Statins are generally not the cause of the muscle aches and pains that stop some people taking the pills prescribed to protect them against serious heart problems, according to a novel study that hopes to dispel some of the concerns.
Two million people in the UK who are at higher risk of heart attack and strokes are eligible for statins, but many people refuse them or have stopped taking them because of sometimes alarming and widespread reports of muscle pain. But the study funded by the National Institute of Health Research showed that most people had the same aches and pains whether they were taking a statin or taking a dummy pill that looked and tasted just like a statin.
Those who say they have pains while on statins are not imagining it, said Liam Smeeth, professor of clinical epidemiology at the London School of Hygiene & Tropical Medicine and senior author of the study in the British Medical Journal.
“We’re not saying anyone is making up aches and pains at all. These are real aches and pains. What we’re showing very clearly is that those aches and pains are no worse on statins than they are on a placebo,” he said.
The study compared each individual’s symptoms at different points in time on the placebo and on the statin rather than comparing one group against another group. That made their findings “really quite convincing”, said Smeeth. It also meant there was no need to have thousands of people in the trial.
They recruited 200 people who had stopped taking statins after reporting severe muscle pains or were thinking about stopping, and ended up with 151 from 50 GP practices in England and Wales. Over the course of a year, each person was assigned to three periods of two months on a statin and three periods of two months on a placebo – but in a random order, so that neither they nor their GP knew what they were taking at any point. Each participant recorded the muscle aches and pains they felt throughout that time.
Overall, the researchers found people had reported slightly more symptoms on the placebo than the statin, but the difference was not enough to be significant. During the year, 80 people withdrew from the study – 32 because of intolerable muscle symptoms. Of those, 18 experienced the pains on statins and 13 on placebo.
At the end of the trial all participants were invited to see the GP to find out their results. Two-thirds decided they would resume their statins. In the case of the 96 people who were told it was unlikely statins were contributing to their aches and pains, 65 resumed taking the pills (68%). Among the 17 who were told statins could possibly be contributing, nine decided to give them another try (53%).
Most of the people in the trial were in the 65- to 79-year-old age bracket, with a quarter aged 50-64 and smaller numbers of other ages. There was no explanation for their muscle pains.
“Aches and pains are sadly pretty common in people in their 70s, and it’s not surprising people look for a cause for those,” said Smeeth.
“We didn’t go into detail about what was causing their aches and pains, but what we did show was that it wasn’t any worse on statins versus placebo. So undoubtedly aches and pains are common, I’m sorry to say. It’d be great if we could cure them all, but no.”
The team would like to see these individual studies carried out in patients who experience muscle pains on the pills but admit it would be difficult because they would need ethical approval and for the placebo pills to be manufactured and randomly allocated. But they hope the results will encourage people at risk of heart problems to persevere with statins.
“Our work should reassure those already taking statins or thinking about taking statins. These drugs prevent heart attacks and save lives. In very rare cases they can cause muscle pain, but the vast majority of people will not be affected. The benefits far outweigh the risks,” said Smeeth.
