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GPs to manage millions more patients on statins as NICE halves primary prevention threshold to 10%

Millions more patients without cardiovascular disease could be placed on statins by GPs, under draft guidance from NICE that reduces the risk threshold for primary prevention with the drugs to 10%.

The guidelines on lipid modification - put out for consultation today - recommend GPs start patients on high-intensity statin treatment if they have a 10% or more risk of CVD in the next 10 years, rather than the previous target of 20%.

The draft guidelines recommend that atorvastatin 20 mg is used as the preferred initial treatment option in patients identified as high risk, replacing simvastatin.

Experts say the move could double the number of patients taking statins – currently seven million people – and would extend treatment to younger patients.

It follows US guidelines on cardiovascular risk assessment – which recommended a statin threshold of 7.5% 10-year CV risk – and came under fire for making a third of the 40-79 CVD-free population eligible for high-intensity statin treatment. 

NICE said they had calculated treating people with a 10% predicted risk with atorvastatin 20 mg would be cost-effective when compared with using lower intensity statins or no treatment at all, with a cost per quality-adjusted-life-year gained of £12,000, when compared with simvastatin 20 mg.

The draft guidance recommends: ‘Offer high-intensity statin treatment for the primary prevention of CVD to people who have a 10% or greater 10-year risk of developing CVD.’

NICE advisers also ruled out the introduction of a lifetime risk calculator, which the Joint British Societies are currently developing and are due to recommend in guidelines to be published later this year.

The major rewrite of the lipid modification guideline also outlined other major changes, including:

  • Using the QRISK2 risk tool to assess CVD risk for primary prevention, or the UKPDS risk tool in people with type 2 diabetes – the Framingham risk equation is no longer recommended
  • Considering switching patients from a low- or medium-intensity statin onto a high-intensity statin at medication review
  • Starting statin treatment in people with established CVD with atorvastatin 80 mg
  • Considering people aged 85 or older to be at risk because of age alone, rather than 75 or older as previously, because the QRISK2 score goes up to age 85
  • Removing the need for fasting bloods –a fasting sample is not needed for non-HDL cholesterol measures

GP cardiovascular medicine experts were split on the guidance, saying that it would be a lot of work for practices as many more patients would now require statin treatment.

Dr Matthew Fay, GPSI in cardiology in Bradford said: ‘In my opinion, anything that makes GPs more aggressive in the treatment of cardiovascular disease has to be a good thing. We’re not aggressive enough, I think we’re too accepting of just “acceptable” blood pressures and cholesterols.’

Dr Terry McCormack, a GP in Whitby and secretary of the British Society of Hypertension said the threshold was low and would result in many more people being treated who may not benefit.

But he added: ‘This means that more people in their 40s and 50s are going to eligible. The thing about the 20% [threshold] is that at a certain age you’re almost guaranteed to be 20% anyway. I’d much rather treat someone in their 50s when they’ve got years to go.’ Read Dr McCormack’s full comments here.

Dr Des Spence, a GP in Glasgow, said NICE had ‘lost its way’ and the move would lead to over-medicalisation of the population.

He said: ‘Why bother with the pretence, statins for all. Cholesterol is no longer a risk factor but now a full blown disease. Champagne corks are popping across the pharma industry with a NICE-endorsed marketing jackpot.’

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Readers' comments (33)

  • This country is blindly following the Americans! Just like we did in McDonaldisation and Coke! As we did in trying to escape to the Moon....
    Do any of these people writing NICE guidelines study or understand human physiology??

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  • Human physiology or psychology? I'm with Spence on this one, both in his views on over medicalisation and NICE giving big pharma a jackpot. The only thing I welcome here is that this targets the younger population who have marginally to gain from using statins. I am fed up of going round the care homes on my patch crossing statins off the drug regimes of 80odd year olds...

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  • I presume NICE members have signed a "no conflict of interest" declaration. Have they?

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  • Abdul QADRI

    It must good news for Statin manufacturing pharmaceutical companies. Nice guidelines have become a joke. One minute simavastatin is good and recommended as no 1 & next minute Atorvastatin is idle as no 1 since USA have said so. It is ironic that a prominent American Cardiac Surgeon question the need of Statin use. Make up your own mind. Here is the article to refresh your memory :

    Heart surgeon speaks out on what really causes heart disease

    Dr. Dwight Lundell
    PreventDisease
    We physicians with all our training, knowledge and authority often acquire a rather large ego that tends to make it difficult to admit we are wrong. So, here it is. I freely admit to being wrong. As a heart surgeon with 25 years experience, having performed over 5,000 open-heart surgeries, today is my day to right the wrong with medical and scientific fact.
    I trained for many years with other prominent physicians labelled "opinion makers." Bombarded with scientific literature, continually attending education seminars, we opinion makers insisted heart disease resulted from the simple fact of elevated blood cholesterol.

    The only accepted therapy was prescribing medications to lower cholesterol and a diet that severely restricted fat intake. The latter of course we insisted would lower cholesterol and heart disease. Deviations from these recommendations were considered heresy and could quite possibly result in malpractice.

    It Is Not Working!

    These recommendations are no longer scientifically or morally defensible. The discovery a few years ago that inflammation in the artery wall is the real cause of heart disease is slowly leading to a paradigm shift in how heart disease and other chronic ailments will be treated.

    © n/a
    We physicians with all our training, knowledge and authority often acquire a rather large ego that tends to make it difficult to admit we are wrong. So, here it is. I freely admit to being wrong. As a heart surgeon with 25 years experience, having performed over 5,000 open-heart surgeries, today is my day to right the wrong with medical and scientific fact.

    I trained for many years with other prominent physicians labelled "opinion makers." Bombarded with scientific literature, continually attending education seminars, we opinion makers insisted heart disease resulted from the simple fact of elevated blood cholesterol.

    The only accepted therapy was prescribing medications to lower cholesterol and a diet that severely restricted fat intake. The latter of course we insisted would lower cholesterol and heart disease. Deviations from these recommendations were considered heresy and could quite possibly result in malpractice.

    It Is Not Working!

    These recommendations are no longer scientifically or morally defensible. The discovery a few years ago that inflammation in the artery wall is the real cause of heart disease is slowly leading to a paradigm shift in how heart disease and other chronic ailments will be treated.

    The long-established dietary recommendations have created epidemics of obesity and diabetes, the consequences of which dwarf any historical plague in terms of mortality, human suffering and dire economic consequences.

    Despite the fact that 25% of the population takes expensive statin medications and despite the fact we have reduced the fat content of our diets, more Americans will die this year of heart disease than ever before.

    Statistics from the American Heart Association show that 75 million Americans currently suffer from heart disease, 20 million have diabetes and 57 million have pre-diabetes. These disorders are affecting younger and younger people in greater numbers every year.

    Simply stated, without inflammation being present in the body, there is no way that cholesterol would accumulate in the wall of the blood vessel and cause heart disease and strokes. Without inflammation, cholesterol would move freely throughout the body as nature intended. It is inflammation that causes cholesterol to become trapped.

    Inflammation is not complicated -- it is quite simply your body's natural defence to a foreign invader such as a bacteria, toxin or virus. The cycle of inflammation is perfect in how it protects your body from these bacterial and viral invaders. However, if we chronically expose the body to injury by toxins or foods the human body was never designed to process,a condition occurs called chronic inflammation. Chronic inflammation is just as harmful as acute inflammation is beneficial.

    What thoughtful person would willfully expose himself repeatedly to foods or other substances that are known to cause injury to the body? Well, smokers perhaps, but at least they made that choice willfully.

    The rest of us have simply followed the recommended mainstream diet that is low in fat and high in polyunsaturated fats and carbohydrates, not knowing we were causing repeated injury to our blood vessels. This repeated injury creates chronic inflammation leading to heart disease, stroke, diabetes and obesity.

    Let me repeat that: The injury and inflammation in our blood vessels is caused by the low fat diet recommended for years by mainstream medicine.

    What are the biggest culprits of chronic inflammation? Quite simply, they are the overload of simple, highly processed carbohydrates (sugar, flour and all the products made from them) and the excess consumption of omega-6 vegetable oils like soybean, corn and sunflower that are found in many processed foods.

    Take a moment to visualize rubbing a stiff brush repeatedly over soft skin until it becomes quite red and nearly bleeding. you kept this up several times a day, every day for five years. If you could tolerate this painful brushing, you would have a bleeding, swollen infected area that became worse with each repeated injury. This is a good way to visualize the inflammatory process that could be going on in your body right now.

    Regardless of where the inflammatory process occurs, externally or internally, it is the same. I have peered inside thousands upon thousands of arteries. A diseased artery looks as if someone took a brush and scrubbed repeatedly against its wall. Several times a day, every day, the foods we eat create small injuries compounding into more injuries, causing the body to respond continuously and appropriately with inflammation.

    While we savor the tantalizing taste of a sweet roll, our bodies respond alarmingly as if a foreign invader arrived declaring war. Foods loaded with sugars and simple carbohydrates, or processed with omega-6 oils for long shelf life have been the mainstay of the American diet for six decades. These foods have been slowly poisoning everyone.

    How does eating a simple sweet roll create a cascade of inflammation to make you sick?

    Imagine spilling syrup on your keyboard and you have a visual of what occurs inside the cell. When we consume simple carbohydrates such as sugar, blood sugar rises rapidly. In response, your pancreas secretes insulin whose primary purpose is to drive sugar into each cell where it is stored for energy. If the cell is full and does not need glucose, it is rejected to avoid extra sugar gumming up the works.

    When your full cells reject the extra glucose, blood sugar rises producing more insulin and the glucose converts to stored fat.

    What does all this have to do with inflammation? Blood sugar is controlled in a very narrow range. Extra sugar molecules attach to a variety of proteins that in turn injure the blood vessel wall. This repeated injury to the blood vessel wall sets off inflammation. When you spike your blood sugar level several times a day, every day, it is exactly like taking sandpaper to the inside of your delicate blood vessels.

    While you may not be able to see it, rest assured it is there. I saw it in over 5,000 surgical patients spanning 25 years who all shared one common denominator -- inflammation in their arteries.

    Let's get back to the sweet roll. That innocent looking goody not only contains sugars, it is baked in one of many omega-6 oils such as soybean. Chips and fries are soaked in soybean oil; processed foods are manufactured with omega-6 oils for longer shelf life. While omega-6's are essential -they are part of every cell membrane controlling what goes in and out of the cell -- they must be in the correct balance with omega-3's.

    If the balance shifts by consuming excessive omega-6, the cell membrane produces chemicals called cytokines that directly cause inflammation.

    Today's mainstream American diet has produced an extreme imbalance of these two fats. The ratio of imbalance ranges from 15:1 to as high as 30:1 in favor of omega-6. That's a tremendous amount of cytokines causing inflammation. In today's food environment, a 3:1 ratio would be optimal and healthy.

    To make matters worse, the excess weight you are carrying from eating these foods creates overloaded fat cells that pour out large quantities of pro-inflammatory chemicals that add to the injury caused by having high blood sugar. The process that began with a sweet roll turns into a vicious cycle over time that creates heart disease, high blood pressure, diabetes and finally, Alzheimer's disease, as the inflammatory process continues unabated.

    There is no escaping the fact that the more we consume prepared and processed foods, the more we trip the inflammation switch little by little each day. The human body cannot process, nor was it designed to consume, foods packed with sugars and soaked in omega-6 oils.

    There is but one answer to quieting inflammation, and that is returning to foods closer to their natural state. To build muscle, eat more protein. Choose carbohydrates that are very complex such as colorful fruits and vegetables. Cut down on or eliminate inflammation- causing omega-6 fats like corn and soybean oil and the processed foods that are made from them.

    One tablespoon of corn oil contains 7,280 mg of omega-6; soybean contains 6,940 mg. Instead, use olive oil or butter from grass-fed beef.

    Animal fats contain less than 20% omega-6 and are much less likely to cause inflammation than the supposedly healthy oils labelled polyunsaturated. Forget the "science" that has been drummed into your head for decades. The science that saturated fat alone causes heart disease is non-existent. The science that saturated fat raises blood cholesterol is also very weak. Since we now know that cholesterol is not the cause of heart disease, the concern about saturated fat is even more absurd today.

    The cholesterol theory led to the no-fat, low-fat recommendations that in turn created the very foods now causing an epidemic of inflammation. Mainstream medicine made a terrible mistake when it advised people to avoid saturated fat in favor of foods high in omega-6 fats. We now have an epidemic of arterial inflammation leading to heart disease and other silent killers.

    What you can do is choose whole foods your grandmother served and not those your mom turned to as grocery store aisles filled with manufactured foods. By eliminating inflammatory foods and adding essential nutrients from fresh unprocessed food, you will reverse years of damage in your arteries and throughout your body from consuming the typical American diet.

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  • As a patient I will not be taking statins, simply because I don't trust NICE to recommend things which are good for me, and I suspect they are in the pay of Big Pharma. I have enough problems with pain from my M.E. without them being made worse.

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  • Deep gasp! There can be only 2 explanations here,
    1. An irresponsible blind idiotic blinkered decision yet again by an out of touch clinical organisation with not an ounce of common sense on health economics .
    2 . Some dark back room political deal with giants of the pharmaceutical world at the highest level .


    Well , that puts me within the 10% bracket at my age , personally I have seen enough over the years with adverse reactions to statins to make a clear decision to prescribe them with caution . Odd situation isn't it when patients ask me "would you take them doctor " where the clear answer is No !

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  • Deep gasp! There can be only 2 explanations here,
    1. An irresponsible blind idiotic blinkered decision yet again by an out of touch clinical organisation with not an ounce of common sense on health economics .
    2 . Some dark back room political deal with giants of the pharmaceutical world at the highest level .


    Well , that puts me within the 10% bracket at my age , personally I have seen enough over the years with adverse reactions to statins to make a clear decision to prescribe them with caution . Odd situation isn't it when patients ask me "would you take them doctor " where the clear answer is No !

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  • I spent a happy hour playing with the QRISK2 calculator. A 60 year old male, 6 ft tall and 13 stone, no diabetes, no premature family history, systolic bp 125 and cholesterol ratio of 5:1 would, by these criteria, need to be on a statin.

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  • We have to be careful here. Someone above wrote: "Big Pharma to win again! ". The doubt is casted. Others may question the "medicalization" of the Western Society. I add that side effects -of medications in general- are under-reported and seldom cholesterol is "the only problem". In parallel, we are already fully aware of pandemic obesity and ageing population, where age per se does bring a cardiovascular risk above the 10% . With limited resources, where the wise man would spend the money: in prevention starting, from VERY young age investing in education, exercise, and healthy meals, or administering lifetime pills to virtually everybody, no matter if still smoking and/or eating in excess and/or not exercising enough? I know what I would like for my children, and I know you know as well.

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  • Oh help! NICE ARE SO UNBELIEVABLE. And statins increase the risk of diabetes too. I think I have done more good by recognising that statins have caused someone's: sleep disturbance or depression or memory loss or generalised weakness and feeling old!! Should we start reporting EVERY time we stop it for whatever reason? I shall start immediately even if not life threatening. Maybe we can get NICE to back track like they have with paracetamol. I give up.

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