Revised SPC: Pradaxa (dabigatran) capsules

electronic Medicines compendium

SPC now advises that concomitant administration with glecaprevir/pibrentasvir is contraindicated owing to increased risk of bleeding due to increased dabigatran levels. Also, alopecia has been added as a potential adverse effect of treatment (frequency unknown).

Meta-Analysis Comparing Double Versus Triple Antithrombotic Therapy in Patients With Atrial Fibrillation and Coronary Artery Disease

American Journal of Cardiology

Review of 9 studies (n=13,437) found no statistically significant difference in mortality, nonfatal myocardial infarction, stent thrombosis, and stroke between double and triple antithrombotic therapy (DATT and TATT). DATT had a lower rate of bleeding (RR 0.64, 95% CI 0.54-0.75).

Association of Ticagrelor vs Clopidogrel With Major Adverse Coronary Events in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

JAMA Internal Medicine

Cohort study (n=11,185) concludes ticagrelor was not associated with lower risk of major adverse coronary events (HR 0.97; 95% CI, 0.85-1.10); however, it was associated with an increased risk of major bleeding (1.51; 1.29-1.78) and dyspnoea vs clopidogrel (1.98; 1.47-2.65).

Effect of Osocimab in Preventing Venous Thromboembolism Among Patients Undergoing Knee Arthroplasty The FOXTROT Randomized Clinical Trial

Journal of the American Medical Association

RCT (n=813) reports postoperative osocimab 0.6mg/kg, 1.2mg/kg, and 1.8mg/kg met criteria for noninferiority vs enoxaparin, and the preoperative 1.8mg/kg dose of osocimab met criteria for superiority vs enoxaparin in incidence of VTE (primary outcome) at 10-13 days postoperatively.

Low molecular weight heparins – should prophylactic doses be used in patients with renal impairment?

Specialist Pharmacy Service

In contrast to unfractionated heparin, low molecular weight heparins are primarily cleared via kidney thus care needed in renal impairment (RI) because they can accumulate and increase bleeding Risk. Q&A reviews current literature on use of prophylactic doses in patients with RI.

Direct acting oral anticoagulants and alopecia: the valuable support of post marketing data

British Journal of Clinical Pharmacology

Analysis identified 1316 reports on VigiBase, most concerning rivaroxaban (58.8%). Overall, 80% of reports were related to females, in particular to those ≥65 years old (23.1%).Median time‐to‐onset was 28 days (IQR 63 days). In 54.3% of reports, causality was assessed as possible.

Efficacy and Safety of Nonvitamin K Oral Anticoagulants in Patients with Atrial Fibrillation and Cancer: A Study-Level Meta-Analysis

Thrombosis and Haemostasis

In analysis of 3 RCTs (n=2661), use of NOACs was linked to similar incidence of stroke/systemic embolism, ischaemic stroke, venous thromboembolism, all-cause death and major bleeding vs. vitamin K antagonists. Results were confirmed in secondary analysis (3 observational studies).

Ticagrelor hits primary endpoint in the THALES Phase III trial for use in stroke

PharmaTimes
In this study, the manufacturers report that ticagrelor 90 mg twice daily plus aspirin for 30 days showed a statistically significant and clinically meaningful reduction in the risk of stroke and death vs aspirin alone.

Committee for Medicinal Products for Human Use (CHMP) issues positive recommendation for new medicine treprostinil sodium (Trepulmix) for treatment of chronic thromboembolic pulmonary hypertension

European Medicines Agency
Treprostinil sodium is a prostacyclin analogue which has a direct vasodilatory effect on pulmonary and systemic arterial circulation, and inhibits platelet aggregation.

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

Patients With Atrial Fibrillation Taking Nonsteroidal Anti-Inflammatory Drugs and Oral Anticoagulants in the ARISTOTLE Trial

Circulation

Review of patients with incident NSAID use in the ARISTOTLE trial (n=2185) found that incident NSAID use was associated with an increased risk of major bleeding (HR 1.61, 95% CI 1.11-2.33) and relevant non-major bleeding (1.70, 1.16-2.48).

Decline in renal function and oral anticoagulation dose reduction among patients with atrial fibrillation

Heart

US-Registry shows among 4120 patients on DOACs, 154 (3.7%) patients had a CrCl decline sufficient to warrant FDA-recommended dose reductions and only 31 patients underwent dose reduction. Those without dose reduction experienced major bleeding 1.7% vs 0% at 1 year.

Apixaban and dalteparin in active malignancy‐associated venous thromboembolism: The ADAM VTE trial

Journal of Thrombosis and Haemastasis

RCT (n=300) found a lower rate of major bleeding and recurrent VTE with apixaban vs dalteparin (0% vs 1.4% and 0.7% vs 6.3%, p<0.05 for both). Rates of major bleeding or clinically relevant non-major bleeding were similar in the two groups (6%).

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