Phase III FOURIER trial of Repatha (evolocumab)shows link between LDL-C levels and CV events in atherosclerotic cardiovascular disease.-Amgen.

Amgen announced a new analysis from the Repatha (evolocumab) cardiovascular outcomes study (FOURIER) that showed a statistically significant relationship between lower achieved low-density lipoprotein cholesterol (LDL-C) levels and lower cardiovascular event rates in patients with established atherosclerotic cardiovascular disease. There was no evidence of a leveling off of effect and no new safety concerns were identified in this analysis.

The analysis demonstrated that there was a highly significant progressive relationship between lower LDL-C and a lower risk of the primary composite endpoint. A similar progressive reduction in the key secondary composite endpoint, which included heart attack, stroke or cardiovascular death, was also observed across all five groups. There was no meaningful difference in the safety profile across the five groups, including the group with the lowest achieved LDL-C level. Lastly, patients were more likely to achieve very low LDL-C levels when treated with Repatha and statin therapy versus statin alone. In a post-hoc analysis, 504 patients who achieved an LDL-C of less than 0.26 mmol/L, or 10 mg/dL, experienced a 31 percent risk reduction in the primary composite endpoint (p=0.035) and a 41 percent risk reduction in the secondary composite endpoint (p=0.020).

No new safety concerns were identified in this large clinical trial with roughly 60,000 patient-years of follow-up; this included the assessment of patients who achieved very low levels of low-density lipoprotein cholesterol (LDL-C). The results were presented in a Late-Breaking Clinical Trials session at the European Society of Cardiology (ESC) Congress 2017.