Colin Baigent: Wider statin use saves lives

Introduction to The Cholesterol Treatment Trialists Collaboration

Over the last decade or two, we have been very successful in reducing mortality from heart disease and strokes and part of that has been because we gradually developed better drugs and one of those drugs has been the statin class of drugs, which lowers cholesterol. Now, currently statins are used very widely in people with heart disease, and who have had a stroke. And they're also offered typically to people who are known to be at increased risk of heart attack or stroke. Typically, the threshold level is greater than 20% risk over about 10 years. And so that is the policy that we currently have. But the problem that we have is that over half of deaths from coronary disease silica in people who've had no previous problems and so it comes out of the blue. So if we're going to do better with that type of person, then we have to consider offering drugs for prevention to healthy people, and that was what we were aiming to look into with the current project.

The Study

We over the last 20 years have accumulated data from around 27 trials involving about 175,000 people and we have an unparalleled level of detail on each of the patients in these trials. What we were able to do was use that information to predict their risk of having a heart disease or stroke, within the trials. What we thought we would do with this particular project would be to try to look at the people with a very lowest risk of heart disease and stroke. So, we did some statistical calculations and subdivided people into those who are very lowest risk, those were slightly highest risk, and so forth until we got to the very highest risk people. All in all, there were five categories of people. What we then did was calculate how effective statin therapy was in each of those groups of people. So obviously, the very lowest risk people had no previous history of any heart disease or stroke and the very highest risk people had a history of vascular disease. What we discovered was that in the very lowest risk people statins were clearly effective, and possibly even more effective than they were in the highest risk people. And what we also discovered was that the benefits of statin therapy in those really lowest risk people was still very much bigger than any known hazards of therapy.

Outcomes from the Study

We think there has been quite a bit of confusion about whether statins are effective in people who are healthy. These data are incontrovertible evidence that statins are effective and they are safe, even at the very lowest risk people. It is very important to realise that somebody can be at increased risk of heart disease or stroke but actually have average cholesterol. And what we know from the trials is that people with average cholesterol, who are increased risk will be better off with lower cholesterol. So one very important piece of our research is the finding that reducing cholesterol is still effective in people with average cholesterol, if they are at increased risk for other reasons. And that has major implications for the way in which we use statin therapy in populations. Doctors are very fixated as are patients on the cholesterol number, but that's not where the action is. Actually, we need to be looking at somebody as risk, and treating risk by lowering cholesterol, irrespective or largely irrespective of what their cholesterol is. If we were to use statins more widely and offer them when people have a predictive risk of more than about 10% over 10 years so at 1% per year then that would bring into treatment around 5 million people aged 40 or over in the UK. And that could prevent each year, about 10,000, heart attacks and strokes, among which there will be around 2000 deaths. So it's really very beneficial treatment. We now know that these drugs are very safe. They increase the risk of muscle problems, of liver problems, but these problems go away when you stop taking treatment, and the risks are very small. We also know that rarely, very rarely, they cause bleeding into the brain, and they may cause an increased risk of diabetes, when compared to the benefits of taking statins these hazards are much much smaller than the benefits, even in people who are low risk of heart disease.

Conclusion

If we were to treat a wider range of people, then this evidence demonstrates really clearly that we could prevent more heart attacks and strokes in people who are currently healthy. We can stop many of these events that come out of the blue, and wreck lives, simply by using a cheap and effective and safe pill. And so we think it's very important that these results are taken seriously and considered widely not just in the UK, but around the world. Ultimately, our aim as researchers is to try to make a difference to public health. So I think the important message is not pride but the conviction that this type of research needs to happen and it needs to happen on a wider scale collaboration between doctors really does have the potential to make a difference to public health and we need to ensure that is possible. So the question now is what should public policy be? We think it's time for NICE and other organisations to review their guidelines and to think about whether it's appropriate for a wider range of people who are at increased risk of heart disease and stroke to be offered statin therapy.