2 min readStudy Suggests Statin Intolerance Is “Over-Estimated and Over-Diagnosed”
Brussels, Belgium — As many as one in two patients stop taking statins, reduce the dose or take them irregularly because they believe the cholesterol-lowering drugs cause muscle pain and other side-effects. Now, a new study of over four million patients has shown that the true prevalence of statin intolerance worldwide is between six to ten percent.
The authors of the research, published in the European Heart Journal, say that their findings show that statin intolerance is over-estimated and over-diagnosed, with the result that patients are at greater risk of heart and blood vessel problems, including death, caused by high cholesterol levels.
There is strong and unambiguous evidence that statin treatment makes a significant difference in preventing cardiovascular disease and dying from it. Statins are among the most commonly prescribed drugs. However, until now, it has not been clear what proportion of people are truly intolerant of the drug, with inconsistent reports from studies, randomised controlled trials and databases suggesting it could range from 5-50%.
Researchers led by Professor Maciej Banach, of the Medical University of Lodz and the University of Zielona Góra, Poland, on behalf of the Lipid and Blood Pressure Meta-Analysis Collaboration and the International Lipid Expert Panel (ILEP), carried out a meta-analysis of 176 studies with 4,143,517 patients worldwide. The aim was to identify the overall prevalence of statin intolerance and the prevalence according to different diagnostic criteria. They also wanted to identify what factors might place people at greater risk of statin intolerance.
They found that the overall prevalence was 9.1%. Prevalence was even less when assessed according to diagnostic criteria from the National Lipid Association, the ILEP and the European Atherosclerosis Society: 7%, 6.7% and 5.9% respectively.
Prof. Banach said: “These results were not a surprise to me but they were for many other experts. They show that in most cases statin intolerance is over-estimated and over-diagnosed, and they mean that around 93% of patients on statin therapy can be treated effectively, with very good tolerability and without any safety issues.
“Our findings mean that we should evaluate patients’ symptoms very carefully, firstly to see whether symptoms are indeed caused by statins, and secondly, to evaluate whether it might be patients’ perceptions that statins are harmful – so called nocebo or drucebo effect – which could be responsible for more than 50% of all symptoms, rather than the drug itself.”
The researchers also found that people who were older, female, of Black or Asian race, obese, or suffering from diabetes, under-active thyroid glands, or chronic liver or kidney failure were more likely to be statin intolerant. In addition, drugs to control irregular heartbeat (arrhythmia), calcium channel blockers (often prescribed for chest pain and high blood pressure), alcohol use and higher statin doses were associated with a higher risk of statin intolerance. The increased risk of statin intolerance ranged from 22% (high alcohol consumption) to 48% (being female) in these groups.
“It is critically important to know about these risk factors so that we can predict effectively that a particular patient is at higher risk of statin intolerance. Then we can consider upfront other ways to treat them in order to reduce the risk and improve adherence to treatment. This could include lower statin doses, combination therapy and use of innovative new drugs,” said Prof. Banach.
Article adapted from a European Society of Cardiology news release.
Image: Courtesy of the European Heart Journal.