Researchers have discovered an experimental medicine that significantly reduces a cholesterol that can increase the risk of heart attacks and stroke.
Many Americans do not know that the high levels of this part, known as lipoproteins (A) or LP (A), circulate in their blood.
LP (a) high cannot be modified with changes in lifestyle, and has been called “one of the latest non -treatable cardiovascular risk” by the Cleveland Clinic, which directed the study.
This new investigation confirmed previous findings that show that the experimental drug – lepodisiran, conducted by Eli Lilly, who financed the study – can “silence” the main gene responsible for synthesizing LP (a).
(Other experimental genetic therapies with a similar mechanism of action are also in development, according to the Cleveland clinic).
The findings were published in the New England Journal of Medicine and were also presented at the Annual Meeting of the American College of Cardiology on March 30.
What to know about LP (A)
Lipoprotein levels (a) are high in approximately 20-25% of people around the world, according to the American Heart Association.
This is equivalent to approximately 64 million people in the United States and 1.4 billion people worldwide.
LP (a) shares similarities with another lipoprotein to which doctors aim to reduce the risk of heart disease, known as low density lipoprotein (LDL) or called “bad cholesterol.”
But lipoprotein (a) is more prone to the accumulation of plaque and clots in the arteries than in LDL, agree to lead the author Steven Nissen, MD, academic director of the Heart, the vascular and thoracic institute in Cleveland Clinic.
“Lipoprotein (a) is an independent risk factor of heart disease that is largely determined by genetics, that is, it is inherited,” added Dr. Ir. Deepak L. Bhatt, director of the Mount Sinai Fuster Heart Hospital and cardiovascular medicine professor at the ICAHN School of Medicine in Mount Sinai in New York, said Fox News Digital. (It was not part of the study).
LP (a) is mainly determined by differences in a gene, while LDL cholesterol levels are influenced by multiple genes.
“That is a big difference, and LDL has a much larger environmental component,” Nissen said.
“LP (A) is an independent risk factor of heart disease that is largely determined by genetics.”
Diet, exercise and weight loss can help reduce LDL levels, but do not have an impact on LP (A) levels, experts say.
And unlike LDL, which can be reduced with medications such as statins, there are currently no approved medication treatments that lower LP (A).
“There is no pharmacotherapy approved for lipoproteins (a) by the regulatory authorities in any country in the world,” Nissen confirmed.
Study design
The researchers conducted a clinical trial of 320 individuals from Argentina, China, Denmark, Germany, Japan, Mexico, Netherlands, Romania, Spain and the United States from November 11, 2022 until April 17, 2023.
The participants were randomly assigned to receive a placebo or one or two subcutaneous injections of lepodisiran.
The normal level of LP (A) is less than 75 nanomoles per liter and the average level for people in the trial was approximately 250 nanomoles per liter, Nissen told Fox News Digital.
“They were very high, more than three times the upper limit of normal,” he added.
After an injection of the highest dose, participants showed a reduction of almost 100% in lipoprotein levels (a) at six months.
Those who recovered a second dose at six months maintained a reduction of almost 100% in the one -year brand.
In other words, therapy eliminated the virtual of the entire lipoprotein (a) of the blood, according to Nissen.
Cardiologists say that these findings can ultimately help treat millions of Americans who have high levels of LP (A).
“The results are very impressions,” Bhatt said.
Potential limitations
The researchers noticed that they were not great security conerns, but 12% of the participants reported minor reactions on the injection site.
The study only had a few black participants, a population that needs more research, since it is more likely to have high concentrations of lipoproteins (a) than white people, according to previous studies.
(To address this concern, researchers are registering many more black patients in their largest phase 3 clinical trial).
Another limitation was that only two doses of lepodisiran were administered in the essay, so the most dose effect is not known.
The study also shows that the reduction of LP (A) levels also reduces the risk of heart attacks and strokes, observed by external experts.
“A phase 3 trial is needed to prove the clinical impact of this medicine to see if the great reduction of LP (A) translates into lower heart attack rates,” Bhatt said.
Nissen confirmed that phase 3 test to address this question is already underway.
“Whatever your level when I am 24 years old, it is the level when you are 64 years old, it does not change, because it is genetic.”
The European Society of Cardiology and the National Association of Lipidic in the US. It should be found that all adults verify their LP (A) levels.
“I have bone control levels (A) in all patients for many years,” Bhatt said.
But unlike traditional cholesterol, that doctors typically monitor over time, Nissen pointed out that lipoprotein (a) only needs to be reviewed once in life.
“Whatever your level when I am 24 years old, it is the level when you are 64 years old, it does not change, because it is genetic,” he said.
“So you just need to get it once, and if you get it early in life, then you know you are at risk and you can live your life in agreement.”