Heart Journal
This review summarises the current knowledge of the management of antithrombotic therapy after valve replacement, paying particular attention to persisting gaps in knowledge.
British Journal of Haematology
This guideline on the clinical effectiveness and health economics of patient self-testing and self-management of oral anticoagulant therapy updates a previous guideline published in 2005.
British Journal of Haematology
This article provides guidance on the clinically important issues regarding the laboratory assessment of non-coumarin anticoagulants (new oral anticoagulants; heparins, bivalirudin; fondaparinux; argatroban; danaparoid) and their impact on laboratory tests of haemostasis.
British Medical Journal
This US study of patients undergoing inpatient or outpatient surgical procedures found that the presence of preoperative systemic inflammatory response syndrome or any sepsis was associated with an increased risk of an arterial or venous thrombosis post-surgery (odds ratio 3.1).
Interventions for treating acute bleeding episodes in people with acquired hemophilia A
Cochrane Database of Systematic Reviews
No randomised clinical trials of haemostatic therapies for acquired hemophilia A were found thus, no recommendations can be made on the optimal haemostatic therapies based on the highest quality of evidence.
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 news items. Week commencing 1st September 2014
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.
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.
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).
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
