Statin Intolerance is Overestimated, Over-Diagnosed for Patients at Greater Risk of Heart, Blood Vessel Problems

The researchers aimed to identify the factors that may influence the risk of statin intolerance.

A new study of more than 4 million patients found that the actual prevalence of statin intolerance is between 6% and 10%, showing that statin intolerance is overestimated and over-diagnosed, according to a European Society of Cardiology press release.

The study, published in the European Heart Journal, is the first to evaluate the proportion of patients who are truly intolerant of statins, according to the authors. They noted that prior research in this area from studies, randomized controlled trials, and databases, shows inconsistent results that suggest intolerance could range anywhere from 5% to 50%.

The research team conducted a meta-analysis of 176 studies with 4,143,157 patients worldwide to identify the overall prevalence of statin intolerance and prevalence by different diagnostic criteria. Further, they aimed to identify the factors that may influence the risk of statin intolerance.

The results showed that the prevalence of statin intolerance was 9.1%—and was even less when assessed according to diagnostic criteria from the National Lipid Association (7%), the ILEP (6.7%), and the European Atherosclerosis Society (5.9%), respectively.

“These results were not a surprise to me, but they were for many other experts. They show that in most cases statin intolerance is overestimated 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,” said professor Maciej Banach, of the Medical University of Lodz, in a press release. “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.”

Additionally, the research team found that people who were older, female, of Black or Asian race, obese, or suffering from diabetes, and who had underactive thyroid glands, or chronic liver or kidney failure were more likely to be statin intolerant. Drugs indicated to control irregular heartbeat, calcium channel blockers, alcohol use, and higher statin doses were associated with a greater risk of statin intolerance, which ranged from 22% to 48%.

“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,” Banach said in the press release. “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.”

Study limitations included the differences between patients enrolled in different studies and a lack of information on the amount of alcohol consumption and types of exercise. However, the researchers have tried to reduce the risk of bias from these limitations by using a large number of studies and patients in the analysis.

“I believe the size of our study, which is the largest in the world to investigate this question, means we are able to finally and effectively answer the question about the true prevalence of statin intolerance,” Banach said in the press release. “These results clearly show that patients needn’t be afraid of statin therapy as it is very well tolerated in as much as 93%, which is similar or even better than other cardiology drugs, including ones for reducing blood pressure and clotting or blocking of blood vessels. What is more, patients need to know that statins may prolong their life, and in cases where side effects appear, we have enough knowledge to manage these effectively.”

REFERENCE

Statin-intolerance is “over-estimated and over-diagnosed”. European Society of Cardiology. February 16, 2022. Accessed February 16, 2022. https://www.escardio.org/The-ESC/Press-Office/Press-releases/Statin-intolerance-is-over-estimated-and-over-diagnosed#:~:text=The%20authors%20of%20the%20research,caused%20by%20high%20cholesterol%20levels.