Items filtered by date: May 2015

Liver injury with novel oral anticoagulants: assessing post-marketing reports in the US Food and Drug Administration adverse event reporting system

British Journal of Clinical Pharmacology

Reports of drug-induced liver injury associated with NOACs including acute liver failure events represented 3.7% (n = 146) and 1.7% (n = 222) of all reports for rivaroxaban and dabigatran, respectively. Disproportionality signals emerged for rivaroxaban in primary analysis.

 

Bleeding, Recurrent Venous Thromboembolism, and Mortality Risks During Warfarin Interruption for Invasive Procedures

JAMA Internal Medicine

This retrospective cohort study of patients whose warfarin therapy was interrupted for invasive diagnostic or surgical procedures (total 1812) found use of bridging increased the rate of clinically relevant bleeding (2.7% v 0.2% in those with no bridging); VTE rates were similar.

 

Standard vs Modified Antiplatelet Preparation for Preventing Thromboembolic Events in Patients With High On-Treatment Platelet Reactivity Undergoing Coil Embolization for an Unruptured Intracranial Aneurysm: A Randomized Clinical Trial

JAMA Neurology

This single-centre study reports that in patients undergoing coiling for unruptured aneurysms, use of a modified antiplatelet regimen for those with high on-treatment platelet reactivity reduced the rate of thromboembolic events vs. standard antiplatelet therapy.

 

Longer Versus Shorter Duration Dual-Antiplatelet Therapy After Drug-Eluting Stent Placement: A Systematic Review and Meta-analysis

Annals of Internal Medicine

This review of 9 RCTs reports that longer-duration dual antiplatelet therapy (DAPT) following drug-eluting stent placement reduced MI risk (RR 0.73, 95% CI 0.58-0.92) but increased mortality (1.19, 1.04-1.36) and major bleeding risk (1.63, 1.34-1.99]) vs. shorter-duration DAPT.

 

 

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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Risk of Substantial Intraocular Bleeding With Novel Oral Anticoagulants: Systematic Review and Meta-analysis

JAMA Oncology

Analysis of 17 RCTs suggests no differences exist in the risk of substantial intraocular bleeding between NOACs and other antithrombotic drugs (vitamin K antagonists, aspirin, low-molecular-weight heparin). However, the number of events was scarce so further studies are needed.

 

Stroke Prevention in Atrial Fibrillation: A Systematic Review

Journal of the American Medical Association

This review highlights that stroke prevention is central to management of AF, irrespective of a rate or rhythm control strategy. Following the initial
focus on identifying low-risk patients, all others with 1 or more stroke risk factors should be offered oral anticoagulation.

 

The Association of Discharge Aspirin Dose With Outcomes After Acute Myocardial Infarction: Insights From the TRANSLATE-ACS Study

Circulation

US study of 10,213 MI patients who underwent PCI and were discharged on dual antiplatelet therapy found that high maintenance dose aspirin (325mg) was linked to similar rates of major adverse cardiovascular events but greater risk of minor bleeding vs. low-dose aspirin (81mg).

 

Efficacy and Harms of Direct Oral Anticoagulants in the Elderly for Stroke Prevention in Atrial Fibrillation and Secondary Prevention of Venous Thromboembolism: Systematic Review and Meta-Analysis

Circulation

Direct oral anticoagulants demonstrate at least equal efficacy to VKAs in managing thrombotic risks in the elderly although bleeding patterns were distinct with dabigatran linked to a particularly higher risk of GI bleeding compared to VKAs.

 

The prognostic utility of tests of platelet function for the detection of ‘aspirin resistance’ in patients with established cardiovascular or cerebrovascular disease: a systematic review and economic evaluation

National Institute for Health Research

This systematic review evaluated whether or not 'aspirin resistance' defined using platelet function tests (PFTs) was linked to occurrence of adverse clinical outcomes and concluded that studies investigating this were of inconsistent quality - no firm conclusions could be made.

 

Efficacy of Prophylactic Low–Molecular Weight Heparin for Ambulatory Patients With Advanced Pancreatic Cancer: Outcomes From the CONKO-004 Trial

Journal of Clinical Oncology

In patients with advanced pancreatic cancer undergoing chemotherapy, prophylactic enoxaparin was associated with a reduced rate of symptomatic VTE (6.4% vs 15.1% with no enoxaparin) and no increase in major bleeding; there was no difference in progression-free or overall survival.

 

 

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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Uninterrupted rivaroxaban vs. uninterrupted vitamin K antagonists for catheter ablation in non-valvular atrial fibrillation

European Heart Journal

RCT (n=248; VENTURE-AF) found that use of uninterrupted rivaroxaban was feasible and bleeding and thromboembolic event rates were similar to those for uninterrupted vitamin K antagonists in patients with non-valvular atrial fibrillation undergoing catheter ablation.

 

Edoxaban vs. warfarin in patients with atrial fibrillation on amiodarone: a subgroup analysis of the ENGAGE AF-TIMI 48 trial

European Heart Journal

In pre-specified subgroup analysis, patients randomised to lower dose edoxaban (DE) who were taking amiodarone at baseline had fewer ischaemic events compared with warfarin vs. patients not on amiodarone. Also amiodarone had no effect on relative efficacy and safety of higher DE.

 

 

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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50 year trends in atrial fibrillation prevalence, incidence, risk factors, and mortality in the Framingham Heart Study: a cohort study

The Lancet

In this analysis (202,417 person-yrs), a roughly 4-times increase in age-adjusted incidence and prevalence of AF in both sexes was reported. Risk of AF in both sexes doubled with each decade of age, and risk of stroke and death after diagnosis were equivalent between the sexes.

 

Antiplatelet therapy following transcatheter aortic valve implantation

Heart

Systematic review and pooled analysis of individual patient data (n=672) found no difference in 30-day net adverse clinical and cerebral events rate between aspirin-only or dual antiplatelet therapy following transcatheter aortic valve implantation.

 

Oral Anticoagulation, Aspirin, or No Therapy in Patients With Nonvalvular AF With 0 or 1 Stroke Risk Factor Based on the CHA2DS2-VASc Score

Journal of the American College of Cardiology

Study (n=39,400) found low-risk patients (CHA2DS2-VASc=0 [male],1 [female]) have a truly low risk for stroke and bleeding. With 1 additional stroke risk factor (score 1 & 2 respectively), there was significant increase in event rates (particularly mortality) if non-anticoagulated.

 

Gender differences in the effect of cardiovascular drugs: a position document of the Working Group on Pharmacology and Drug Therapy of the ESC

European Heart Journal

This position paper discusses the gaps in knowledge on the effects of gender on pharmacokinetics and pharmacodynamics of cardiovascular drugs, and how such differences may influence their effectiveness and safety.

 

Low-Molecular-Weight Heparin for Women With Unexplained Recurrent Pregnancy Loss: A Multicenter Trial With a Minimization Randomization Scheme

Annals of Internal Medicine

In 449 women with unexplained recurrent pregnancy loss, a daily injection of LMWH (dalteparin 5000IU) for up to 24 weeks' gestation did not improve the rate of ongoing pregnancy at 24 weeks (86.8% v 87.9%) or the live birth rate (86.0% v 86.7%) v control.

 

EMA approves Raplixa™ powdered fibrin sealant for surgical bleeding

European Medicines Agency

The EMA has approved Raplixa™ (fibrin sealant) for use in adults as a supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis. It must be used in combination with an approved CE marked gelatin sponge (supplied separately).

 

 

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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Comparative risk of gastrointestinal bleeding with dabigatran, rivaroxaban, and warfarin: population based cohort study

British Medical Journal

A US analysis of almost 220 000 new users of dabigatran, rivaroxaban, or warfarin (2010-2013) found that risk of GI bleeding with dabigatran or rivoroxaban was similar to warfarin but risk exceeded that of warfarin with age, particularly in those over 75 years.

 

Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study

British Medical Journal

A US analysis (n= 46,000) found that neither dabigatran nor rivaroxaban was associated with a statistically significantly increased risk of GI bleeding relative to warfarin. However the study had wide confidence intervals and an increased risk of bleeding cannot be ruled out.

 

 Positive CHMP opinion for edoxaban (Lixiana™) for prevention of stroke and systemic embolism in atrial fibrillation and treatment and prevention of deep vein thrombosis and pulmonary embolism

European Medicines Agency

The CHMP has adopted a positive opinion recommending approval of edoxaban (Lixiana™), for prevention of stroke and systemic embolism in adults with atrial fibrillation and for treatment and prevention of deep vein thrombosis and pulmonary embolism.

 

 

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