A recent study, published in the Lancet, suggests that common side effects of statins, namely muscle pain and weakness, are not directly a result of the drugs but more because of patients’ negative expectations. This phenomenon has been labelled as the ‘nocebo’ effect.
Statins heart
Statins are a group of drugs that are prescribed for the treatment of ‘bad cholesterol’, with the aim of reducing the risk of heart attack or stroke in high-risk patients. The clinical safety and efficacy of these drugs have been well documented over the years with a recent report estimating they prevent around 80,000 cardiovascular events each year in the UK alone.
Despite the advantages statins offer, there have been concerns raised over the side-effects, particularly in light of the fact that there are now recommendations to prescribe them to patients at a lower risk of heart attack.
Therefore, it is hoped that this study, performed by researchers at the Imperial College London, Royal London Hospital, the London School of Hygiene and Tropical Medicine, the University of Gothenburg and the University of Oxford, will end the debate around this therapeutic class.
These recent results echo those found in prior studies, including one published three years ago, which suggested that the side-effects of statins are minimal, despite nearly a fifth of patients experiencing, for the most part, muscle pain and weakness.
“You only get the muscle-related symptoms when you know you are taking the drug,” said Peter Sever, lead author of the study from the national heart and lung institute at Imperial College London. “It is important to note that patients genuinely get the symptoms. But you cannot attribute that, in this case, to the drug.”
The researchers noted: “Seldom in history of modern therapeutics have substantial proven benefits of a treatment been compromised to such an extent by serious misrepresentations of the evidence for its safety.”
Another study, published recently in the BMJ Open journal, has revealed that there are potentially more than six million people in the UK who are considered ‘at risk’ who are not taking statins or are not on a high enough dose.
“There are people out there who are dying because they are not taking statins and the numbers are huge — the numbers are tens of thousands if not hundreds of thousands, and they are dying because of a nocebo effect, in my opinion,” added Sever. “We would hope that the MHRA will withdraw that request that these side effects should be listed.”
An MHRA spokesperson commented: “Our priority is to ensure that the benefits of medication outweigh the risks. Any new significant information on the efficacy or safety of statins will be carefully reviewed and action taken if required, including updates to product labelling.”
Although this study received funding from Pfizer, a manufacturer of statins, the researchers stressed that the company played no role in the results.