A new study reinforces the importance of lowering cholesterol in people at risk for heart attack or stroke who haven’t had either.
The study looked at a statin alternative called bempedoic acid and found that it reduced levels of LDL cholesterol and also lowered the risk for heart attack, stroke and death.
But researchers say bempedoic acid shouldn’t be used instead of statins.
It’s far more expensive. And it doesn’t have the decades-long track record of safety and effectiveness.
But, for people who can’t tolerate statins or can’t take a high enough dose to bring their cholesterol levels down adequately, the new study suggests it’s important to find alternatives and that bempedoic acid can be at least part of the solution.
High cholesterol on top of diabetes, obesity, tobacco use or high blood pressure puts people at risk for heart attack and stroke.
But fewer than half of those at high risk are taking appropriate medication, said Dr. Steven Nissen, the Cleveland Clinic cardiologist who led the new research, presented at the American Diabetes Association annual conference in San Diego.
“I think this is a wakeup call to the medical community and to patients that people who have high cholesterol and risk factors need to be treated,” Nissen said.
Dr. Christie Ballantyne, director of the center for cardiometabolic disease prevention at Baylor College of Medicine in Houston, said he sees the study as “good news.”
“You can get your LDL down if you can’t get a statin,” said Ballantyne, who wasn’t involved in the research. “I think that’s an important message to the public.”
The research followed up on a large study looking at bempedoic acid that Nissen published earlier this year. That study showed bempedoic acid was a viable alternative to statins for people who can’t take the cheaper, more established drugs.
The study looked at a portion of those studied — 4,200 people who hadn’t yet had a major cardiac event, such as a heart attack or stroke. The half who took bempedoic acid were 39% less likely to die from a cardiac event over the next three and a half years than those who received a placebo, a result Nissen called “simply stunning.”
Dr. Salim Virani, a preventive cardiologist affiliated with the Texas Heart Institute who is vice provost for research at Aga Khan University in Pakistan and who wasn’t involved in the study, puts less stock in the details of the results because it relied on a subset of trial participants who might not be representative of the larger population. In the group who hadn’t had a heart attack or stroke, more people dropped out of the trial if they received a placebo than if they received bempedoic acid.
Those people might also be less likely to follow healthy lifestyle recommendations and therefore be more likely to have a heart attack or stroke, Virani said, perhaps accounting for what looks like a better outcome among those who took the drug.
Drawing conclusions from a subgroup can be misleading, said Dr. Rita Redberg, a cardiologist at the University of California, San Francisco who editor in chief of the journal JAMA Internal Medicine. She cited a well-known 2011 study in which researchers found that aspirin prevented heart attacks among participants overall but not in those who were born under the astrological signs of Gemini or Libra — a distinction that was clearly meaningless.
Redberg said the study wasn’t representative of the average American because most participants were from Eastern Europe, where they likely had unhealthier diets, lower physical activity levels and other differences.
“I will continue to recommend a healthy diet and regular physical activity and no smoking as the best way to prevent heart disease and live longer,” Redberg said.
Not instead of statins
Bempedoic acid, approved by the federal Food and Drug Administration in 2020, is sold by Esperion Therapeutics of Ann Arbor, Michigan, under the brand name Nexletol and often in combination with another cholesterol-lowering drug ezetimibe, sold as Nexlizet. Both drugs cost about $400 a month.
Statins are known to cause muscle aches in a subset of people, which usually can be minimized by reducing the dose. Bempedoic acid can increase the risk of gout, muscle pain and gallstones.
People shouldn’t take the study as license to use bempedoic acid instead of statins, Virani said. Statins have a 40- to 45-year safety record, which is important for a drug meant to be taken for the rest of someone’s life. “I hope it does not take people away from statin therapy,” he said.
Nissen agreed that statins are still better drugs for people who can tolerate them. Still, he said he has “taken on the pharmaceutical industry over drugs I thought did not provide a benefit over its risk,” but thinks the benefits in this case far outweigh the risks.
Prevention still key
The latest study that looked at the potential health benefits of lowering cholesterol for people who haven’t had a heart attack or stroke was 17 years ago. It was stopped early because it showed people who lowered their cholesterol lived longer, but, because it was never completed, some of its findings remained controversial.
Other studies had failed to show a benefit in this group. And it’s cheaper and easier to study people who’ve already had a heart attack or stroke to see if treatment can prevent a second event. For them, it’s clear that lowering cholesterol can be helpful.
Ballantyne’s aunt and brother never got a chance to have a second event. Both died from a first heart attack. He’s happy to have the new study confirm that there’s a benefit to LDL-lowering in people at high risk who haven’t had a heart attack or stroke.
Ballantyne said he’s seen a lot of progress against heart disease but that recently that has started to reverse.
“We have tremendous tools for prevention, and we’re not using them that well,” he said.
The bottom line for lowering cholesterol, Nissen said, is “the benefits are large, the risks are small, and the number of people out there [who might benefit] is enormous. It’s literally tens of millions of people.”
Read more at USA Today.
