Items filtered by date: July 2015

Cangrelor for reducing atherothrombotic events in people undergoing percutaneous coronary intervention or awaiting surgery requiring interruption of anti platelet therapy (terminated appraisal) – technology appraisal guidance (TA351)

National Institute for Health and Care Excellence

NICE is unable to make a recommendation about the use in the NHS of cangrelor for reducing atherothrombotic events in people undergoing PCI or awaiting surgery requiring interruption of anti-platelet therapy because no evidence submission was received from The Medicines Company.

 

Genotype-guided drug prescribing: a systematic review and meta-analysis of randomized control trials

British Journal of Clinical Pharmacology

This meta-analysis of fifteen studies (n=5688; 19 drugs) reports a statistically significant benefit in favour of genotype-guided warfarin dosing to achieve time in therapeutic INR, resulting in reduction in warfarin-related minor and major bleeding and thromboembolisms.

 

Oral direct thrombin inhibitors or oral factor Xa inhibitors for the treatment of deep vein thrombosis

Cochrane Database of Systematic Reviews

Review of 11 RCTs (n=27,945) deemed to be of high methodological quality and low risk of bias found that NOACs may be an effective and safe alternative to conventional anticoagulation treatment for acute DVT.

 

Lixiana®▼(Edoxaban): risk minimisation resources

Daiichi Sankyo

Educational materials have been developed to help manage important risks such as bleeding associated with edoxaban (ED) use. Clinicians should familiarise themselves with these materials before prescribing ED and ensure all patients familiarise themselves with Patient Alert Card.

 

Primary prophylaxis for venous thromboembolism in patients undergoing cardiac or thoracic surgery

Cochrane Database of Systematic Reviews

There is limited evidence on efficacy and safety. Data for important outcomes such as PE or major bleeding were often lacking. Give uncertainties around benefit-to-risk balance, no conclusions can be drawn and case-by-case risk evaluation of VTE and bleeding remains preferable.

 

Comparison of the Short-Term Risk of Bleeding and Arterial Thromboembolic Events in Nonvalvular Atrial Fibrillation Patients Newly Treated With Dabigatran or Rivaroxaban versus Vitamin K Antagonists: A French Nationwide Propensity-Matched Cohort Study

Circulation

In this study of 19,713 vitamin K antagonists (VKA), 8,443 dabigatran and 4,651 rivaroxaban new users, no statistically significant difference in bleeding or thromboembolic risk was observed between newer oral anticoagulants users and VKA new users in non-valvular AF patients.

 

Independent expert review concludes alteplase is safe and effective for use within existing treatment guidelines

Medicines and Healthcare products Regulatory Agency

Following questions about the safety of alteplase, and the methodology used in trials assessing it, an expert working group of the UK's Commission on Human Medicines (CHM) has concluded that alteplase is safe and effective for use up to 4.5 hours after the onset of symptoms.

 

 

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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rivaroxaban (Xarelto®)

Scottish Medicines Consortium

The SMC does not recommend use of rivaroxaban (co-administered with aspirin ± clopidogrel or ticlopidine) within NHS Scotland for the prevention of atherothrombotic events in adults after an acute coronary syndrome with elevated cardiac biomarkers.

 

tinzaparin sodium (Innohep®)

Scottish Medicines Consortium

The SMC has accepted tinzaparin for use within NHS Scotland for the extended treatment of symptomatic VTE and prevention of its recurrence in patients with solid tumours. This advice takes account of the benefits of a Patient Access Scheme that improves its cost-effectiveness.

 

Peri-procedural management of patients taking oral anticoagulants

British Medical Journal

This review summarises the pharmacology of oral anticoagulants (OA) relevant to the peri-procedural period, and reported outcomes of peri-procedural management of oral anticoagulants used for therapeutic purposes.

 

Choice of Estimated Glomerular Filtration Rate Equation Impacts Drug-Dosing Recommendations and Risk Stratification in Patients With Chronic Kidney Disease Undergoing Percutaneous Coronary Interventions

Journal of the American College of Cardiology

This study, aimed at identifying which equation is superior in estimating GFR for predicting adverse outcomes after PCI, supports use of CKD-EPI equation for risk stratification and calls for standardisation in estimation of GFR for studies to improve dosage recommendations.

 

Deep vein thrombosis, pulmonary embolism (treatment, secondary prevention) - edoxaban tosylate: final appraisal determination

National Institute for Health and Care Excellence

In DRAFT guidance, NICE recommends edoxaban, within its marketing authorisation, as an option for treating and for preventing recurrent deep vein thrombosis and pulmonary embolism in adults.

 

Intracranial Hemorrhage After Ischemic Stroke: Incidence, Time Trends, and Predictors in a Swedish Nationwide Cohort of 196 765 Patients

Circulation: Cardiovascular Quality and Outcomes

Incidence of intracranial hemorrhage within 1-year after stroke was ≈2%/year at risk, about 15 times higher vs. reference population. Risk increased within first 30 days but decreased thereafter. Thrombolysis, but not increased use of antithrombotics/statins, affected risk.

 

Androgen Deprivation Therapy for Prostate Cancer and the Risk of Venous Thromboembolism

European Urology

Cohort study (n=21,729 of whom 609 hospitalised for VTE) found current (vs. non) use of androgen deprivation therapy was linked to 84% increased relative risk of VTE (incidence rates:10.1 vs 4.8/1000 person-years;HR:1.84;95% CI,1.50–2.26), whereas there was no link with past use.

 

Heparin-Induced Thrombocytopenia

New England Journal of Medicine

Treatment of acute heparin-induced thrombocytopenia (HIT) requires the cessation of heparin and initiation of therapeutic-dose anticoagulation with an alternative agent (argatroban, danaparoid, fondaparinux, or bivalirudin). Warfarin should be avoided in patients with acute HIT.

 

Risk of intracranial haemorrhage in antidepressant users with concurrent use of non-steroidal anti-inflammatory drugs: nationwide propensity score matched study

British Medical Journal

This analysis of a Korean nationwide health insurance database found combined use of antidepressants and NSAIDs was associated with an increased risk of intracranial haemorrhage within 30 days versus use of antidepressants without NSAIDs (hazard ratio 1.6, 95% CI 1.32 to 1.85).

 

Oral anticoagulants for stroke prevention in atrial fibrillation: current status, special situations, and unmet needs

The Lancet
This paper addresses the role of anticoagulation for stroke prevention in AF in the era of NOACs, with a focus on special situations including management in the event of bleeding and around the time of procedures including cardioversion, catheter ablation, and device implantation.

 

Pharmacology of antithrombotic drugs: an assessment of oral antiplatelet and anticoagulant treatments

The Lancet
This paper focuses on the pharmacological properties of the most commonly used oral antithrombotic drugs (aspirin, P2Y12 receptor antagonists, other targets, vitamin K antagonists, and non-VKA anticoagulants).

 

 

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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Revised SPC: Xarelto (rivaroxaban) 2.5 mg film-coated tablets

electronic Medicines Compendium

Additions include advice on how to reduce the potential bleeding risk associated with concurrent use of rivaroxaban and neuraxial anaesthesia or spinal puncture (section 4.4) and post-marketing adverse events of cholestasis, hepatitis and thrombocytopenia (section 4.8).

 

Six Months vs Extended Oral Anticoagulation After a First Episode of Pulmonary Embolism: The PADIS-PE Randomized Clinical Trial

Journal of the American Medical Association

This RCT of adults with a first unprovoked PE who had already received 6 months of warfarin found that extended treatment (further 18 months) reduced the composite outcome of recurrent VTE and major bleeding (3.3% v 13.5% placebo).

 

A practical guideline for the haematological management of major haemorrhage

British Journal of Haematology

This guideline provides recommendations for the haematological management of major haemorrhage in any clinical situation, with practical guidance on the content and delivery of major bleeding protocols, including the use of blood components and transfusion alternatives.

 

Atrial flutter and thromboembolic risk: a systematic review

Heart

This analysis of 52 studies (observational; no RCTs) confirms clinical thromboembolic events are highly prevalent in atrial flutter. The authors say thromboprophylaxis should strongly be considered in the presence of ≥1 additional stroke risk factors.

 

Antiplatelet therapy as a modulator of stroke aetiology: a meta-analysis

British Journal of Clinical Pharmacology

This meta-analysis (9 studies; n=5739) evaluating antiplatelet therapy (APT) on incidence of each subtype of stroke: large artery atherosclerosis (LAA), cardioembolic and small vessel occlusion concluded that APT preferentially reduces the incidence of LAA stroke.

 

Anticoagulant vs. antiplatelet therapy in patients with cryptogenic stroke and patent foramen ovale: an individual participant data meta-analysis

European Heart Journal

This meta-analysis of 804 patients on oral anticoagulants and 1581 patients on antiplatelets did not find a statistically significant difference between the two groups for stroke/TIA or death in patients being treated for cryptogenic stroke or patent foramen ovale.

 

The clinical effectiveness and cost-effectiveness of point-of-care tests (CoaguChek system, INRatio2 PT/INR monitor and ProTime Microcoagulation system) for the self-monitoring of the coagulation status of people receiving long-term vitamin K antagonists

National Institute for Health Research

An analysis of 26 RCTs found that compared with standard monitoring, self-monitoring appears to be safe and effective, especially for people with artificial heart valves.

 

FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes

US Food and Drug Administration

Following a comprehensive review of new safety information, the FDA is requiring updates to the drug labels of all prescription NSAIDs, to strengthen an existing label warning that NSAIDs increase the chance of a heart attack or stroke.

 

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

European Heart Journal

This paper discusses pharmacokinetic and pharmacodynamic variables influencing the efficacy and safety of drugs in elderly subjects and makes recommendations regarding use of oral and IV antiplatelets and anticoagulants and how to prevent and manage bleeding in the elderly.

 

 

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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New product: Edoxaban (Lixiana) 60mg Film-Coated Tablets

electronic Medicines Compendium

Licensed for prevention of stroke and systemic embolism in adults with non valvular AF with 1 or more risk factors such as CHF, HBP, age ≥ 75 years, DM, prior stroke or TIA, prevention of recurrent DVT/PE, and treatment of DVT/PE.

 

Revised SPC: Rivaroxaban (Xarelto) 10 and 20mg tablets

electronic Medicines Compendium

Advice on how to reduce the potential bleeding risk associated with concurrent use of rivaroxaban and neuraxial (epidural/spinal) anaesthesia or spinal puncture have been added. The following AEs are now listed: cholestasis, hepatitis and thrombocytopenia.

 

Cohort study of Anticoagulation Self-Monitoring (CASM): a prospective study of its effectiveness in the community

British Journal of General Practice

This UK cohort study of 296 adults self-monitoring their oral anticoagulation therapy (median 61 years; predominately professional or held a university qualification) found 90.2% were still self-monitoring after 12 months, with a mean time in therapeutic range of 75.3%.

 

How to Monitor Patients Receiving Direct Oral Anticoagulants for Stroke Prevention in Atrial Fibrillation: A Practice Tool

Annals of Internal Medicine

This tool advocates regular, standardised clinical monitoring of patients receiving novel oral anticoagulants. It consists of a checklist covering adherence assessment and counselling, bleeding risk assessment, creatinine clearance, drug interactions and examination (e.g. BP).

 

Socioeconomic Inequalities in the Prescription of Oral Anticoagulants in Stroke Patients With Atrial Fibrillation

Stroke

This analysis of the Swedish stroke register found the prescribing of anticoagulants after stroke in patients with AF varied according to age, income, education and country of birth. This was not explained by common risk factors suggesting socioeconomic inequalities.

 

 

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

Published in News