Lawrence Leiter, M.D., on evolocumab in high-risk patients with diabetes and elevated cholesterol | ADA 2026

Adding evolocumab to standard lipid-lowering therapy cut first major cardiovascular events by 29% in patients with high-risk diabetes who had never had a heart attack or stroke, according to a VESALIUS-CV subgroup analysis. Lawrence Leiter, M.D., professor in the departments of medicine and nutritional sciences at the University of Toronto and head of the Lipids Clinic at St. Michael’s Hospital in Toronto, presented the findings at the 2026 American Diabetes Association Scientific Sessions.

VESALIUS-CV tested the PCSK9 inhibitor in more than 12,000 patients without a prior heart attack or stroke. Leiter and colleagues focused on roughly 6,000 participants with high-risk diabetes — defined by microvascular disease, insulin use, or a diabetes duration of at least 10 years — and elevated LDL cholesterol. Layered on top of statins and other lipid-lowering therapy, evolocumab reduced LDL cholesterol by more than 50%, to an average of 45 milligrams per deciliter, over a median 4.6 years. Heart attack risk fell by roughly a third, with nominally lower mortality and no apparent safety differences.

In this interview with Managed Healthcare Executive, Leiter walks through what those numbers mean for a population that guidelines have long flagged as high risk but that practice has often treated less aggressively, reserving intensive LDL lowering for patients who've already had an event.

Leiter points to the lower LDL targets in current diabetes guidelines and notes that many high-risk patients won't reach them on oral therapy alone, making evolocumab a logical add-on to lipid-lowering regimens in this population.