"Doctors have been told to offer cholesterol-lowering statins to millions more people," BBC News reports.
New guidelines from the National Institute for Health and Care Excellence (NICE) recommend lowering the bar for statin use in adults at risk of heart disease.
NICE suggests up to 8,000 lives could be saved every three years if everyone with a 10% risk of developing cardiovascular disease within the next 10 years is offered one of the widely used cholesterol-lowering medications.
NICE says the evidence clearly shows statins are safe and effective and would be a good use of healthcare resources if given to these people.
The announcement has been met with a variable response, with the Daily Mail saying up to half of all adults could now be eligible for the drugs, and that, "GPs warn of chaos" at being "told to trawl medical records to find at-risk patients".
On the other side of the argument, Professor Baker, director of the Centre for Clinical Practice at NICE, says the new recommendations would not create an additional workload for GPs.
On the NICE website, he said: "Most patients will already be under surveillance by their GPs, so this won't add any additional workload. But you can do the QRISK2 risk assessment yourself. It can be done online or via an app, so it doesn't need to be done by the GP."
You can assess your own risk online using a risk assessment tool based on factors such as smoking history, body mass index (BMI) and family history of heart disease.
The NICE guidelines have now been published, which means they will come into effect in the NHS in England. However, NICE still recommends preventable lifestyle measures, such as losing weight or stopping smoking, are addressed first before starting statin treatment.
Ultimately, the decision to take a statin – even if it is recommended – will always remain a choice that sits with the patient.
What are statins?
Statins are usually the first medication of choice to reduce the levels of low-density lipoprotein (LDL, or "bad") cholesterol in the blood.
Cholesterol and other fatty substances can build up and clog the arteries in the heart and elsewhere in the body, leading to cardiovascular diseases. Reducing cholesterol levels helps reduce the risk of cardiovascular events such as heart attack or stroke.
What is NICE recommending?
NICE has published an update to its previous clinical guideline on the cardiovascular risk assessment and management of lipids (fats in the blood, which includes cholesterol and triglycerides) in people who either already have cardiovascular disease (such as those who've had a heart attack or stroke), or people who are at risk of developing cardiovascular disease.
The main new recommendations are that:
- A systematic strategy should be used in general practice to identify people who are likely to be at high risk for developing cardiovascular disease (CVD).
- People should be prioritised for a full risk assessment if their estimated 10-year risk of CVD is 10% or more (using the QRISK2 assessment tool).
- Before starting lipid-lowering medications for the prevention of CVD, at least one blood sample should be taken to measure total cholesterol, high-density lipoprotein (HDL, or "good") cholesterol, non-HDL cholesterol, and triglyceride concentrations.
- In people who have a 10% or greater risk of developing CVD within the next 10 years, the recommended statin to start treatment with is atorvastatin, given at a dose of 20mg daily.
- In people who already have established CVD (people who have heart disease or have had a stroke), the recommended starting dose of atorvastatin is 80mg daily (unless there are side effects or other contraindications).
For people at risk of developing CVD within the next 10 years, the recommendations to start 20mg atorvastatin applies to adults of all ages, including people over the age of 85 years (in very elderly people, statins may reduce the risk of a non-fatal heart attack). This advice stands unless there are other health-related factors that make statin treatment inappropriate.
NICE does make several important provisions around decisions to start treatment for the prevention of CVD in people considered to be at risk.
These are outlined below.
The decision whether to start a statin should be made after an informed discussion between the doctor and patient about the risks and benefits of treatment, taking into account factors such as:
- possible benefits from lifestyle modifications (measures that could be tried first before starting a statin, such as exercising more, eating a healthier diet and stopping smoking)
- patient preference
- other medical illnesses
- the problems of adding another tablet if the person is already taking a lot of daily medications
- general frailty and life expectancy
Before starting statin treatment, assessment should be made into other health and lifestyle factors that may need management, including:
- smoking and alcohol consumption
- blood pressure
- kidney or liver disease
The benefits of optimising all other modifiable lifestyle risk factors (for example, overweight/obesity or smoking) should be discussed, and people offered support for this if needed, such as exercise referral programmes.
Statin treatment may then be considered if lifestyle modifications don't work.
What is the rationale for lowering the threshold for the drugs?
Currently, one-third of deaths in the UK are caused by cardiovascular disease, accounting for around 180,000 deaths each year.
Cardiovascular disease is well known to have a significant burden of disability. It is believed £8 billion of healthcare resources are tied up in the disease.
Professor Mark Baker, director of the Centre for Clinical Practice at NICE, says: "Doctors have been giving statins to 'well people' since NICE first produced guidance on this in 2006. We are now recommending the threshold is reduced further.
"The overwhelming body of evidence supports their use, even in people at low risk of CVD. The effectiveness of these medicines is now well proven and their cost has fallen. The weight of evidence clearly shows statins are safe and cost effective for use in people with a 10% risk of CVD over 10 years."
Dr Anthony Wierzbicki, from Guy's and St Thomas' Hospitals, London, and chair of the Guideline Development Group, also commented on the new guidance: "We've been able to simplify the guideline so it's now much easier for patients to be assessed and for GPs and nurses to make sense of the results. There is greater clarity, a simpler framework, and a systematic way of identifying people who could benefit from treatment.
"We've got the best evidence base, huge numbers, and the biggest set of clinical trials ever done. Other areas of medicine would give their teeth for this evidence, it's that good. Statins work, they are very cheap, and are becoming considerably cheaper as they come off-patent, which, in a cost-limited health service, is a big consideration.
"That enables us to actually say that we should treat people with heart disease a lot more intensively because we know that will prevent further events. In people with diabetes or kidney disease, giving a statin will reduce heart attacks and strokes. For people at risk of heart disease, if lifestyle measures fail, we have a second option of giving them a statin if they want and require it."
Are there any risks or side effects with statins?
Statins are fairly safe drugs, though there are a range of possible side effects and groups of people who should use them with caution. This includes people with an underactive thyroid, kidney disease and liver disease. Women should also not take statins while pregnant or breastfeeding.
Possible side effects include headaches and dizziness, sleep disturbances, fatigue, tummy disturbances, altered sensation, and sensitivity reactions such as rash or itching.
Very rarely, statins have been associated with the risk of having a toxic effect on the muscles, causing muscle pain and weakness, and even a serious condition called rhabdomyolysis, where the muscle fibres start to break down.
However, the risks and benefits would be discussed and taken into account for any individual before a statin is prescribed, including their personal and family medical history.
How has the announcement been received by the media?
As the BBC News headline indicates, NICE's decision has been met with controversy.
Professor Mark Baker, the director of the Centre for Clinical Practice at NICE is quoted as saying: "Prevention is better than cure. One of the mainstays of modern medicine is to use treatments to prevent bad things happening in the future. It's why we use vaccines and immunisation to prevent infectious disease, it's why we use drugs to lower blood pressure to prevent heart attacks, strokes, and kidney disease, and it's why we're using statins now."
Meanwhile, in opposing camps there is debate about "medicalising" a nation and encouraging people to just pop a pill rather than following a healthy lifestyle.
The British Medical Association's General Practitioner Committee is quoted as saying: "There is insufficient evidence of significant overall benefit to low-risk individuals to allow GPs to have confidence in the recommendation. The measure would distort health spending priorities and disadvantage other patients."
However, as quoted in the Daily Mail, Professor Baker responded: "It is ludicrous to suggest that we are overmedicalising the population when the whole point of using modern, safe and effective drugs in an economic way is to prevent bad things happening in the future."
Dr Chaand Nagpaul, chair of the British Medical Association's GP committee, feels NICE has not taken into account the additional pressures they'll be placing on GPs. "In making their decision, NICE has failed to take the current pressures on general practice into account, and the further impact this will have on already overstretched GPs and those patients requiring treatment for other illnesses."
Despite the extensive debate and opposition, as BBC News also highlights, the 10% threshold for statin treatment is comparable to that already used in other European countries.
As the president of the Academy of Medical Sciences, Professor Sir John Tooke, points out on the BBC News website: "Whether or not someone takes drugs to diminish their risk is a matter of personal choice, but it must be informed by accurate information on the balance of risk and benefit in their particular case. The weight of evidence suggests statins are effective, affordable and have an acceptable risk-benefit profile."
Despite somewhat hysterical media coverage to the contrary ("millions more to be given statins," according to the Daily Express), nobody will be forced to take statins.
If your GP does recommend statins, you should ask them to explain the benefits and risks for you personally of starting statin treatment. You may want to find out more about statins before making up your mind – the NHS Choices Health A-Z information on statins is a good place to start.
If you do experience troublesome side effects while taking statins, contact your GP or the doctor in charge of your care. It could be the case that adjusting your dosage or switching to a different type of statin could help relieve any side effects.