Statins, the cholesterol-busting drugs already taken by 7 million people in England, should be offered to millions more who have only a low risk of heart disease or stroke, new NHS guidance says.
The National Institute for Health and Care Excellence (Nice) says in draft guidance which now goes out to consultation that the threshold for GPs to prescribe statins to their patients should be cut in half. At the moment they are given to those with a 20% risk of cardiovascular disease, but Nice says that should be reduced to 10%.
The plan is applauded by some doctors and heart disease charities but criticised by other experts, who warn that the drugs have side-effects – which can include muscle pains, memory loss and erectile dysfunction – and may not be as effective as is claimed.
They are also concerned that GPs will hand out pills instead of tackling the root causes of heart attacks and strokes by encouraging people to stop smoking, reduce their drinking, eat more healthy food and take more exercise.
Cardiovascular disease is still the leading cause of deaths in the UK, responsible for one in every three, even though the numbers have halved since the 1970s and 1980s. In 2010, about 80,000 deaths were caused by cardiovascular disease and 49,000 by strokes. Both conditions also cause a great deal of long-term damage and ill-health to people who survive.
The original Nice guidance was produced in 2008. Since then, the institute says, the cost of the pills has dropped – they are no longer under patent – and there has been further evidence that they prevent disease. Nice also agrees that the best prevention is a healthy lifestyle, and wants people at risk to be advised to eat fewer foods containing saturated fat, such as meat, cheese and butter, consume less sugar, to stop smoking and exercise more. “Smoking, high blood pressure and raised cholesterol levels are big causes of cardiovascular disease, especially in people with more than one of the factors,” said Prof Mark Baker, director of the centre for clinical practice at Nice. “But the risk is measurable and we can substantially reduce someone’s chance of a heart attack, angina, stroke and the other symptoms of cardiovascular disease by tackling the risk factors. People should be encouraged to address lifestyle factors including smoking, drinking too much or eating unhealthily.”
In addition, he says, they “recommend that statins are now offered to many more people – the effectiveness of these medicines is now well proven and their cost has fallen”.
However, some doctors believe that the benefits of statins have been overstated, particularly for the lowest-risk group.
“The overwhelming majority of people in this category are not going to benefit,” said cardiologist Aseem Malhotra. “Real world data [as opposed to clinical trials] tells us that one in five people will suffer a side-effect that is unacceptable.”
Those side-effects could include muscle pains, memory loss and erectile dysfunction, he said. Some people on the drugs also develop type 2 diabetes.
John Abramson, senior lecturer in the department of healthcare policy at Harvard medical school, said the trials on statins did not show that they prevented deaths. They also prevented only a small number of heart attacks and strokes, he said.
“You have to treat 345 people at that level of risk (10%) for a year to prevent one heart attack,” he said. “If you add in stroke, you have to treat 265 people for a year to prevent a heart attack or a stroke.”
The full data on the efficacy and the side-effects of statin treatment was not publicly available, he said, because all the trials were funded by drug companies and they had not released the figures.
It is important, he said, that the patient should make the decision that is right for him or her, weighing up the benefits of the drugs against the side-effects and also considering the other option – to get fitter and healthier.
If lifestyle modification were a drug, it would have considerable benefits over statins and be free of side-effects apart from a possible occasional athletic injury, he pointed out.But other experts supported the move to increase the numbers of people on statins.
The British Heart Foundation’s medical director, Prof Peter Weissberg, said: “Reducing your cholesterol level, whether that’s through medication or lifestyle changes, will reduce your risk of cardiovascular disease … as most people who have a heart attack or stroke have average cholesterol levels and since statins are now much cheaper it makes sense to reconsider the threshold.”