Researchers from Mass General Brigham found that the cholesterol drug evolocumab cuts the risk of first-time major cardiovascular events by 31% in high-risk patients with diabetes who lack diagnosed atherosclerosis. The results, from a subgroup analysis of the VESALIUS-CV trial, were presented at the American College of Cardiology's Annual Scientific Session and published in JAMA. Patients on the drug saw LDL cholesterol levels drop significantly alongside standard treatments.
Mass General Brigham cardiologist Nicholas A. Marston, MD, MPH, led the study on 3,655 patients with high-risk diabetes, defined as having the condition for at least 10 years, requiring daily insulin, or showing diabetes-related small blood vessel damage. None had significant atherosclerosis. Participants received either evolocumab injections every two weeks or a placebo, while all continued statins or ezetimibe as standard care. The trial, funded by Amgen Inc., followed patients for nearly five years. evolocumab belongs to PCSK9 inhibitors and lowers LDL-C, or 'bad cholesterol,' by about 60% when added to statins. After 48 weeks, median LDL-C levels fell to 52 mg/dL in the evolocumab group, compared to 111 mg/dL in the placebo group—a 51% greater reduction. Over the follow-up, 5% of evolocumab patients experienced a first major cardiovascular event, such as death from coronary heart disease, heart attack, or ischemic stroke, versus 7.1% in the placebo group. This marked a 31% lower risk for the treatment group. Serious side effects occurred at similar rates between groups, suggesting good tolerability. Marston noted, '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.' Heart disease remains the leading cause of death worldwide, and reducing LDL-C proves effective for risk reduction. Researchers call for more studies on other high-risk groups without established atherosclerosis.
