Researchers at Massachusetts General Brigham have found that evolocumab, an intensive cholesterol-lowering therapy, reduces the risk of a first major cardiovascular event in high-risk patients with diabetes but no known atherosclerosis (plaque buildup within the walls of arteries). Results were presented at the American College of Cardiology’s Annual Scientific Sessions and Expo and published concurrently. Japan Automobile Manufacturers Association.
For more than a decade, intensive cholesterol-lowering treatments have been limited to patients who already have cardiovascular disease. These results demonstrate the benefits of early and intensive lowering of cholesterol and should change the way we think about preventing heart attack, stroke, and heart disease in patients without known significant atherosclerosis. ”
Nicholas A. Marston, MD, MPH, corresponding author, cardiologist at Massachusetts General Brigham Heart and Vascular Institute
Cardiovascular disease remains the leading cause of death worldwide. Lowering low-density lipoprotein cholesterol (LDL-C), often referred to as “bad cholesterol,” is an important strategy to reduce risk. Evolocumab, a potent PCSK9 inhibitor, reduces LDL-C by approximately 60% and adds to the effects of statins. Currently, people who do not have atherosclerosis but are at increased risk are typically prescribed statins if they are prescribed cholesterol-lowering drugs.
In a subgroup analysis of the Amgen-sponsored VESALIUS-CV randomized trial, researchers evaluated whether evolocumab could prevent cardiovascular events in 3,655 patients with high-risk diabetes and no significant atherosclerosis. High-risk diabetes was defined as diabetes lasting at least 10 years, requiring daily insulin use, or with microvascular disease.
Participants were treated with evolocumab injections every two weeks or a placebo. Patients in both groups also continued standard cholesterol-lowering therapy, including statins and ezetimibe.
Patients receiving evolocumab had significantly lower cholesterol levels during the trial. After 48 weeks, median LDL-C levels were reduced by approximately 51% in the evolocumab group compared with placebo (52 mg/dL vs. 111 mg/dL).
Over a median follow-up of approximately 5 years, patients who received evolocumab in addition to standard cholesterol-lowering therapy had a 31% lower risk of a first major cardiovascular event compared with patients treated with standard cholesterol-lowering therapy alone. Events include death from coronary heart disease, heart attack, and ischemic stroke. The 5-year event rate was 5% for patients who received evolocumab versus 7.1% for patients who received placebo.
Serious adverse events occurred at similar rates in both the evolocumab and placebo groups, suggesting that the treatment was well tolerated in this population.
The researchers note that future studies will be important to determine whether similar benefits extend to other groups of high-risk patients without established atherosclerosis.
sauce:
Reference magazines:
Marston, North Carolina; others. (2026). Evolocumab reduces the first major cardiovascular event in diabetic patients without known significant atherosclerosis. Japan Automobile Manufacturers Association. DOI: 10.1001/jama.2026.3277. https://jamanetwork.com/journals/jama/fullarticle/2847162
