Items filtered by date: March 2021

Bleeding Risks With Aspirin Use for Primary Prevention in Adults: A Systematic Review for the U.S. Preventive Services Task Force

Annals of Internal Medicine

This systematic review concluded that consideration of the safety of primary prevention with aspirin requires an individualized assessment of aspirin's effects on bleeding risks and expected benefits because absolute bleeding risk may vary considerably by patient.

 

Aspirin for the Prevention of Cancer Incidence and Mortality: Systematic Evidence Reviews for the U.S. Preventive Services Task Force

Annals of Internal Medicine

In CVD primary and secondary prevention trials, aspirin reduced both 20-year colorectal cancer (CRC) mortality (n= 14033) and CRC incidence 10 to 19 years after initiation. (n=47464) (RR, 0.67 [CI, 0.52 to 0.86] and 0.60 [CI, 0.47 to 0.76], respectively).

 

Aspirin for the Primary Prevention of Cardiovascular Events: A Systematic Evidence Review for the U.S. Preventive Services Task Force

Annals of Internal Medicine

This updated systematic review (11 RCTs) found a beneficial effect of aspirin (including at doses of 100mg or less per day) in reducing nonfatal MI
(absolute risk reduction, 0.15 to 1.43 events per 1000 person-years). Older adults seem to achieve a greater relative MI benefit.

 

The ‘obesity paradox’ in atrial fibrillation: observations from the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial

European Heart Journal

This analysis (n=17913) found that in patients with AF treated with oral anticoagulants, higher BMI was associated with a lower risk of all-cause
mortality vs. normal BMI [overweight: HR 0.67 (95% CI 0.59–0.78); obese: HR 0.63 (95% CI 0.54–0.74), P < 0.0001].

 

Fresh frozen plasma versus prothrombin complex concentrate in patients with intracranial haemorrhage related to vitamin K antagonists (INCH): a randomised trial

The Lancet Neurology

Study (n=50) found proportion of patients with INR ≤1.2 within 3 hours of treatment initiation was achieved in 9 vs. 67% of patients given fresh frozen plasma and prothrombin complex concentrate, respectively (p=0•0003). The trial was stopped because of safety concerns.

 

COMP recommends Alprolix (eftrenonacog alfa) maintains Orphan Designation for treatment of Haemophilia B in EU

Biospace Inc.

Alprolix® (eftrenonacog alfa), is a recombinant factor IX Fc fusion protein therapy for the treatment of haemophilia B. An application for marketing authorisation was submitted in EU in June 2015. The COMP's recommendation is now referred to the EC.

 

Should Patients With Atrial Fibrillation and 1 Stroke Risk Factor (CHA2DS2-VASc Score 1 in Men, 2 in Women) Be Anticoagulated? Yes: Even 1 Stroke Risk Factor Confers a Real Risk of Stroke

Circulation

This article compares the different stroke stratification schemes, highlighting interpretation difficulties and pitfalls as well as assessing the net benefit of stroke prophylactic treatment vs. alternative treatments.

 

Stroke prevention in atrial fibrillation in patients with Chronic Kidney Disease (CKD)

Circulation

This article presents a case of a 68 year old woman with hypertension, diabetes and congestive heart failure presenting with palpitations. It assesses stroke risk and looks at different options for anticoagulation in CKD.

 

 

 

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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Ischaemic risk and efficacy of ticagrelor in relation to time from P2Y12 inhibitor withdrawal in patients with prior myocardial infarction: insights from PEGASUS-TIMI 54

European Heart Journal

The benefit of ticagrelor for long-term secondary prevention in patients with prior MI and ≥1 additional risk factor appeared more marked in patients continuing on or re-starting after only a brief interruption of P2Y12 inhibitors, compared with patients off them for > 1 year.

 

The novel biomarker-based ABC (age, biomarkers, clinical history)-bleeding risk score for patients with atrial fibrillation: a derivation and validation study

The Lancet

The ABC-bleeding score, using age, history of bleeding, and three biomarkers (haemoglobin, cTn-hs, and GDF-15 or cystatin C/CKD-EPI) score performed better than HAS-BLED and ORBIT scores in patients with AF on anticoagulants from the ARISTOTLE and RE-LY trials.

 

Indiscriminate Testing for Heparin-Induced Thrombocytopenia: A Teachable Moment

JAMA Internal Medicine

This case report illustrates the ramifications of overtesting, and advises that it is crucial to consider other causes of thrombocytopenia and determine pretest probability to guide management whenever heparin-induced thrombocytopenia is suspected.

 

 

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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Effect of prior clopidogrel use on outcomes in medically managed acute coronary syndrome patients

Heart

Compared with medically managed patients newly started on clopidogrel (CP) in TRILOGY ACS trial, patients previously on CP had a higher risk of CV events. There were no differences in outcomes as stratified by prior CP use by randomised treatment assignment (prasugrel or CP).

 

Duration of Dual Antiplatelet Therapy: A Systematic Review for the 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease

Circulation

Review of 11 RCTs (n=33,051 who received predominantly newer-generation drug eluting stents) found moderately strong evidence that prolonged dual antiplatelet therapy entails a trade-off between reductions in stent thrombosis and MI and increases in major haemorrhage.

 

 

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 duration of anticoagulation with edoxaban in patients with venous thromboembolism: a post-hoc analysis of the Hokusai-VTE study

The Lancet Haematology

Analysis suggests extended treatment with edoxaban (ED) is as effective as warfarin (WF) [incidence recurrent venous thromboembolism between 3 and 12 months = 0·3% (11 of 3633) with ED and 0.4% (14 of 3594) with WF; HR 0.78, 95% CI 0.36–1.72] and linked to less major bleeding.

 

Astra Zeneza announces that ticagrelor fails to meet primary efficacy endpoint in SOCRATES trial

PharmaTimes

The drug failed on the primary efficacy endpoint of increasing the time to first occurrence of stroke (ischaemic or haemorrhagic), myocardial infarction or death vs aspirin in patients who have experienced an acute ischaemic stroke or transient ischaemic attack.

 

Positive results in first six months for anticoagulant hospital referral service

Pharmaceutical Services Negotiating Committee

Since launch (6 months) 138 patients have been referred to Swindon and Wiltshire Local Pharmaceutical Committee anticoagulant referral service with Great Western Hospital. This report highlights the positive outcomes experienced.

 

 

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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Safer Prescribing — A Trial of Education, Informatics, and Financial Incentives

New England Journal of Medicine

Trial in 34 Scottish practices found a complex intervention combining professional education, informatics, and financial incentives reduced rate of high-risk prescribing of antiplatelets and NSAIDs (OR 0.63; 95% CI, 0.57 to 0.68; p<0.001) and may have improved clinical outcomes.

 

Reimagining anticoagulation clinics in the era of direct oral anticoagulants

Circulation: Cardiovascular Quality and Outcomes

Review outline 3 key purposes that a reimagined clinic would serve: assist patients/clinicians with selecting most appropriate drug/dose, help patients minimise risk of serious bleeding with careful long-term monitoring/peri-procedural management, and encourage ongoing adherence.

 

Non-vitamin K antagonist oral anticoagulants (NOACs) for the management of venous thromboembolism

Heart

This review aims to provide the reader with an understanding of the importance of venous thrombosis in cardiovascular medicine, the mode of action of different oral anticoagulants, and the uses, risks and benefits of each non-vitamin K antagonist oral anticoagulant.

 

Cardiovascular safety of non-aspirin non-steroidal anti-inflammatory drugs: review and position paper by the working group for Cardiovascular Pharmacotherapy of the European Society of Cardiology

European Heart Journal

This review summarises the current evidence from randomised and observational studies on the cardiovascular safety of non-aspirin NSAIDs and presents a position for their use.

 

Risk of Cerebral Venous Thrombosis (CVT) in Obese Women

JAMA Neurology

This case-control study (185 cases, 6134 controls) found an increased risk of CVT among obese women (OR, 2.63, 95% CI, 1.53-4.54).The risk is 30-fold higher in obese women using oral contraceptives (OCs) compared with normal-weight women not using OCs.

 

The Use of Oral Anticoagulants for Stroke Prevention in Atrial Fibrillation Patients with History of Intra-Cranial Hemorrhage

Circulation

This review of people with atrial fibrillation and prior Intra-Cranial Haemorrhage (ICH), found that the NNT (warfarin vs anti-platelet) for preventing 1 ischaemic stroke was lower than NNH for 1 ICH if CHA2DS2-VASc≥6 (37vs56). NNT was higher than NNH if CHA2DS2-VASc<6 (63vs53).

 

 

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 in coronary intervention

European Heart Journal

This review article summarises the current status of anticoagulation for percutaneous coronary intervention and the results of most recent trials and gives recommendations for different clinical scenarios.

 

Antithrombotic therapy in medically managed patients with non-ST-segment elevation acute coronary syndromes

Heart

This review article covers the mechanism of action and roles of antithrombotic therapy in non-ST-segment elevation acute coronary syndromes. Treatments covered are aspirin, clopidogrel, ticagrelor, vorapaxar, unfractionated heparin, low-molecular-weight heparins and fondaparinux.

 

Coagulation Factor IX (recombinant) albumin fusion protein (albutrepenonacog alfa), for haemophila B approved for use in US

US Food and Drug Administration

This has been approved in the US, for use in children and adults, following two trials of patients aged 1-61 years. It was shown to be effective in controlling bleeding episodes and managing perioperative bleeding.

 

 

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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Effect of oral factor Xa inhibitor and low-molecular-weight heparin on surgical complications following total hip arthroplasty

Thrombosis and Haemostasis

This study (n=351) found no significant differences between rivaroxaban (RV) and enoxaparin (EN) in surgical wound complications, with similar rates of venous thromboembolic (VTE) events. Only wound oozing continued longer in RV/EN than in placebo group for patients <60 years.

 

Outcomes and costs of left atrial appendage closure from randomized controlled trial and real-world experience relative to oral anticoagulation

European Heart Journal
Treatment with this device can reduce risk of stroke, major bleeding, and death vs. other therapeutic strategies, which may offset additional upfront costs of device. Benefits are most apparent in those with higher baseline thromboembolic risk or unsuitable for anticoagulation.

 

Is the HAS-BLED score useful in predicting post-extraction bleeding in patients taking warfarin? A retrospective cohort study

BMJ Open

Japanese study of 258 cases (462 teeth) who had undergone tooth extraction (TE) whilst on warfarin found HAS-BLED score alone could not predict post TE bleeding. Concomitant use of antiplatelets was a risk factor. No episodes of bleeding required more than local measures.

 

New product: Octaplex (blood coagulation factors IX, II, VII, and X) 1000IU

electronic Medicines Compendium

This is licensed for treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex coagulation factors (CFs), and in congenital deficiency of vitamin K dependent CFs II and X when purified specific CF product is not available.

 

New product: Exembol (argatroban) Multidose 100 mg/ml concentrate for solution for infusion

electronic Medicines Compendium

Exembol is licensed as anticoagulation in adults with heparin-induced thrombocytopenia type II who need parenteral antithrombotic therapy. Diagnosis should be confirmed by heparin induced platelet activation assay or equivalent. However, such confirmation must not delay treatment.

 

NIHR Signal: Extending anticoagulant treatment beyond three months reduces the risk of recurrent blood clots

National Institute for Health Research Signal

This commentary discussing a systematic review of 7 studies (n=6778), which found that warfarin, NOACs and aspirin all significantly reduced the rate of recurrent clots in patients treated for >3 months, notes a non-significant trend towards major bleeding with active vs. placebo.

 

Compression Stockings for Preventing the Postthrombotic Syndrome in Patients with Deep Vein Thrombosis

American Journal of Medicine

This meta-analysis of 5 RCTs (n=1418) suggests no effect of elastic compression stockings on postthrombotic syndrome. Effects however remain uncertain as results differed substantially, and there was significant heterogeneity between trials.

 

 

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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European CHMP issues positive opinion on granting marketing authorisation for eftrenonacog alfa (Alprolix)

European Medicines Agency

Eftrenonacog alfa, an antihaemorrhagic, blood coagulation factor IX, is intended for the treatment and prophylaxis of bleeding in patients with haemophilia B. It will be available as 250 IU, 500 IU, 1000 IU, 2000 IU and 3000 IU powder and solvent for solution for injection.

 

European CHMP starts review on medicines containing dienogest 2mg and ethinylestradiol 0.03mg used for acne

European Medicines Agency

The review has been requested by MHRA because of concerns that benefits of these agents have not been sufficiently demonstrated in treatment of acne. MHRA was also concerned about venous thromboembolism risk, which has not been sufficiently characterised for this combination.

 

Non-vitamin K antagonist oral anticoagulants (NOACs) (KTT16)

National Institute for Health and Care Excellence

This document summarises the evidence-base on NOACs. It is a key therapeutic topic which has been identified to support medicines optimisation. It is not formal NICE guidance.

 

Stopping vs. Continuing Aspirin before Coronary Artery Surgery

New England Journal of Medicine

RCT (n=2100) found that administration of preoperative aspirin resulted in neither a lower risk of death or thrombotic complications (occurred in 202 [19.3%] on aspirin and 215 [20.4%] placebo) nor a higher risk of major haemorrhage leading to reoperation (1.8% vs. 2.1% placebo).

 

Improving anticoagulation in patients with atrial fibrillation using the GRASP AF audit tool

West Hampshire CCG and Boehringer Ingelheim Ltd

This audit tool (developed by Boehringer Ingelheim and PRIMIS) was used to improve stroke prevention in patients with AF. The project specifically focussed on patients receiving antiplatelet monotherapy and no treatment despite being at high risk of stroke, based on NICE CG180.

 

FibCLOT (human fibrinogen) obtains first Marketing Authorisations in Europe

Biospace Inc.

EU marketing authorisations for this product to treat patients with a congenital fibrinogen deficiency have been granted in Germany, Denmark and Hungary. Thirteen more marketing authorisations are expected in Europe in the coming months.

 

 

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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The impact of atrial fibrillation type on the risk of thromboembolism, mortality, and bleeding: a systematic review and meta-analysis

European Heart Journal

Guidelines recommend decisions on oral anticoagulation be made independently of classification into paroxysmal AF (PAF) or non-PAF. This study suggests NPAF may be linked to increased risk of stroke and mortality vs. PAF, thus AF type may need to be considered.

 

Boehringer announces that idarucizumab (Praxbind®) is now available to be used commercially in England, Ireland and Wales

Biospace Inc.

According to Boehringer, the Health Technology Appraisal bodies in these countries agreed that idarucizumab, which specifically reverses anticoagulant effect of dabigatran, is eligible for full reimbursment without the need for a full appraisal.

 

The past and future of haemophilia: diagnosis, treatments, and its complications

The Lancet

In this seminar, the authors provide an overview of the diagnosis of haemophilia and describe the clinical manifestations and treatment (both on-demand and prophylactic). Inhibitor formation as a complication of replacement therapy and its treatment is also discussed.

 

Rivaroxaban compared with standard thromboprophylaxis after major orthopaedic surgery: co-medication interactions

British Journal of Clinical Pharmacology

This retrospective analysis (n=17,701) found that major bleeding events were more common with NSAID use (vs non-use) in both standard of care (SOC) and rivaroxaban groups. NSAID use had no influence on thromboembolic events in either SOC or rivaroxaban groups.

 

Biologics License Application for andexanet alfa to reverse anticoagulant activity of direct and indirect Factor Xa inhibitors accepted for review by FDA

Biospace Inc.

Andexanet alfa is being developing as an antidote for use in patients treated with a direct or indirect Factor Xa inhibitor when reversal of anticoagulation is needed, such as in life-threatening or uncontrolled bleeding or for emergency surgery and urgent 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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Long-term antiplatelet therapy following myocardial infarction: implications of PEGASUS-TIMI 54

European Heart Journal

This review on dual antiplatelet therapy (DAPT) discusses the implications of the PEGASUS-TIMI 54 study which showed that patients with a history of ACS and at high risk of further ischaemic events, may benefit from prolonged ticagrelor-based DAPT.

 

Oral direct thrombin inhibitors or oral factor Xa inhibitors for the treatment of pulmonary embolism

Cochrane Database of Systematic Reviews

Moderate to high quality evidence suggests that there are no differences between these agents and standard anticoagulation for long-term treatment of PE for the outcomes recurrent PE, recurrent venous thromboembolism, DVT, all-cause mortality and major bleeding.

 

 

 

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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