- Researchers say the non-statin drug Nexletol performed well in a study of lowering cholesterol levels and reducing heart attack risk by 23%.
- They say the drug could be an alternative for people who don’t tolerate states well.
- Experts say an alternative is welcome, but they note statins are highly effective in reducing cholesterol for people who are able to take them.
A non-statin drug known as bempedoic acid may be effective in lowering the risk of a heart attack in people who cannot tolerate statins.
Research published this week in The New England Journal of Medicine concluded that bempedoic acid, sold under the brand name Nexletol, lowered the risk of cardiovascular events among those who are statin intolerant by 13%.
“Until now, there have not been any drugs designed specifically for statin-intolerant patients,” Dr. Steven Nissen, the lead author of the study and chief academic officer of the Heart Vascular & Thoracic Institute at Cleveland Clinic, said in a press release.
“While statins remain the cornerstone of risk reduction in patients with elevated LDL cholesterol, this is a major step forward for a population who need statins but suffer troublesome side effects,” he added.
The research was funded by Esperion Therapeutics, the company that developed bempedoic acid.
The researchers reported that people who were treated with bempedoic acid had a lower risk of nonfatal stroke, nonfatal heart attack, and death from cardiovascular causes.
Heart attack risk was reduced by 23% in people treated with bempedoic acid and coronary revascularizations were reduced by 19%.
Dr. Rigved Tadwalkar, a cardiologist at Providence Saint John’s Health Center in California, said the findings are impressive.
“It’s definitely compelling, especially for this specific drug. Because we have been using it for the past couple of years with really the only data present being that it can lower bad cholesterol. We just didn’t know if it in fact also had an effect on outcomes, which many cholesterol drugs in the past had this issue. Basically, we would lower the bad cholesterol, but we didn’t necessarily see a significant reduction in cardiovascular endpoints,” he told Healthline.
“When you look at the degree of lowering LDL that you get from Nexletol, it’s still impressive,” Tadwalkar added. “The amount of risk reduction that we see is still quite impressive. And that does sort of corroborate what we’ve known now for some time, which is that the lower that we can bring the LDL cholesterol, the lower the event rates go. And it’s great to see this done with a drug that has a novel mechanism.”
The researchers said Nexletol may be a useful alternative for those who can’t take statin medications.
Statins are considered the first-line treatment in preventing cardiovascular disease by lowering the level of cholesterol in the blood.
“They’re very, very effective. They lower LDL cholesterol by about 50 percent and they reduce cardiovascular risk very substantially. But there are some patients who either can’t take statins or who need a greater than 50% reduction in LDL cholesterol. And that’s where we need add-on medications… This is another pill that lowers LDL cholesterol,” Dr. Joshua Knowles, an associate professor of cardiovascular medicine at Stanford University in California, told Healthline.
“It’ll add a nice arrow to our quiver,” he added.
LDL cholesterol is sometimes referred to as “bad cholesterol.”
Having too much of it in the blood can increase the risk of heart attacks and strokes.
Medications like statins work to lower this.
While statins are highly effective, not everyone can tolerate them. Statins are associated with side effects such as muscle pain or weakness, indigestion, nausea, and headaches.
Studies suggest statin intolerance occurs in 5% to 30% of people. Between 40% and 70% of people discontinue their statin therapy within one year of beginning.
Experts say bempedoic acid may be a suitable alternative to statins as it works in a different way than statins.
“There’s a synthesis pathway for cholesterol that statins inhibit, it inhibits one particular enzyme,” Knowles said. “This new drug inhibits a different enzyme in that cholesterol synthesis pathway. So your liver, your cells, your other cells make less cholesterol and then that tricks the body into thinking, especially the liver, it needs to pull more cholesterol from the bloodstream to offset that deficit. So they really inhibit a different part of that cholesterol synthesis pathway.”
By not activating until it reaches the liver, bempedoic acid has less impact on organs, tissues and muscles and that may reduce the chance of side effects.
However, some adverse reactions with bemedoic acid are still possible.
“The main side effect that we see with Nexletol is an increase in blood uric acid levels. And this is of clinical importance because it can lead to gout, especially for those who have a history of gout, they can have gout flares. So we do look out for this,” Tadwalkar said.
Other possible adverse reactions include muscle spasms, upper respiratory tract infection, back pain, abdominal pain, bronchitis, anemia, and elevated liver enzymes.
While statins reduce LDL cholesterol by 40% to 50%, the researchers reported that bempedoic acid lowered LDL cholesterol by 20% to 25%.
Dr. Eugene DePasquale, a cardiologist with Keck Medicine of USC in California, says that while statins should remain the first-line treatment, there is a place for bempedoic acid.
“Statins should be the mainstay at this point. Based on this clinical trial, I think there is evidence to support it (bempedoic acid) in a pathway for lowering cardiovascular risk,” he told Healthline. “We’ll have to see what the guidelines committees do. But I certainly think it can be part of the armamentarium, especially if someone is completely unable to take a statin therapy.”
However, the researchers argue that overall bempedoic acid could be a good option for those who can’t take statins.
“Overall, these results reveal bempedoic acid can still make a significant difference in the risk of serious cardiac events for patients who cannot tolerate statins,” Nissen said.