Evolocumab reduced the risk of major cardiovascular events by 15% in patients with atherosclerotic cardiovascular disease who were already taking statins, a study has found.
The study randomised 27 564 patients with clinically evident atherosclerotic cardiovascular disease to evolocumab (either 140 mg every two weeks or 420 mg monthly by subcutaneous injection) or to placebo.1 Study participants had fasting concentrations of low density lipoprotein (LDL) cholesterol of ≥1.8 mmol/L on moderate or high intensity statin therapy, and 81% had a previous myocardial infarction.
Evolocumab inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and has been shown to reduce LDL cholesterol levels by around 60%. Its effect on risk of cardiovascular events was unknown.
Results of the trial, reported in the New England Journal of Medicine, showed that patients who took evolocumab had a 15% lower risk of major cardiovascular events at 48 weeks compared with those on placebo (9.8% versus 11.3%, hazard ratio 0.85, 95% confidence interval 0.79 to 0.92, P<0.001). The primary endpoint was major cardiovascular event, including cardiovascular death, myocardial infarction, stroke, hospitalisation for unstable angina, and coronary revascularisation.
Treatment with the PCSK9 inhibitor reduced LDL cholesterol levels by 59%, from a median baseline value of 2.4 mmol/L to 0.78 mmol/L (P<0.001).
All subgroups of patients in the study, which was supported by Amgen, showed a similar reduction in cardiovascular events with evolocumab, including those in the lowest quarter for baseline LDL cholesterol levels (median 1.9 mmol/L).