Preventability of serious thromboembolic and bleeding events related to the use of oral anticoagulants: a prospective study

British Journal of Clinical Pharmacology

Analysis of data from 46 DOAC and 43 VKA patients admitted with a thrombotic or bleeding event shows that 53% of DOAC‐ and 61% of VKA‐related serious ADRs were deemed potentially preventable, with prescribing issues and inadequate monitoring the most pertinent causative factors.

US FDA grants “Breakthrough Therapy Designation” for emicizumab (Hemlibra) for hemophilia A without factor VIII inhibitors

Biospace Inc.

The designation was based on results from the Phase III HAVEN 3 clinical trial, in which patients received the drug subcutaneously. Those receiving the drug showed a reduction in treated bleeds compared to the group that did not receive prophylactic treatment.

US FDA approves fostamatinib disodium hexahydrate for thrombocytopenia in adults with chronic immune thrombocytopenia

PharmaTimes

The approval for use is in patients who have failed to respond to previous treatment. Fostamatinib is a Spleen tyrosine kinase (Syk) inhibitor, currently in phase III development in the EU.

US FDA approves Vonvendi (von Willebrand factors) for perioperative management of bleeding in adults with von Willebrand disease

PharmaTimes

The therapy was initially approved in the US for on-demand treatment and control of bleeding episodes, and is the first and only recombinant treatment for adults living with von Willebrand disease, the most common inherited bleeding disorder.

Direct oral anticoagulants versus warfarin for preventing stroke and systemic embolic events among atrial fibrillation patients with chronic kidney disease

Cochrane Database of Systematic Reviews

This review (5 studies; n=12,545) concludes that DOAC are as likely as warfarin to prevent all strokes and systemic embolic events without increasing risk of major bleeding events among AF patients with kidney impairment. The results chiefly apply to CKD stage G3 patients.

Safety and efficacy of dual vs. triple antithrombotic therapy in patients with atrial fibrillation following percutaneous coronary intervention: a systematic review and meta-analysis of randomized clinical trials

European Heart Journal

Review (4 RCTs; n=5137), found that dual antithrombotic therapy reduced TIMI major or minor bleeding by 47% vs triple therapy [4.3 vs. 9.0%; HR, 0.53) with comparable outcomes of major adverse cardiac events (10.4% vs. 10.0%; 0.85).

Anticoagulation for the initial treatment of venous thromboembolism in people with cancer

Cochrane Database of Systematic Reviews

This review (15 RCTs; n=1615) concludes LMWH likely decreases 3-month mortality compared to UFH (risk difference: 57 fewer per 1000; 95% CI 101 fewer to 17 more; moderate evidence). The choice should balance benefits and harms and consider the person's values and preferences.

Prognostic Significance of Nuisance Bleeding in Anticoagulated Patients with Atrial Fibrillation

Circulation

This analysis of registry data (n=6771) found documented minor bleeding was common (20%) but not associated with a statistically significantly increased risk of major bleeding or stroke/systemic embolism, suggesting occurrence should not lead to changes in treatment strategy.

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