Mass General Brigham researchers announced on Mar. 28 that the cholesterol-lowering therapy evolocumab reduced the risk of a first major cardiovascular event in high-risk patients with diabetes who did not have known atherosclerosis. The findings were presented at the American College of Cardiology's Annual Scientific Session & Expo and published in JAMA.
Cardiovascular disease is a leading cause of death worldwide, and lowering low-density lipoprotein cholesterol (LDL-C), also known as "bad cholesterol," is an important strategy for reducing this risk. Evolocumab, which is classified as a PCSK9 inhibitor, lowers LDL-C by about 60% and works alongside statins.
The study analyzed data from the VESALIUS-CV randomized trial, which was sponsored by Amgen Inc., focusing on 3,655 patients without significant atherosclerosis but with high-risk diabetes. High-risk diabetes was defined as having diabetes for at least ten years, requiring daily insulin use, or having microvascular disease. Participants received either evolocumab injections every two weeks or placebo while continuing standard therapies such as statins and ezetimibe.
After 48 weeks of treatment, those receiving evolocumab had median LDL-C levels about 51% lower than those taking placebo (52 mg/dL versus 111 mg/dL). Over nearly five years of follow-up, patients treated with evolocumab had a 31% lower risk of experiencing their first major cardiovascular event—including coronary heart disease death, heart attack, or ischemic stroke—compared to those on standard therapy alone. Five-year event rates were reported at 5% for the evolocumab group versus 7.1% for placebo.
Serious adverse events occurred at similar rates between both groups during the study period, indicating that evolocumab was well tolerated among participants.
Researchers say further studies are needed to determine if these benefits extend to other groups of high-risk patients without established atherosclerosis.
