FDA approves dabigatran etexilate oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism

US Food and Drug Administration
Approval is for oral pellets to treat children age 3 months to <12 years and for capsules to treat patients age ≥8 years, with VTE after parenteral anticoagulation for ≥5 days, and also for prevention of recurrent clots in those who have completed treatment for their first VTE.

Comparison of effectiveness and safety between ticagrelor and clopidogrel in patients with acute coronary syndrome and on dialysis in Taiwan

British Journal of Clinical Pharmacology
Study (n=2185) of dialysis patients with ACS found at 12 months, ticagrelor group had higher risk for major adverse CV event (aHR 1.29; 95% CI 1.16–1.44) and also higher risk of major bleeding event vs clopidogrel group (sHR 1.49; 95% CI 1.34–1.65).

Pulmonary embolism in patients with COVID-19: incidence, risk factors, clinical characteristics, and outcome

European Heart Journal
Spanish retrospective study identified 368 PE in 74,814 patients with COVID-19 attending A+E (~ 0.5%), the incidence of which is ~ninefold higher than in the general (non-COVID-19) population. It notes that mortality is higher in COVID-19 than in non-COVID-19 patients with PE.

Number needed to treat for net effect of anticoagulation in atrial fibrillation: Real-World vs. Clinical Trial Evidence

British Journal of Clinical Pharmacology
Post-hoc analysis demonstrated potential clinical applicability of the NNT for net benefit approach; the Calculator of Absolute Stroke Risk was used to show that the NNTnet of anticoagulation therapy at 1-year was 34 in a real-world cohort and 46 in a clinical trial population.

Ticagrelor or Prasugrel for Patients With Acute Coronary Syndrome Treated With Percutaneous Coronary Intervention: A Prespecified Subgroup Analysis of a Randomized Clinical Trial

JAMA Cardiology
Analysis (n=3024) found incidence of primary composite end point (all-cause death, MI or stroke) at 12 months occurred less frequently in prasugrel vs. ticagrelor group (120 [7.1%] vs 162 [9.8%], respectively; HR 1.41; 95% CI, 1.11-1.78; p= 0.005); bleeding events were comparable.

XIENCE stent receives FDA approval for use of only one-month dual antiplatelet therapy (DAPT) in (HBR) high bleeding risk patients

Biospace Inc.
Patients who receive stents are typically on DAPT for 6 to 12 months but may cause bleeding in HBR patients. According to Abbott, the XIENCE 28 and XIENCE 904 studies showed that DAPT can be safely discontinued early (as short as 28 days) with no increased risk in adverse events.

Cerebral Venous Thrombosis

New England Journal of Medicine
This review covers diagnosis, based on clinical and imaging features, and treatments that have become available since the subject was last reviewed, in light of current interest, due to rare cases associated with certain of the Covid-19 vaccines.

DTB select: Aspirin and gastrointestinal bleeding risk in older people

Drug and Therapeutics Bulletin
Summary and context is provided for an analysis of data from the ASPREE study, which found the 5-year risk of a gastrointestinal bleed in older people taking low-dose aspirin (100mg) ranged from 0.40% in those aged 70 years to 5% in those aged 80 years with multiple risk factors.

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