Jordan Daily - A drug called evolocumab has shown promise in preventing first-time heart attacks and strokes in diabetes patients without prior cardiovascular issues, according to a new study. The findings, presented at the American College of Cardiology's annual scientific session and published in the Journal of the American Medical Association (JAMA), suggest the drug could significantly reduce the risk of major cardiovascular events in this high-risk population.
Evolocumab, a PCSK9 inhibitor, is an injectable medication that dramatically lowers low-density lipoprotein (LDL) cholesterol, often referred to as "bad" cholesterol. It is typically prescribed for patients with familial hypercholesterolemia or those at high risk for heart attacks and strokes.
The study revealed that evolocumab lowered LDL cholesterol levels by 51% and reduced the risk of a first major cardiovascular event, such as a heart attack or stroke, by 31% in patients predisposed to these complications.
The research was conducted by investigators from the TIMI Study Group, specializing in myocardial infarction research, at Brigham and Women's Hospital, Harvard Medical School.
The trial involved 12,301 patients with diabetes, divided into two groups. One group received evolocumab injections every two weeks, while the other received placebo injections. All participants continued taking traditional cholesterol-lowering statin medications.
Over a 48-week period, from 2019 to 2025, researchers monitored the occurrence of heart attacks or strokes in participants.
The results indicated that evolocumab prevented first-time major cardiovascular events in diabetes patients without prior diagnoses of atherosclerosis. Only 5% of the evolocumab group experienced strokes, heart attacks, or death from coronary artery disease, compared to 7.1% in the placebo group.
Mortality rates over approximately five years due to these cardiac emergencies were 7.8% in the evolocumab group and 10.1% in the placebo group.
While the study, supported by Amgen, the drug's manufacturer, showed promising results, experts emphasize the need for independent, extended studies to evaluate the drug's efficacy in broader patient populations.
Evolocumab was approved for adult use in 2015 by the U.S. Food and Drug Administration (FDA) to manage high LDL-C levels in individuals with familial hypercholesterolemia or atherosclerotic cardiovascular disease. These medications are often prescribed alongside statins and a suitable diet to lower elevated LDL-C levels.
Statins are widely used to lower LDL cholesterol and triglycerides by inhibiting an enzyme in the liver, significantly reducing the risk of heart attacks, strokes, and atherosclerosis. Although generally safe, they can cause side effects like muscle pain.
Evolocumab belongs to the PCSK9 inhibitor class, which are monoclonal antibodies. The discovery of PCSK9 proteins in 2003 was a breakthrough, leading to the identification of potential steps to reduce genetic blood cholesterol.
PCSK9 proteins damage LDL cholesterol receptors in the liver, raising LDL levels in the blood. PCSK9 inhibitors like evolocumab protect these receptors, enhancing their ability to capture LDL cholesterol and keep it under control.
Multiple studies have demonstrated the efficacy of evolocumab in lowering LDL cholesterol levels. A 2014 study published in the New England Journal of Medicine showed that evolocumab reduced LDL levels by 60% compared to the placebo group.
The study included 901 patients over 52 weeks. Similarly, a research team from several countries found that evolocumab reduced LDL levels by 60% in a study of 331 patients, with results published in The Lancet.
Statins have been the primary treatment for high LDL cholesterol since lovastatin's introduction in 1987. PCSK9 inhibitors have emerged as a safe and effective alternative for individuals who do not respond to or tolerate statins, or those with genetic hypercholesterolemia. Recommendations published in the European Heart Journal in 2017 confirmed that PCSK9 inhibitors could lower LDL levels by 60% compared to statins.
Cardiovascular diseases are a leading cause of death globally. According to 2021 World Health Organization statistics, cardiovascular diseases accounted for 19.8 million deaths worldwide, with heart attacks and strokes comprising 85% of these fatalities, three-quarters of which occurred in developing countries.
Elevated LDL cholesterol levels are a significant risk factor for heart attacks and strokes. Cholesterol plaques accumulate on the inner walls of arteries, causing blockages and impeding blood flow, a condition known as atherosclerosis. According to the American Heart Association, high LDL cholesterol was responsible for 4.51 million deaths globally in 2020.
