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/ Source: NBC News
By A. Pawlowski and Lauren Dunn
A new type of anti-cholesterol drug has been well tolerated by patients and has led to "significantly lower" LDL levels – the harmful type of cholesterol – in a one-year trial, reported Wednesday. researchers.
Bipedoic acid, taken daily, may be an option for people who can not sufficiently lower their LDL levels with statin therapy alone or who do not tolerate statins due to side effects such as muscle pain.
After three months of taking the new drug on statins, patients saw their LDL levels drop by an average of 18% compared to people taking a placebo, according to the study published in the New England Journal of Medicine.
The trial was funded by Esperion Therapeutics, a pharmaceutical company seeking approval from the US Food and Drug Administration for the drug to be available in the United States.
Bempedic acid has the same properties as statins, but at a different site, said Dr. Kausik Ray, cardiologist, lead author of the study and a professor at the School of Public Health at Imperial College London. It blocks a key enzyme that the body uses to make cholesterol.
"We have several different studies that show that this seems to be another very good option. Doctors like the options because patients do not fit the same size, which gives us an option for people whose needs are not being met, "Ray told NBC News.
"I think it's a great development."
Low-density lipoprotein, or LDL, contributes to the accumulation of fat in the arteries, increasing the risk of heart attack and stroke. According to the Center for Disease Control and Prevention, about 71 million American adults have high LDL levels.
Heart disease is the leading cause of death for both men and women in the United States and the reduction of LDL cholesterol has become a cornerstone of heart health. When diet and exercise do not work, statins – drugs that inhibit the production of cholesterol – may be the simplest and cheapest treatment. Known under brands such as Lipitor, Zocor and Crestor, they are among the most prescribed drugs in the world.
But 10 to 15% of patients report side effects, most often muscle pain, weakness and cramps. Many people simply stop taking the pills.
The new drug – once converted to its active form in the liver – can not leave the liver cells, so it can not penetrate the muscles, making side effects related to muscles less likely, Ray said.
A good candidate for this drug would be a person who is at high risk for heart disease and who still has high LDL levels despite the maximum dose of a statin that he can tolerate, said Dr. Christie Mitchell Ballantyne, head of the cardiology department at Baylor College of Medicine. in Houston, Texas.
"This medicine could help a lot of people," said Ballantyne. "We hope to help more people achieve a very safe and healthy level of LDL."
The trial involved 2,230 people – mostly white men – who were, on average, 66 years old and had an average LDL cholesterol level of about 103 at first. More than 97% had a history of atherosclerotic cardiovascular disease.
Two-thirds of the patients were assigned to bempedic acid and the others swallowed a placebo. All continued the statins diet of maximum intensity that they could tolerate.
"The main reason is that, when you follow the same pathways, there is always the following question: if you want to add it over a statin, have you maximized the system, or have you to win others? "Ray noted.
The answer seems to be yes. Most people who took the new drug saw their LDL cholesterol drop – about 19 milligrams per deciliter on average – with the effects still apparent a year after the trial began. The new drug was tolerated as well as placebo, although there was a slight increase in the number of new cases of gout.
Jack Manley, 71, of Pearland, Texas, has been taking Lipitor for years for his high cholesterol, but he has had severe leg cramps due to the statin side effect.
"I needed relief from leg cramps because it was constant," said Manley, a survivor of a stroke. His dose of Lipitor was reduced, but the cholesterol level was not brought to the limit desired by his doctor.
After trying the last drug in the trial, his cholesterol dropped and he had no side effects.
"Hopefully it will be an affordable drug that will keep my cholesterol in the range it needs," Manley said.
It is not known how much Bempedic acid would cost if it were approved for the US market, but it would probably be cheaper than the PCSK9 inhibitors – injectable cholesterol-lowering drugs that are potent, but can cost thousands of dollars a year, said Ray.
In addition to stimulating statins, bempedic acid could be taken alone or in combination with ezetimibe (known as Zetia brand), a drug that prevents the absorption of cholesterol in the body. The intestine, he added.
A current trial even tests for long-term safety and determines whether the new drug has an effect on heart disease. Earlier medications have shown promising prospects for improving cholesterol levels, but did not actually reduce the number of heart attacks and strokes.
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