Items filtered by date: October 2020

Rituximab for treating inhibitors in people with inherited severe haemophilia

Cochrane Database of Systematic Reviews
This review did not identify any relevant randomised controlled trials. The research evidence available was limited to case reports and case series therefore no conclusions could be drawn on the efficacy and safety of rituximab for treating inhibitors in people with haemophilia.

 

Topline Phase III data of avatrombopag for treatment of chemotherapy-induced thrombocytopenia

Biospace Inc.
Though avatrombopag increased platelet counts relative to placebo, the study did not meet the composite primary endpoint of avoiding platelet transfusions, chemotherapy dose reductions by 15% or greater, and chemotherapy dose delays by four days or more.

 

Cessation of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation

Heart
In 'real world' cohort (n=1415), persistence of DOAC use was found to be high with only 8.8 cessations/100 patient-years follow-up and rate of serious adverse events rate was low at 1.6/100 patient-years; most common cause of cessation of index DOAC (53.1%) was patient choice.

 

Microbleeds and the Effect of Anticoagulation in Patients With Embolic Stroke of Undetermined Source: An Exploratory Analysis of the NAVIGATE ESUS Randomized Clinical Trial

JAMA Neurology
Analysis (n=3699) found those with cerebral microbleeds had higher rates of recurrent stroke, ischaemic stroke, intracerebral haemorrhage, and mortality during 11 months of follow-up, but this did not appear to influence the effects of rivaroxaban (15mg) on clinical outcomes.

 

Lifelong Aspirin for All in the Secondary Prevention of Chronic Coronary Syndrome: Still Sacrosanct or Is Reappraisal Warranted?

Circulation
This narrative review discusses recent trials that inform the current use of aspirin in the secondary prevention of chronic coronary syndrome (CCS), a new term for stable coronary artery disease defined in the 2019 European Society of Cardiology guidelines.

 

Revised SPC: Praxbind (idarucizumab) 2.5 g/50 mL solution for injection/infusion

electronic Medicines compendium
Section 5.1 has been updated with information on a paediatric patient (between 16-<18 years old) treated with idarucizumab during an open-label safety trial.

 

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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Warfarin and other anticoagulants – monitoring of patients during the COVID-19 pandemic

Medicines and Healthcare products Regulatory Agency
MHRA has published guidance following concerns over an apparent increase in the number of patients taking warfarin found to have elevated INR values during the pandemic; and reminds healthcare professionals and patients that continued close INR monitoring is crucial.

 

Stroke Thrombolysis With Tenecteplase to Reduce Emergency Department Spread of Coronavirus Disease 2019 and Shortages of Alteplase

JAMA Neurology
Viewpoint from US perspective notes the situation of an acute stroke emergency is a particularly vulnerable situation for exposure and transmission of COVID-19; it advocates for expanded usage of tenecteplase as means of avoiding spread and easing potential shortages of alteplase.

 

Effect of Pre-Hospital Crushed Prasugrel Tablets in Patients with STEMI Planned for Primary Percutaneous Coronary Intervention: The Randomized COMPARE CRUSH Trial

Circulation
RCT (n=727) found pre-hospital administration of loading dose of crushed prasugrel tablets does not improve TIMI 3 flow in infarct-related artery pre-PCI or complete ST-segment resolution 1h post-PCI vs. intact tablets, and there were no differences in ischaemic events at 30 days.

 

A perfect storm: Root cause analysis of supra-therapeutic anticoagulation with vitamin K antagonists during the COVID-19 pandemic

Thrombosis Research
Study of INR results show significant increase in high INRs during COVID-19 pandemic, with majority occurring after introduction of lockdown, with 30/3214 (0.9%) INR samples >8.0 (n=30) vs. 6/4079 (0.1%; n=6) during same period in previous year (OR 6.3, 95% CI, 2.6–15.2; p<0.001).

 

Warfarin in patients with mechanical heart valves

British Medical Journal
Practice article highlights these patients require lifelong anticoagulation with warfarin to prevent thromboembolism, low dose aspirin can be added in patients with higher risk of thromboembolic events, and DOACs are not currently recommended as safety has not been established.

 

Investigation into management of venous thromboembolism risk in patients following thrombolysis for an acute stroke

Healthcare Safety Investigation Branch
Follow review of a case of a 78-year old woman who suffered a pulmonary embolism whilst recovering from a stroke in hospital, this report makes a safety recommendation for a stroke specific venous thromboembolism assessment tool.

 

 

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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Multiple versus fewer antiplatelet agents for preventing early recurrence after ischaemic stroke or transient ischaemic attack

Cochrane Database of Systematic Reviews
This review (15 RCTs; n=17,091) concludes multiple antiplatelet drugs reduced risk of stroke recurrence (5.78% v 7.84%, RR 0.73, 95% CI 0.66-0.82; P<0.001) but increased risk of bleeding (e.g. extracranial haemorrhage 6.38% vs 2.81%, RR 2.25, 95% CI 1.88-2.70; P<0.001).

 

American Society of Hematology publishes draft guidelines on the use of anticoagulation in patients with COVID-19 for review

American Society of Hematology
The DRAFT guidelines, agreed by an international panel, suggest using prophylactic-intensity over intermediate-intensity or therapeutic-intensity anticoagulation in patients with COVID-19 related critical illness or acute illness who do not have suspected or confirmed VTE.

 

Antiphospholipid Antibodies in Critically Ill Patients With COVID‐19

Arthritis & Rheumatology

Study (n=66) found antiphospholipid antibodies (APSA) were common (47%) in patients in critical condition (CC) but were not present among those not in CC. APSA may be transient & disappear in few weeks, but in genetically predisposed, may trigger condition similar to APS syndrome.

Interventions commonly available during pandemics for heavy menstrual bleeding: an overview of Cochrane Reviews

Cochrane Database of Systematic Reviews
Review (44 RCTs, n=3196) found moderate‐certainty evidence that shows antifibrinolytics & combined hormonal contraceptives reduce heavy menstrual bleeding vs. placebo; and low‐certainty evidence that antifibrinolytics are more effective vs. NSAIDs/short‐cycle progestogens.

 

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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Dabigatran trough concentrations in very elderly patients

European Journal of Hospital Pharmacy
Observational study of 75 patients with atrial fibrillation, found trough concentrations were considerably higher in the highest age category. Dose-normalised medians were 0.66, 0.83 and 1.20 ng/mL/mg in the <75, 75–84 and ≥85 age groups, respectively (p=0.004).

 

NIHR Alert: Tranexamic acid should not be used for patients with severe gastrointestinal bleeding

National Institute for Health Research
Expert commentary is provided on the HALT-IT (Haemorrhage alleviation with tranexamic acid-Intestinal system) trial of more than 12,000 patients; which showed tranexamic acid does not improve outcomes but increases side effects for this group of patients compared to placebo.

 

Rivaroxaban and Aspirin in Patients With Symptomatic Lower Extremity Peripheral Artery Disease: A Subanalysis of the COMPASS Randomized Clinical Trial

JAMA Cardiology
Secondary analysis of RCT (n=4129) found risk of major vascular events was greater than 10% over 30 months for high risk patients and treatment with combination of rivaroxaban and aspirin vs aspirin alone resulted in estimated 4.2% absolute risk reduction for major vascular event.

 

 

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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Evaluating prophylactic heparin in ambulatory patients with solid tumours: a systematic review and individual participant data meta-analysis

The Lancet Haematology
Meta-analysis of individual participant data from 14 of 20 eligible RCTs (n=8278) found LMWH was associated with a lower VTE risk (adjusted RR 0.58; 95% CI 0.47-0.71), but there was no survival benefit. Risk of minor bleeding (1.34; 1.19-1.51), but not major, was increased.

 

NICE issues draft updated guideline on the management of atrial fibrillation

National Institute for Health and Care Excellence
This DRAFT guideline, which will update CG180 (published June 2014), will cover the diagnosis and management of AF in adults. It aims to ensure people receive the best care to help prevent complications, such as a stroke, and side effects of treatment, such as bleeding.

 

Low molecular weight heparin for prevention of central venous catheter‐related thrombosis in children

Cochrane Database of Systematic Reviews
Updated review identified 2 studies (n=1135) and noted they did not provide evidence to support this use; and studies did not report on the outcome of catheter occlusion, days of catheter patency, episodes of catheter‐related bloodstream infection and other side effects.

 

Effect of Clopidogrel and Aspirin vs Aspirin Alone on Migraine Headaches After Transcatheter Atrial Septal Defect Closure: One-Year Results of the CANOA Randomized Clinical Trial

JAMA Cardiology
In prespecified analysis of RCT (n=171), occurrence & severity of migraine attacks (MAs) decreased over time with low percentage of patients with MAs at 6-12-month follow-up; only 1% with new-onset MAs after cessation of clopidogrel at 3 months after atrial septal defect closure.

 

Vonicog alfa for the treatment and prevention of bleeding in adults with von Willebrand disease

NHS England
NHS England will commission vonicog alfa for the treatment and prevention of bleeding in adults with von Willebrand disease in accordance with the criteria outlined in these documents.

 

 

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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Haemorrhagic complications in patients with renal insufficiency during treatment or prophylaxis with dalteparin

European Journal of Hospital Pharmacy
Spanish retrospective cohort study reported higher risk of bleeding with dalteparin in patients with renal insufficiency (RI) vs those with normal renal function (n=367; 17.9% vs 7.3%) and identified RI (MDRD-4 (Modification of Diet in Renal Disease) <50 mL/min) as a risk factor.

 

What factors should be considered when using LMWH to treat venous thromboembolism in patients with high body weight?

Specialist Pharmacy Service
This Q&A offers guidance on what factors should be considered when calculating a LMWH treatment dose following a VTE in non-pregnant adult patients with a high body weight, defined as more than 120 kg.

 

Interventions for preventing venous thromboembolism in adults undergoing knee arthroscopy

Cochrane Database of Systematic Reviews
Updated review (8 studies;n= 3818) found there is a small risk that healthy adult patients undergoing knee arthroscopy will develop venous thromboembolism & there is moderate‐ to low‐certainty evidence of no benefit from use of LMWH, aspirin or rivaroxaban in reducing this risk.

 

Premature permanent discontinuation of apixaban or warfarin in patients with atrial fibrillation

Heart
Posthoc analysis of ARISTOTLE found premature permanent discontinuation of study drug was common, less frequent in patients on apixaban than warfarin and followed by high 30-day rates of death, TED &major bleeding, but no significant difference in clinical outcomes between groups.

 

Aspirin or heparin or both for improving pregnancy outcomes in women with persistent antiphospholipid antibodies and recurrent pregnancy loss

Cochrane Database of Systematic Reviews
This review (11 studies; n=1672) found the combination of heparin plus aspirin during the course of pregnancy may increase live birth rate in women with persistent antiphospholipid antibodies compared to aspirin treatment alone; safety is uncertain due to the lack of reporting.

 

 

 

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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EU review extended for marketing authorisation application for haemophilia A gene therapy Valrox (valoctocogene roxaparvove)

PharmaTimes
The company disclosed in a US Securities and Exchange Commission filing that European Medicines Agency has asked for full 52-week results from 134 patients taking part in ongoing phase III study and potential submission of data is anticiparted by end of first quarter of 2021.

 

Treatment of distal deep vein thrombosis

Cochrane Database of Systematic Reviews
Review of 8 RCTs (n=1,239) found evidence of benefit for anticoagulation therapy using vitamin K antagonists with little or no difference in major bleeding events although there was an increase in clinically relevant non‐major bleeding vs no intervention or placebo.

 

Effect of Out-of-Hospital Tranexamic Acid vs Placebo on 6-Month Functional Neurologic Outcomes in Patients With Moderate or Severe Traumatic Brain Injury

Journal of the American Medical Association
RCT (n=1,063) found that, among patients with moderate to severe traumatic brain injury, out-of-hospital tranexamic acid administration within 2 hours of injury vs placebo did not significantly improve 6-month neurologic outcome as measured by the Glasgow Outcome Scale.

 

Andexanet alfa (Ondexxya®) accepted for use within NHS Scotland on interim basis subject to ongoing evaluation and future reassessment

Scottish Medicines Consortium
Andexanet alfa intravenous infusion is approved for adult patients treated with a direct factor Xa inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

 

Low molecular weight heparin for prevention of microvascular occlusion in digital replantation

Cochrane Database of Systematic Reviews
In this updated review (4 RCTs, n=258) low to very low‐certainty evidence showed no benefit from low molecular weight compared to unfractionated heparin on success rates of replantation or affect microvascular insufficiency due to vessel occlusion.

 

Andexanet alfa for reversing anticoagulation from apixaban or rivaroxaban – second appraisal consultation

National Institute for Health and Care Excellence
In DRAFT guidance, NICE recommends andexanet alfa as an option for reversing anticoagulation from apixaban or rivaroxaban in adults with life-threatening or uncontrolled bleeding, only if the bleed is in the GI tract and it is provided according to the commercial arrangement.

 

 

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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Pulmonary Arterial Thrombosis in COVID-19 With Fatal Outcome: Results From a Prospective, Single-Center, Clinicopathologic Case Series

Annals of Internal Medicine
Study notes COVID-19 mainly involves lungs, causing diffuse alveolar damage and acute respiratory insufficiency. Autopsy findings (n=10) found death may be caused by thrombosis observed in segmental and subsegmental pulmonary arterial vessels despite prophylactic anticoagulation.

 

The Effect of Adding Ticagrelor to Standard Aspirin on Saphenous Vein Graft Patency in Patients Undergoing Coronary Artery Bypass Grafting (POPular CABG): A Randomized, Double-Blind, Placebo-Controlled Trial

Circulation
In RCT (n=499≥1 saphenous vein graft [SVGs]), addition of ticagrelor to standard aspirin did not reduce SVG occlusion at one year after CABG (occlusion rate, ticagrelor group 10.5% vs. 9.1% placebo group; OR 1.29; 95% CI: 0.73 -2.30; p=0.38).

 

Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation

New England Journal of Medicine
RCT (n=665) found incidence of bleeding (15.1% vs. 26.6%; risk ratio, 0.57; 95% CI, 0.42-0.77; p=0.001) and composite of bleeding or thromboembolic events at 1 year were significantly less frequent with aspirin compared to aspirin plus clopidogrel administered for 3 months.

 

Low-Dose Edoxaban in Very Elderly Patients with Atrial Fibrillation

New England Journal of Medicine
RCT in 984 Japanese patients (aged ≥80 years) found once-daily 15mg dose of edoxaban superior to placebo in preventing stroke/systemic embolism (event rate 2.3% vs. 6.7%; HR 0.34; 95% CI 0.19 to 0.61;p<0.001), and did not result in significantly higher incidence of major bleeding.

 

Prasugrel-based de-escalation of dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (HOST-REDUCE-POLYTECH-ACS): an open-label, multicentre, non-inferiority randomised trial

The Lancet
RCT (n=2338; South Korea) found prasugrel-based dose de-escalation strategy from 1 month after PCI reduced risk of net adverse clinical outcomes (HR 0.70; 95% CI,0.52–0.92), up to 1 year, mainly driven by reduction in bleeding (0.48; 0.32–0.73), without increase in ischaemia.

 

2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation

European Heart Journal
Guidance covers diagnosis, risk assessment and outcomes, pharmacological & invasive treatments, MI with non-obstructive coronary arteries and alternative diagnoses, special populations, long-term management, quality measures, management strategy, key messages and gaps in evidence.

 

Comparison Between Ticagrelor and Clopidogrel in Elderly Patients with an Acute Coronary Syndrome: Insights from the SWEDEHEART Registry

Circulation
Secondary analysis of a study (n=14,005) found that, in those ≥80 years, the incidence of the primary ischaemic outcome was similar for ticagrelor and clopidogrel, but ticagrelor was associated with a 17% and 48% higher risk of death & bleeding, respectively.

 

Edoxaban in atrial fibrillation patients with percutaneous coronary intervention by acute or chronic coronary syndrome presentation: a pre-specified analysis of the ENTRUST-AF PCI trial

European Heart Journal
Analysis of the ENTRUST-AF PCI trial (n=1,506) found the difference in primary bleeding endpoint between edoxaban with P2Y12 inhibitor vs vitamin K antagonist with aspirin and P2Y12 inhibitor was nonsignificant, and consistent between acute and chronic coronary syndrome cohorts.

 

 

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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Perioperative oral eltrombopag versus intravenous immunoglobulin in patients with immune thrombocytopenia: a non-inferiority, multicentre, randomised trial

The Lancet Haematology

In this Canadian RCT (n=74) eltrombopag was non-inferior to IV immunoglobulin; with perioperative platelet targets achieved in 79% on eltrombopag and 61% on IV immunoglobulin (absolute risk difference 17.8%, p for non-inferiority=0.005). Eltrombopag was linked to 1 case of PE.

 

Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy

Cochrane Database of Systematic Reviews
Current evidence (34 RCTs; n=1960) does not support overall superiority of any anticoagulant. Compared to unfractionated heparin, citrate probably reduces major bleeding and probably has little or no effect on preventing clotting or death at 28 days. Further studies are required.

 

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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Management of Acute Pulmonary Embolism

Journal of the American Medical Association

This guidelines synopsis focuses on 2019 guidance from the European Society of Cardiology on diagnosis and management of acute pulmonary embolism, a common and potentially fatal disease with an estimated incidence of 0.7 to 1.4 per 1000 person-years.

Venous Thromboembolism Risk Assessment in Psychiatric Inpatients Audit

Sussex Partnership NHS Foundation Trust
The aim of this audit was to assess the use of VTE risk assessments and management of high-risk groups of psychiatric inpatients, and identify and implement ways in which VTE risk assessment can be carried out more systematically.

 

 

 

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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