Items filtered by date: September 2015

European CHMP recommends granting of marketing authorisation for idarucizuma (Praxbind) as antidote to dabigatran

European Medicines Agency

Idarucizuma is a specific reversal agent for dabigatran and is intended for use in adults when rapid reversal is required for emergency surgery/urgent procedures; or in life-threatening or uncontrolled bleeding. It is proposed that use be restricted to hospital only.

 

Edoxaban for preventing stroke and systemic embolism in people with non valvular atrial fibrillation – guidance (TA355)

National Institute for Health and Care Excellence

NICE recommends the use of edoxaban as an option for preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation with one or more risk factors. The decision about whether to start treatment with edoxaban should be made after an informed discussion.

 

 

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

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An Observational Study of the Factor Xa Inhibitors Rivaroxaban and Apixaban as Reported to Eight Poison Centers, Editor’s Capsule Summary

Annals of Emergency Medicine

Study (n=243) found bleeding after ingestion of Xa inhibitor is uncommon. Prothrombin time, APTT, or INR may be elevated in minority of cases but appears unreliable to measure bleeding risk. Massive acute ingestion in suicides may result in significant anticoagulation.

 

Incidence of cardiovascular events and gastrointestinal bleeding in patients receiving clopidogrel with and without proton pump inhibitors: an updated meta-analysis

Open Heart

Meta-analysis of 39 studies suggests that the controversial interaction between PPIs and clopidogrel seen in in-vitro studies has no clinical significance. Rather, patients on PPIs have higher burden of comorbidities and thus most likely have increased risk for adverse CV events.

 

FDA approves recombinant Factor VIII (Nuwiq®) for the treatment of Haemophilia A

Biospace Inc.

The FDA has approved Nuwiq® for the treatment of adults and children with Haemophilia A. This is the first B-domain deleted recombinant Factor VIII derived from a human cell-line, not chemically modified or fused with another protein, designed for the treatment of this population.

 

Combined oral contraceptives: the risk of myocardial infarction and ischemic stroke

Cochrane Database of Systematic Reviews

Risk was only increased in women using COCs containing ≥ 50 µg of estrogen. When combined with results of studies on risk of venous thrombosis in COC users, it seems that the COC pill containing levonorgestrel and 30 µg of estrogen is safest oral form of hormonal contraception.

 

 

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

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Diagnostic prediction models for suspected pulmonary embolism: systematic review and independent external validation in primary care

British Medical Journal

Five diagnostic prediction models to rule out PE were evaluated for transportability to primary care in a cohort of 598 patients. Although efficiency was similar (43-48%), the three Wells rules performed better than the revised Geneva models for safety (failure rate 1.2% v 3.1%).

 

The CHA2DS2-VASc score for stroke risk stratification in patients with atrial fibrillation: a brief history

European Heart Journal

The CHA2DS2-VASc score is now recommended in many guidelines for stroke risk stratification in AF. The article discusses the evolution of this scoring system.

 

 

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

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Long-term dual antiplatelet therapy for secondary prevention of cardiovascular events in the subgroup of patients with previous myocardial infarction: a collaborative meta-analysis of randomized trials

European Heart Journal

In high-risk patients with prior MI, dual antiplatelet therapy (DAPT) for >1 year decreased the risk of major adverse cardiovascular events and CV death versus aspirin alone, with no difference in overall mortality. Major bleeding, but not fatal bleeding, was increased with DAPT.

 

Strategies for thromboprophylaxis in Fontan circulation: a meta-analysis

Heart

his meta-analysis of 10 studies (n=1,200) found aspirin or warfarin prophylaxis reduced the risk of thromboembolic events in patients who underwent the Fontan procedure; there was no significant difference between the two agents.

 

A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan

European Heart Journal

The Absorb bioresorbable vascular scaffold was deemed non-inferior to cobalt-chromium everolimus-eluting stents in terms of target lesion failure at 12 months (incidence of 4.2% vs 3.8%, respectively) in patients with one or two de novo lesions in different epicardial vessels.

 

Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes

New England Journal of Medicine

In patients with ACS for whom PCI was anticipated, bivalirudin was associated with a similar rate of major adverse CV events to unfractionated heparin (10.3% v 10.9%; RR 0.94; 95% CI 0.81 to 1.09; P=0.44). A post-PCI bivalirudin infusion did not appear to be of any benefit.

 

How to Monitor Patients Receiving Direct Oral Anticoagulants for Stroke Prevention in Atrial Fibrillation

Annals of Internal Medicine

This evidence-based practice tool, endorsed by Thrombosis Canada, the Canadian Stroke Consortium, the Canadian Cardiovascular Pharmacists Network and the Canadian Cardiovascular Society, aims to help healthcare professionals provide best-practice anticoagulant follow-up care.

 

XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation

European Heart Journal

This study investigating the safety and efficacy of rivaroxaban in routine clinical use reported that rates of stroke and major bleeding were low in patients receiving rivaroxaban in routine clinical practice (0.7 and 2.1 events per 100 patient-years respectively).

 

The Efficacy and Safety of Vorapaxar With and Without a Thienopyridine for Secondary Prevention in Patients with Prior Myocardial Infarction and no History of Stroke or TIA: Results from TRA 2 P-TIMI 50

Circulation

Pre-specified analysis (n=16,897) found vorapaxar (VX) significantly reduced composite of CV death, MI and stroke vs. placebo, regardless of planned thienopyridine (TP) therapy. Moderate/severe bleeding risk was increased with VX and was not significantly altered by planned TP.

 

Coronary artery bypass grafting-related bleeding complications in patients treated with ticagrelor or clopidogrel: a nationwide study

European Heart Journal

Retrospective study (n=2244) found discontinuation of platelet inhibitor 3 days before surgery, as opposed to 5 days, did not increase the incidence of major bleeding complications in ticagrelor-treated patients, but increased the incidence in clopidogrel-treated patients.

 

Assessment of the CHA2DS2-VASc Score in Predicting Ischemic Stroke, Thromboembolism, and Death in Patients With Heart Failure With and Without Atrial Fibrillation

Journal of the American Medical Association

Cohort study (n=42,987) found that among patients with incident heart failure with/without AF, CHA2DS2-VASc score was linked to risk of ischaemic stroke, thromboembolism, and death. However, predictive accuracy was modest and clinical utility of score remains to be determined.

 

Effect of clopidogrel with aspirin on functional outcome in TIA or minor stroke: CHANCE substudy

Neurology

This subgroup analysis suggests that clopidogrel plus aspirin vs. aspirin alone improves 90-day functional outcome (poor functional outcome occurred in 254 [9.9%] on combination vs 299 [11.6%] on aspirin alone; p=0.046) in patients with acute minor stroke or TIA.

 

Bispecific antibody ACE910 assigned ‘breakthrough’ designation in US for prophylactic treatment of haemophilia A patients who have developed factor VIII inhibitors

PharmaTimes

ACE910 is an investigational humanised bispecific monoclonal antibody engineered to mimic the function of blood coagulation factor VIII, and thus provide a new approach to treating the condition, regardless of whether patients have developed inhibitors.

 

Ticagrelor approved in US for long-term use in patients with acute coronary syndrome or a history of myocardial infarction

PharmaTimes

FDA approval of long term use is based on data from PEGASUS TIMI-54 study, which showed that in patients on aspirin with MI more than 1 year previously, treatment with ticagrelor significantly reduced risk of CV death, MI, or stroke (but increased risk of major bleeding).

 

 

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

Published in News