Friday, 25 May 2018 17:54

Anticoagulation news items. Week commencing 21st May 2018

Periprocedural Outcomes of Direct Oral Anticoagulants vs. Warfarin in Non-Valvular Atrial Fibrillation: A Meta-analysis of Phase III Trials

Circulation

Meta-analysis of sub-analysis of RE-LY, ROCKET AF, ARISTOTLE, and ENGAGE AF trials found in short-term, safety/efficacy of DOACs and warfarin (WF) periprocedurally are not different. DOACs were linked to 38% lower risk of major bleeding vs. WF with uninterrupted anticoagulation.

 

Factor Xa inhibitors versus vitamin K antagonists for preventing cerebral or systemic embolism in patients with atrial fibrillation

Cochrane Database of Systematic Reviews

Review of 13 RCTs (n=67,688), most of which involved apixaban, edoxaban, rivaroxaban, found treatment with factor Xa inhibitors significantly reduced number of strokes and systemic embolic events vs. warfarin with AF; the absolute effect vs. warfarin was, however, rather small.

 

US FDA accepts supplemental biologics license application for prophylactic and paediatric use of Coagadex® (Coagulation Factor X, Human) for treatment of hereditary factor X deficiency

Biospace Inc.

Application relates to use in children under 12 years of age and is based on data from phase 3 prospective TEN02 study in children with moderate to severe deficiency. Coagadex is currently only licensed in UK for use in children over age of 12 years.

 

Data from Haven III and Haven IV trials suggest efficacy of emicizumab in haemophilia patients without factor VIII inhibitors

PharmaTimes

A 96% and 97% reduction in treated bleed were found in these studies respectively vs no prophylaxis. Emicizumab is currently licensed for routine prophylaxis of bleeding episodes in patients with haemophilia A with factor VIII inhibitors.

 

US FDA approves avatrombopag (Doptelet) for treatment of thrombocytopenia in patients with chronic liver scheduled to undergo a medical or dental procedure

Biospace Inc.

This thrombopoietin receptor agonist has been evaluated in ADAPT-1 /ADAPT-2 trials (n=435) which reported higher proportion of patients had increased platelet (PL) counts and did not require PL transfusion/rescue therapy on day of -and up to 7 days after procedure vs. placebo.

 

Use of Venous Thromboembolism Prophylaxis in Hospitalized Patients

JAMA Internal Medicine

Analysis (n=44,775 in 52 Michigan hospitals) noted anticoagulant (AC) use among low-risk patients (18 584 [57.1%]) was most important contributor to excess use of VTE prophylaxis. Excess use of mechanical VTE prophylaxis was common among both low-and high risk patients.

 

Effectiveness and Safety of Apixaban, Dabigatran, and Rivaroxaban Versus Warfarin in Frail Patients With Nonvalvular Atrial Fibrillation

Journal of the American Heart Association

At 2 yrs, database study (n=19077) found no difference in stroke or systemic embolism (SE) with apixaban or dabigatran (HR=0.78 % 0.94) or major bleeding (0.72 & 0.87) vs warfarin. Rivaroxaban reduced stroke or SE (0.68) without altering major bleeding risk (1.07) vs warfarin.

 

Revised SPC: Brilique (ticagrelor) – all formulations

electronic Medicines compendium

SPC now states that delayed and decreased exposure to oral P2Y12 inhibitors, including ticagrelor (TG) and active metabolite, has been observed in patients with ACS on morphine (35% reduction in TG exposure). May apply to other opioids; clinical relevance unknown.

 

 

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