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zondag 12 november 2017

DTB: An update on the bleeding risks associated with DOACs

An update on the bleeding risks associated with DOACs

The direct oral anticoagulants (DOACs), also referred to as novel (or non-vitamin K antagonist) oral anticoagulants (NOACs), represent a major development in anticoagulation therapy due to their rapid onset of action, predictable dose–response with fixed doses and limited interactions with food and drugs.1,2 However, these agents have been in widespread clinical use for less than a decade and, compared with extensive experience with warfarin, there is uncertainty relating to optimal laboratory monitoring of anticoagulation, perioperative management and treatment of bleeding.3 In addition, there is currently only one drug licensed in the UK for rapid reversal of the anticoagulant effect of a DOAC. Here, we review DOAC-related bleeding and the role of drugs to reverse the anticoagulant action of DOACs.

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Naltrexone/bupropion for obesity

Naltrexone/bupropion (Mysimba - Orexigen Therapeutics Ireland Limited) is a fixed-dose combination product for the treatment of adults who are obese or overweight with at least one weight-related comorbidity, as an adjunct to diet and lifestyle modifications. Originally licensed by the European Medicines Agency (EMA) in 2015, it has recently been launched in the UK. Here, we review the evidence for its efficacy and safety and consider its place in therapy.

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Cost effectiveness of the New Medicine Service

The English community pharmacy, New Medicine Service (NMS), offers support to people who have been newly prescribed a medicine for a long-term condition to help them manage their condition and encourage adherence.1 It is targeted at people with asthma and chronic obstructive pulmonary disease, type 2 diabetes, hypertension and those prescribed antiplatelet/anticoagulant therapy. The aims of the service include helping to reduce the symptoms and long-term complications of the long-term condition and to identify problems with the medicine and management of the condition. A study has examined the cost effectiveness of NMS compared with normal practice by combining adherence improvement and intervention costs with the effect of increased adherence on patient outcomes and healthcare costs.2

The authors used data from a pragmatic randomised controlled trial of the NMS in 46 community pharmacies in England.3 The trial reported that of 378 patients still taking...

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Dietary fats versus carbohydrates

The latest study to question advice on dietary fats, carbohydrates and cardiovascular disease and mortality is a large epidemiological cohort study of people aged 35–70 years, enrolled between 2003 and 2013 in 18 countries.1 The study recorded the dietary intake of 135,335 people using validated food frequency questionnaires, with a median follow-up of 7.4 years. Primary outcomes were total mortality and major cardiovascular events. Participants were categorised into quintiles of nutrient intake (carbohydrate, fats and protein) based on percentage of energy provided by nutrients.

The study found that higher carbohydrate intake was associated with an increased risk of total mortality (highest quintile vs. lowest quintile category, HR 1.28, 95% CI 1.12 to 1.46) but not with the risk of cardiovascular disease or cardiovascular disease mortality. Intake of total fat and each type of fat was associated with lower risk of total mortality (total fat, HR 0.77, 95%...

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Rivaroxaban plus aspirin for secondary prevention

Aspirin is well established in the secondary prevention of cardiovascular disease. In a meta-analysis of 16 secondary prevention trials (17,000 participants), aspirin has been shown to reduce serious vascular events (6.7% vs 8.2% per year, p<0.0001) with reductions in total stroke (2.08% vs 2.54% per year, p=0.002) and in coronary events (4.3% vs. 5.3% per year, p<0.0001).1 A trial has assessed whether rivaroxaban alone or in combination with aspirin is more effective than aspirin alone for secondary cardiovascular prevention.2

The trial randomly assigned 27,395 participants with stable atherosclerotic vascular disease to receive one of three treatments: rivaroxaban (2.5mg twice daily) plus aspirin (100mg once daily); rivaroxaban (5mg twice daily); or aspirin (100mg once daily). The primary outcome was a composite of cardiovascular death, stroke or myocardial infarction (MI) and the main safety outcome was major bleeding. Net-clinical-benefit was the composite of cardiovascular death, stroke, MI,...

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Over-prescribing of antipsychotics in dementia: have warnings worked?

For many years, there have been concerns about the prescribing of antipsychotics to people with dementia.1 A study has assessed the impacts of guidance and drug safety warnings in the UK about prescribing antipsychotic drugs to people with dementia who do not have a diagnosis of psychosis.2 The study focused on warnings issued by the Medicines Healthcare products Regulatory Agency (MHRA) in 2004, 2009 and 2012, and on the National Institute for Health and Care Excellence (NICE) guidance published in 2006.2-7 The authors used primary care data from 111,346 patients attending one of 689 general practices.2

The study estimated the proportion of patients prescribed antipsychotic drugs at least twice (with at least 3 months between the first and last prescription) during the 6 months leading up to an audit date, out...

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Delayed antibiotic prescriptions for respiratory tract infections

Antibiotics continue to be commonly prescribed for respiratory tract infections (RTIs), even though evidence suggests that for many people they provide little clinical benefit.1,2 To tackle over-use of antibiotics, a strategy of using delayed prescriptions is recommended in clinical guidelines.3,4 An updated Cochrane review has assessed the effects of a delayed antibiotic prescription on clinical outcomes, antibiotic use, antibiotic resistance and patient satisfaction in RTIs.1

The Cochrane review included 11 randomised controlled trials involving 3,555 participants of all ages, defined as having an RTI (including acute otitis media, streptococcal pharyngitis, cough, sore throat and common cold).1 Delayed antibiotics were compared with immediate or no antibiotics.

For many clinical outcomes including pain, malaise, fever, cough and rhinorrhoea, there were no differences between groups prescribed delayed or immediate antibiotics or those not given antibiotics. Immediate antibiotics showed a small...

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Fast-track FDA drug approvals and safety warnings

To ensure that patients have more timely access to new and innovative medicines, regulatory bodies such as the European Medicines Agency (EMA) and the USA Food and Drug Administration (FDA), have developed a range of accelerated approval pathways.1 For such abbreviated development processes, drugs may be approved after a single phase II trial or using surrogate measures rather than actual clinical outcomes.1,2 In general, trials of drugs that have been through accelerated approval pathways involve relatively small numbers of patients and less is known about the drugs' safety profiles.3

The authors of a retrospective cohort study have compared rates of post-approval safety-related changes for drugs approved through the expedited programmes with those that were subject to standard pathways.2 Previous studies have disagreed on whether fast-tracked drug approvals lead to an increase in serious safety issues. The study's primary outcome...

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Updated advice on adrenaline auto-injectors

Earlier this year, the European Medicines Agency (EMA) reported the findings of its review on the use of adrenaline auto-injectors.1 The review was instigated as a result of concerns that currently available devices may deliver adrenaline under the skin instead of into a muscle. The EMA–s Committee for Medicinal Products for Human Use (CHMP) acknowledged that several factors affect whether adrenaline is delivered into muscle, and these include needle length, the thickness of fat under the skin, the way the auto-injector works, the angle at which the device is placed on the skin and the force used to activate the device, as well as how well the user follows the instructions for injection.

The EMA–s review concluded that owing to uncertainties about the site of drug delivery and the speed of adrenaline action, healthcare professionals should prescribe two autoinjectors, which patients should carry at all times.1 The...

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Prescribing in pregnancy - stop stopping and start planning

The legacy of thalidomide use by pregnant women persists beyond the harm done to their children and subsequent complex pharmacological politics and legal arguments.1 The realisation that a drug taken during pregnancy could harm the offspring was frightening for prescribers and women alike, and as a result, women frequently stop taking long-term medication when they learn that they are pregnant. Such decisions (which may result from a discussion with a healthcare professional or worried family and friends) are rarely planned or involve a balanced discussion of the available evidence of drug safety. Women often express sentiments of 'not wanting to take any risks for the baby' and 'not minding feeling unwell'. However, cessation of treatment increases the risk of acute exacerbations of the underlying condition, which may require higher doses or more potent agents to regain control. Increasingly, evidence suggests that adverse maternal wellbeing can have a...

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