Items filtered by date: August 2019

Safety of Proton Pump Inhibitors Based on a Large, Multi-Year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin

Gastroenterology

RCT (n=17,598 followed up for median 3.01 years, with 53,152 patient-years of follow-up) found no statistically significant difference between pantoprazole and placebo groups in safety events except for enteric infections (1.4% vs 1.0% placebo group; OR 1.33; 95% CI, 1.01–1.75).

 

Increasing number of patients prescribed risky anticoagulant drug combinations

Pharmaceutical Journal

Statistics from the Medication Safety Dashboard show that between Sept 18 and Nov 18, there were more than 14,000 patients in England prescribed an NSAID with an anticoagulant and more than 30,000 patients prescribed an antiplatelet and anticoagulant without gastro-protection.

 

 

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

Published in News

Venous thromboembolism prophylaxis strategies for people undergoing elective total knee replacement: a systematic review and network meta-analysis

The Lancet Haematology

Review (25 RCTs) found that vs no prophylaxis, rivaroxaban was most effective for prevention of DVT (RR 0.12; 95% CI 0.06–0.22). LMWH, vs no prophylaxis was found to be more effective for pulmonary embolism and best for major bleeding but these findings are highly uncertain.

 

Emicizumab as prophylaxis in people with severe congenital haemophilia A without factor VIII inhibitors (all ages)

NHS England

NHS England will commission emicizumab as prophylaxis in adults and children with severe congenital haemophilia A (defined as factor VIII level <1 IU/dL, or <1% of normal) without current inhibitors to prevent bleeding episodes.

 

Catheter Ablation for Atrial Fibrillation in 2019

Journal of the American Medical Association

This article reviews management approaches to atrial fibrillation (AF), including assessment of the need for anticoagulation, and controversies over the need for rhythm control and the role of catheter ablation for maintaining sinus rhythm and reducing AF-associated symptoms.

 

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

RCT (n=184) found patients on continuous anticoagulants +cold snare polypectomy (CSP;without electrocautery) did not have increased incidence of polypectomy-related major bleeding, and procedure time and hospitalisation were shorter vs. periprocedural heparin bridging plus hot SP.

 

Effect of Recombinant Activated Coagulation Factor VII on Hemorrhage Expansion Among Patients With Spot Sign–Positive Acute Intracerebral Hemorrhage: The SPOTLIGHT and STOP-IT Randomized Clinical Trials

JAMA Neurology

RCTs included 69 patients and found that recombinant activated coagulation factor VII did not significantly improve radiographic or clinical outcomes vs. placebo among patients with spot sign–positive intracerebral haemorrhage treated a median of ~3 hours from stroke onset.

 

Outcomes Associated With Clopidogrel-Aspirin Use in Minor Stroke or Transient Ischemic Attack: A Pooled Analysis of Clopidogrel in High-Risk Patients With Acute Non-Disabling Cerebrovascular Events (CHANCE) and Platelet-Oriented Inhibition in New TIA and

JAMA Neurology

Analysis of POINT and CHANCE trials (n=10,051) found clopidogrel-aspirin treatment reduced risk of major ischaemic events at 90 days vs. aspirin, that appeared to be confined to the first 21 days (5.2% vs 7.8%; HR 0.66; 95% CI, 0.56-0.77; p <0 .001), but not from day 22 to day 90.

 

Prevention of Stroke in Atrial Fibrillation After Coronary Stenting: Systematic Review and Network Meta-Analysis

Stroke

Review of 3 RCTs and 15 observational studies (total n=23,478) found that DOACs were associated with less major bleeding and major cardiovascular adverse effects, but vitamin K antagonists were associated with decreased mortality and stroke.

 

 

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

Published in News

Bodyweight-adjusted rivaroxaban for children with venous thromboembolism (EINSTEIN-Jr): results from three multicentre, single-arm, phase 2 studies

The Lancet Haematology

Study (93 children) found that bodyweight adjusted rivaroxaban appears to be safe in children (no major bleeds, 4% rate of non-major bleed and no recurrent VTEs). Doses for <20kg showed low exposure, so the dosages for this group will be adjusted for the phase 3 study.

 

A Meta-Analysis of Aspirin for the Primary Prevention of Cardiovascular Diseases in the Context of Contemporary Preventive Strategies

American Journal of Medicine

Analysis of 14 RCTs(n=164,751) found aspirin decreases MI risk at expense of increased risks for major bleeding (BD) and haemorrhagic stroke. With contemporary aggressive preventive strategies, effect on MI risk seems to be much attenuated whereas its harmful effects on BD remain.

 

NIHR Signal: On balance, antiplatelet drugs may be restarted for stroke survivors who have bled into the brain

National Institute for Health Research

Expert commentary is provided of UK trial of 537 adults (RESTART) on antiplatelets before intracerebral haemorrhage, which found no material difference in risk of further bleeding or occlusive vascular event if they restarted on the drugs when feasible.

 

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

 

Published in News

NIHR Signal: Reminders to assess clotting risk increase the use of preventive measures

National Institute for Health Research

Expert commentary is provided for a review of 13 RCTs (n=35,997) which found that alert based interventions increased the proportion of patients who received mechanical or drug prophylaxis vs standard care. Unfortunately, trial data are lacking on multifaceted interventions.

 

Long-term antithrombotic therapy and risk of intracranial haemorrhage from cerebral cavernous malformations: a population-based cohort study, systematic review, and meta-analysis

The Lancet Neurology

Scottish cohort study (n=300) found antithrombotic therapy linked to lower risk of subsequent intracranial haemorrhage (ICH) or focal neurological deficit. Meta-analysis of 6 cohort studies (n=1342) also noted lower ICH risk (3 vs. 14%; IRR 0.25; 95% CI,0.13–0.51;p<0.0001).

 

Meta-Analysis of Oral Anticoagulant Monotherapy as an Antithrombotic Strategy in Patients With Stable Coronary Artery Disease and Nonvalvular Atrial Fibrillation

American Journal of Cardiology

Analysis of 6 trials (n=8855) found no significant difference in major adverse CV event in patients on oral anticoagulant (OAC) plus single antiplatelet therapy (SAPT) vs. OAC monotherapy. OAC plus SAPT was linked to higher risk of major bleeding (HR 1.61; 95% CI 1.38-1.87).

 

Perioperative Management of Patients With Atrial Fibrillation Receiving a Direct Oral Anticoagulant

JAMA Internal Medicine

Cohort study (n=3007) followed up post-operatively for 30 days suggests DOAC therapy interruption without heparin bridging or coagulation function testing before elective surgery were associated with low rates of major bleeding (<2%) and arterial thromboembolism.

 

Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer: ASCO Clinical Practice Guideline Update

Journal of Clinical Oncology

This updated guideline now recommends thromboprophylaxis with apixaban, rivaroxaban, or low molecular weight heparin to selected high-risk outpatients with cancer, whilst rivaroxaban and edoxaban have been added as options for VTE treatment.

 

Thromboembolic events around the time of cardioversion for atrial fibrillation in patients receiving antiplatelet treatment in the ACTIVE trials

European Heart Journal

Study (n=962) found that thromboembolic risk increased in 30 days before cardioversion and persisted until 30 days post-cardioversion (0.47% and 0.96%, respectively; HR 2.2, 95% CI 0.7–7.1). Authors suggest that this increased risk may not be entirely causal.

 

 

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

 

Published in News

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

Published in News