Statins safer than you think: Study finds doctors ‘over-estimate’ intolerance to cholesterol-lowering drugs

ŁÓDŹ, Poland — Statins are a common medication patients take to keep their cholesterol in check. However, many people stop taking these drugs because of the potential risk they’ll develop an intolerance to statins, which causes muscle pains and other side-effects. Now, a new study is pushing back on this idea, finding that statin intolerance is actually “over-estimated and over-diagnosed.”

An international team, reporting to the European Society of Cardiology, says nearly half the patients taking statins either reduce their usage or stop completely over fear of the side-effects. The new report, however, finds less than 10 percent of the people taking cholesterol-lowering drugs develop an intolerance. Specifically, researchers place the number between six and 10 percent.

Study authors warn that stopping statin use can increase the risk of heart and circulation problems due to the buildup of harmful fats — or lipids. This can lead to potentially fatal blood clots. The most common side-effects of taking statins include muscle pain, headaches, dizziness, nausea, tiredness, and digestive problems.

“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,” says lead author Professor Maciej Banach from the Medical University of Lodz, in a media release.

Suffering from the ‘nocebo’ effect?

The largest study of its kind to date examined more than four million individuals across the world. According to the CDC, around one in four American adults take a cholesterol-lowering drug, with the vast majority using statins.

“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,” Prof. Banach says.

Until now, researchers say it’s been unclear what proportion of the population actually develop an intolerance to statins. Inconsistent reports from studies, randomized controlled trials, and databases previously suggested that the number sat between five and 50 percent.

The study, published in the European Heart Journal, found the real figure is at the lower end of the scale. That conclusion comes from a review of 176 studies.

Overall prevalence of statin intolerance was nine percent, falling to 7.0, 6.7, and 5.9 percent respectively when using diagnostic criteria from the National Lipid Association, the International Lipid Expert Panel, and the European Atherosclerosis Society.

Some patients are still at higher risk

Older adults, women, Blacks, Asians, obese individuals, or those suffering from diabetes, under-active thyroid glands, or chronic liver or kidney failure were more likely to be statin intolerant. Additionally, drugs to control irregular heartbeat, calcium channel blockers for chest pain and high blood pressure, heavy drinking, and higher statin doses also aggravated a statin intolerance.

“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,” Prof. Banach explains.

Among people at higher risk of developing a statin intolerance, the study finds the risk increased to 22 percent for people consuming large amounts of alcohol and 48 percent among female patients.

“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,” Prof. Banach continues. “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.”

Patients with cholesterol issues ‘should keep on taking statins’

“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. The most important message to patients as a result of this study is that they should keep on taking statins according to the prescribed dose, and discuss any side effects with their doctor, rather than discontinuing the medication,” the study author says. “The same clear message can be addressed to physicians treating patients with high cholesterol levels.”

“Most cases of statin intolerance observed in clinical practice are associated with effects caused by patients’ misconceptions about the side effects of statins or may be due to other reasons,” Banach concludes.

“Therefore, we should carefully evaluate symptoms, assessing in detail patients’ medical histories, when the symptoms appeared, specific details of pain, other medications the patients are taking, and other conditions and risk factors. Then we will see that statins can be used safely in most patients, which is critically important for reducing their cholesterol levels and preventing heart and blood vessel diseases and death.”

South West News Service writer Mark Waghorn contributed to this report.