Revised SPC: TachoSil (human fibrinogen and thrombin) sealant matrix

electronic Medicines Compendium

SPC advises that to prevent development of tissue adhesions (AHs) at undesired sites, tissue areas outside desired application area should be adequately cleansed before administration of TachoSil. AHs to GI tissues have been reported with use during abdo surgery close to bowel.

 

Oral direct factor Xa inhibitor versus enoxaparin for thromboprophylaxis after hip or knee arthroplasty: Systemic review, traditional meta-analysis, dose–response meta-analysis and network meta-analysis

Thrombosis Reasearch

Review of 20 trials (n= 38,507) found that direct oral factor Xa inhibitors are more effective than enoxaparin in preventing venous thromboembolism after total hip or knee replacement. Their anticoagulant effect was not necessarily compromised with a higher bleeding risk.

 

Stent Retrievers for the Treatment of Acute Ischemic Stroke A Systematic Review and Meta-analysis of Randomized Clinical Trials

JAMA Neurology

Patients randomised to stent-retriever therapy (used for mechanical thrombectomy) with recombinant tissue plasminogen activator (rtPA) had improved rates of functional independence at 90 days v those on rtPA alone (RR 1.72; 95% CI, 1.48-1.99).

 

 

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 with rivaroxaban for livedoid vasculopathy (RILIVA): a multicentre, single-arm, open-label, phase 2a, proof-of-concept trial

The Lancet Haematology

In this phase 2a proof-of concept trial (n=36) patients with livedoid vasculopathy and minimum pain score of 40 on the visual analogue scale (VAS) received rivaroxaban. Median pain decreased from VAS 65.0 at baseline to 6.0 at 12 weeks treatment (p<0.0001).

 

Bivalirudin in the treatment of acute coronary syndrome

British Medical Journal

This review covers the evidence and clinical implications for use of bivalirudin as an anticoagulant in Percutaneous Coronary Intervention and compares efficacy and outcome data with that of heparin.

 

Atrial fibrillation as risk factor for cardiovascular disease and death in women compared with men: systematic review and meta-analysis of cohort studies

British Medical Journal

In this meta-analysis of 30 studies (n=4,371,714) atrial fibrillation was associated with a higher risk of all cause mortality, stroke, CV mortality, and CV events in women compared with men; however, it was noted that further research is needed to confirm causality.

 

 

 

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

Drug Discontinuation and Follow-up Rates in Oral Antithrombotic Trials

JAMA Internal Medicine

Researcher examined participant loss–to–follow-up rates for major trials of oral antithrombotics, comparing rates reported in medical journals with rates using data submitted by manufacturers to FDA and found published rates were consistently lower than FDA rates (0.4% vs. 12%).

 

Elocta [rFVIIIFc] launched in UK for prophylaxis and on-demand treatment of bleeding in patients with haemophilia A

PharmaTimes

Elocta [rFVIIIFc], a fully recombinant fusion protein, is first haemophilia A treatment approved in Europe that offers prolonged protection against bleeding episodes through prophylactic injections every 3-5 days instead of every other day with conventional therapies.

 

Meta-Analysis of Renal Function on the Safety and Efficacy of Novel Oral Anticoagulants for Atrial Fibrillation

American Journal of Cardiology

Analysis of 4 RCTs of NOACs for treatment of nonvalvular AF (n=58,338) noted that their use was linked to reduced risk of stroke or systemic embolism, and reduced risk of major bleeding compared with warfarin in subjects with mild or moderate renal impairment.

 

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

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

In this RCT, 37 patients (43%) allocated to catheter-directed thrombolysis developed post-thrombotic syndrome, v 63 (71%) allocated to control group (compression stockings+anticoagulation, p<0.0001), corresponding to an absolute risk reduction of 28% (NNT=4).

 

Risk of death and stroke associated with anticoagulation therapy after mitral valve repair

Heart

In this cohort study of 2188 patients undergoing mitral valve repair, patients on vitamin K antagonists (VKA) had a lower risk of death/stroke at 3 months (HR=0.28, CI 0.13 to 0.62, p=0.002) without an excess major bleeding risk vs. patients not on VKA post discharge.

 

A population database study of outcomes associated with vitamin K antagonists in atrial fibrillation before DOAC

British Journal of Clinical Pharmacology

In this French cohort study of new vitamin K antagonist (VKA) users with atrial fibrillation (n=3,345) there were 3.8 deaths, 2.8 hospitalisations due to bleeding, 1.6 acute coronary syndrome events and 1.5 acute thrombotic events per 100 patient-years.

 

Dabigatran etexilate and reduction in serum apolipoprotein B

Heart

This data review of 2513 patients in the RE-LY trial showed that dabigatran therapy reduced apolipoprotein B after 3 months treatment by -0.057 g/L and -0.065g/L at low dose (110mg bd) and high dose (150mg bd) respectively whereas no reduction was seen with warfarin.

 

Reversal strategies for non-vitamin K antagonist oral anticoagulants: a critical appraisal of available evidence and recommendations for clinical management

European Heart Journal

Summary: This joint paper covers the risk of bleeding with non-vitamin K antagonist oral anticoagulants and existing reversal strategies including the potential benefit of specific reversal agents.

 

Newer antiplatelet agents in acute coronary syndrome

British Medical Journal

Prasugrel and ticagrelor have more predictable pharmacokinetics than clopidogrel (CP) and are appreciably faster in onset of action. Many cardiologists thus use these 2 agents over CP. This editorial discusses whether prescribing of newer antiplatelets has outpaced the evidence?

 

Long-acting haemophilia B therapy nonacog beta pegol filed for approval in EU 

PharmaTimes

Nonacog beta pegol is a glycopegylated recombinant factor IX with an improved pharmacokinetic profile and 5-times longer half-life than standard factor IX. The filing is based on data from paradigm clinical trial programme of 115 patients with moderate- severe haemophilia B.

 

 

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 doses of thromboprophylaxis are appropriate for adult patients at extremes of body weight?

UKMi

This updated Medicines Q&A prepared by the Haemostasis Anticoagulation and Thrombosis Committee of the UK Clinical Pharmacy Association reviews the data available and offers guidance on dosing of thromboprophylaxis in patients who are obese or of low body weight.

 

Bivalirudin, glycoprotein inhibitor, and heparin use and association with outcomes of primary percutaneous coronary intervention in the United Kingdom

European Heart Journal

Analysis of UK national PCI registry (n=61,138 procedures) noted no significant difference in short- or medium-term mortality between ST elevation myocardial infarction patients treated with bivalirudin vs. heparin-plus-glycoprotein inhibitors at primary PCI.

 

Time to Reperfusion and Treatment Effect for Acute Ischemic Stroke A Randomized Clinical Trial

JAMA Neurology

RCT (n=500) found that for every hour of reperfusion delay, the initially large benefit of intra-arterial treatment decreases, with the absolute risk
difference for a good outcome being reduced by 6% per hour of delay.

 

 

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

 

Treatment for superficial infusion thrombophlebitis of the upper extremity

Cochrane Database of Systematic Reviews

Review of 13 studies (n=917) of a topical (11 studies), an oral and a parenteral treatment noted that evidence for treating acute infusion superficial thrombophlebitis is limited and of low quality and is insufficient to recommend the use of any of the treatments studied.

 

Polypharmacy and the Efficacy and Safety of Rivaroxaban versus Warfarin in the Prevention of Stroke in Patients With Nonvalvular Atrial Fibrillation

Circulation

In a population of patients in ROCKET AF, polypharmacy was not linked to higher risk of stroke or non-CNS embolism (NCE), but it was linked
to higher risks of combined endpoint of stroke, NCE, vascular death, or MI, and non-major clinically relevant or major bleeding.

 

Early Clinical and Radiological Course, Management, and Outcome of Intracerebral Hemorrhage Related to New Oral Anticoagulants

JAMA Neurology

In this observational study of 61 patients with non-traumatic NOAC-associated intracerebral haemorrhage admitted between 2012 and 2014 it
is reported that mortality was 28% and 65% of survivors had an unfavourable outcome at 3 months. Haematoma expansion occurred in 38%.

 

Safety of antithrombotic drugs in patients with atrial fibrillation and non-end-stage chronic kidney disease: Meta-analysis and systematic review

Thrombosis Reasearch

This review of 12 studies showed no significant difference in bleeding risk between warfarin and antiplatelets (RR 1.05; 95% CI = 0.74 to
1.36), but reduced bleeding risk with direct oral anticoagulants compared to warfarin (RR 0.81; 95% CI = 0.75 to 0.88).

 

Early time courses of recurrent thromboembolism and bleeding during apixaban or enoxaparin/warfarin therapy – sub-analysis of the AMPLIFY trial

Thrombosis and Haemostasis

Analysis of data from this RCT (n=5,395) comparing apixaban to enoxaparin followed by warfarin for treating venous thromboembolism showed
apixaban to be non-inferior at 7, 21, 90 days and 6 months and that the reduced bleeding risk with apixaban began early during treatment.

 

 

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

Primary Care Atrial Fibrillation Service: outcomes from consultant-led anticoagulation assessment clinics in the primary care setting in the UK

BMJ Open

Service was delivered in 56 GP practices. Eligible patients on anticoagulation improved from 77% to 95% (p<0.0001). Audit of 8 practices after 195 days showed 90% continued treatment; ~30–35 strokes/year may have been prevented in these previously under-treated high-risk patients.

 

Association between use of warfarin with common sulfonylureas and serious hypoglycemic events: retrospective cohort analysis

British Medical Journal

Study of 465,918 Medicare fee for service beneficiaries noted a substantial positive link between use of warfarin (WF) with glipizide/glimepiride and hospital admission/emergency department visits for hypoglycemia and related diagnoses, particularly in patients first starting WF.

 

The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation

European Heart Journal

In this report of a validation of a new risk-scoring tool to assess bleeding risk in patients with AF, it is claimed that the five-element ORBIT bleeding risk score had better ability to predict major bleeding than either HAS-BLED and ATRIA risk scoring tools.

 

A Multinational Trial of Prasugrel for Sickle Cell Vaso-Occlusive Events

New England Journal of Medicine

In this RCT, 341 patients with sickle cell anaemia (aged 2 – 17) were randomised to receive prasugrel or placebo. At the end of the trial no significant differences were seen in the primary end-point of vaso-occlusive crises (2.30 vs 2.77 per patient per year).

 

Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international, prospective, non-interventional study

The Lancet Haematology

In this real-life comparison of outcomes in patients receiving rivoroxaban (RV) (n=2619) or standard anticoagulation (n=2149) it was reported that although RV patients had a lower baseline risk, adjusted analyses show it to be a safe and effective alternative to standard treatment.

 

Oral antiplatelet agents – are they safe in breastfeeding?

UKMi

This updated medicines Q&A provides advice on the safety of oral antiplatelet agents in breastfeeding mothers.

 

Antithrombotic therapy in the elderly: expert position paper of the European Society of Cardiology Working Group on Thrombosis

European Heart Journal

This expert opinion paper reviews the evidence and benefit and risk balance for antithrombotic therapy in the older age group and makes recommendations for maximising benefits and minimising risks.

 

 

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

Heart failure and risk of venous thromboembolism: a systematic review and meta-analysis

The Lancet Haematology

Review of 71 studies found heart failure is a common independent risk factor for venous thromboembolism, with overall relative risk of 1.51 (1.36–1.68). Researchers suggest thromoboprophylaxis should be considered in clinical practice for high-risk patients.

 

Data on phase III ROCKET-AF trial of rivaroxaban to be reanalysed after discovery investigators used faulty point of care device (INRatio)

British Medical Journal

The device has been subject to recall following reports it could deliver INR results "clinically significantly lower" vs. laboratory INR method. This could have made rivaroxaban appear safer in terms of bleeding risk. European Medicines Agency has launched investigation.

 

What are the risks of using antiplatelet agents in combination with the Novel Oral Anticoagulants (NOACs) in patients with atrial fibrillation, and how should the potential risks be managed?

UKMi

This new Medicines Q&A examines the risks of using antiplatelet medicines in combination with oral anticoagulants and how these risks may be managed.

 

 

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

edoxaban (Lixiana) for the prevention of stroke and systemic embolism

Scottish Medicines Consortium

The SMC has accepted for use within NHS Scotland, edoxaban (Lixiana®) for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as CHF, hypertension, age ≥75 years, DM, prior stroke or TIA.

 

edoxaban (Lixiana) for the treatment of DVT and PE

Scottish Medicines Consortium

The Scottish Medicines Consortium has accepted for use within NHS Scotland, edoxaban (Lixiana®) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

 

FDA Drug Safety Communication: Review finds long-term treatment with clopidogrel does not change risk of death

US Food and Drug Administration

This review stated that long-term use (12 months or longer) of clopidogrel does not increase or decrease overall risk of death in patients with, or at risk for, heart disease. The evaluation also does not suggest that clopidogrel increases the risk of cancer or death from cancer.

 

 

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

Treatment strategies for coronary in-stent restenosis: systematic review and hierarchical Bayesian network meta-analysis of 24 randomised trials and 4880 patients

British Medical Journal

Compared with plain balloons, bare metal stents, brachytherapy, rotational atherectomy, and cutting balloons, drug coated balloons and drug eluting stents were linked to reduced risk of target lesion revascularisation, major adverse cardiac events, and reduced late lumen loss.

 

Effect of the REG1 anticoagulation system versus bivalirudin on outcomes after percutaneous coronary intervention (REGULATE-PCI): a randomised clinical trial

The Lancet

Trial was terminated early after enrolment of 3232 patients due to severe allergic reactions with reversible factor IXa inhibitor REG1, as currently formulated. Although statistical power was limited, there was no evidence REG1 reduced ischaemic events/bleeding vs. bivalirudin.

 

 

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

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