Evolocumab Shows Promise in Preventing Cardiovascular Events in High-Risk Diabetics
Researchers from Mass General Brigham have reported a significant breakthrough: evolocumab, an intensive cholesterol-lowering therapy, reduced the risk of a first major cardiovascular event in high-risk diabetic patients who did not have known atherosclerosis. The results were presented at the American College of Cardiology's Annual Scientific Session & Expo and simultaneously published in JAMA.
These findings suggest potential changes to current prevention strategies for heart attacks, strokes, and heart disease in this patient group.
Key Study Findings
Over a median follow-up period of nearly five years, patients treated with evolocumab in addition to standard therapy experienced a 31% lower risk of a first major cardiovascular event. These events included coronary heart disease death, heart attack, or ischemic stroke. Five-year event rates were observed at 5% in the evolocumab group compared to 7.1% in the placebo group.
Additionally, after 48 weeks, median low-density lipoprotein cholesterol (LDL-C) levels were approximately 51% lower in the evolocumab group (52 mg/dL) compared to the placebo group (111 mg/dL). Evolocumab is a PCSK9 inhibitor that reduces LDL-C levels and is used in conjunction with statins.
Study Design and Participants
The findings stem from a subgroup analysis of the VESALIUS-CV randomized trial, sponsored by Amgen Inc. The study included 3,655 participants with high-risk diabetes but no significant atherosclerosis. High-risk diabetes was specifically defined by criteria such as a duration of at least 10 years, daily insulin use, or the presence of microvascular disease.
Participants were randomly assigned to receive either evolocumab injections every two weeks or a placebo. Crucially, all participants continued their standard cholesterol-lowering therapy, which included medications such as statins and ezetimibe.
Implications for Cardiovascular Prevention
Historically, intensive cholesterol-lowering treatments have typically been reserved for individuals already diagnosed with existing cardiovascular disease. These current findings, however, indicate a potential benefit for earlier intervention in patients without significant atherosclerosis.
Nicholas A. Marston, MD, MPH, a cardiologist with the Mass General Brigham Heart and Vascular Institute, noted that these results could influence prevention strategies for heart attacks, strokes, and heart disease in patients without established significant atherosclerosis.
Currently, high-risk patients without atherosclerosis are typically prescribed statins, if any cholesterol-lowering medication is given.
Safety and Future Research
Serious adverse events occurred at similar rates in both the evolocumab and placebo groups, indicating a favorable safety profile. Investigators suggest that further research is required to determine if similar benefits extend to other high-risk patient populations who do not yet have established atherosclerosis.