Items filtered by date: September 2017

Miconazole (Daktarin): over-the-counter oral gel contraindicated in patients taking warfarin

Medicines and Healthcare products Regulatory Agency

Patients taking warfarin should not use over-the-counter miconazole oral gel. If concomitant use is planned via prescription, the anticoagulant effect of warfarin should be monitored carefully. Patients who experience signs of bleeding should seek immediate medical attention.

 

Meta-Analysis of Safety and Efficacy of Uninterrupted Non–Vitamin K Antagonist Oral Anticoagulants Versus Vitamin K Antagonists for Catheter Ablation of Atrial Fibrillation

American Journal of Cardiology

Review of 13 studies (3 RCTs and 10 observational studies, total n=4,878) found no significant difference in the risk of major bleeding, systemic thromboembolism and symptomatic stroke/TIA, though the evidence was not of high quality.

 

Evolving landscape of stroke prevention in atrial fibrillation within the UK between 2012 and 2016: a cross-sectional analysis study using CPRD

BMJ Open

Cohort study showed an increasing proportions of patients with non-valvular AF receiving anticoagulant therapy (16.7% rise), together with similar reductions in antiplatelet (16.8% decrease). The proportion of patients not receiving antithrombotics remained the same (15%).

 

Effect of Genotype-Guided Warfarin Dosing on Clinical Events and Anticoagulation Control Among Patients Undergoing Hip or Knee Arthroplasty: The GIFT Randomized Clinical Trial

Journal of the American Medical Association

RCT (n=1,650) found that fewer patients in the geno-type guided group had a composite outcome event (major bleeding, INR>4, VTE or death) vs clinically guided warfarin (10.8% vs 14.7%, RR 0.73, 95% 0.56 to 0.95).

 

Phase III L-PLUS2 study investigating lusutrombopag for the treatment of thrombocytopenia in patient with chronic liver disease undergoing elective invasive procedures meets primary endpoint

Biospace Inc.

This study (n=215) reports that more patients on lusutrombopag vs placebo (64.8% vs 29.0%) met the primary efficacy endpoint (defined as proportion of patients who required no platelet transfusion prior to the invasive procedure) and no rescue therapy for bleeding post procedure.

 

Interhospital Transfer Prior to Thrombectomy is Associated with Delayed Treatment and Worse Outcome in the STRATIS Registry

Circulation

Median onset-to-revascularisation time was 202 minutes for direct presentation vs 311 minutes for interhospital transfer in 984 patients undergoing mechanical thrombectomy for severe stroke (p<0.001). Mortality did not differ and IV alteplase did not impact outcomes.

 

New Drug Application submission to FDA for avatrombopag, an oral second generation thrombopoietin receptor agonist

Biospace Inc.

The NDA was based on data from two Phase III trials, ADAPT-1 and ADAPT-2, that evaluated the efficacy and safety of avatrombopag for the treatment of severe thrombocytopenia (<50,000/μL) in patients with chronic liver disease who are scheduled to undergo a procedure.

 

Diagnosis and management of postpartum haemorrhage

British Medical Journal

Review notes this is second leading direct cause of maternal deaths in UK. It recommends tranexamic acid for all women with atonic and traumatic postpartum haemorrhage as well as for ongoing haemorrhage during a caesarean section.

 

National community pharmacy oral anticoagulant safety audit

Specialist Pharmacy Service

This audit will provide insight on patient awareness of key information about their anticoagulant, use of alert cards and compliance with monitoring requirements. Results will be used to inform a national update of patient held oral anticoagulant information and alert cards.

 

 

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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Screening for Occult Cancer in Patients With Unprovoked Venous Thromboembolism: A Systematic Review and Meta-analysis of Individual Patient Data

Annals of Internal Medicine

10 studies (n=2,316) found a 12 month prevalence of cancer after VTE of 5.2%. The point prevalence of cancer was higher in those with extensive screening vs limited screening initially (OR 2.0, 95% CI 1.2 to 3.4), but not at 12 months (OR 1.4, 95% CI 0.89 to 2.1).

 

Effects of Anticoagulants in Patients With Cirrhosis and Portal Vein Thrombosis: A Systematic Review and Meta-analysis

Gastroenterology

Review of 8 studies (n=353) found that more patients given anticoagulants underwent portal vein thrombosis recanalization vs no treatment (71% vs 42%, p<0.0001). There was no difference in major or minor bleeding in the 6 studies that reported this.

 

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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Bleeding-related hospital admissions and 30-day readmissions in patients with non-valvular atrial fibrillation treated with dabigatran versus warfarin

Journal of Thrombosis and Haemastasis

Dabigatran vs warfarin, was associated with comparable incidence of first hospital admission (incidence rate ratio, 0.92; 95% CI, 0.66-1.28) but higher risk of 30-day readmission with respect to bleeding (adjusted HR, 2.87; 95%CI, 1.10-7.43) in 51,946 Hong Kong patients with AF.

 

The management of antiplatelet therapy in acute coronary syndrome patients with thrombocytopenia: a clinical conundrum

European Heart Journal

In the absence of clinical guidance, this review discusses the evidence and proposes management strategies for antiplatelet therapy in patients with acute coronary syndrome and thrombocytopenia.

 

Rivaroxaban vs Warfarin Sodium in the Ultra-Early Period After Atrial Fibrillation–Related Mild Ischemic Stroke A Randomized Clinical Trial

JAMA Neurology

This RCT (n=195) reports in patients with mild acute ischaemic stroke and AF, new ischaemic lesions or intracranial haemorrhage (noted on MRI imaging) after 4 weeks occurred in 49.5% of patients receiving rivaroxaban v 54.5% receiving warfarin (nonsignificant difference, p=0.49).

 

Long-term mortality and prehospital tirofiban treatment in patients with ST elevation myocardial infarction

Heart
Subgroup analysis of the On-TIME 2 trial (n=984) found that baseline N-terminal pro-B-type natriuretic peptide level predicted long-term mortality. In those with high levels, early prehospital treatment with tirofiban significantly reduced 30-day and 1-year mortality vs placebo.

 

Factor VIII medicines: no clear and consistent evidence of difference in risk of inhibitor development between classes

European Medicines Agency

The European Medicines Agency has concluded there is no clear evidence of a difference in risk of inhibitor development between recombinant factor VIII medicines and those derived from plasma. The risk of inhibitor development should be evaluated individually for each medicine.

 

 

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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Pharmacovigilance Risk Assessment Committee (PRAC) confirms its previous conclusion on risk of inhibitor development with factor VIII medicines

European Medicines Agency

The PRAC has confirmed its previous conclusion that there is no clear and consistent evidence of a difference in the incidence of inhibitor development between the two classes of factor VIII medicines: plasma-derived and made with recombinant DNA technology.

 

 

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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Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): a randomised, open-label, multicentre trial

The Lancet

Guided de-escalation of antiplatelet therapy (one week prasugrel then one week clopidogrel, followed by maintenance treatment dictated by platelet function testing) was non-inferior to 12 months prasugrel for net clinical benefit at one year (7% v 9%; HR 0.81; 95% CI 0.62-1.06]).

 

Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation

New England Journal of Medicine

In patients with AF who had undergone PCI (n= 2725), dabigatran (110 mg or 150 mg bd) plus P2Y12 inhibitor (clopidogrel or ticagrelor) resulted in risk of major or clinically relevant non-major bleeding events that was significantly lower than risk with warfarin triple therapy.

 

Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease

New England Journal of Medicine

In patients with stable atherosclerotic vascular disease (n=27,395), rivaroxaban (2.5 mg bd) plus aspirin led to better CV outcomes but more major bleeding events vs aspirin. Rivaroxaban (5 mg bd) did not result in better CV outcomes vs aspirin and more major bleeding events.

 

A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial

The Lancet

Educational intervention (providers and patients, with regular monitoring and feedback), aimed to improve use of oral anticoagulation in patients with AF, resulted in an increase in patients treated with oral anticoagulants (68% to 80%) vs usual care (64% to 67%).

 

Bivalirudin versus Heparin Monotherapy in Myocardial Infarction

New England Journal of Medicine

This Swedish registry-based study (n=6006) reports among patients undergoing PCI for MI, the rate of the composite of death from any cause, MI, or major bleeding was similar among those who received bivalirudin vs heparin monotherapy (12.3% vs 12.8%, HR 0.96; p=0.54).

 

 

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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