Statins: side effects or not?

Blister packs of statins

Why do people report side effects of statins when large studies show most are not caused by the drug? Sarah Brealey explains how BHF-funded research can find out.

Statins must be one of the most controversial topics of modern medicine. They save lives by reducing your risk of heart attack and stroke. Well-run trials, in which patients don’t know whether they’re taking a statin or a dummy pill (placebo), find rates of side effects are almost identical between the two. But when they’re prescribed in real life, as many as a third of people complain of side effects.

Statins are extremely powerful in preventing heart disease.

Now, a BHF-funded study is trying to find out why. It’s an important question because evidence shows statins reduce death rates. If someone stops taking their statin, their risk of death is higher than it needs to be.

Professor Darrel Francis, Professor of Cardiology at the National Heart and Lung Institute at Imperial College London, says: “Statins are extremely powerful in preventing heart disease. But a lot of people aren’t taking statins because of their worries about side effects.

“Some people experience a reaction, and it may be real, without it being caused by the chemical effect of the statin. If I’m looking forward to a curry, thinking about it will make my mouth water. It’s not the food that’s making my mouth water, it’s my mind.

“Also, you might be unlucky and happen to get ill when you start taking a statin. So you stop taking it and your symptoms go away – but they could have gone away anyway. Even if you try a second time, your body and mind could have linked the two, so you expect to feel ill when you take the statin, and you do.”

Concerns about statin side effects

The results of this research could have big implications. Different studies estimate that between half and three-quarters of people prescribed a statin stop taking it within two years, with symptoms such as muscle pain being the most commonly given reason. And many more people decide not to take them in the first place because of concerns about side effects.

For some patients, this study will offer reassurance that the statin is not causing their problem and it will make it easier to help the minority of people who do suffer real side effects.

Professor Francis says: “When you choose a carpet, you don’t just guess how big your floor is, you measure it – and that isn’t even a matter of life or death. This is more life or death than most decisions you make: one in 10 people who stop taking statins will die sooner because they aren’t taking them. So why don’t we take some measurements? This study is a tape measure for your symptoms.

SAMSON trial

Now, for the first time, patients who have stopped taking statins because of apparent side effects can see for themselves what’s actually causing them.

In the trial, called SAMSON, each patient is given a set of 12 bottles, one for each month. Four contain statins, four contain a placebo and four are empty. A computer randomly allocates each bottle to a specific month. Each day for a year, the patient records whether they’ve taken the pill and how they feel (on a scale of 1 to 100) using a smartphone app or computer (smartphones can be provided). At the end of the year they’re given the results.

“If the symptoms from the placebo are like those from the statin, it shows that the effect is because they know they’re taking a tablet,” Professor Francis explains. “Then we can advise the patients on what to do. Sometimes just knowing how your mind works can change your body’s reaction.

“If it shows you’re getting genuine side effects, then alternatives to statins can be explored. Or you might not have any symptoms at all. This is a really personalised medicine trial. It’s nice that we can publish this, but far nicer that people can have a printout of their results for themselves.”

Patients can then make their own decision about whether to continue taking statins. There are just a few months left to join the trial and the findings are due to be published in 2020. “My vision is that, in future, once someone says they’re getting bad side effects, they can be given the SAMSON kit and they can get the answers for themselves,” says Professor Francis.

John Chapple from Action The patients view

John Chapple, from Acton, London, was prescribed a statin in 2012 after quadruple bypass surgery, but he experienced aches and pains. After trying a different statin, he stopped taking it. In 2016, he had a heart attack. “They asked me why I wasn’t taking a statin. When I explained, they told me about the SAMSON trial, and I was happy to take part.”

John got his results in March 2018 – and they showed there was no difference in how he felt in the months when he was taking a statin versus a dummy pill. He says: “That convinced me that whatever happened six years ago isn’t a problem now. I’m now taking a statin again and I can’t detect any difference to when I’m not taking it.”

John, 75, is still working as a beekeeper – his second career since retiring from his job as an engineer. “Psychologically it’s nice to know that the statin is reducing my cholesterol and lowering my risk of another heart attack. I’m trying to do everything I can to stay alive, active and a useful member of society.”

He says he would recommend the trial to others. “Knowledge is important. They can only get knowledge from people volunteering for trials. And I have learned something too – that you shouldn’t go into things with your mind already made up. Lots of people say you mustn’t take statins – you will have aches and all sorts of things. But that might have nothing to do with the statins.”

 

How to take part

If you have been prescribed a statin and stopped taking it because of side effects, you may be eligible to take part.

You need to be over 18, based in the UK and able to make one visit to Imperial College London (travel expenses paid). You don’t need a smartphone or computer – these can be provided and training given.

Find out more on the SAMSON website or call 020 7594 9647.

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