Studie FOURIER - evalocumab v sekundární prevenci.

Elevated LDL cholesterol (LDL-C) concentration is an independent risk factor for cardiovascular morbidity and mortality aimed at by numerous therapeutic interventions. However, despite maximum possible treatment with statins, a wide range of patients fail to reach satisfactory control. It is these patients who can now be offered modern treatment with proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors. The FOURIER trial involved 27,564 patients with established cardiovascular disease treated with a maximum tolerated statin dose who were randomized to receive evalocumab or placebo. The reduction in LDL cholesterol levels with evalocumab was 59 %, from a median of 90 mg/dL to 30 mg/dL, i.e. approximately 0.8 mmol/L. The primary end point (myocardial infarction, stroke, hospitalization for angina pectoris, revascularization and/or death) was reduced from 14.6 % to 12.6 % (p < 0.0001), and the key secondary end point (death, myocardial infarction, and stroke) from 9.9 % to 7.9 % (p < 0.0001). There was no effect on all-cause mortality (2.5 % vs. 2.4 %); there was a significant reduction in myocardial infarction rate (4.4 % vs 6.3 %) and stroke rate (2.2 % vs. 2.6 %). It made no difference whether patients received one dose in 2 weeks or one in 4 weeks. No significant differences between adverse effects were reported. The Ebbinghaus substudy showed no negative effect on neurocognitive function. [ABSTRACT FROM AUTHOR]