Impact of P-glycoprotein and/or CYP3A4-interacting drugs on effectiveness and safety of NOACs in patients with atrial fibrillation: a meta-analysis

British Journal of Clinical Pharmacology
Review (15 studies) found in AF patients treated with NOACs, concomitant use of P-gp/CYP3A4 inhibitors was associated with higher risk of major bleeding (RR 1.10, 95% CI 1.01-1.19) and all-cause mortality (1.14, 95% CI 1.05-1.23); authors recommend close monitoring.

Risk factors associated with venous and arterial neonatal thrombosis in the intensive care unit: a multicentre case-control study

The Lancet Haematology
Study of 118,952 admissions to 31 neonatal intensive care units found bloodstream infection (OR 2.07), maternal diabetes (1.62), abdominal surgery (1.36) and thrombocytopenia (2.44) were the most significant risk factors for venous thrombosis (p<0.0001 for all).

Revised SPC: Clexane (enoxaparin)- all presentations

electronic Medicines compendium
SPC updated to warn acute generalised exanthematous pustulosis reported (unknown frequency); patients should be advised of signs/symptoms & monitored for skin reactions, enoxaparin should be withdrawn immediately & alternative treatment considered (as appropriate), if this occurs.

Association of Recent Use of Non–Vitamin K Antagonist Oral Anticoagulants With Intracranial Hemorrhage Among Patients With Acute Ischemic Stroke Treated With Alteplase

Journal of the American Medical Association
Retrospective study (n=163,038) found NOAC use within past 7 days was not associated with increased risk of intracranial haemorrhage among patients with acute ischaemic stroke treated with alteplase (3.7% vs 3.2% in those not taking NOACs; adjusted OR 0.88 [95% CI 0.70 to 1.10]).

Effect of Intra-arterial Alteplase vs Placebo Following Successful Thrombectomy on Functional Outcomes in Patients With Large Vessel Occlusion Acute Ischemic Stroke: The CHOICE Randomized Clinical Trial

Journal of the American Medical Association
Phase 2b trial (n=121) found use of intra-arterial alteplase following thrombectomy resulted in a greater likelihood of excellent neurological outcome (modified Rankin Scale score of 0 or 1) than placebo at 90 days (59.0% vs 40.4%; P=0.047); these findings require confirmation.

US FDA grants Fast Track Designation for asundexian for the secondary prevention in patients with non-cardioembolic ischaemic stroke

Biospace Inc.
Asundexian is an oral inhibitor of Factor Eleven (FXIa) that is also being developed for atrial fibrillation and recent myocardial infarction. It is currently in Phase II clinical trials in all three conditions either as monotherapy or in combination with antiplatelets.

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