\n Investigators suggest LDL targets typically reserved for secondary prevention are best in high-risk patients with diabetes.\n <\/p>\n
NEW ORLEANS\u2014Adding the PCSK9 inhibitor evolocumab (Repatha; Amgen) to statin therapy significantly cuts the risk of major cardiovascular events when compared with statins alone in high-risk patients without evidence of atherosclerosis, a prespecified subgroup analysis of the VESALIUS-CV trial shows. <\/p>\n
These new data, which were presented today at the American College of Cardiology 2026 Scientific Session and published simultaneously<\/a> in JAMA, suggest that some high-risk patients without cardiovascular disease should be treated to LDL-cholesterol targets typically reserved for secondary prevention, say investigators. <\/p>\n \u201cWe are currently using evolocumab for patients with high-risk atherosclerosis, so this subgroup with no known atherosclerosis is really a novel group,\u201d Nicholas Marston, MD (Brigham and Women\u2019s Hospital, Boston, MA), who led the analysis, said during a media briefing. \u201cI think targeting LDL down below 55 [mg\/dL]\u2014down to 40 [mg\/dL] in high-risk diabetes without known atherosclerosis\u2014is certainly something we should be seeing in the next round of the guidelines.\u201d<\/p>\n The latest dyslipidemia guidelines<\/a> were released just last week, however. In the 2026 iteration, it\u2019s recommended that patients who have diabetes but not clinical atherosclerotic cardiovascular disease (ASCVD) should be treated with a moderate-intensity statin to achieve an LDL cholesterol target of less than 100 mg\/dL. For the patient with diabetes and multiple ASCVD risk factors, the target is less than 70 mg\/dL. In the guidelines, a target of less than 55 mg\/dL is reserved for the very-high-risk patient with ASCVD. <\/p>\n Ann Marie Navar, MD, PhD (UT Southwestern Medical Center, Dallas, TX), one of the discussants following the presentation, said that prevention is shifting in the US such that there\u2019s a growing awareness that lower is better, even in primary prevention. <\/p>\n \u201cI think our challenge now is to figure out how to translate that into clinical practice,\u201d she said. <\/p>\n Marston, a preventive cardiologist, said he is likely more aggressive than others with respect to LDL lowering, but these high-risk patients with diabetes are typically not seen in cardiology clinics. They are treated by endocrinologists or in diabetes clinics. <\/p>\n \u201cPCSK9 inhibitors have been approved now for 11 years, and we just haven\u2019t seen the uptake throughout medical practice,\u201d he told TCTMD. \u201cI hope that with this analysis we can really message the importance of PCSK9 inhibitor use out to community primary care and other specialties.\u201d \u00a0<\/p>\n There is a bit of an \u201cevidence gap\u201d around high-risk patients with diabetes in the current clinical guidelines, said John D. Bucheit, PharmD (Virginia Commonwealth University, Richmond), a member of the ACC\u2019s Prevention Council. <\/p>\n \u201cWe all see these patients in clinic,\u201d he said. \u201cWe have high-risk patients with diabetes, and this subgroup analysis really helps us. This trial, to me, reinforces that lower is better and that we are going to continue as we go forward to look at our high-risk primary prevention patients and really think about reexamining LDL targets.\u201d <\/p>\n VESALIUS-CV<\/p>\n VESALIUS-CV included 12,257 patients at high cardiovascular risk\u2014defined as having diabetes plus a cardiovascular risk enhancer or atherosclerosis with or without diabetes and elevated LDL cholesterol (\u2265 90 mg\/dL)\u2014who were randomized to placebo or evolocumab 140 mg every 2 weeks on top of statin therapy. As TCTMD reported last fall<\/a>, the main results showed that evolocumab significantly reduced the absolute and relative risks of death from coronary heart disease, MI, or stroke.<\/p>\n