Mass General Brigham researchers report that the cholesterol-lowering drug evolocumab can significantly reduce the risk of a first major cardiovascular event in people with high-risk diabetes who are considered high risk but do not yet have diagnosed atherosclerosis. The findings were presented at the American College of Cardiology's Annual Scientific Session and published in JAMA. This study suggests a shift in prevention strategies for high-risk patients without known significant atherosclerosis.
Key Details
Researchers studied 3,655 patients who had high-risk diabetes but no significant atherosclerosis. Participants were assigned to receive either evolocumab injections every two weeks or a placebo. All participants continued standard cholesterol treatments such as statins and ezetimibe during the study.
Patients treated with evolocumab experienced much larger reductions in cholesterol. After 48 weeks, median LDL-C levels were about 51% lower in the evolocumab group compared with the placebo group. These results indicate a substantial biological impact from the PCSK9 inhibitor class of drugs.
Over a follow-up period of nearly five years, those receiving evolocumab in addition to standard therapy had a 31% lower risk of experiencing their first major cardiovascular event. At five years, 5% of patients in the evolocumab group had experienced an event, compared with 7.1% in the placebo group. Serious side effects were reported at similar rates in both groups.
"These results demonstrate the benefit of intensive lowering cholesterol earlier and should change how we think about the prevention of heart attacks, strokes, and heart disease in patients without known significant atherosclerosis," said corresponding author Nicholas A. Marston, MD, MPH. Marston is a cardiologist with the Mass General Brigham Heart and Vascular Institute. He noted that intensive cholesterol-lowering has been reserved for patients who already have cardiovascular disease for over a decade.
The VESALIUS-CV randomized trial was funded by Amgen Inc. Other authors include Ajay K. Bhatia, Gaetano M. De Ferrari, and Lawrence A. Leiter. Several researchers reported personal fees from Amgen or are employees of the pharmaceutical company.
What This Means
Heart disease continues to be the leading cause of death worldwide. Reducing levels of low-density lipoprotein cholesterol is one of the most effective ways to lower risk. Evolocumab belongs to a class of drugs known as PCSK9 inhibitors and can cut LDL-C levels by about 60%.
Researchers note that additional studies will be needed to determine whether these benefits apply to other high-risk groups who do not yet have established atherosclerosis. The findings could influence clinical guidelines regarding early intervention in diabetes management. Healthcare systems may face decisions on cost-effectiveness for widespread prescription.
This development marks a potential shift in how medical professionals approach cardiovascular prevention in diabetic populations. Future research will likely focus on long-term outcomes and broader demographic applications. The medical community will monitor how these results integrate into standard practice protocols.
