A group of researchers revealed distinctive results during the annual scientific conference of the American College of Cardiology, coinciding with the publication of their study in the journal JAMA, which showed that the drug evolocumab has important protective properties in diabetic patients who do not suffer from atherosclerosis.
Evolocumab is a breakthrough biologic (PCSK9 inhibitor) administered subcutaneously to significantly lower LDL cholesterol. It is prescribed by prescription to treat familial hypercholesterolemia or for heart patients at risk of heart attacks and strokes.
The results showed that the drug succeeded in reducing harmful cholesterol levels (LDL) by 51%, and also contributed to reducing the risk of a first serious cardiovascular event such as a heart attack or stroke by 31% in patients most at risk for these complications.
Clear preventive superiority
The study was led by researchers from the TIMI Myocardial Infarction Research Group at Brigham and Women’s Hospital of Harvard Medical School.
It included 12,301 patients with diabetes, who were divided into two groups: the first received injections of evolocumab once every two weeks, while the other group received placebo injections devoid of the active ingredient.
The trial lasted 48 weeks, with all participants continuing to take conventional cholesterol-lowering treatments (statins). The participants’ odds of having a heart attack or stroke were then tracked from 2019 to 2025.
It was later shown that evolocumab was able to prevent the first serious cardiac emergency in diabetic patients who had not previously been diagnosed with atherosclerosis. The incidence of strokes, heart attacks, or death resulting from coronary heart disease in the group that took evolocumab was 5%.
While the rate in the group that did not take the drug reached 7.1%, and the deaths that were monitored over a period of approximately 5 years as a result of one of these emergency heart problems was 7.8% in the group that continued taking evolocumab, while it reached 10.1% in the control group that was given placebo injections.
Despite the promising results shown by the study supported by Amgen, the company that manufactures the drug, experts stress the necessity of conducting independent, long-term studies to evaluate the effectiveness of the drug on broader segments of patients.
A safe and effective alternative
Evolocumab was approved for adult use in 2015 by the US Food and Drug Administration (FDA) to control high LDL-C levels in people with familial hypercholesterolemia or atherosclerotic cardiovascular disease. These drugs are usually prescribed with statins to lower high LDL-C levels, along with an appropriate diet.
Statins are effective and commonly used medications to lower the level of harmful cholesterol and triglycerides in the blood, by inhibiting an enzyme in the liver, which significantly reduces the risk of heart attacks, strokes, and atherosclerosis. They are generally considered safe and taken regularly, but they may cause side effects such as muscle pain.
Evolocumab belongs to the PCSK9 inhibitors, which are monoclonal antibodies. The discovery of PCSK9 proteins was amazing in 2003. It later contributed to identifying the actual possible steps to reduce hereditary blood cholesterol.
PCSK9 proteins cause damage to the harmful LDL cholesterol receptors in the liver, causing the level of LDL in the blood to rise. Thus, PCSK9 inhibitors, to which the drug evolocumab belongs, protect these receptors, increasing their capture of LDL cholesterol to keep it under control.
Evolocumab in studies
Many studies have proven the efficacy and efficacy of evolocumab in reducing levels of harmful LDL cholesterol. In a study published in the New England Journal of Medicine in 2014, evolocumab was able to reduce LDL levels by 60% compared to the group that did not receive the drug.
The study included 901 patients and lasted for 52 weeks. A research team from several countries also reached the same result after they tested the drug evolocumab on 331 patients. The results were published in The Lancet, showing a reduction in LDL levels by 60%.
Evolocumab and statins
Statin drugs have been classified as the first choice for treating high levels of harmful LDL cholesterol since the introduction of lovastatin in 1987 as the first drug available on the market in the category of statins. Then, PCSK9 inhibitor drugs emerged as a safe and effective alternative to statins for people whose bodies do not respond to them, or who cannot tolerate them and annoying side effects appear, or for those with hereditary hypercholesterolemia, as the effectiveness of PCSK9 drugs was recorded in recommendations published in the European magazine. European Heart Journal in 2017 confirmed that it can reduce LDL levels by 60% compared to statins.
High cholesterol and heart disease
Cardiovascular diseases are one of the main causes of death globally. According to 2021 statistics published by the World Health Organization, cardiovascular diseases claimed the lives of 19.8 million people around the world. Clots and strokes constituted 85% of all these deaths, three-quarters of whom were from developing countries.
High levels of harmful LDL cholesterol are referred to as one of the factors that raise the risk of heart attacks or strokes, as cholesterol plaques accumulate on the walls of the internal arteries, leading to their blockage and impeding blood flow in what is known as atherosclerosis. Therefore, according to the report published by the American Heart Association, high LDL was a cause of death for 4.51 million people in the world in 2020.