Revised SPC: Tildiem (diltiazem) – all formulations

electronic Medicines compendium

Following a recent update highlighting that diltiazem has been shown to inhibit platelet aggregation, the SPC now advises that concomitant administration with acetylsalicylates (e.g. aspirin) should be undertaken with caution.

Reasons for and consequences of oral anticoagulant underuse in atrial fibrillation with heart failure

Heart

Analysis of data from Swedish Heart Failure Registry noted of 21 865 patients, only 12 659 (58%) received oral anticoagulants (OACs). Reasons for not receiving OACs were not based on rational grounds and bleeding risk inappropriately affected decision-making more than stroke risk.

Association of Intracerebral Hemorrhage Among Patients Taking Non–Vitamin K Antagonist vs Vitamin K Antagonist Oral Anticoagulants With In-Hospital Mortality

Journal of the American Medical Association

Retrospective cohort study (n=141,311 with intracerebral haemorrhage) found prior use of NOACs/warfarin was linked to higher in-hospital mortality (IHM) vs. no oral anticoagulants. Prior use of NOACs (vs. warfarin) was linked to lower risk of IHM (OR, 0.75; 97.5% CI, 0.69-0.81).

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

Risk for Arterial and Venous Thrombosis in Patients With Myeloproliferative Neoplasms: A Population-Based Cohort Study

Annals of Internal Medicine

Cohort analysis(n=45,249) reports increased incidence of arterial/venous thrombosis with HRs for arterial thrombosis at 3 months, 1 year, and 5 years of 3.0, 2.0, and 1.5, respectively and corresponding HRs for venous thrombosis of 9.7, 4.7, and 3.2 compared with matched controls.

Dual antiplatelet therapy: how, how long, and in which patients?

European Heart Journal

In a themed issue focusing on dual antiplatelet therapy, the 2017 European Society of Cardiology dual antiplatelet therapy guidelines are discussed and supported with case-based examples.

European marketing authorisation approval of rurioctocog alfa pegol (Adynovi) for haemophilia A

PharmaTimes

According to Pharmatimes, rurioctocog alfa (Adynovi) has been approved for use in Europe for on-demand and twice weekly prophylactic use in patients 12 years and older with haemophilia A.

Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial

The Lancet

This pre-specified subgroup analysis of the COMPASS trial (n=24,824) found rivaroxaban (2.5mg twice daily) plus aspirin (100mg daily) reduced the composite of CV death, myocardial infarction, or stroke versus aspirin alone (4% v 6%; HR 0.74, 95% CI 0.65-0.86, p<0.0001).

Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial

The Lancet

This pre-specified subgroup analysis of the COMPASS trial (n=7470) found rivaroxaban (2.5mg twice daily) plus aspirin (100mg daily) reduced the composite of CV death, myocardial infarction, or stroke versus aspirin alone (5% v 7%; HR 0.72, 95% CI 0.57-0.90, p=0.0047).

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

Current recommendations for anticoagulant therapy in patients with valvular heart disease and atrial fibrillation: the ACC/AHA and ESC/EACTS Guidelines in Harmony…but not Lockstep!

Heart

Based on guideline concordance and evidence, the article concludes NOACs can be used in patients with atrial fibrillation (AF) and native valve diseases (except rheumatic mitral stenosis, due to lack of data), using standard AF risk scores and AF guidelines.

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

Eltrombopag receives breakthrough designation in US for first line use in severe aplastic anaemia

Reuters Health

Eltrombopag is currently licensed in the UK for severe aplastic anaemia in patients who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation.

Telemonitoring-based feedback improves adherence to non-vitamin K antagonist oral anticoagulants intake in patients with atrial fibrillation

European Heart Journal

In small study (n=48), telemonitoring-only led to very high taking- and regimen-adherence (97.4 and 93.8% and respectively). Direct feedback further improved both to 99.0% and 96.8%. Observation without daily monitoring resulted in a significant waning of taking adherence (94.3%).

Antiplatelet therapy with aspirin, clopidogrel, and dipyridamole versus clopidogrel alone or aspirin and dipyridamole in patients with acute cerebral ischaemia (TARDIS): a randomised, open-label, phase 3 superiority trial

The Lancet

RCT (n=3096), which was stopped early, found 30 days of intensive antiplatelet therapy did not reduce incidence and severity of recurrent stroke or TIA in this population vs. guideline-based therapy, but did significantly increase risk of major bleeding.

FDA approves launch of betrixaban in US in January 2018

Biospace Inc.

Betrixaban is an oral once daily factor Xa inhibitor intended for use in patients who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE. It is currently under review by the European Medicines Agency.

Early access to medicines scheme (EAMS) scientific opinion: emicizumab for routine prophylaxis of bleeding episodes in patients, aged 1 year and over, with haemophilia A with factor VIII inhibitors

Medicines and Healthcare products Regulatory Agency

Positive scientific opinion issued to Roche Products Limited includes a public assessment report, and treatment protocols for healthcare professionals and patients, and on the pharmacovigilance system and background information for Medical Directors.

Urgent reversal of vitamin K antagonists

British Medical Journal

This practice article discusses the available options for urgent reversal of the anticoagulant effects of vitamin K antagonists (prothrombinase complex concentrate; vitamin K; fresh frozen plasma), including benefits and harms, administration, monitoring and cost-effectiveness.

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