Patients with type 1 diabetes mellitus (T1DM) and atherosclerotic cardiovascular disease (ASCVD) remain at very high cardiovascular risk despite statin therapy. The FOURIER trial, published in Diabetes Care, assessed the efficacy of evolocumab for intensive LDL cholesterol (LDL-C) lowering in this population. This randomized study included 27,564 participants with ASCVD on statins, of whom 10,834 had type 2 diabetes mellitus (T2DM) and 197 had T1DM. The median follow-up was 2.2 years.

In the placebo group, Kaplan-Meier rates of the primary endpoint, which included cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, rose stepwise at 2.5 years. Rates were 11.0% in participants without diabetes, 15.2% in those with T2DM, and 20.4% in those with T1DM (P < 0.0001). Evolocumab reduced primary events across all groups. Hazard ratios were 0.87 (95% CI 0.79–0.96) for no diabetes, 0.84 (0.75–0.93) for T2DM, and 0.66 (0.32–1.38) for T1DM. Absolute risk reduction was 1.3%, 2.5%, and 7.3%, respectively.

The findings suggest that intensive LDL-C lowering with evolocumab may provide substantial clinical benefit in T1DM with ASCVD, although larger randomized cardiovascular outcomes trials are still needed.