A new FOURIER analysis evaluating the effects of Repatha in patients with established cardiovascular disease by kidney function.- Amgen

Amgen announced a new Repatha cardiovascular outcomes study (FOURIER) analysis evaluating the effects of Repatha (evolocumab) in patients with established cardiovascular disease by kidney function. In line with previous FOURIER subgroup analyses, these results further demonstrate Repatha's efficacy in reducing not only low-density lipoprotein cholesterol (LDL-C) levels, but also the relative risk for major cardiovascular events such as heart attack and stroke, in high-risk patients including those with mild-to-moderate chronic kidney disease (CKD).

In these patients (N=4,443), absolute reductions tended to be greater in the risk for the composite secondary endpoint which included cardiovascular death, heart attack or stroke. Adverse events were similar across patients regardless of CKD stage and consistent with the Repatha known safety profile. The results were presented at the American Society of Nephrology's (ASN) annual Kidney Week in San Diego.

Analysis of the FOURIER subgroup of patients with CKD showed treatment with Repatha resulted in consistent and robust reductions in LDL-C levels across all patients independent of kidney function (58.7 percent LDL-C reduction in patients with stage 3 CKD versus 58.2 percent LDL-C reduction in those with preserved kidney function). Treatment with Repatha was also associated with significant reductions in the risk for the composite of cardiovascular death, heart attack or stroke across patient subgroups regardless of CKD stage. Patients with more advanced CKD tended to have greater reductions in the absolute risk for cardiovascular events (2.5 percent reduction in absolute risk in patients with = stage 3 CKD compared to 1.7 percent absolute risk reduction in patients with preserved kidney function at year three). This subanalysis is the first to report the effects of a PCSK9 inhibitor in patients with CKD and established cardiovascular disease. Stage CKD, which is often associated with comorbidities such as diabetes, high blood pressure and heart disease, affects an estimated 10 percent of Americans.6,7 CKD is an independent risk factor for the development of cardiovascular disease, with the frequency and risk for adverse outcomes increasing with worsening kidney function.