Items filtered by date: August 2017

FDA grants priority review to licensing application for haemophilia drug emicizumab

Reuters Health

Roche said submission is based on positive data from phase 3 study in adolescents/adults with haemophilia A with inhibitors (IHs) and interim phase III results in children. It said ~30% patients develop IHs limiting treatment options and increasing risk of life-threatening bleeds.

 

NIHR Signal: Drug reduces deaths from bleeding after childbirth

National Institute for Health Research Signal

Expert commentary is provided for an RCT (20,600 women with post-partum haemorrhage) which found that IV tranexamic acid reduced the risk of death from bleeding vs placebo. The challenge is to promptly implement the early use of tranexamic acid into best practice.

 

Predicting major bleeding in patients with noncardioembolic stroke on antiplatelets. S2TOP-BLEED

Neurology

A prediction model for major bleeding in patients with a TIA or ischaemic stroke on antiplatelets was developed following review of data from 6 RCTs. Authors claim that the S2TOP-BLEED score had a reasonable external validation but slightly underestimated the major bleeding risk.

 

 

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

Resubmission of licence application for andexanet alfa accepted by the FDA

Biospace Inc.

The resubmission contains supplementary information that had been requested by the FDA. Andexanet alfa is a factor Xa inhibitor reversal agent. In December 2016, following a market authorisation application. In the EU additional data from the manufacturers had also been requested.

 

Update on antithrombotic therapy after percutaneous coronary revascularisation

The Lancet

This article, the third in a Series of three about percutaneous coronary intervention, provides an update on antithrombotic therapy after percutaneous coronary revascularisation, discussing current available evidence and how to integrate these findings into clinical decisions.

 

 

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

Disease understanding in patients newly diagnosed with atrial fibrillation

Heart

Survey analysis (1,004 responses) found that about half of patients with new-onset atrial fibrillation understood the benefits of anticoagulation at the time of diagnosis and understanding improved over the first 6 months. Authors suggest a need for more ongoing patient education.

 

New product: Inhixa (enoxaparin biosimilar) solution for injection in prefilled syringe

electronic Medicines compendium

Inhixa (first enoxaparin biosimilar launched in the UK) is licensed for the same indications as Clexane® and is available in the following strengths: 2,000 IU (20mg) in 0.2mL, 4,000 IU (40mg) in 0.4mL, 6,000 IU (60mg) in 0.6mL, 8,000 IU (80mg) in 0.8mL, 10,000 IU (100mg) in 1mL.

 

Impact of design of coronary stents and length of dual antiplatelet therapies on ischaemic and bleeding events: a network meta-analysis of 64 randomized controlled trials and 102 735 patients

European Heart Journal

Rates of major adverse CV events were similar in all treatment arms, but some secondary outcomes varied by stent type. Prolonged dual antiplatelet therapy was linked to lower MI incidence in patients with an everolimus/zotarolimus-eluting stent but a higher bleeding rate.

 

 

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

Tenecteplase versus alteplase for management of acute ischaemic stroke (NOR-TEST): a phase 3, randomised, open-label, blinded endpoint trial

The Lancet Neurology

In patients with acute stroke, achievement of an excellent functional outcome (modified Rankin Scale score 0–1) at 3 months was similar for tenecteplase (64%) and alteplase (63%). Further trials are needed to establish whether tenecteplase is non-inferior to alteplase.

 

Non-vitamin-K antagonist oral anticoagulants (NOACs) for the prevention of stroke and systemic embolism in people with atrial fibrillation: commissioning support

Midlands Therapeutics Review and Advisory Committee

Commissioners should ensure robust processes/local initiatives are in place to identify patients with AF at increased risk of stroke, and a record made of decision whether or not to proceed with treatment. They should refer to NICE CG 180 and range of decision support tools.

 

Predictors of pre-procedural concentrations of direct oral anticoagulants: a prospective multicentre study

European Heart Journal

In trial of 422 DOAC-treated patients requiring invasive procedure, last dose of DOAC 3 days before procedure resulted in minimal pre-procedural anticoagulant effect for almost all patients. Moderate renal impairment and antiarrhythmics should result in longer DOAC interruption.

 

Drug Trial Snapshots: Bevyxxa (betrixaban)

US Food and Drug Administration

This Drug Trials Snapshot is intended as a tool for consumers to use when discussing risks/benefits of betrixaban for the prevention of venous thromboembolism (VTE) in hospitalised adults at risk for developing VTE. The FDA approval was based on evidence from one clinical trial.

 

Mechanical versus bioprosthetic aortic valve replacement

European Heart Journal

Review notes main reason to opt for bioprosthesis is to avoid lifelong anticoagulation (AC) which has resulted in increase in use of bioprosthetic as opposed to mechanical valves. Currently, there is not enough evidence to support routine AC after bioprosthetic valve implantation.

 

Direct Healthcare Professional Communication: Clexane (enoxaparin sodium): Updates to strength expression, dose regimens in DVT/PE, use in patients with severe renal impairment

Sanofi UK

Product information has been harmonised in EU. Strength will now be expressed both in IU of anti-Xa activity and in mg. Treatment dose for DVT/PE has been clarified. Use in end stage renal disease (creatinine clearance <15 ml/min) is not recommended outside haemodialysis setting.

 

Shortage of enoxaparin injection: alternative treatment options

Specialist Pharmacy Service

In light of current shortage of enoxaparin injection (all strengths), a table of licensed low molecular weight heparins has been drawn up to compare/contrast key prescribing parameters and a section on DOACs included to highlight where they could be used in certain settings.

 

Antiphospholipid syndrome and pregnancy: Pathogenesis to translation

Arthritis & Rheumatology

Antiphospholipid syndrome (APS) is an autoimmune condition linked with thrombosis and adverse pregnancy outcomes. Review discusses abnormal placental development, prediction of adverse pregnancy outcomes in APS and SLE, and potential targets to prevent obstetric APS.

 

Subarachnoid Hemorrhage

New England Journal of Medicine

Subarachnoid hemorrhage without preceding trauma is caused by rupture of an intracranial aneurysm in 80% of cases. This review discusses signs /symptoms, evaluation, medical interventions to reduce risk of rupture, treatment of ruptured cerebral aneurysms and of complications.

 

Duration of Dual Antiplatelet Therapy in Patients with an Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

American Journal of Medicine

Meta-analysis of 8 trials (n=12,917) found no significant difference in CV mortality/MI/major bleeding between shortterm and 12-month/extended dual antiplatelet therapy (eDAPT).However, 12-month DAPT showed significantly higher risk of MI but reduced major bleeding risk vs. eDAPT.

 

 

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