BBC News – Scrap plan to extend statin use, say doctorsScrap plan to extend statin use, say doctors
By Nick Triggle Health correspondent, BBC News
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Proposals to extend the use of statin drugs should be scrapped, a group of leading doctors and academics says.
The National Institute for Health and Care Excellence published draft guidance in February calling for their use to be extended to save more lives.
It could mean another five million people in England and Wales using them on top of seven million who already do.
But in a letter to NICE and ministers, the experts expressed concern about the medicalisation of healthy people.
The letter said the draft advice was overly reliant on industry-sponsored trials, which “grossly underestimate adverse effects”.
And it added: “The benefits in a low-risk population do not justify putting approximately five million more people on drugs that will then have to be taken lifelong.”
The drugs reduce levels of cholesterol in the blood, lowering the risk of a heart attack or stroke.
The signatories include Royal College of Physicians president Sir Richard Thompson and former Royal College of GPs chairwoman Clare Gerada as well as cardiologists and leading academics.
Side-effects
Prof Simon Capewell, an expert in clinical epidemiology at Liverpool University and one of the signatories, said: “The recent statin recommendations are deeply worrying, effectively condemning all middle-aged adults to lifelong medications of questionable value.
“They steal huge funds from a cash-strapped NHS and they steal attention from the major responsibilities that government and food industry have to promote healthier life choices for ourselves and our children.”
Currently, doctors are meant to offer statin tablets to the estimated seven million people who have a 20% chance of developing cardiovascular disease over 10 years, based on risk factors such as their age, sex, whether they smoke and what they weigh.
Statins and risk
• Statins are a group of medicines that can help lower rates of so-called “bad cholesterol” in the blood
• They do this by curbing the production of low-density lipoprotein cholesterol in the liver
• High rates of LDL are potentially dangerous as they can lead to hardening and narrowing of the arteries, known as atherosclerosis, which increases the risks of strokes and heart attacks
• Doctors use a risk calculator called QRisk2 to work out a person’s chance of having a stroke or heart attack to decide if they should be given statins
• The calculation factors include age, weight and smoking
• If someone has a 10-year QRisk2 score of 20%, then in a crowd of 100 people like them, on average, 20 people would get cardiovascular disease over the next 10 years
But the draft guidance suggested that people with as low as a 10% risk should be offered the treatment.
Cardiovascular disease develops when fatty substances build up in the arteries and narrow them, which can lead to heart attacks and stroke.
Too much cholesterol in the blood can lead to these fatty deposits. Statin drugs work by lowering cholesterol.
Eating a healthy diet, doing regular exercise and keeping slim will also help lower cholesterol.
Like all medicines, statins have potential side-effects. They have been linked to muscle, liver and kidney problems, but just how common these are is a contentious issue.
One of the signatories to the letter is London cardiologist Dr Aseem Malhotra, who last month had to withdraw claims he made in a British Medical Journal article that a fifth of people who use statins experience side-effects.
‘Extremely painful’
“I was prescribed Simvastatin about nine years ago following heart problems,” says John Cakebread, from Kent.
“I stopped taking the medication six years later after researching the subject on the internet and finding out about side effects.
“I have now been left with peripheral neuropathy in the feet.
“This is extremely painful.
“My GP refuses to acknowledge this condition and that it could be caused by statins.
“He still wants me to take this medication, but I have refused.”
Mike Knapton, of the British Heart Foundation, said NICE was right to want to extend the use of statins.
“Evidence shows that statins are a safe, effective, cholesterol-lowering drug and proven to lower the risk of heart disease.”
He added that, if anything, NICE should go further by looking at the lifetime risk rather than 10-year timeframe being proposed.
NICE has consulted on its draft proposals and is expected to publish final guidance at the end of July.
Prof Mark Baker, from NICE, said as well as the consultation the recommendations are being peer-reviewed.
He also pointed out that the guidance did not say patients had to go on these drugs – as GPs and patients can also discuss lifestyle changes to reduce risk – but just gave them the option of using them.
“This guidance does not medicalise millions of healthy people. On the contrary, it will help prevent many from becoming ill and dying prematurely,” he added.
6:30AM GMT 20 Mar 2013
Taking strong doses of simvastatin, atorvastatin or rosuvastatin increases the risk of being hospitalised with a condition called acute kidney injury, or AKI, by 34 per cent on average, found the Canadian team.
AKI is when the kidneys “suddenly fail to work as they should”, according to the Kidney Alliance, and causes anywhere between 62,000 and 210,000 deaths a year in Britain.
It is more common in those with long-term health conditions like heart failure, diabetes and chronic kidney disease.
Between five and seven million people take cholesterol-lowering statins in Britain, mostly over 60.
The vast majority take simvastatin, the cheapest type, although some take others including atorvastatin, better known by its brand name Lipitor, and rosuvastatin, sold as Crestor. These latter two are more potent, requiring smaller doses for the same effect.
Doctors prescribe different strengths depending on the patient’s cholesterol - the higher the level, the stronger the dose.
Researchers at the Lady Davis Institute for Medical Research in Quebec defined high-doses as 40mg+ for simvastatin, 20mg+ for atorvastatin, and 10mg+ for rosuvastatin.
After analysing the health records of two million Canadians, they found that among people without chronic kidney disease, those taking high-dose statins were at a 34 per cent increased risk of hospitalisation for AKI, compared to those taking low-dose statins.
Although this figure related to the first 120 days of treatment, the researchers said the increased risk seemed to last for two years.
Rates were not significantly increased in those who had chronic kidney disease. Their study is published in the online edition of the British Medical Journal.
Commenting in a related article in the BMJ, professors Robert Fassett and Jeff Coombes of Queensland University said more investigation was needed to find out what exactly was going on, including establishing a biological cause for the link.
Professor Donal O’Donoghue, the national clinical director for kidney care, said: "Every person on a statin needs careful assessment of their AKI risk."
He continued: "We know AKI occurs in over half a million people in the UK each year. At least 1 in 5 are due to medicines. This costs the NHS £1.3 billion per year.
"This new study shows the need to 'think kidney' when drugs are prescribed. In England there are over 55,000 excess deaths per year due to AKI – at least 12,000 are unnecessary."
But Peter Weissberg, medical director of the British Heart Foundation, said the apparent increased risk of AKI needed to be kept in proportion, because such kidney problems were “rare”.
He said: “These researchers have shown that people taking strong statins or high doses of weak statins are at increased risk of developing acute kidney injury, a serious but treatable condition.
“However, episodes of kidney damage are rare and need to be considered alongside the much larger number of heart attacks and strokes that are likely to be prevented by statins.
“It’s always important to take the lowest effective dose of any drug and most people in the UK are on low doses of statins unless there is a compelling medical reason for taking a higher dose.
“Further research is needed to establish whether it is the statins or the underlying blood vessel disease in people taking high doses that causes kidney problems.
“In the meantime, if you have concerns about your prescription, it’s important that you don’t stop taking your medication. Make an appointment with your doctor to talk it through.
