BENEFITS OF ASPIRIN A DAY FOR CANCER PREVENTION IN MIDDLE-AGED PEOPLE ‘OUTWEIGH HARMS’

From the FMS Global News Desk of Jeanne Hambleton Pulse Today Posted 6 August 2014 | By Caroline Price

GPs can advise people over 50 to take aspirin daily to help cut deaths from cancer, UK academics have claimed after carrying out a review of the latest evidence.

The researchers said that for people aged 50–65 years, taking a low daily dose of aspirin – between 75 and 100 mg – cut the risk of dying from cancer over the next 20 years.

People would need to take aspirin for five years or longer, but – at least for this age group – the benefits outweighed the risks from potential bleeding, according to the team.

The researchers said daily aspirin was the next best approach to preventing cancer for the population ‘after stopping smoking and preventing obesity’ but called for people to ask their GP before taking aspirin daily as ‘there are some serious side effects that can’t be ignored’.

However, leading GPs and experts in cancer research warned more evidence was needed regarding which patients should be targeted for aspirin prevention before GPs could advise people to start taking a daily dose.

The review was carried out by an international team led by Professor Jack Cuzick, from Queen Mary University of London, with backing from Cancer Research UK and the British Heart Foundation.

Overall, studies showed aspirin cut the risk of colorectal cancer deaths by around 40% over 10 years, and oesophageal and stomach cancer deaths by 35-50%.

The benefits were seen for aspirin 75-100 mg daily if taken for at least five years between the ages of 50 and 65; no benefit was seen for the first three years and death rates were only reduced after five years.

However, the risks of bleeding – particularly from the digestive tract – were significantly increased with daily aspirin use.

For example, in people aged 60 years taking daily aspirin increased the risk of gastrointestinal bleeds from 2.2% to 3.6%, although the authors say this would be potentially life-threatening in a small proportion (less than 5%).

Based on the evidence, the authors calculated that for average-risk people aged 50-65 years, taking aspirin daily for 10 years would cut the risk of cancer, heart attack or stroke by 7% in women and 9% in men over 15 years and lead to a 4% overall reduction in deaths over 20 years – entirely due to a reduction in cancer deaths.

They calculated that despite the increase in bleeding risk, for people in this age bracket the net benefit in reduction of deaths favoured treatment.

However, the review authors cautioned that it remains unclear what dose of aspirin is best to maximise the benefit-to-harm ratio, or whether taking aspirin longer than 10 years would result in greater benefits.

But lead author Professor Cuzick said he believed the benefits of daily aspirin would outweigh the harms for most people and the risk of bleeding could be assessed on an individual basis.

Professor Cuzick said: ‘Until our study, where we analysed all the available evidence, it was unclear whether the pros of taking aspirin outweighed the cons.’

‘Whilst there are some serious side effects that cannot be ignored, taking aspirin daily looks to be the most important thing we can do to reduce cancer, after stopping smoking and reducing obesity, and will probably be much easier to implement.’

He added: ‘The risk of bleeding depends on a number of known factors which people need to be aware of before starting regular aspirin and it would be advisable to consult with a doctor before embarking on daily medication.’

But GPs and other experts said it was still too soon to recommend people over 50 start taking aspirin.

Dr Andrew Green, chair of the GPC clinical and prescribing subcommittee, said the findings were ‘interesting’ but cautioned it would be difficult to convince individual patients of the benefits – particularly with the absence of clear information to weigh up the risks of nonfatal bleeding.

Dr Green said: ‘The difficulty, as always, is in applying changes in disease incidence within a population to the individual sat in front of us in surgery.’

He added: ‘It must also be remembered that in the real world only a minority of people have the discipline to comply with medication for a full 10 years, and as a population intervention the benefits will be less than those obtained in trials.’

Professor Willie Hamilton, professor of primary care diagnostics at the University of Exeter, said there was ‘not much difference’ between the latest research and a recent review by the National Institutes of Health Research, which drew less certain conclusions, and agreed GPs would find it difficult to start advising healthy people to take aspirin in practice.

Professor Hamilton said: ‘There’s not that much difference between the findings – just the interpretation is a bit more positive.’

Dr Julie Sharp, head of health information at Cancer Research UK, the charity is ‘funding a number of trials and research projects to make the picture clearer’.

GPS TOLD TO REVIEW ASPIRIN USE IN PATIENTS WITH ATRIAL FIBRILLATION

From the FMS Global News Desk of Jeanne Hambleton Pulse Daily Posted 18 June 2014 | By Caroline Price

GPs are to be tasked with reviewing all their patients with atrial fibrillation who are taking aspirin, under final NICE guidance published in June. This recommends anticoagulant therapy as the only option for stroke prevention in these patients.

The new guidance means GPs will need to start advising patients with atrial fibrillation who are on aspirin to stop taking it, and encourage them to take warfarin or one of the newer oral anticoagulants.

NICE said just over a fifth of the UK population with atrial fibrillation – around 200,000 patients – are currently on aspirin, many of whom should be able to be switched onto anticoagulation therapy of some sort.

GP leaders have warned that practices do not have the capacity to proactively call in patients, and suggested that changing management of this number of patients could only be achieved through incentive schemes such as enhanced services or the QOF.

But NICE advisors and CCG cardiology leads have claimed that GPs can do the reviews opportunistically over the coming year.

The final publication comes after it emerged the GPC had raised serious concerns over the complexity of the draft guidance – and warned CCGs would need to consider developing enhanced services to support GPs in delivering it.

Local GP leaders told Pulse practices would not take a systematic approach to reviewing and updating patients’ medications unless the work was specifically funded.

But Dr Matthew Fay, a GP in Shipley, Yorkshire, and member of the NICE guidelines development group, acknowledged the workload concerns and said GPs should be advised to review patients opportunistically.

Dr Fay said: ‘I think anticoagulation is an intimidating topic for clinicians – both in primary and secondary care. I would suggest one person in each practice one clinician is involved with the management of the anticoagulated patients – whether that is keeping a check on them during the warfarin clinic or being the person who initiates the novel oral anticoagulants.

‘If GPs feel uncomfortable with [managing anticoagulation] then they should be approaching the CCG executive to say, “We need a service to provide expert support for this”. The CCG may choose to come up with an enhanced service – but then whoever is providing the service needs to make sure they are well versed in use of the latest anticoagulants.’

The new guidance says GPs must use the CHA₂DS₂-VASc score to assess patients’ stroke risk and advise any patients with a score of at least one (men) or two (women) to go onto anticoagulation therapy with warfarin, or another vitamin K antagonist, or with one of the novel oral anticoagulants (NOACs) dabigatran, apixaban or rivaroxaban.

It adds that aspirin should no longer be prescribed solely for stroke prevention to patients with atrial fibrillation.

The HAS-BLED score should be used to assess patients’ risk of bleeding as part of the decision over which anticoagulant to choose.

In the only major revision to the draft guidance, aspirin is no longer to be considered even as part of dual antiplatelet therapy for patients at particularly high bleeding risk, as this combination has now also been ruled out.

STOP ASPIRIN AND CONSIDER NEWER ANTICOAGULANTS, SAYS NICE

From the FMS Global News Desk of Jeanne Hambleton Pulse Daily – Posted 1 July 2014

NICE’s guidance to stop using aspirin in AF patients is clinically sound, but comes with little sign of the necessary additional resources, finds Caroline Price

Practices will face a major drive to review all patients with atrial fibrillation who are on aspirin and switch most of them to an oral anticoagulant, after NICE published its long-awaited updated guidance on management of the arrhythmia.

All parties are agreed on the evidence behind the main recommendation of the guideline – that anticoagulation therapy should be the only option for stroke prevention – but it has sparked concerns for practices on how they will be able to implement the recommendations systematically without additional resources being made available.

It could even leave GPs with little option other than to refer patients on to secondary care, the GPC warns.

The numbers of patients affected will differ by practice, but various studies suggest 20-40% of those with atrial fibrillation across the UK – anywhere between 200,000 and 350,000 patients – are still on aspirin, 90% of whom are eligible for anticoagulation.^1-3

The guidance also adds some additional elements of complexity for GPs, advising them to adopt the CHA₂DS₂-VASc risk score instead of tholder CHADS₂ score. They should also use the unfamiliar HAS-BLED score to weigh up and then modify patients’ risk of bleeding.

The updated guidance has been warmly received by cardiology experts, mainly because it brings the NICE recommendations up to date and in line with European Society of Cardiology guidelines, published in 2010.

In particular, it draws on overwhelming evidence that anticoagulation is much more effective than antiplatelet treatment in terms of reducing stroke and all-cause mortality, while aspirin treatment is no longer considered beneficial because any effect on the risk of ischaemic stroke is offset by the harms of bleeding.^5-8

For practices, though, the workload issues are significant and will require extra resources. CCG leads estimate practices will have an average of 140 patients with atrial fibrillation on their list, of whom around 45 will be on aspirin and therefore need review and then several follow-up consultations to manage the transition to anticoagulation.

Dr Peter Scott, a GP in Solihull and GPC representative for the West Midlands, says: ‘It is not going to happen unless it’s resourced and incentivised as part of a DES or LES, or through the QOF. Until then, I don’t think a systematic approach to this will happen.’

The GPC, while welcoming the guidance, in particular the clarification of the role of aspirin, has also warned the updated recommendations will be too complex for GPs to manage within normal routine care and has called on CCGs to develop enhanced services to support the process.

Dr Andrew Green, chair of the GPC clinical and prescribing subcommittee, says unless GPs are given more resources and support, they may feel they need to refer patients to secondary care.

The scale of GPs’ task

40% – Highest estimated percentage of AF patients on aspirin

45 – Number of patients on an average practice list who will need reviewing

350,000 – Highest estimated number of AF patients on aspirin across the UK

>90% – Percentage of AF patients eligible for anticoagulation

Dr Green says: ‘I would expect GPs as part of their normal work to consider whether [atrial fibrillation] patients not on anticoagulation should be, in the light of the new guidance.

‘If they should be, then the choice is between anticoagulation with warfarin or one of the newer agents, and if GPs do not feel they have the expertise or resources to do this properly, they have a duty to refer to someone who can.’

He adds: ‘Commissioners need to predict this activity and may want to commission a service specifically for this, which is more cost-effective than a traditional outpatient referral.’

What the new AF guidance says

GPs should use the CHA₂DS₂-VASc score to assess stroke risk in patients with atrial fibrillation and offer anticoagulation to men with a score above 0, and women with a score above 1.
Offer anticoagulation therapy with warfarin, another vitamin K antagonist or one of the new oral anticoagulants – dabigatran, rivaroxaban or apixaban.
Aspirin should no longer be offered solely for stroke prevention. Only continue aspirin if a patient is on it for another reason, such as occlusive vascular disease and is at low risk of stroke, does not want to start on anticoagulation, or is advised to continue on aspirin as well as anticoagulation by a cardiologist –for example as part of dual or triple antithrombotic therapy following coronary stenting.
GPs should also use the HAS-BLED score to assess patients’ bleeding risk and then monitor and correct risk factors for bleeding, including high blood pressure, poor INR control and harmful alcohol consumption.
Patients on warfarin should now have their time in therapeutic range calculated at each visit, with dosing adjusted accordingly. If poor anticoagulation control cannot be improved, discuss an alternative anticoagulant with the patient.

Source: NICE 2014. The management of atrial fibrillation. CG180. guidance.nice.org.uk/CG180

Opportunistic review

CCG leads acknowledge they may see more referrals into secondary care, but have said GPs should be able to manage the transition with the support of networks in primary care.

Dr Chris Arden, NHS West Hampshire CCG’s lead on cardiology and a GP in Southampton, says: ‘I do think GPs may refer on to other colleagues in the community or secondary care, which is going to be something we will need to try to manage.

‘It is a real concern if everyone reacts quickly on it and you could see patients pushed into secondary care – but I don’t think that’s necessarily appropriate. I think there are colleagues within the CCG and within practices who can advise.’

Dr Matthew Fay a GP in Shipley, Yorkshire, and a member of the NICE AF guidelines development group, concedes practices may need extra help.

Dr Fay adds that GPs can look at reviewing patients opportunistically. He says: ‘I think that’s perfectly acceptable. A lot of these patients who are at risk in this situation we will be reviewing because of their hypertension and other comorbidities, and those patients on aspirin should have that discussed at the next presentation.’

Others insist CCGs need to take a more proactive approach if the work is to be prioritised. Dr John Robson, a GP in Tower Hamlets and University College London Partners primary care lead for cardiovascular disease, recently led a programme in Tower Hamlets, east London, that saw practices raise the proportion of atrial fibrillation patients on anticoagulation by 10% over two years.⁹

Education

The programme provided practices with software to identify patients on aspirin who would be suitable for anticoagulation, arranged educational sessions with local cardiologists and haematologists and also involved publishing individual practices’ performance to encourage bench-marking relative to peers.

Although the improvements in Tower Hamlets were made without financial incentives, the CCG has since introduced an enhanced service and Dr Robson says CCGs do need to set aside resources to identify patients proactively and educate GPs about the new recommendations, including the use of the newer oral anticoagulants.

Dr Robson says: ‘It does require some resource, because somebody has to organise the educational meetings and put the software tools onto practices’ computer systems. We need to make it easy for practices to do it.’

In the meantime, GPs without such support will need to take responsibility for reviewing and updating patients.

According to medicolegal advisors, practices should take steps to ensure patients are identified and reviewed, whether opportunistically or more proactively, or risk being in breach of their duty of care.

Dr Pallivi Bradshaw, a medicolegal advisor at the Medical Protection Society, says: ‘If it was found such steps had not been taken, and a patient slipped through the system, the practice could be criticised if the person went on to have a stroke. You might be able to establish there was a breach in the duty of care. That could also be the case if an individual doctor had been informed the guidance had changed and perhaps forgot to change it.’

Dr Bradshaw adds that GPs should document any decisions that depart from the NICE guidance, particularly as discussions with patients who have been on aspirin for a long time may be tricky.

She says: ‘Patients may not understand or even be scared if they are suddenly going from aspirin to an anticoagulant. GPs might need to get a second opinion from a specialist for the patient, or have a discussion with the consultant.’

How we moved most of our patients with atrial fibrillation onto anticoagulation:

Stroke risk assessment

We took a pragmatic approach and continued to use the CHADS₂ tool for routine assessment, as a score of 1 or greater is equivalent to a CHA₂DS₂-VASc score of 2 or greater. Only in cases where the patient had a CHADS₂ score of 0 did we consider using the CHA₂DS₂-VASc score, to determine if the patient was trulylow risk and did not require anticoagulation.

Bleeding risk

To assess bleeding risk, we used the SPARC tool (www.sparctool.com), or the HAS-BLED score, the use of which is now recommended in the updated NICE guidance. Bleeding risk was a great concern for GPs, and to a lesser extent patients, but even if the risk on HAS-BLED is high (a score greater than 3), if the CHA₂DS₂-VASc score is above 1 then the net clinical benefit is always in favour of an anticoagulant.

Choice of intervention

We used material produced by the Atrial Fibrillation Association extensively to assess the risks and benefits of intervention with an oral anticoagulant or no intervention, and referred patients to the association for further information and support.

Offering NOACs

Since NICE approved the use of non-vitamin K antagonist oral anticoagulants (NOACs) in 2011, we have widened the discussion with patients who are being initiated on anticoagulation so that, as well as offering either clinic-monitored warfarin or self-testing and self-managed warfarin, we also discuss the option of taking a NOAC.

Some patients who have struggled to achieve a stable therapeutic dose of warfarin, resulting in either very frequent visits to the practice-based clinic or poor time in therapeutic range (<65%), have been offered the option of changing to a NOAC. Clinicians were supported in NOAC dosing by a locally developed prescribing guide, and currently 18% of our anticoagulated patients are on a NOAC.

Dr Matthew Fay is a GP in Shipley and NICE advisor on the atrial fibrillation guidelines. He is also a medical advisor to the Arrhythmia Alliance, the Atrial Fibrillation Association and Anticoagulation Europe.

References:

Holt TA et al. Risk of stroke and oral anticoagulant use in atrial fibrillation: a cross-sectional survey.
Br J Gen Pr 2012; 62: e710-17

Murphy NF et al. A national survey of the prevalence, incidence, primary care burden and treatment of atrial fibrillation in Scotland. Heart 2007; 93: 606–612

NICE personal communication, based on IMS disease Analyzer 2012/12 and GRASP-AF database. April 2014

Estimates by CCG leads

Aguilar MI et al. Oral anticoagulants versus antiplatelet therapy for preventing stroke in patients with non-valvular atrial fibrillation and no history of stroke or transient ischemic attacks. Cochrane Database Syst Rev 2007; 3: CD006186

Mant J et al. Warfarin versus aspirin for stroke prevention in an elderly community population with atrial fibrillation (the Birmingham Atrial Fibrillation Treatment of the Aged Study, BAFTA): a randomised controlled trial. Lancet 2007; 370: 493– 503

Petersen P et al. Placebo-controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation. The Copenhagen AFASAK study. Lancet 1989; 1 :175-179

Sato H et al. Low-dose aspirin for prevention of stroke in low-risk patients with atrial fibrillation: Japan Atrial Fibrillation Stroke Trial. Stroke 2006; 37: 447-451

Robson J et al. Improving anticoagulation in atrial fibrillation: observational study in three primary care trusts. Br J Gen Pr 2014; 64: e275-e281

My comments

If you are one of these AF patients it is worth making an appointment to discuss the new anticoalgulants if these are said to be safer. My husband had a heart condition and had taken dispersable asprins for years. He died just before Christmas with a blood clot.