In a large international trial, the PCSK9 inhibitor evolocumab reduced the risk of a first cardiovascular event among high-risk patients without a previous myocardial infarction or stroke.
In Finland, the study was led by Professor Johanna Kuusisto at the University of Eastern Finland. According to her, the results are significant and will likely change current treatment recommendations. “Early and effective LDL cholesterol management is crucial in the prevention of cardiovascular diseases, but the most common cholesterol medications, statins and ezetimibe, are not always sufficient to lower LDL cholesterol.”
“PCSK9 inhibitors are effective LDL cholesterol reducers, and the use of evolocumab alongside statins is an important option not only for patients with cardiovascular disease, but also for those with diabetes.”
Evolocumab or placebo was added to an earlier cholesterol-lowering regimen
PCSK9 is a protein that regulates the activity of LDL receptors in the liver. PCSK9 inhibition with evolocumab increases the clearance of LDL cholesterol from the blood.
A total of 12,257 participants from 33 countries participated in the internationally significant VESALIUS CV trial, including 122 participants from Finnish centres. The average age of the participants was 66 years. They had been diagnosed with atherosclerosis or diabetes or both, as well as elevated LDL cholesterol levels, and were on a cholesterol-lowering medication, 87 per cent on statins and 20 per cent on ezetimibe. Statin therapy was not suitable for 13 per cent of the participants.
The participants in the double-blind trial were randomised to receive either 140 mg of evolocumab or a placebo injected under the skin every two weeks for an average of 4.6 years.
Key results
- Adding evolocumab to a high-intensity, cholesterol-lowering regimen significantly reduced the risk of a first cardiovascular event, compared to placebo.
- Compared to placebo, evolocumab reduced the risk of coronary heart disease death, heart attack or ischemic stroke by 25%.
- The risk of heart attack alone was reduced by as much as 36%.
- Evolocumab efficiently lowered LDL cholesterol levels: LDL cholesterol was lowered by nearly 55% compared to the placebo group, resulting in a median level of 1.16 mmol/l.
- There was no difference in the number of adverse events or treatment discontinuations between the evolocumab and placebo groups.
The results were published in The New England Journal of Medicine, one of the world's most prestigious and influential medical journals. The study was funded by the biotechnology company Amgen.
For further information, please contact:
Professor Johanna Kuusisto, Specialist in cardiology and internal medicine, [email protected]
University of Eastern Finland, School of Medicine; Kuopio University Hospital, Medical Centre
Research article:
Bohula, E.A., Marston, N.A., Bhatia, A.K., De Ferrari, G.,M., Leiter, L.A., Nicolau, J.C., Park, J., Kuder, J.F., Murphy, S.A., Walsh, E., Wang, H., Blaha, V., Budaj, A., Cornel, J.H., Goudev, A., Kiss, R.G., Lorenzatti, A.J., Parkhomenko, A., Cyrille, M., Paiva da Silva Lima, Gabriel, Ohman, E.M., Giugliano, R.P., & Sabatine, M.S. 2025 for the VESALIUS-CV Investigators, "Evolocumab in Patients without a Previous Myocardial Infarction or Stroke", The New England journal of medicine, (Nov 8, 2025). DOI: 10.1056/NEJMoa2514428
