Evolocumab to Reduce First Major Cardiovascular Events in Patients Without Known Significant Atherosclerosis and With Diabetes

Do high-risk primary prevention patients without known significant atherosclerosis and with diabetes benefit from intensive lowering of low-density lipoprotein cholesterol levels with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor therapy?In this prespecified subgroup analysis of 3655 patients from a randomized clinical trial, the addition of evolocumab, compared with placebo, in high-risk primary prevention patients without known significant atherosclerosis and with diabetes led to lower risk of a first major cardiovascular event (5-year Kaplan-Meier estimate of 5.0% vs 7.1%, respectively, for 3-component outcome [hazard ratio, 0.69] and 7.6% vs 10.5%, respectively, for 4-component outcome [hazard ratio, 0.69]).These data show the value of intensification of lipid-lowering therapy with the PCSK9 inhibitor evolocumab earlier in the disease process in a high-risk population without known significant atherosclerosis and with diabetes.

Corresponding Author: Nicholas A. Marston, MD, MPH, TIMI Study Group, Heart and Vascular Institute, Brigham and Women’s Hospital, 350 Longwood Ave, Boston, MA 02115 (nmarston@bwh.harvard.edu).

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