New draft guidance issued by the National Institute for Health and Care Excellence (NICE) for public consultation recommends that the threshold for starting treatment to prevent cardiovascular disease should be halved from a 20% risk of developing cardiovascular disease over 10 years to a 10% risk. The guideline is being updated to allow for a consideration of new evidence on cardiovascular disease risk assessment tools, and to reflect changes in the price and availability of generic statins.
The “hyping” of various statin trials has also had a major effect on medical thinking in this area. I have tremendous respect for NICE, but, in my personal view this recommendation is flawed. NICE is basing this guidance on an analysis of industry sponsored trials that may have exaggerated benefits while under-reporting harm. The BMJ re-analysed data from normal medical practice and concluded that harm outweighs benefits in this group of patients.
At present, it is estimated that six to seven million people in the UK take statins. The evidence for the benefit in primary prevention, i.e. preventing cardiovascular disease in people who do not have any diagnosed cardiovascular disease, is weak. Most studies, even a large randomised controlled trial like WOSCOPS (West of Scotland Prevention Study) showed no impact on overall mortality. True, there was a reduction in incidence rates of strokes and heart attacks, but no one lived longer. Most of the data on statins are presented using a reduction in relative risks, which inflates the benefit—for example, the Heart Protection Study claimed a 40% reduction in mortality from cardiovascular disease, but the reduction in overall mortality was 0.3% per year.
Even if you accept NICE’s recommendation, your chance of avoiding a “serious vascular event” such as a heart attack or a stroke is 140:1—that is, if you are healthy with a low risk of cardiovascular disease. And you have to keep taking the statins for five years.
The NICE guidance is remarkably vague about the side effects of taking statins. Mark Baker, director of the Centre for Clinical Practice at NICE, states there was no excessive need to worry about “possible serious adverse effects.” Others are far less relaxed about the risks. Because the benefits from a reduction of risk of cardiovascular disease are so small, it becomes very important to know your chance of suffering side effects. Of these, myalgia has always been a concern. But while the evidence from trials puts this at about 1%, others, especially clinicians who see patients on a daily basis, put side effects at 18%. This isn’t just unpleasant, it can seriously interfere with the ability to exercise, one of the best ways of avoiding heart disease. There is also a big debate going on about statins raising the risk of diabetes. The Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin trial (JUPITER) revealed 1 in every 100 women taking a statin risked developing type 2 diabetes at 1.9 years.
Now imagine the costs and workload of follow-up appointments and hospital investigations that patients experiencing such side effects could incur.
Perhaps more worryingly, statins provide false reassurances that may discourage patients from taking the steps that actually reduce cardiovascular disease. According to the World Health Organization, 80 % of cardiovascular disease is caused by smoking, lack of exercise, an unhealthy diet, and other lifestyle factors. Statins give the illusion of protection to many people who would be much better served, for example, by simply walking an extra 10 minutes per day.
Good medicine should always be evidence based and given to the right patient at the right time. There is no doubt that statins have an important role when it comes to the care of patients who have either had heart attacks or have been diagnosed with heart disease.
I believe that the new guidelines are not adequately supported by objective data, and that statins should not be recommended for this vastly expanded class of healthy people. I urge NICE to reconsider its position. Instead of converting millions of people into statin users, we should be focusing on the real factors that undeniably reduce the risk of heart disease: healthy diets, exercise, and avoiding smoking. This does not mean that statins should be stopped for patients who are currently taking them and have shown benefits. It’s about statins being used appropriately, in the treatment and secondary prevention of cardiovascular disease. Patients should be sceptical about the guidelines, and have a meaningful dialogue with their doctors about statins, including what the evidence does and does not show, before deciding what is best for them.
Kailash Chand has been a GP for last 30 years. He is deputy chair of the BMA council and he was on the general practitioner’s committee. He was awarded an OBE in 2010 for services to the NHS. The views he expresses in his blog posts are entirely his own.