"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 of the study, Nicholas A. Marston, MD, MPH, a cardiologist with the Mass General Brigham Heart and Vascular Institute, in a press release.
The researchers analyzed a subgroup of patients from a randomized, double-blind, placebo-controlled trial of evolocumab which included close to 12, 300 patients across 33 countries. Altogether, they analyzed data from 3655 patients with an average age of 65 years old who had diabetes but did not have significant atherosclerosis— plaque build-up inside arterial walls. Patients were followed for an average of 4.8 years across the whole study.
Around half of the patients received subcutaneous evolocumab every two weeks, while half received a placebo. Both also received an optimally tolerated statin therapy, which is a standard treatment. High-risk patients who do not have atherosclerosis are typically treated with statins alone, if any medication at all.
Ultimately, the researchers found that patients receiving evolocumab alongside standard therapy were 31% less likely to have a first major cardiovascular event after around five years, including death from coronary heart disease, heart attack, or ischemic stroke. Over the same period, 5% of those taking evolocumab and 7.1% of the placebo group experienced an event. They further found that after 48 weeks, those taking evolocumab had 51% lower levels of low-density lipoprotein cholesterol (LDL-C) than those on the placebo.
Serious adverse events thought to be linked to the drug and those leading to patients discontinuing treatment occurred at similar rates between the groups, indicating the drug was generally well-tolerated. The researchers noted that more research is needed to understand whether the benefits apply to other high-risk groups without known atherosclerosis.
Sources: Science Daily, JAMA
