Cholesterol is a fatty substance that the body needs to work properly.
It helps build cells and make important hormones, but having too much of one type, known as LDL cholesterol, can increase the risk of serious heart and blood vessel disease.
LDL is often called “bad” cholesterol because high levels can help fatty deposits build up inside arteries. Over many years, these deposits can narrow blood vessels or break apart, potentially leading to a heart attack or stroke.
For decades, statins have been the main medicines used to lower LDL cholesterol. They reduce the amount of cholesterol made by the liver and have strong evidence showing that they can prevent heart attacks, strokes and deaths from heart disease.
However, statins are not suitable for everyone. Some people report muscle pain or other side effects that make it difficult to continue treatment, while others may still have LDL levels that remain too high even when they take cholesterol-lowering medicine.
A newer medicine called bempedoic acid could provide another option. It also reduces cholesterol production in the liver, but it acts on a different step in the process from statins.
Importantly, bempedoic acid becomes active mainly in the liver rather than in skeletal muscles. Researchers have therefore been interested in whether it could help people who have experienced muscle-related problems while taking statins.
The CLEAR Outcomes trial tested this question in nearly 14,000 adults who had heart disease or were at high risk of developing it and who were unable or unwilling to take recommended doses of statins because of side effects. Participants were randomly assigned to receive either bempedoic acid or a placebo.
The study found that bempedoic acid lowered LDL cholesterol by about 21% compared with placebo after six months. More importantly, people taking the medicine had a lower risk of a group of major cardiovascular events, including heart attack and stroke.
Overall, the risk of the study’s main combined cardiovascular outcome was about 13% lower in the bempedoic acid group. The findings provided important evidence that lowering LDL with this medicine does more than improve a number on a blood test—it can also reduce serious health problems.
Researchers later examined how the cardiovascular benefit compared with the benefit expected from statins. Their analysis suggested that for a similar amount of LDL reduction, bempedoic acid produced a reduction in cardiovascular risk that was broadly consistent with what has been seen with statin treatment.
This supports a major idea in heart medicine: lowering LDL cholesterol itself is an important way to reduce cardiovascular risk. Different medicines can work through different biological pathways, but reducing harmful LDL particles can still protect arteries and the heart.
Bempedoic acid is not necessarily a replacement for statins for everyone. Statins remain widely used, inexpensive and supported by decades of research, and many people can take them safely without significant problems.
The newer drug may instead be especially useful for people who genuinely cannot tolerate enough statin therapy or who need additional LDL reduction. Doctors can also choose from other cholesterol-lowering treatments, including ezetimibe and injectable medicines that target a protein called PCSK9.
Like all medicines, bempedoic acid can cause side effects. Studies have found higher rates of problems such as gout and gallstones in people taking the drug, so treatment decisions should consider a person’s overall health, cholesterol level and cardiovascular risk.
The main CLEAR Outcomes results were published in The New England Journal of Medicine in 2023. Additional analyses of the trial were also presented at ENDO 2023, the Endocrine Society’s annual meeting in Chicago, adding evidence about how the heart benefits of bempedoic acid relate to its ability to lower LDL cholesterol.
For people who struggle with statins, the findings offer another evidence-based way to reduce dangerous cholesterol. Having more treatment choices could help more patients reach healthier LDL levels and lower their long-term risk of heart attack and stroke.
If you care about heart health, please read studies about top 10 foods for a healthy heart, and how to eat right for heart rhythm disorders.
For more health information, please see recent studies about how to eat your way to cleaner arteries, and salt and heart health: does less really mean more?
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