Statin drugs are the gold standard for lowering LDL (or ‘bad’) cholesterol. However, many patients at high risk of developing heart disease will refuse to take them due to severe side effects such as weakness or muscle pain.
According to a large clinical trial, bempedoic Acid, a new medication, significantly lowers cholesterol levels and increases the chance of heart attacks. It also reduces the need for an operation that unblocks blocked arteries. The results of this large clinical trial were presented at Saturday’s annual meeting of American College of Cardiology. The New England Journal of Medicine published the research on Saturday.
“Statins are the cornerstone in cardiovascular disease prevention and are highly recommended to patients who have or are at high risk of developing it,” stated Dr. Steven E. Nissen (chief academic officer at the Heart and Vascular Institute of the Cleveland Clinic). Patients can experience side effects that they don’t like anywhere from 7% to 29%. Muscle pain is the main problem.
Nissen stated that these patients will not do well if their cholesterol isn’t controlled. He explained that Bempedoic does not cause side effects in muscle because it isn’t activated in muscle or other tissues. It isn’t activated until it reaches the liver.
Low density lipoprotein cholesterol, also known as LDL, contributes to fatty buildups within the arteries, increasing the risk of strokes and heart attacks. LDL, which is the most common cause of death in America, can be reduced by taking steps to lower it. The American Heart Association states that the ideal total cholesterol level for adults is around 150 mg/dL and LDL levels below 100 mg/dL.
The Food and Drug Administration has already approved bempedoic acid for use in conjunction with statins.
Nissen and his colleagues recruited 13970 patients who couldn’t tolerate statins. They randomly assigned them to either a daily dose bempedoic acid (or a placebo) and then conducted a new trial. The average LDL cholesterol level of the patients was 139.0 at the beginning.
LDL cholesterol levels dropped by 29.2 percentage points after six months. The median follow-up period lasted 40.6 months. At the end, patients who had received the medication saw a 23% decrease in the likelihood of suffering from heart attack. In contrast, the risk that they would need to undergo cardiac revascularization (a procedure to clear blocked arteries) fell by 19%.
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Patients who took the medication had a slightly higher risk of developing complications such as gout or gall stones than those who received placebos.
Researchers found that patients who received bempedoic acid had a 13% lower chance of dying from nonfatal strokes, cardiovascular disease and heart attacks, when compared to those in the placebo group.
Instead of focusing on cholesterol levels alone, researchers looked at data that could be more relevant to patients, such as the risk of having a heart attack. Nissen hopes this will encourage more patients who are interested in taking a cholesterol-lowering medication.
Esperion, which makes and markets bempedoic Acid, can sell it as a standalone product or in combination with another cholesterol-lowering medication called ezetimibe. According to Dr. JoAnne Feasty, Esperion’s chief medical officer and cardiologist, both versions cost $395 per month.
Foody stated that they aren’t looking to replace statins. They are the first-line treatment. Everyone who is able to take statins should.
Although bempedoic acid is not as effective as statins it could still be life-saving for those at high risk for heart disease, Dr. Howard Weintraub, clinical chief of the Center for the Prevention of Cardiovascular Disease at the Leon H. Cheney Division of Cardiology, NYU Langone Health, stated that the medication can be life-saving for patients who are unable or unwilling to take statins.
Dr. Marc Eisenberg was happy to accept the new research.
Eisenberg, a Columbia University Vagelos College of Physicians and Surgeons cardiologist, said, “This is an exciting research, but statins remain the best treatment for most people who have high cholesterol and other cardiovascular risk factors.”
Eisenberg stated in an email that “more studies comparing statins and bempedoic acids in head-to-head trials will be very helpful in the future.”
Dr. Robert Rosenson warned doctors and patients against treating bempedoic the same as statins.
Rosenson, a professor of medicine from the Icahn School of Medicine in Mount Sinai, New York, stated that “Bempedoic Acid is not a substitute for statin therapy.” “The LDL-lowering efficacy was modest, and the reductions in cardiovascular events were less than with statins.”
