Science
No difference in side effects with a statin or dummy pill
People experienced the same side effects when taking a statin or dummy pill, according to new research we’ve funded. The findings are being presented at the American Heart Association Scientific Sessions and published in the New England Journal of Medicine (NEJM).
For the first time, a personalised clinical trial - the SAMSON trial - has found that 90 per cent of the symptoms people reported when they unknowingly took a daily statin were also experienced when they took a daily placebo pill.
Researchers at Imperial College London recruited 60 adults who had recently stopped taking their statins. They found that people were just as likely to need to temporarily stop taking their placebo tablets due to intolerable side effects as they were with statins. They also found that people felt better when they were not taking any form of tablet.
The nocebo effect
The results suggest that these side effects are mostly caused by the nocebo effect - where people experience side effects from a therapy because of a negative association with it, rather than the actual biological effect of the drug.
After participants received an explanation of their results at the end of the study, half of them successfully restarted taking their statins, despite them being unable to tolerate side effects before the trial began. Four more participants planned to do so.
Each patient was given a set of 12 bottles, one for each month. Four contained 20mg of atorvastatin, four contained a placebo tablet and four were empty. A computer randomly allocated each bottle to a specific month. Each day for a year, participants recorded whether they’d taken the pill and how they felt on a scale of 0 (no symptoms) to 100 (worst imaginable) using a smartphone app. If the symptoms became too severe, they were able to discontinue the tablets for that month. Forty-nine of the 60 patients completed the full 12 months of the trial.
Amongst the 60 patients, the average perceived symptom intensity score was 15.4 in the months taking the placebo and 16.3 in the statin months. The intensity was much lower at 8.0 during the no-tablet months.
Statins reduce a person's risk of a heart attack or stroke by lowering the levels of ‘bad cholesterol’ in the blood. They are particularly beneficial for people who have already had a heart attack or stroke and are also effective in those who are identified as being at risk of having one in future. Although side effects such as muscle pain are rare, it’s a reason why some people stop taking these potentially life-saving drugs.
The researchers hope that these findings will help to encourage more people at high risk of heart and circulatory diseases to take their statins.
Undeniable evidence
Professor Sir Nilesh Samani, our Medical Director, said:
“The beauty of this study is that it’s personalised. For the first time, patients were able to see for themselves that statins did not cause their side effects but the physical act of taking a pill did. These results undeniably show that statins are not responsible for many of the side effects attributed to them. Decades of evidence have proven that statins save lives and they should be the first port of call for individuals at high risk of heart attack and stroke.
“This study empowered many of the participants to go back onto statins, which will undoubtedly lower their risk of having a life-threatening heart attack or stroke. We now hope that these findings continue to encourage more people to consider statins with an open mind, and help healthcare professionals to have evidence-based conversations with their patients to ensure they receive the treatment that’s right for them.”