Statin alternative passes key test

Bempedoic acid lowers cholesterol, stroke risk

More than a quarter of Americans over 40 take medications to lower their cholesterol, most of them statins. But not everyone can tolerate statins or wants to.

Now a new study confirms that bempedoic acid, approved in 2020, not only lowers cholesterol but also reduces the risk for heart attack and stroke.

Statins will remain the first therapy patients are given to lower cholesterol. But the news means more people will likely be prescribed a once-daily pill of bempedoic acid.

Bempedoic acid is sold under the brand name Nexletol from Esperion Therapeutics of Ann Arbor, Michigan. It is sold with another drug, ezetimibe, as Nexlizet.

Dr. Steven Nissen, the Cleveland Clinic cardiologist who led the study, said he often has patients in his office who won’t or can’t tolerate a statin.

“This establishes a therapy that for these really difficult-to-treat patients will be a major addition,” he said.

The study, published Saturday in the New England Journal of Medicine, randomized nearly 14,000 patients, half to receive daily bempedoic acid and half a placebo.

Both groups were followed for more than three years.

At six months, those who received the drug saw a 21% greater reduction in LDL cholesterol – the bad kind – than those who got the placebo.

“This establishes a therapy that for these really difficult-to-treat patients will be a major addition.” Dr. Steven Nissen Cleveland Clinic cardiologist

At the end of three years, 9.5% of those in the placebo group had suffered a heart attack, stroke or died from a cardiovascular cause, compared with just over 8% of those who received the drug, a significant difference.

People who took the drug were more likely to develop gout, gallstones or some early signs of liver disease, but few had severe reactions.

They did not get type 2 diabetes, which is a known risk of statins.

In combination with ezetimibe, bempedoic acid lowers cholesterol by 35% to 40%, Nissen said, which is about as much as a moderate-intensity statin. The combination worked well in women and prevented first heart attacks and strokes, he said.

High levels of LDL cholesterol drive heart attacks and strokes, and decades of data show that reducing it lowers the risk of cardiovascular events, said Dr. Sadiya Sana Khan, a cardiologist and assistant professor at Northwestern University’s Feinberg School of Medicine, who was not involved in the new study.

Statins and other cholesterol-lowering drugs essentially trick the liver into thinking it doesn’t have enough cholesterol, so it pulls more from the bloodstream, said Dr. Joshua Knowles, a cardiologist at Stanford Health Care and an associate professor of medicine at Stanford University, who was not involved in the study.

So-called PCSK9-inhibitors, which lower LDL cholesterol by as much as 50%, can also work as statin substitutes or in combination with statins, but they are delivered by injection and cost about $12,000 a year.

Bepoidic acid is available for about $425 a month or just over $5,100 a year. Generic statins can cost about $20 a month.

Nissen and others said statins should remain the first treatment given to patients with high cholesterol, because they are inexpensive and proven to work well in hundreds of thousands of people over decades.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.