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A new cross-sectional analysis, published in the British Journal of General Practice, reports that under the 2014 NICE guidelines, 11.8 million (37%) adults in England aged 30-84 years, require statin therapy.
Prof. Peter Sever, Professor of Clinical Pharmacology & Therapeutics, Imperial College London, said:
“These results are no surprise, but the analyses confirm around 12 million people are eligible for and would benefit from statins. NICE guidelines are in line with US guidelines, both aiming to lower risk of heart disease in those eligible for statins. For comparison one third of UK adults have high blood pressure and are recommended for blood pressure treatment. Age is a powerful determinant of heart disease risk, hence most of the elderly in the UK will meet the 10% risk threshold.”
Dr Amitava Banerjee, Senior Clinical Lecturer in Clinical Data Science and Honorary Consultant Cardiologist, UCL, said:
“The 2014 guidelines for prevention of cardiovascular disease (CVD) suggest that individuals with a risk of 10% or more in the next 10 years, should be offered statin therapy. The QRISK2 tool has been extensively validated in the UK and is arguably the best available calculator for assessing long-term risk of CVD in the UK.
“The decision to start statins is based on a combination of assessing the risk of CVD, the potential benefit of statins and the patient’s preferences, which is consistent with current NICE guidelines. This new analysis using the QRISK2 score confirms previous findings that age alone drives a large part of an individual’s risk. For example, almost all men over 60 years, and all women over 75 years would be recommended statins, based on this study, which is 37% of all adults aged 30-84 years and is higher than previous estimates.
“Clinicians and patients then need to assess the benefit of statins. We know that statins are effective in secondary prevention (stopping further events in people who already have CVD). We need to treat 28 people over the age of 65 for 5 years in order to save one life, yet 19% of eligible people are not on statins, according to this study.
“In primary prevention (people who do not have CVD) in people over 75 years old, there is still controversy as to whether statins have benefit. There is an ongoing trial (STAREE) specifically looking at statin use for primary prevention in older people in Australia which is due to report in 2020, which will give a more definitive answer. In the current study, 64% of eligible individuals were not on statins for primary prevention.
“Every decision to start statins is the balance of evidence and a patient’s preference. This study does not change my practice. In people under 75 at a high risk of heart disease, and in anyone who has had a heart attack or stroke, statins are recommended. In people over 75 who have not had a heart attack and for whom age is the only risk factor, the balance is often against the use of statins, especially in the context of multiple comorbidities, poly-pharmacy and frailty. If statins were definitively proven to have benefit in older individuals, then giving them to all the eligible people in the UK is a serious challenge to financial and human resources in the NHS. However, we do not have that knowledge of benefit for statins in people over the age of 75. In people who have a high risk of CVD by QRISK2, drug therapy is one option alongside lifestyle changes such as increasing physical activity and stopping smoking.”
Dr Gavin Sandercock, Reader in Clinical Physiology (Cardiology), University of Essex, said:
“The Q-Risk2 algorithm is correct (as far as we know) but, as age is the most important risk factor for heart disease, this means we all have a 10% risk by time we reach 70 years.
“There’s nothing wrong with the algorithm but the guidance may not be one size fits all – the evidence that statins can be of benefit for healthy older adults (over 75) isn’t as strong as it is for people who already have heart disease. There’s only very little good they can do if you start taking them when you are 75. This is because they work by reducing cholesterol, which is a risk factor for CVD. Over many years, high cholesterol in the blood can cause blocked arteries so if treated early lowering cholesterol can reduce this problem or stop it getting worse – treatment at a younger age in those at risk is therefore better than beginning treatment when elderly. A healthy 75 year old with normal cholesterol would probably get no benefit form statins. A 75 year old with high cholesterol may see a drop in cholesterol levels if they take statins, but this won’t reverse the damage. Doctors and patients are going to have to make choices to decide whether people want to spend the later years of their lives taking drugs which may have side effects and if it is really worth it.”
Prof. Rafael Perera, Professor of Medical Statistics, Nuffield Department of Primary Care Health Sciences, University of Oxford, said:
“The estimate that most of the men over 60 and women over 75 should be taking statin based on a threshold of 10% is probably correct. Our own research published in 2015 also concluded that more than nine out of ten middle-aged to elderly people would soon exceed the risk threshold in the new guidelines. This is regardless of which risk calculator is used – the choice of using the new cut-off value (10% risk) is what is important. Whether this is a good thing depends very much on the safety profile of statins. Further research, such as the StatinWISE trial, may resolve any lingering doubts about whether statins cause muscle pain, for example.”
Dr Mike Knapton, Associate Medical Director at the British Heart Foundation, says:
“This is a robust study. The results are dependent on the 2011 Health Survey for England data looking at 3000 people, extrapolated up to represent the England adult population.
“There is no question that statins lower people’s risk of heart attack and stroke. This study suggests that an estimated 6.3 million people are missing out on the potential lifesaving benefits of statins. If these people were taking statins, we could not only potentially prevent 290,000 heart attacks and strokes, but also reduce the burden of these events on both the NHS and people’s lives.
“We already know that heart attack and stroke are more common as you get older, which is why it’s so important to address risk factors at a young age. Thanks to the NHS Health Check programme, all adults over the age of 40 can have a free health check to find out if that are at risk of developing cardiovascular disease. As well as taking statins, keeping active, eating a balanced diet and not smoking are vital to lowering your risk and keeping your heart healthy.”
Prof. Naveed Sattar, Professor of Metabolic Medicine, University of Glasgow, said:
“This new research in fact tells us what we already know – that since statins are so cheap and effective, many stand to benefit from using them and so the 10% threshold is considered cost effective.
“However, there is a balance to be reached – many who are only slightly above the risk threshold of 10% may only gain small benefits in terms of life year gained free from a cardiovascular benefit from taking statins and so how the GP communicates the benefits is important. This is especially the case when statins are prescribed to more and more elderly individuals who merely because of their age are deemed at elevated risk. Whilst statins are amongst the safest medicines prescribed in any area of medicine, many do not wish to be taking tablets if their health gains are deemed to be modest at best and others are already taking lots of other medications. The 10% risk threshold recommended by NICE is therefore controversial in many people’s minds and only a minority of GPs are likely following this to the full extent. Hence, new ways to look at risk are needed e.g. lower risk thresholds in the younger individuals and higher thresholds for older individuals. In this way, more people who have more to gain (i.e. more life years free from a heart attack or stroke) from statins are recommended them.”
Prof Kevin McConway, Emeritus Professor of Applied Statistics, The Open University, said:
“Just because the algorithm for calculating the risk of a cardiovascular event over the next 10 years puts that risk at over 10% for almost all males aged 60-74, and for a majority of women in that age group too, that doesn’t mean that it’s incorrectly calibrated.
“I’ll be personal here. I’m 66, and according to the official life tables put out by Britain’s Office for National Statistics, the risk of death in the next 10 years for an average man of my age is about 18%. None of us lives forever, and, despite all the medical advances and increases in life expectancy, well, I am still getting on a bit. More than one in four of deaths of men in my age group in the UK are from cardiovascular disease. The risk calculated by the algorithm is of all cardiovascular events, not just those that lead to a death. So I’m well aware that the risk of a cardiovascular event in the next 10 years for an average man of my age is over 10%. That’s about averages, but (for example) the charts published by Heart UK (see http://heartuk.org.uk/healthcare-professionals/resources-and-publications/risk-charts), which relate the risk to age, smoking, blood pressure and cholesterol levels, and use a different risk algorithm, also put the 10 year risk at over 10% for all men aged 60 and over, and for most women.
“Actually the key question here for me is not about the risk algorithm, but about whether the NICE advice makes sense. If someone’s 10 year risk of a cardiovascular event is over 10%, but not by much, below the old guideline of 20%, is the balance between the health gains from the statins and the risk of possible adverse effects, taking into account the cost of the drugs, in favour of them taking the statins? NICE thinks it is, though it does very clearly recommend that statins should be offered only after a full discussion between the patient and their doctor, taking into account personal circumstances, other ways that cardiovascular risk might be reduced, and the risks and benefits involved. Personally I agree with NICE on this (and I do take statins daily myself, for what that’s worth – my personal circumstances are my own and others will differ), though I do acknowledge that there remains some controversy about these recommendations. The authors of this paper are right to point out that there are resource implications for GPs (and others), but it’s no secret that there are costs associated with keeping us older people healthy.”
Dr James Rudd, HEFCE Senior Lecturer in Cardiovascular Medicine, and Consultant Cardiologist, University of Cambridge, said:
“This analysis is important because it has wide implications for UK patients and their GPs. What’s new here is the point that a person’s age is a big driver of heart attack risk – and that’s obviously not modifiable. We know that taking a daily statin tablet lowers the chance of having a heart attack by about a quarter. When combined with lifestyle changes like exercising 5 days a week, not smoking and eating a healthy diet, this benefit is magnified.
“The study has limitations though – it’s based on incomplete, historic data from 2011. And statins will not suit everyone identified as high risk by the QRISK calculator – a discussion with a health professional is needed before starting.”
Dr Tim Chico, Reader in Cardiovascular Medicine / consultant cardiologist, University of Sheffield, said:
“This paper does not suggest that we should be treating more people with statins, so it would be a mistake to take it as a message that more people will be on statins, or that doctors are planning to change their practice to offer this treatment more widely.
“The NICE guidance in 2014 suggested it would be reasonable to offer statins to people whose risk of heart disease in the next 10 years was 10% or more. This caused a huge uproar, with some commentators decrying the supposed ‘medicalisation’ of society, and looking back it is clear that this hysteria was unjustified. In my view the guidelines were simply a sensible suggestion about when to talk to patients about the pros and cons of statins, not an attempt to force these on people. We already knew that if the 2014 guidelines were applied to everyone, this would make a lot more people ‘eligible’ for statins, but just because someone is ‘eligible’ does not mean that they will or should be prescribed these drugs. Many people whose risk is estimated at 10% or above are not given statins, and it is important that any treatment decision is a joint one between patient and doctor.
“It is very hard to predict who will suffer heart disease, and every day I see people who have suffered life-threatening heart attacks without any warning, so we should all be doing what we can to reduce our risk and drug treatment is only part of this.
“There are a lot of very simplistic messages circulating about how to reduce heart disease, when it is a far more complex issue than these admit. The truth is that any single drug, diet, or lifestyle alteration cannot completely protect against heart disease. To realistically reduce risk of heart disease needs us to change many things, such as stopping smoking, more exercise, a better diet, improvements to working patterns and social behaviours, less traffic pollution, and for some people drug treatment (cholesterol or blood pressure lowering) is an important part of this multi-pronged approach to reducing heart disease.”
Prof. Mark Baker, Director of the Centre for Guidelines at NICE, said:
“Heart disease and stroke are largely age-related, killing 1 in 3 of us and disabling many more. To make progress in the battle against heart disease and stroke, we must encourage exercise, improve our diets still further, stop smoking, and where appropriate offer statins to people at risk. Their use in people who have established cardiovascular disease is not controversial. Their use to prevent the development of cardiovascular disease in well people is a more recent role but is equally widespread and robustly evidence-based.
“NICE’s guidance on reducing cholesterol recommends that doctors should offer statins to people with a 10% risk of developing cardiovascular disease over 10 years. The purpose is to reduce further the numbers of people suffering heart attacks and strokes.
“But people, including older people, should not take statins instead of making the lifestyle adjustments that those at risk of cardiovascular disease need to make – such as stopping smoking, being more active, drinking less alcohol, eating more healthily and losing weight.”
* ‘Application of the 2014 NICE cholesterol guidelines in the English population: a cross-sectional analysis’ by Peter Ueda et al. published in the British Journal of General Practice on Tuesday 1 August 2017.
Declared interests
Prof. Peter Sever: “Peter Sever has received consultancies from Pfizer and Amgen.”
Dr Amitava Banerjee: “No conflicts of interest.”
Dr Gavin Sandercock: “No conflicts to report.”
Prof. Rafael Perera: “Rafael Perera is Professor of Medical Statistics in the Nuffield Department of Primary Care Health Sciences in the University of Oxford and Fellow of St Hugh’s College. He has received funding for his research from the National Institute for Health Research (NIHR) Health Technology Assessment Programme, NIHR Research for Patient Benefit Programme, the UK Medical Research Council, and the Wellcome Trust. Currently he is PI on an NIHR funded Programme of Applied Research studying long-term monitoring in primary care and is deputy-lead on the multimorbidity theme of the NIHR Oxford Biomedical Research Centre based at Oxford University Hospitals NHS Trust and University of Oxford. He has collaborated with Professor Clarke (co-author in the reviewed BJGP paper) in the past on a related project funded by the NIHR HTA.”
Prof. Naveed Sattar: “I was Chair of the SIGN (Scottish Intercollegiate Guidelines Network) guideline on CVD prevention. Consulted for AMGEN and Sanofi.”
Prof. Kevin McConway: “I do take statins, and I live in England and am in the age group to which this applies, but apart from that I have no interests to declare.”
Dr James Rudd: “No conflicts of interest.”
Dr Tim Chico: “I am a committee member and Treasurer of the British Atherosclerosis Society, a charity established in 1999 to promote UK atherosclerosis research.”
None others received.