Items filtered by date: September 2020

Drug-disease and drug-drug interactions: systematic examination of recommendations in 12 UK national clinical guidelines

British Medical Journal

This research finds guideline recommendations often don't consider potential drug-drug or -disease interactions that may be present if patients have co-morbidities. The authors call for guideline developers to more explicitly account for multimorbidity in their recommendations.

 

Revised SPC: Plavix™ (clopidogrel) tablets

Annals of Emergency Medicine

Section 4.8 has been updated to include two new undesirable effects - acute generalised exanthematous pustulosis (very rare) and gynaecomastia (rare).

 

Apixaban (Eliquis)

Scottish Medicines Consortium

The SMC has accepted apixaban (Eliquis) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults.

 

 

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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Treatment for preventing bleeding in people with haemophilia or other congenital bleeding disorders undergoing surgery

Cochrane Database of Systematic Reviews

There is insufficient evidence from randomised controlled trials to assess the most effective and safe haemostatic treatment to prevent bleeding in people with haemophilia or other congenital bleeding disorders undergoing surgical procedures.

 

Diagnosis of atrial fibrillation after stroke and transient ischaemic attack: a systematic review and meta-analysis

The Lancet Neurology

By sequentially combining cardiac monitoring methods, AF might be newly detected in ~25% patients with CVA/TIA. Proportion with CVA known to have AF seems higher than previously estimated, so more could be treated with oral anticoagulants and more CVA recurrences prevented.

 

Vorapaxar approved for use in the EU for the reduction of atherothrombotic events in adults with a history of MI

European Medicines Agency

The European Medicines Agency has approved vorapaxar (Zontivity®) for use in combination with aspirin and, where appropriate, clopidogrel, for the reduction of atherothrombotic events in adult patients with a history of myocardial infarction.

 

Efficacy of Antiplatelet Therapy in Secondary Prevention Following Lacunar Stroke: Pooled Analysis of Randomized Trials

JAMA Stroke

Analysis of data from 17 trials (n=42,234, follow up 4 wks-3.5 yrs) found that use of any single antiplatelet agent was linked to significant reduction in recurrence of any stroke (risk ratio 0.77, 0.62–0.97, 2 trials) and ischaemic stroke (0.48, 0.30–0.78, 2 trials) vs. placebo.

 

Digoxin use in patients with AF and adverse cardiovascular outcomes: a retrospective analysis of the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in AF

The Lancet

In 14,171 patients, digoxin (DG) was used at baseline in 5239 (37%). DG was linked to significant increase in all-cause mortality, vascular death, and sudden death in patients with AF. A randomised trial of DG in treatment of AF patients with and without heart failure is needed.

 

NICE issues Final Appraisal Determination on apixaban for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism

National Institute for Health and Care Excellence

DRAFT guidance supports use of apixaban, within its marketing authorisation, as an option for treating and for preventing recurrent deep vein thrombosis and pulmonary embolism in adults. Anticipated publication date of guidance is June 2015.

 

 

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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Impact of clinical presentation on ischaemic and bleeding outcomes in patients receiving 6- or 24-month duration of dual-antiplatelet therapy after stent implantation: a pre-specified analysis from the PRODIGY

European Heart Journal

This study(n=1970) suggests clinical presentation may be treatment modifier with respect to DAPT duration post stenting consistent with theory that stable CAD but not ACS-patients are exposed to significant increase in bleeding/net adverse clinical events with 24 vs. 6-month therapy.

 

6- Versus 24-Month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents in Patients Nonresistant to Aspirin : The Randomized, Multicenter ITALIC Trial

Journal of the American College of Cardiology

RCT in good aspirin responders which was prematurely terminated due to recruitment problems (n=941 on 24-month and 953 on 6-month DAPT), found that rates of bleeding and thrombotic events were not significantly different between the 2 groups after PCI with new-generation DES.

 

Four-factor prothrombin complex concentrate versus plasma for rapid vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions: a phase 3b, open-label, non-inferiority, randomised trial

The Lancet

RCT (n=181) found addition to vitamin K (VK) of single dose of four-factor prothrombin complex concentrate was non-inferior and superior to addition of plasma for rapid INR reversal and effective haemostasis in patients needing VK antagonist reversal pre-operatively.

 

Factor Xa inhibitor antidote andexanet alfa receives orphan drug designation in US

Biospace Inc.

Andexanet alfa is intended for reversing anticoagulant effect of direct or indirect factor Xa inhibitors in patients experiencing a serious uncontrolled bleeding event or who require urgent or emergent surgery. Currently, there is no approved antidote for these patients.

 

Alteplase versus tenecteplase for thrombolysis after ischaemic stroke (ATTEST): a phase 2, randomised, open-label, blinded endpoint study

The Lancet Neurology

This Scottish RCT in 104 (71 analysed) adults with supratentorial ischaemic stroke eligible for intravenous thrombolysis within 4.5 hours of onset found that neurological and radiological outcomes did not differ between the tenecteplase and alteplase groups.

 

Anticoagulant Reversal, Blood Pressure Levels, and Anticoagulant Resumption in Patients With Anticoagulation-Related Intracerebral Hemorrhage

Journal of the American Medical Association

This retrospective cohort study of patients with oral anticoagulant (OAC)-associated ICH found reversal (INR <1.3 within 4 hours) and systolic
BP <160mmHg at 4 hours were associated with reduced rates of haematoma enlargement, and OAC resumption reduced rates of ischaemic events.

 

Association of NSAID Use With Risk of Bleeding and Cardiovascular Events in Patients Receiving Antithrombotic Therapy After Myocardial Infarction

Journal of the American Medical Association

An analysis of Danish registry data (n=61,971) found that use of NSAIDs among adults receiving antithrombotic therapy after a first MI was associated with an increased risk of bleeding requiring hospitalisation (HR 2.02) and an excess of cardiovascular events (HR 1.40).

 

Venous Thromboembolism - Reducing the risk: addendum consultation

National Institute for Health and Care Excellence

NICE is currently updating its guidance on 'Venous thromboembolism - reducing the risk' following new evidence identified on intermittent pneumatic compression for preventing VTE in hospitalised stroke patients. New DRAFT recommendations have been published for consultation.

 

 

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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Vorapaxar in Patients With Diabetes and Prior MI: Findings from the TRA 2°P-TIMI 50 Trial

Circulation

In this subgroup analysis of patients with DM and recent MI (n=3,623), vorapaxar reduced the composite primary endpoint of CV death, MI, or stroke at 3 years (11.4% vs. 14.3%, HR 0.73, 95% CI 0.60-0.89; p=0.002) with a number needed to treat to avoid 1 major CV event of 29.

 

Edoxaban vs. warfarin in vitamin K antagonist experienced and naive patients with atrial fibrillation

European Heart Journal

In this subgroup analysis of patients with/without prior VKA exposure, higher-dose edoxaban reduced risk of stroke or systemic embolic events in patients who were VKA naive (HR 0.71, 95% CI 0.56–0.90) and was similar to warfarin in the VKA experienced (HR 1.01, 0.82–1.24; P=0.028.

 

Association Between the Use of Fondaparinux vs Low-Molecular-Weight Heparin and Clinical Outcomes in Patients With Non–ST-Segment Elevation Myocardial Infarction

Journal of the American Medical Association

Swedish registry data (40,616 consecutive patients with NSTEMI) identified that fondaparinux was associated with lower odds than LMWH of major bleeding events and death both in-hospital and up to 180 days afterwards. These data are consistent with trial data.

 

Comparative Risk of Ischemic Stroke Among Users of Clopidogrel Together With Individual Proton Pump Inhibitors

Stroke

PPIs evaluated in this study (esomeprazole, lansoprazole, omeprazole, rabeprazole) of 325,559 concomitant users of clopidogrel and a PPI, did not increase the rate of ischaemic stroke vs. pantoprazole, a PPI thought to be devoid of the potential to interact with clopidogrel.

 

Atrial fibrillation: quality standard consultation

National Institute for Health and Care Excellence

This quality standard for adults with atrial fibrillation (AF) is expected to contribute to improvements in rates of: mortality, stroke and transient ischaemic attack, admission with a primary diagnosis of AF, and quality of life.

 

 

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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Antiplatelet treatment compared with anticoagulation treatment for cervical artery dissection (CADISS): a randomised trial

The Lancet Neurology

Pilot study data (n=250) found no difference in efficacy of antiplatelet and anticoagulant drugs at preventing stroke and death in patients with symptomatic carotid and vertebral artery dissection. However, stroke events were rare in both groups.

 

Medicines Evidence Commentary: Medicines optimisation: identifying medicines associated with serious medication errors

National Institute for Health and Care Excellence

Discussion of a systematic review which has identified those medicines reported in the literature that most commonly cause serious adverse reactions because of medication errors.

 

EMA receives marketing authorisation application for eltrombopag to include children with chronic immune (idiopathic) thrombocytopenic purpura

Biospace Inc.

A variation in Marketing Authorisation has been submitted to the EMA for the use of eltrombopag (Revolade) for the treatment of children >1 year with chronic immune (idiopathic) thrombocytopenic purpura who have had an insufficient response to corticosteroids or immunoglobulins.

 

 

 

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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Medicines Evidence Commentary : Bleeding risk with apixaban in people with renal impairment: meta-analysis of randomised controlled trials

National Institute for Health and Care Excellence

Discussion of a systematic review and meta-analysis published in 2014 in the American Journal of Cardiology which explored whether apixaban is superior to conventional agents with regard to bleeding complications in the subset of people with renal failure.

 

The association between kidney function and major bleeding in older adults with atrial fibrillation starting warfarin treatment: population based observational study

British Medical Journal

Among 12, 403 older Canadian adults with AF who started warfarin, rates of major bleeding were significantly higher in those with lower eGFR, particularly during the first 30 days of treatment. The NNH was 22 during the first 30 days vs 206 in the remainder of the follow-up.

 

Revised SPC: Revolade (eltrombopag)

electronic Medicines Compendium

Section 4.8 (undesirable effects) has been updated based on the latest pooled analysis of adverse events/ adverse drug reactions for ITP-controlled trials.

 

Outcomes in Mild Acute Ischemic Stroke Treated With Intravenous Thrombolysis: A Retrospective Analysis of the Get With the Guidelines–Stroke Registry

JAMA Neurology

This retrospective analysis found that use of thrombolysis after mild stroke (poorly represented in thrombolytic trials) was associated with infrequent complications; however 30% could not ambulate independently at discharge and 29.4% could not go directly home.

 

Revised SPC: Pradaxa tablets (dabigatran etexilate mesilate) – all strengths

electronic Medicines Compendium

Sections 4.8 and 5.1 have been updated to include new safety and efficacy data.

 

 

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) – all strengths

electronic Medicines Compendium

A new paragraph on neuraxial (epidural/spinal) anaesthesia has been added to section 4.4 (all strengths), and new information on patients undergoing cardioversion has been added to sections 4.2 and 5.1 (15mg and 20mg strengths).

 

 

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 for acute coronary syndrome: final appraisal determination

National Institute for Health and Care Excellence

In DRAFTguidance, NICE supports use of rivaroxaban, in combination with aspirin plus clopidogrel or aspirin alone, for preventing atherothrombotic events in people who have had an ACS with elevated cardiac biomarkers. Bleeding risk should be assessed before treatment is started.

 

Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update 2014

Journal of Clinical Oncology

An evidence update which included a review of 53 publications, found that the 2014 recommendations are consistent with the 2013 recommendations.

 

Patient Safety Alert (stage one): Harm from using Low Molecular Weight Heparins when contraindicated

NHS England

Consideration of contraindications is a prominent feature of available local and national guidance for prescribing and administering LMWHs. This stage one Patient Safety Alert aims to reinforce the need for reliable systems to ensure that this always occurs.

 

Dabigatran and Rivaroxaban Use in Atrial Fibrillation Patients on Hemodialysis

Circulation

A US report found approx 5.9% of end-stage renal disease patients with AF are started on dabigatran or rivaroxaban despite the drugs being contraindicated in these patients; both were associated with a higher risk of hospitalisation or death from bleeding compared to 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

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Characterizing Major Bleeding in Patients With Nonvalvular Atrial Fibrillation: A Pharmacovigilance Study of 27 467 Patients Taking Rivaroxaban

Clinical Cardiology

In a large observational study of 27,467 patients on rivaroxaban, the major bleeding rate (496 events in 478 patients; incidence of 2.86 per 100 person-years) was generally consistent with the registration trial results, and fatal bleeds were rare (0.08 per 100 person-years).

 

Phase IV study of Factor Xa inhibitor antidote andexanet alfa initiated to support US accelerated approval

Biospace Inc.

A Phase IV study of the investigational Factor Xa inhibitor antidote andexanet alfa in patients receiving apixaban, rivaroxaban or enoxaparin who present with an acute major bleed has been initiated to support its approval by the FDA under an Accelerated Approval pathway.

 

Ultrasound enhanced catheter-directed thrombolysis for pulmonary embolism: consultation

National Institute for Health and Care Excellence

This DRAFT guidance states there is inadequate evidence of any enhancement of thrombolysis with ultrasound-enhanced, catheter-directed thrombolysis (CDT) over CDT alone for PE; it should only be used with special arrangements for clinical governance, consent and audit or research.

 

Is Prophylactic Anticoagulation for Deep Venous Thrombosis Common Practice After Intracerebral Hemorrhage?

Stroke

US analysis (n=32,690 with intracerebral haemorrhage) found <20% receive prophylactic anticoagulation for DVT during hospital stay, even though this is safe to do after cessation of haematoma growth, and when used, time to initiation is <2 days in less than half of 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

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Anticoagulation during pregnancy in women with prosthetic valves: evidence, guidelines and unanswered questions

Heart

Managementof this patient group remains difficult and controversial. There is no ideal anticoagulation regimen as there are inherent risks and benefits of each approach for both mother and foetus. There are limited data on optimal treatment strategy for an individual patient.

 

FDA approves licensing of edoxaban (Savaysa) tablets

US Food and Drug Administration

The FDA has approved edoxaban, a factor Xa inhibitor, to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

 

d-Dimer Testing to Select Patients With a First Unprovoked Venous Thromboembolism Who Can Stop Anticoagulant Therapy: A Cohort Study

Annals of Internal Medicine

This cohort study found a 6.7% per patient-year (PPY) risk for recurrent VTE in patients with a first unprovoked proximal DVT or PE who had a negative d-dimer test result during anticoagulant therapy and 1 month after withdrawal; the recurrence risk was higher in men (9.7% PPY).

 

Misperceptions of aspirin efficacy and safety may perpetuate anticoagulant underutilization in atrial fibrillation

European Heart Journal

The authors of this discussion conclude it may be necessary to exclude aspirin for stroke prevention in AF (without comorbid conditions requiring its use) from all AF guidelines, as done by NICE, to remove the 'soft option' of prescribing a drug that is neither effective nor safe.

 

 

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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