Heart attacks and strokes can seem sudden, but the damage behind them often builds silently for many years. Fatty material can slowly collect inside arteries without causing obvious symptoms.
A major new study suggests that treating people at very high risk before serious artery disease appears may prevent some first heart attacks and strokes.
The research was led by investigators from Mass General Brigham and was published in JAMA. The findings were also presented at the American College of Cardiology’s Annual Scientific Session. Researchers studied evolocumab, a powerful medicine designed to lower LDL cholesterol.
The trial focused on people with diabetes who had a high risk of cardiovascular disease but had not developed significant known blocked arteries. Diabetes can damage blood vessels over time and greatly increases the risk of heart disease and stroke. High cholesterol can add to that danger.
LDL is often called “bad” cholesterol because high levels help fatty plaque build up inside artery walls. Plaque can gradually narrow an artery or suddenly break open, causing a blood clot. If the clot blocks blood flowing to the heart or brain, a heart attack or stroke can occur.
Statins are normally the first medicines doctors use to lower LDL cholesterol. They are inexpensive, widely studied and can greatly reduce cardiovascular risk. However, some people remain at high risk even while taking statins or need a much larger drop in LDL than statins alone can provide.
Evolocumab works differently. It belongs to a group of medicines called PCSK9 inhibitors and helps the liver remove more LDL cholesterol from the blood. The drug is given by injection and is already used for some people with established heart disease or very high cholesterol.
The new clinical trial included 3,655 people with diabetes who were considered at high cardiovascular risk. Participants continued standard medical care, including cholesterol-lowering treatment when appropriate. They were randomly assigned to receive either evolocumab or an inactive placebo injection every two weeks.
After 48 weeks, LDL cholesterol was much lower among people receiving evolocumab. But researchers were mainly interested in whether this reduction would prevent serious health problems. They therefore followed the participants for nearly five years.
During that period, people receiving evolocumab had a 31% lower risk of experiencing a first major cardiovascular event than those receiving placebo. These events included heart attack, stroke and death from cardiovascular causes. The result suggests that intensive cholesterol lowering can benefit some people even before major artery disease becomes obvious.
The treatment also appeared generally well tolerated. Serious health problems reported during the trial occurred at similar rates in the evolocumab and placebo groups. This is important because preventive cholesterol medicines may need to be used for many years.
However, the 31% reduction describes the relative difference in risk between the two groups. It does not mean that every person taking evolocumab has a 31-percentage-point lower chance of a heart attack or stroke. The actual benefit for an individual depends on that person’s starting level of cardiovascular risk.
The findings also do not mean that everyone with diabetes needs evolocumab. Doctors must consider LDL levels, blood pressure, blood sugar, smoking, existing medicines, overall cardiovascular risk, possible side effects and treatment cost. Healthy eating, physical activity and other proven preventive measures remain important.
The study adds to a growing shift toward preventing cardiovascular disease earlier rather than waiting until after a first heart attack or stroke.
Its findings apply most directly to people with diabetes and very high cardiovascular risk who resemble the patients in the trial. Future treatment guidelines may help define which patients are most likely to benefit from starting powerful LDL-lowering therapy earlier.
If you care about heart health, please read studies about top foods to love for a stronger heart, and why oranges may help fight obesity, diabetes, and heart disease.
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