Medications known as statins are the first-line treatment for high cholesterol, but millions of people who can’t or won’t take these pills due to side effects may have another option.
In a major study, another type of cholesterol-lowering drug called Nexletol produced by Esperion Therapeutics Inc.
reduced the risk of heart attacks and certain other cardiovascular problems in people who cannot tolerate statins, researchers reported on Saturday.
Doctors are already prescribing the drug, chemically known as bempedoic acid, for use with a statin drug to help some high-risk patients further lower their cholesterol. The new study tested Nexletol without the combination of statins – and offers the first evidence that it also reduces the risk of health problems caused by cholesterol.
Statins remain “the cornerstone of cholesterol-lowering therapies,” said Dr. Steven Nissen of the Cleveland Clinic, who led the study.
But people who can’t take these proven pills “are very needy patients, they’re extremely difficult to treat,” he said. This option “will have a huge impact on public health”.
Too much so-called LDL or “bad” cholesterol can clog arteries and lead to heart attacks and strokes.
Statin pills like Lipitor and Crestor – or their inexpensive generic equivalents – are the mainstay for lowering LDL cholesterol and preventing heart disease or treating those who already suffer from it. They work by blocking some of the liver’s cholesterol production.
But some people suffer from severe muscle pain from statins. Although it’s unclear exactly how often this happens, some estimates say 10% of people who would otherwise qualify for the pills either can’t or won’t take them. They have limited options, including expensive cholesterol injections and another type of pill sold as Zetia.
Nexletol also blocks the production of cholesterol in the liver, but in a different way to statins and without this muscle side effect.
The new five-year study followed nearly 14,000 people unable to tolerate more than a very low dose of a statin. Half received daily Nexletol and the other half a dummy pill.
The key finding: Patients treated with Nexletol had a 13% lower risk of a group of major heart problems.
Then the researchers untangled these different conditions and found a 23% reduction in heart attack risk, the biggest impact. The drug also reduced artery clearing procedures by 19%. There was no difference in deaths, which the researchers could not explain but which they believe may take longer to detect.
The data was published in the New England Journal of Medicine and presented Saturday at a meeting of the American College of Cardiology. The study was funded by the manufacturer of Nexletol Esperion Therapeutics.
The results are “compelling,” Dr. John H. Alexander of Duke University, who was not involved in the study, wrote in the journal. They “will and should” boost the use of the drug by patients who are unwilling or unable to take statins.
“However, it is premature to consider bempedoic acid as an alternative to statins,” he warned. “Given the overwhelming evidence of vascular benefits,” statins remain the first choice for most patients.