Items filtered by date: January 2020

Revised SPC: Xarelto (rivaroxaban) tablets

electronic Medicines compendium

SPC now advises that rivaroxaban should not be used for thromboprophylaxis in patients having recently undergone transcatheter aortic valve replacement as the safety and efficacy have not been studied in this population.

 

Educational Risk Minimisation Materials to help reduce the risk associated with the use of combined hormonal contraceptives (CHCs)

Bayer

Bayer has published a checklist for prescribers, a Q&A on important information for women and a summary of important information about risk of blood clots with combined hormonal contraceptives, for all Bayer CHC products.

 

 

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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Clinical Effectiveness of Direct Oral Anticoagulants vs Warfarin in Older Patients With Atrial Fibrillation and Ischemic Stroke: Findings From the Patient-Centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER) Study

JAMA Neurology

Data from 11,662 patients discharged after stroke shows those on DOACs (v warfarin) had fewer deaths (HR 0.88, P<0.001), all-cause readmissions (0.93; P=0.003), CV readmissions (0.92, P=0.02), haemorrhagic strokes (0.69, P=0.02), and hospitalisation with bleeding (0.89, P=0.009).

 

Long term risk of symptomatic recurrent venous thromboembolism after discontinuation of anticoagulant treatment for first unprovoked venous thromboembolism event: systematic review and meta-analysis

British Medical Journal

Review (18 studies;n=7515) found in patients with 1st episode unprovoked VTE who completed ≥3 months anticoagulation, risk of recurrent VTE was 10% in 1st year after treatment, 16% at 2 years, 25% at 5 years, and 36% at 10 years, with 4% of recurrent VTE events resulting in death.

 

 

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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Continuous Anticoagulation and Cold Snare Polypectomy Versus Heparin Bridging and Hot Snare Polypectomy in Patients on Anticoagulants With Subcentimeter Polyps: A Randomized Controlled Trial

Annals of Internal Medicine

This RCT (n=184) suggests small colorectal polyps may be resected safely with cold-snare polypectomy while oral anticoagulation continues, compared to heparin bridging with hot-snare polypectomy, and was associated with a lower incidence of major bleeding.

 

Benefits and Harms of Oral Anticoagulant Therapy in Chronic Kidney Disease: A Systematic Review and Meta-analysis

Annals of Internal Medicine

Review of 45 RCTs (n=34,082) concludes in early-stage CKD, non–vitamin K oral anticoagulants (NOACs) had benefit–risk profile superior to that of vitamin K antagonists (VKAs). For advanced CKD or ESKD, there was insufficient evidence to establish benefits or harms of VKAs v NOACs.

 

Rivaroxaban (Xarelto▼): reminder that 15 mg and 20 mg tablets should be taken with food

Medicines and Healthcare products Regulatory Agency

MHRA has received a small number of reports suggesting lack of efficacy (thromboembolic events) in patients taking 15 mg or 20 mg rivaroxaban on an empty stomach. Healthcare professional are advised to remind patients to take 15 mg or 20 mg rivaroxaban tablets with food.

 

Direct Acting Oral Anticoagulants (DOACs) in Renal Impairment: Practice Guide to Dosing Issues

Specialist Pharmacy Service

This paper explains the background to dosing decisions for DOACs in patients with impaired renal function and focusses on the use of DOACs in patients with AF. It provides case study examples from current clinical practice and is intended as a practice aid.

 

 

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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Optimal route for administering tranexamic acid in primary unilateral total hip arthroplasty: Results from a multicenter cohort study

British Journal of Clinical Pharmacology

Data collection from 7,667 total hip arthroplasties found that IV, topical, and combined tranexamic acid all showed a significantly lower incidence of DVT than controls (0.08% vs 0.47%, p=0.001) as well as a lower rate of other complications (0.34% vs 0.67%, p=0.044).

 

Atrial fibrillation groups lobby patients to overturn screening committee decision

British Medical Journal

Article reports that patients' groups with funding from drug companies with vested interests are putting pressure on the National Screening Committee to overturn its decision not to recommend an AF screening programme. Doctors are concerned the campaign goes against the evidence.

 

Revised SPC: Eliquis (apixaban) film-coated tablets

electronic Medicines compendium

The SPC has been updated to include information about dosing in patients undergoing interventions (e.g. catheter ablation) for non-valvular 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

 

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Association Between Warfarin Control Metrics and Atrial Fibrillation Outcomes in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation

JAMA Cardiology

In this cohort study of 10,137 patients with atrial fibrillation, historical INR variance was associated with future bleeding events, but not with future stroke risk, suggesting caution when using historical INR to assess likelihood of bleeding or thrombotic events.

 

Antithrombotic doses: clinical observations from published clinical trials

British Journal of Clinical Pharmacology

This review discusses uncertainties around optimal doses of antithrombotic agents e.g. data from RCTs show aspirin is effective at doses below 75 mg daily and direct oral anticoagulants reduce risk of stroke in AF patients at doses 1/4 of those currently recommended.

 

Duration of dual antiplatelet therapy after percutaneous coronary intervention with drug-eluting stent: systematic review and network meta-analysis

British Medical Journal

Review found long vs short term (>12 vs <6 months) DAPT resulted in higher rates of major bleeding (OR 1.78, 95% CI 1.27 to 2.49) and non-cardiac death (1.63, 1.03 to 2.59); standard term (12 months) DAPT was associated with higher rates of any bleeding (1.39, 1.01 to 1.92).

 

A Practical Approach to Low-Dose Aspirin for Primary Prevention

Journal of the American Medical Association

This article discusses use of aspirin for primary prevention of atherosclerotic cardiovascular disease in the context of 3 large trials demonstrating bleeding risks comparable with benefits, and proposes a practical approach to initiate, continue, or discontinue aspirin.

 

 

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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Extended Anticoagulation for VTE: A Systematic Review and Meta-Analysis

Chest

Review of 16 studies (n=12,458) found DOACs linked to decrease in overall (risk ratio 0.48;95% CI;0.27-0.86;p=0.01) and VTE-related (0.36;0.15-0.89;p=0.03) mortality whereas VKAs were not. Both similarly prevented recurrent VTE but only VKAs linked to increased major bleeding risk.

 

Time Course for Benefit and Risk of Clopidogrel and Aspirin after Acute Transient Ischemic Attack and Minor Ischemic Stroke: A Secondary Analysis from the POINT Randomized Trial

Circulation

Secondary analysis of POINT (n=4,881) noted benefit of clopidogrel+aspirin occurs predominantly within first 21 days and outweighs low, but ongoing risk of major haemorrhage suggesting limiting use to 21 days may maximize benefit/reduce risk after TIA/minor ischaemic stroke.

 

Conference report: Increasing Dietary Vitamin K Intake Stabilizes Anticoagulation Therapy in Warfarin-Treated Patients with a History of Instability- A 24-week Randomized Controlled Trial

American Society for Nutrition

RCT (n=49) found increasing dietary vitamin K intakes resulted in greater proportion patients with %TTR ˃70% over assessment period. (50 % who increased intake by ≥150 µd/day through specific food choices met criteria vs. 19% control [general dietary information] group; p=0.026.

 

A systematic review of patient‐reported outcomes associated with the use of direct‐acting oral anticoagulants

British Journal of Clinical Pharmacology

Review of 21 studies reports patients appear to prefer treatment with DOACs vs warfarin, as shown by the higher quality of life, satisfaction and adherence described in the studies. However, heterogeneity in the analysed studies does not allow firm conclusions.

 

A comprehensive analysis of the effects of rivaroxaban on stroke or transient ischaemic attack in patients with heart failure, coronary artery disease, and sinus rhythm: the COMMANDER HF trial

European Heart Journal

In this post hoc analysis (n=5022), rivaroxaban significantly reduced the primary neurological endpoint of all-cause stroke or TIA compared with placebo by 32% (2.4% vs. 3.5%; 1.29 events vs. 1.90 events per 100 patient-years; HR 0.68; P = 0.02).

 

Effect of 1-Month Dual Antiplatelet Therapy Followed by Clopidogrel vs 12-Month Dual Antiplatelet Therapy on Cardiovascular and Bleeding Events in Patients Receiving PCI The STOPDAPT-2 Randomized Clinical Trial

Journal of the American Medical Association

This RCT (n=2974) reports 1-month DAPT was both noninferior and superior to 12-month DAPT for the primary end point, occurring in 2.36% with 1-month DAPT v 3.70% with 12-month DAPT (difference −1.34%; HR 0.64, meeting criteria for noninferiority (P<0.001) and superiority (P=0.04).

 

Effect of P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention The SMART-CHOICE Randomized Clinical Trial

Journal of the American Medical Association

In this RCT (n=2912) P2Y12 inhibitor monotherapy after 3-month duration of DAPT resulted in a noninferior rate of major cardiovascular events (all-cause death, MI, and stroke) vs prolonged DAPT at 12 months (2.9% vs 2.5%; difference 0.4%; P=0.007 for non-inferiority).

 

Revised SPC: Xarelto (rivaroxaban) film-coated tablets

electronic Medicines compendium

The SPC has been updated in line with PRAC recommendations to advise DOACs, including rivaroxaban, are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome, in particular for patients that are triple positive.

 

Coagulation Testing in Patients Taking Direct Oral Anticoagulants: A Teachable Moment

JAMA Internal Medicine

This Teachable Moment examines the case of a man taking a direct oral anticoagulant (DOAC) who received a high INR test result during a visit to the emergency department, and highlights that INR is an unreliable measure of therapeutic anticoagulation in patients taking DOACs.

 

 

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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Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome

Medicines and Healthcare products Regulatory Agency

MHRA advises that DOACs are not recommended in patients with antiphospholipid syndrome, particularly high-risk patients (those who test positive for all 3 antiphospholipid tests — lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2 glycoprotein I antibodies).

 

Safety and Efficacy of Antithrombotic Strategies in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention: A Network Meta-analysis of Randomized Controlled Trials

JAMA Cardiology

Review of 4 RCTs (n = 10 026) found DOAC plus P2Y12 inhibitor was linked to less bleeding vs. vitamin K antagonists + dual antiplatelets; strategies omitting aspirin caused less bleeding without significant difference in major adverse CV event vs. strategies including aspirin.

 

Warfarin dose requirement in patients having severe thrombosis or thrombophilia

British Journal of Clinical Pharmacology

Study (n=50) found that currently the most used pharmacogenetics dosing algorithms (IWPC and Gage) underestimate the warfarin dose required for effective anticoagulation in thrombogenic young (age <50 years) patients, particularly those who are at the highest thrombotic risk.

 

Revised SPC: Brilique (ticagrelor) tablets

electronic Medicines compendium

Thrombotic thrombocytopenic purpura has been added as a potential adverse effect of treatment (frequency unknown).

 

Ticagrelor Versus Clopidogrel in Patients With STEMI Treated With Fibrinolysis: TREAT Trial

Journal of the American College of Cardiology

Open-label RCT (n=3,799) found that ticagrelor did not significantly reduce the frequency of CV events vs clopidogrel when used after fibrinolytic therapy (combined outcome of CV mortality, MI or stroke = 6.7% vs 7.3% for ticagrelor vs clopidogrel, HR 0.93, 95% CI 0.73-1.18).

 

Oral anticoagulants in atrial fibrillation with valvular heart disease and bioprosthetic heart valves

European Heart Journal

Network meta-analysis (n=13,574) found that NOACs are superior, vs warfarin, in reducing stroke or systemic embolisation, MI and intracranial haemorrhage in AF and valvular heart disease. Analysis of 280 patients with AF and bioprosthetic heart valve showed similar outcomes.

 

 

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 SPCs: Eliquis (apixaban) film-coated tablets- all strengths

electronic Medicines compendium

SPCs highlight DOACs are not recommended for patients with history of thrombosis diagnosed with antiphospholipid syndrome, in particular, triple positive patients, where use of DOACs could be associated with increased rates of recurrent thrombotic events vs. vitamin K antagonists.

 

 

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 With or Without Aspirin in Patients with Heart Failure and Chronic Coronary or Peripheral Artery Disease: The COMPASS Trial

Circulation

Analysis of data from the COMPASS RCT (n=27,395) found that in heart failure patients specifically (5,902 patients), rivaroxaban plus aspirin was similarly superior to aspirin alone as per the overall trial population.

 

Evaluation of the Incidence of New-Onset Atrial Fibrillation After Aortic Valve Replacement

JAMA Internal Medicine

This population-based study reports new-onset AF was present in 50% of hospitalisations for transcatheter aortic valve implantation and aortic valve replacement. It advises shared patient-doctor decision making regarding potential need for anticoagulation after these 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:

http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services

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Efficacy and safety of direct oral factor Xa inhibitors compared with warfarin in patients with morbid obesity: a single-centre, retrospective analysis of chart data

The Lancet Haematology

Retrospective analysis of data evaluating safety and efficacy of direct oral anticoagulants and warfarin in 795 morbidly obese patients (BMI>40kg/m2) suggests concludes similar efficacy and safety of apixaban and rivaroxaban, compared to warfarin in patients with AF and VTE.

 

Randomized trial of ticagrelor vs. aspirin in patients after coronary artery bypass grafting: the TiCAB trial

European Heart Journal

Study (n=1,859) showed no significant difference in major cardiovascular events occurring in 9.7% ticagrelor patients vs. 8.2% aspirin patients [HR 1.19; 95% CI 0.87–1.62; p= 0.28]), or in major bleeding. RCT was terminated early & underpowered however due to recruitment issues.

 

 

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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