Tinzaparin vs Warfarin for Treatment of Acute Venous Thromboembolism in Patients With Active Cancer: A Randomized Clinical Trial

Journal of the American Medical Association

In patients with active cancer and proximal DVT or PE, there was no statistically significant difference between tinzaparin and warfarin for recurrent VTE (6-month incidence 7.2% v 10.5%; P=0.07) or mortality; clinically relevant non-major bleeding was lower with tinzaparin.

 

Longer-term results of recombinant factor IX therapy in haemophilia B

Biospace Inc.

Interim results from the phase III B-YOND open-label extension study support the long-term safety and efficacy of an investigational recombinant clotting factor IX therapy (Alprolix®) in the treatment of severe haemophilia B for up to two years.

 

Does warfarin interact with oseltamivir or zanamivir?

UKMi

This updated Medicines Q&A evaluates the available evidence for an interaction between warfarin and oseltamivir or zanamivir.

 

Is it safe to take herbal medicines with non-vitamin K antagonist oral anticoagulants (NOACs)?

UKMi

This new Medicines Q&A evaluates the available evidence for the safety of co-administering herbal medicines with the non-vitamin K antagonist oral anticoagulants (NOACs).

 

Long working hours and risk of coronary heart disease and stroke: a systematic review and meta-analysis of published and unpublished data for 603 838 individuals

The Lancet

Review of 25 studies from 24 cohorts in Europe, US, and Australia found employees who work long hours (≥55 h/week) have a higher risk of stroke (RR 1.33,95% CI,1.11–1.61;p=0.002) than those working standard hours (35–40h/week); the link with CHD is weaker (1.13;1.02–1.26;p=0.02).

 

Prothrombin complex concentrate for reversal of vitamin K antagonist treatment in bleeding and non-bleeding patients

Cochrane Database of Systematic Reviews

Four RCTs (high risk of bias; underpowered) suggest prothrombin complex concentrate does not appear to reduce mortality or transfusion requirements but demonstrates possibility of reversing vitamin K-induced coagulopathy without need for transfusion of fresh frozen plasma.

 

 

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

Use and Outcomes of Triple Therapy Among Older Patients With Acute Myocardial Infarction and Atrial Fibrillation

Journal of the American College of Cardiology

Analysis (n=4959) found that ~ 1 in 4 older AF patients undergoing PCI for MI were discharged on triple therapy; and those receiving triple therapy vs. dual antiplatelet therapy had higher rates of major bleeding without a measurable difference in composite MI, death, or stroke.

 

Optimizing the Safe Use of Direct Oral Anticoagulants in Older Patients: A Teachable Moment

JAMA Internal Medicine

Case of 86-year-old woman with AF who presents with persistent epistaxis and found to have supratherapeutic levels of rivaroxaban and creatinine clearance of 21 mL/min highlights challenge of ensuring appropriate and safe use of direct oral anticoagulants in frail older patients.

 

Recanalization Therapies in Acute Ischemic Stroke Patients: Impact of Prior Treatment with Novel Oral Anticoagulants on Bleeding Complications and Outcome - A Pilot Study

Circulation

The results of this observational study suggest IV thrombolysis or intra-arterial treatment in carefully selected patients with an ischaemic stroke who are taking NOACs may not be associated with an excessive risk of intracranial haemorrhage; further data are however required.

 

Oral dual antiplatelet therapy: what have we learnt from recent trials?

European Heart Journal

This paper outlines the evidence base for clinical decisions regarding timing of initiation and duration of dual antiplatelet therapy in acute coronary syndrome.

 

Pregnancy Complicated by Venous Thrombosis

New England Journal of Medicine

This clinical practice article starts with a case vignette of a pregnant women presenting with venous thrombosis. The author's recommendations are based on supporting evidence and guidelines.

 

Hemostatic efficacy, safety and pharmacokinetics of a recombinant von Willebrand factor in severe von Willebrand disease

Blood

In patients with severe type 1, 2, or 3 von Willebrand disease, a recombinant von Willebrand factor (initially administered together with recombinant Factor VIII) led to excellent or good control in 96.9% of 192 treated bleeds, with a single infusion effective in 81.8%.

 

Atrial fibrillation (non-valvular) - edoxaban tosylate [ID624]: final appraisal determination

National Institute for Health and Care Excellence

In DRAFT guidance (final appraisal determination), NICE recommends edoxaban, within its marketing authorisation, as an option for preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation with one or more of the stated risk factors.

 

Venous thromboembolic diseases - management (Standing Committee B update): addendum consultation

National Institute for Health and Care Excellence

This DRAFT guideline update includes new recommendations on use of systemic thrombolysis in patients with 'intermediate-risk' pulmonary embolism, and on long-term use of compression stockings for the prevention of post-thrombotic syndrome in patients who have had a proximal DVT.

 

 

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

Real world effectiveness of warfarin among ischemic stroke patients with atrial fibrillation: observational analysis from Patient-Centered Research into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER) study

British Medical Journal

RCT (n=12 552) found that compared to those not anticoagulated, warfarinised patients had more days at home (as opposed to institutional care) during 2-years after discharge and a reduced risk of major adverse cardiovascular events and recurrent ischaemic stroke.

 

FDA accepts for review biologics license application for rVIII-SingleChain therapy for haemophilia A

Biospace Inc.

rVIII-SingleChain has a strong affinity for von Willebrand factor, leading to greater stability and integrity of FVIII in circulation. In the pivotal clinical trial, it met all primary endpoints.

 

Outcomes with prolonged clopidogrel therapy after coronary stenting in patients with chronic kidney disease

Heart

In this cohort of 4880 patients undergoing drug-eluting stents, clopidogrel (CL) use of 12 months after PCI was linked to lower risks of death/MI (18% v 24%, HR=0.74) and death v patients with normal renal function, supporting a patient-centred approach to prolonging CL after PCI.

 

 

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

Cangrelor for reducing atherothrombotic events in people undergoing percutaneous coronary intervention or awaiting surgery requiring interruption of anti platelet therapy (terminated appraisal) – technology appraisal guidance (TA351)

National Institute for Health and Care Excellence

NICE is unable to make a recommendation about the use in the NHS of cangrelor for reducing atherothrombotic events in people undergoing PCI or awaiting surgery requiring interruption of anti-platelet therapy because no evidence submission was received from The Medicines Company.

 

Genotype-guided drug prescribing: a systematic review and meta-analysis of randomized control trials

British Journal of Clinical Pharmacology

This meta-analysis of fifteen studies (n=5688; 19 drugs) reports a statistically significant benefit in favour of genotype-guided warfarin dosing to achieve time in therapeutic INR, resulting in reduction in warfarin-related minor and major bleeding and thromboembolisms.

 

Oral direct thrombin inhibitors or oral factor Xa inhibitors for the treatment of deep vein thrombosis

Cochrane Database of Systematic Reviews

Review of 11 RCTs (n=27,945) deemed to be of high methodological quality and low risk of bias found that NOACs may be an effective and safe alternative to conventional anticoagulation treatment for acute DVT.

 

Lixiana®▼(Edoxaban): risk minimisation resources

Daiichi Sankyo

Educational materials have been developed to help manage important risks such as bleeding associated with edoxaban (ED) use. Clinicians should familiarise themselves with these materials before prescribing ED and ensure all patients familiarise themselves with Patient Alert Card.

 

Primary prophylaxis for venous thromboembolism in patients undergoing cardiac or thoracic surgery

Cochrane Database of Systematic Reviews

There is limited evidence on efficacy and safety. Data for important outcomes such as PE or major bleeding were often lacking. Give uncertainties around benefit-to-risk balance, no conclusions can be drawn and case-by-case risk evaluation of VTE and bleeding remains preferable.

 

Comparison of the Short-Term Risk of Bleeding and Arterial Thromboembolic Events in Nonvalvular Atrial Fibrillation Patients Newly Treated With Dabigatran or Rivaroxaban versus Vitamin K Antagonists: A French Nationwide Propensity-Matched Cohort Study

Circulation

In this study of 19,713 vitamin K antagonists (VKA), 8,443 dabigatran and 4,651 rivaroxaban new users, no statistically significant difference in bleeding or thromboembolic risk was observed between newer oral anticoagulants users and VKA new users in non-valvular AF patients.

 

Independent expert review concludes alteplase is safe and effective for use within existing treatment guidelines

Medicines and Healthcare products Regulatory Agency

Following questions about the safety of alteplase, and the methodology used in trials assessing it, an expert working group of the UK's Commission on Human Medicines (CHM) has concluded that alteplase is safe and effective for use up to 4.5 hours after the onset of symptoms.

 

 

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

rivaroxaban (Xarelto®)

Scottish Medicines Consortium

The SMC does not recommend use of rivaroxaban (co-administered with aspirin ± clopidogrel or ticlopidine) within NHS Scotland for the prevention of atherothrombotic events in adults after an acute coronary syndrome with elevated cardiac biomarkers.

 

tinzaparin sodium (Innohep®)

Scottish Medicines Consortium

The SMC has accepted tinzaparin for use within NHS Scotland for the extended treatment of symptomatic VTE and prevention of its recurrence in patients with solid tumours. This advice takes account of the benefits of a Patient Access Scheme that improves its cost-effectiveness.

 

Peri-procedural management of patients taking oral anticoagulants

British Medical Journal

This review summarises the pharmacology of oral anticoagulants (OA) relevant to the peri-procedural period, and reported outcomes of peri-procedural management of oral anticoagulants used for therapeutic purposes.

 

Choice of Estimated Glomerular Filtration Rate Equation Impacts Drug-Dosing Recommendations and Risk Stratification in Patients With Chronic Kidney Disease Undergoing Percutaneous Coronary Interventions

Journal of the American College of Cardiology

This study, aimed at identifying which equation is superior in estimating GFR for predicting adverse outcomes after PCI, supports use of CKD-EPI equation for risk stratification and calls for standardisation in estimation of GFR for studies to improve dosage recommendations.

 

Deep vein thrombosis, pulmonary embolism (treatment, secondary prevention) - edoxaban tosylate: final appraisal determination

National Institute for Health and Care Excellence

In DRAFT guidance, NICE recommends edoxaban, within its marketing authorisation, as an option for treating and for preventing recurrent deep vein thrombosis and pulmonary embolism in adults.

 

Intracranial Hemorrhage After Ischemic Stroke: Incidence, Time Trends, and Predictors in a Swedish Nationwide Cohort of 196 765 Patients

Circulation: Cardiovascular Quality and Outcomes

Incidence of intracranial hemorrhage within 1-year after stroke was ≈2%/year at risk, about 15 times higher vs. reference population. Risk increased within first 30 days but decreased thereafter. Thrombolysis, but not increased use of antithrombotics/statins, affected risk.

 

Androgen Deprivation Therapy for Prostate Cancer and the Risk of Venous Thromboembolism

European Urology

Cohort study (n=21,729 of whom 609 hospitalised for VTE) found current (vs. non) use of androgen deprivation therapy was linked to 84% increased relative risk of VTE (incidence rates:10.1 vs 4.8/1000 person-years;HR:1.84;95% CI,1.50–2.26), whereas there was no link with past use.

 

Heparin-Induced Thrombocytopenia

New England Journal of Medicine

Treatment of acute heparin-induced thrombocytopenia (HIT) requires the cessation of heparin and initiation of therapeutic-dose anticoagulation with an alternative agent (argatroban, danaparoid, fondaparinux, or bivalirudin). Warfarin should be avoided in patients with acute HIT.

 

Risk of intracranial haemorrhage in antidepressant users with concurrent use of non-steroidal anti-inflammatory drugs: nationwide propensity score matched study

British Medical Journal

This analysis of a Korean nationwide health insurance database found combined use of antidepressants and NSAIDs was associated with an increased risk of intracranial haemorrhage within 30 days versus use of antidepressants without NSAIDs (hazard ratio 1.6, 95% CI 1.32 to 1.85).

 

Oral anticoagulants for stroke prevention in atrial fibrillation: current status, special situations, and unmet needs

The Lancet
This paper addresses the role of anticoagulation for stroke prevention in AF in the era of NOACs, with a focus on special situations including management in the event of bleeding and around the time of procedures including cardioversion, catheter ablation, and device implantation.

 

Pharmacology of antithrombotic drugs: an assessment of oral antiplatelet and anticoagulant treatments

The Lancet
This paper focuses on the pharmacological properties of the most commonly used oral antithrombotic drugs (aspirin, P2Y12 receptor antagonists, other targets, vitamin K antagonists, and non-VKA anticoagulants).

 

 

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

Revised SPC: Xarelto (rivaroxaban) 2.5 mg film-coated tablets

electronic Medicines Compendium

Additions include advice on how to reduce the potential bleeding risk associated with concurrent use of rivaroxaban and neuraxial anaesthesia or spinal puncture (section 4.4) and post-marketing adverse events of cholestasis, hepatitis and thrombocytopenia (section 4.8).

 

Six Months vs Extended Oral Anticoagulation After a First Episode of Pulmonary Embolism: The PADIS-PE Randomized Clinical Trial

Journal of the American Medical Association

This RCT of adults with a first unprovoked PE who had already received 6 months of warfarin found that extended treatment (further 18 months) reduced the composite outcome of recurrent VTE and major bleeding (3.3% v 13.5% placebo).

 

A practical guideline for the haematological management of major haemorrhage

British Journal of Haematology

This guideline provides recommendations for the haematological management of major haemorrhage in any clinical situation, with practical guidance on the content and delivery of major bleeding protocols, including the use of blood components and transfusion alternatives.

 

Atrial flutter and thromboembolic risk: a systematic review

Heart

This analysis of 52 studies (observational; no RCTs) confirms clinical thromboembolic events are highly prevalent in atrial flutter. The authors say thromboprophylaxis should strongly be considered in the presence of ≥1 additional stroke risk factors.

 

Antiplatelet therapy as a modulator of stroke aetiology: a meta-analysis

British Journal of Clinical Pharmacology

This meta-analysis (9 studies; n=5739) evaluating antiplatelet therapy (APT) on incidence of each subtype of stroke: large artery atherosclerosis (LAA), cardioembolic and small vessel occlusion concluded that APT preferentially reduces the incidence of LAA stroke.

 

Anticoagulant vs. antiplatelet therapy in patients with cryptogenic stroke and patent foramen ovale: an individual participant data meta-analysis

European Heart Journal

This meta-analysis of 804 patients on oral anticoagulants and 1581 patients on antiplatelets did not find a statistically significant difference between the two groups for stroke/TIA or death in patients being treated for cryptogenic stroke or patent foramen ovale.

 

The clinical effectiveness and cost-effectiveness of point-of-care tests (CoaguChek system, INRatio2 PT/INR monitor and ProTime Microcoagulation system) for the self-monitoring of the coagulation status of people receiving long-term vitamin K antagonists

National Institute for Health Research

An analysis of 26 RCTs found that compared with standard monitoring, self-monitoring appears to be safe and effective, especially for people with artificial heart valves.

 

FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes

US Food and Drug Administration

Following a comprehensive review of new safety information, the FDA is requiring updates to the drug labels of all prescription NSAIDs, to strengthen an existing label warning that NSAIDs increase the chance of a heart attack or stroke.

 

Antithrombotic therapy in the elderly: expert position paper of the European Society of Cardiology Working Group on Thrombosis

European Heart Journal

This paper discusses pharmacokinetic and pharmacodynamic variables influencing the efficacy and safety of drugs in elderly subjects and makes recommendations regarding use of oral and IV antiplatelets and anticoagulants and how to prevent and manage bleeding in the elderly.

 

 

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

New product: Edoxaban (Lixiana) 60mg Film-Coated Tablets

electronic Medicines Compendium

Licensed for prevention of stroke and systemic embolism in adults with non valvular AF with 1 or more risk factors such as CHF, HBP, age ≥ 75 years, DM, prior stroke or TIA, prevention of recurrent DVT/PE, and treatment of DVT/PE.

 

Revised SPC: Rivaroxaban (Xarelto) 10 and 20mg tablets

electronic Medicines Compendium

Advice on how to reduce the potential bleeding risk associated with concurrent use of rivaroxaban and neuraxial (epidural/spinal) anaesthesia or spinal puncture have been added. The following AEs are now listed: cholestasis, hepatitis and thrombocytopenia.

 

Cohort study of Anticoagulation Self-Monitoring (CASM): a prospective study of its effectiveness in the community

British Journal of General Practice

This UK cohort study of 296 adults self-monitoring their oral anticoagulation therapy (median 61 years; predominately professional or held a university qualification) found 90.2% were still self-monitoring after 12 months, with a mean time in therapeutic range of 75.3%.

 

How to Monitor Patients Receiving Direct Oral Anticoagulants for Stroke Prevention in Atrial Fibrillation: A Practice Tool

Annals of Internal Medicine

This tool advocates regular, standardised clinical monitoring of patients receiving novel oral anticoagulants. It consists of a checklist covering adherence assessment and counselling, bleeding risk assessment, creatinine clearance, drug interactions and examination (e.g. BP).

 

Socioeconomic Inequalities in the Prescription of Oral Anticoagulants in Stroke Patients With Atrial Fibrillation

Stroke

This analysis of the Swedish stroke register found the prescribing of anticoagulants after stroke in patients with AF varied according to age, income, education and country of birth. This was not explained by common risk factors suggesting socioeconomic inequalities.

 

 

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

High-dose ibuprofen (≥2400mg/day): small increase in cardiovascular risk

Medicines and Healthcare products Regulatory Agency

EU review confirms that CV risk of high-dose ibuprofen (≥2400mg/day) is similar to COX 2 inhibitors and diclofenac. Clinicians are advised that naproxen and low-dose ibuprofen (≤1200mg per day) are considered to have most favourable thrombotic CV safety profiles of all NSAIDs.

 

Meta-analysis of Comparison of the Newer Oral P2Y12 Inhibitors (Prasugrel or Ticagrelor) to Clopidogrel in Patients with Non-ST-elevation Acute Coronary Syndrome

American Journal of Cardiology

Review of 4 RCTs (n=31,470 with NSTE-ACS) found newer oral P2Y12 inhibitors decrease major cardiovascular events (MACEs) and MI at expense of significant increase in bleeding risk. Treatment of 1000 patients will prevent 16 MACEs at expense of increase in 6 major bleeds.

 

Is self-monitoring an effective option for people receiving long-term vitamin K antagonist therapy? A systematic review and economic evaluation

BMJ Open

Review of 26 RCTs (n=8763) suggests self-monitoring (SM) appears to be a safe and cost-effective option. It found that both SM and self-testing were as safe as standard care (SC) in terms of major bleeding events. SM was also linked to fewer thromboembolic events vs. SC.

 

Prevalence, Clinical Features, and Prognosis of Acute Myocardial Infarction Due to Coronary Artery Embolism

Circulation

Of 1776 Japanese patients who presented with de novo AMI between 2001 and 2013, prevalence of coronary artery embolism (CE) was 2.9% (n=52). AF was the most common cause (n=38, 73%). Only 39% of patients with CE were treated with vitamin K antagonists, and median INR was 1.42.

 

Association of Rivaroxaban Anticoagulation and Spontaneous Vitreous Hemorrhage

JAMA Opthalmology

This report describes 3 patients who developed spontaneous vitreous haemorrhage after initiating rivaroxaban. All 3 patients were taking an additional antithrombotic agent (2 warfarin, 1 clopidogrel) at the time of haemorrhage.

 

CHMP adopts positive opinion on licence extension of Voncento (human coagulation factor VIII / von Willebrand factor) in EU

European Medicines Agency

The licence extension will be for prophylaxis and treatment of haemorrhage or surgical bleeding in patients with von Willebrand Disease, when desmopressin treatment alone is ineffective or contraindicated.

 

Revised SPC: Konakion (phytomenadione) MM (10mg/ml and Paediatric 2 mg/0.2 ml)

electronic Medicines Compendium

SPC notes reports of anaphylactoid reactions after IV injection. Local irritation may occur at injection site but is unlikely due to the small injection volume. Rarely, injection site reactions may occur which may be severe, including inflammation, atrophy and necrosis.

 

Apixaban Compared with Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease: Findings From the ARISTOTLE Trial

Circulation

Analysis (n=18,201 of which 4808 had valvular heart disease [VHD]) or prior valve surgery found no evidence of differential effect of apixaban over warfarin in patients with and without VHD in reducing stroke and systemic embolis, causing less bleeding, and reducing death.

 

Characterising and predicting bleeding in high-risk patients with an acute coronary syndrome

Heart

Analysis of APPRAISE-2 study (n=7392) found that when compared with placebo, use of apixaban is linked to an important short-term and long-term risk of bleeding in high-risk post-ACS patients, with GI bleeding being most common source of major bleeding.

 

Superficial thrombophlebitis (superficial venous thrombosis)

British Medical Journal

This reviews covers epidemiology, diagnosis, causes, types of superficial thrombophlebitis, complications, investigations, treatment (hosiery, NSAIDs, anticoagulation, antibiotics, surgery), and when to refer.

 

Edoxaban (Lixiana) approved in EU for stroke prophylaxis and prevention and treatment of venous thromboembolism

PharmaTimes

Edoxaban is a once-daily selective factor Xa-inhibitor which has been licensed for prevention of stroke and systemic embolism in patients with nonvalvular AF with one or more risk factors; and treatment and prevention of DVT and pulmonary embolism.

 

Venous thromboembolism in adults admitted to hospital: reducing the risk - guideline (CG92)

National Institute for Health and Care Excellence

This guidance is about the care and treatment of adults who are at risk of developing deep vein thrombosis (DVT) while in hospital in the NHS in England and Wales. It should be read in conjunction with TA 245 (published in January 2012).

 

Preliminary findings from the GARFIELD-AF registry show poor anticoagulation control and high risk scores increase mortality and strokes in newly diagnosed AF patients

Biospace Inc.

Preliminary results from GARFIELD-AF study (n=17,200) presented at the International Society on Thrombosis and Haemostasis conference have shown that fewer patients diagnosed at a hospital have good anticoagulant control vs patients diagnosed at an office/anticoagulation clinic.

 

Idarucizumab for Dabigatran Reversal

New England Journal of Medicine

Interim results of the RE-VERSE AD cohort study (n=90) show that idarucizumab (5g IV) rapidly and completely reversed the anticoagulant activity of dabigatran in 88 to 98% of those with elevated clotting times at baseline.

 

Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation

New England Journal of Medicine

In AF patients requiring warfarin interruption for an elective procedure, no bridging (placebo) was non-inferior to dalteparin bridging for the prevention of arterial thromboembolism (incidence of 0.4% v 0.3%) and decreased the risk of major bleeding (1.3% v 3.2%).

 

Positive Phase III data for anticoagulant antidote andexanet alfa

PharmaTimes

In Phase III ANNEXA-A trial, andexanet alfa rapidly reversed the anticoagulant effect of apixaban by 93.5%, and sustained a high level of efficacy across the two-hour infusion period. No serious adverse events were reported.

 

 

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

Thromboembolic Complications and Prophylaxis Patterns in Colorectal Surgery

JAMA Surgery

US study of 16,120 patients who had undergone colorectal surgery found venous thromboembolism rates are low and largely unchanged despite increases in peri-and postoperative prophylaxis. With ~40% events occurring after discharge, this represents an area for quality improvement.

 

Interventions for prophylaxis of hepatic veno-occlusive disease in people undergoing haematopoietic stem cell transplantation

Cochrane Database of Systematic Reviews

There is low quality evidence that ursodeoxycholic acid may reduce incidence of disease, all-cause mortality and mortality in HSCT recipients. There is insufficient evidence to support use of heparin, LMWH, defibrotide, glutamine, FFP, antithrombin III, and PGE1.

 

Revised SPC: Plavix (clopidogrel) 75mg tablets

electronic Medicines Compendium

In section 4.5 (interactions), the list of CYP2C19 inhibitors has been amended so that it now only lists examples of strong or moderate inhibitors (ciprofloxacin, cimetidine, oxcarbazepine and chloramphenicol have been removed).

 

Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: a randomised, placebo-controlled, double-blind phase 1 trial

The Lancet

In a proof-of-concept study in healthy volunteers, idarucizumab (monoclonal antibody fragment that binds dabigatran) was found to immediately and completely reverse dabigatran-induced anticoagulation in a dose-dependent manner.

 

Doctors call on health secretary to intervene in release of all data on alteplase for acute ischaemic stroke

British Medical Journal

Some doctors have been questioning efficacy and safety of alteplase —and methodology of some of trials assessing it. Unpublished data are still missing on certain endpoints including early mortality. The MHRA is due to publish a review on alteplase towards end of 2015.

 

 

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

Guideline on aspects of cancer-related venous thrombosis

British Committee for Standards in Haematology

This aims to provide healthcare professionals with clear guidance on prevention and management of venous thromboembolism (VTE) in patients with cancer and to advise on an approach to screening for cancer in patients with unprovoked VTE in whom cancer was not initially suspected.

 

Restarting Anticoagulant Treatment After Intracranial Haemorrhage in Patients With Atrial Fibrillation and the Impact on Recurrent Stroke, Mortality and Bleeding: A Nationwide Cohort Study

Circulation

Danish study (n=1752) found AF patients with intracranial haemorrhage (ICH) are at very high risk of ischaemic stroke/mortality, if not on antithrombotic. Oral anticoagulant was linked to reduction in this risk, supporting feasability of its reintroduction post-ICH.

 

Drug-related problems in a clinical setting: a literature review and cross-sectional study evaluating factors to identify patients at risk

European Journal of Hospital Pharmacy

A narrative review of 21 papers found that although risk factors associated with drug-related problems (DRPs) differed greatly among these publications, comorbidity, polypharmacy and the use of specific drugs (antithrombotics, antidiabetics) were frequently associated with DRPs.

 

 

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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