Results of FOURIER study shows Repatha (evolocumab) reduces cardiovascular events in patients with and without diabetes.- Amgen.

Amgen announced that a new analysis of the cardiovascular outcomes study (FOURIER) demonstrated that lowering low-density lipoprotein cholesterol (LDL-C) levels with Repatha (evolocumab) significantly and consistently reduced cardiovascular events in patients with and without diabetes at baseline. The analysis showed that diabetes was independently associated with a substantially increased risk of cardiovascular morbidity and mortality in patients with atherosclerotic cardiovascular disease. Patients with diabetes tended to have a greater absolute risk reduction of cardiovascular events with Repatha treatment because of their heightened baseline risk. Consistent with recent trials of more intensive LDL lowering, Repatha has not shown an effect on cardiovascular mortality.

The analysis also showed that Repatha was not associated with an increased risk of new-onset diabetes or worsening glycemia (increased presence of glucose in the blood) over a median of 2.2 years of follow-up in patients without diabetes or pre-diabetes. Additionally, no new safety concerns were identified in this analysis. The results were presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes and simultaneously published in The Lancet Diabetes & Endocrinology.

Comment: This analysis demonstrates the benefits of achieving LDL-C levels well below current targets among atherosclerotic cardiovascular disease patients both with and without diabetes. It also provides additional evidence that evolocumab is equally safe in patients with and without diabetes.