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Amgen Announces New FOURIER Analysis Showing Benefit With Repatha

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.

“Patients with chronic kidney disease are considered a high-risk population due to increased rates of cardiovascular events associated with impaired kidney function,” said Robert P. Giugliano, M.D., S.M., Brigham and Women’s Hospital, Harvard Medical School and lead investigator. “The results of this analysis demonstrate evolocumab is a safe and effective approach for the reduction of LDL-C and cardiovascular risk in patients with established cardiovascular disease and mild-to-moderate kidney impairment on background lipid-lowering therapies, who require additional treatment options.” 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).5

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. These results continue to reinforce Repatha’s efficacy and safety across a wide range of high-risk patient populations,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “It is vitally important for patients with CKD to have additional treatment options to help manage their LDL-C levels and heightened risk of cardiovascular events.”

Early stage CKD, which is often associated with comorbidities such as diabetes, high blood pressure and heart disease, affects an estimated 10 percent of Americans. 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.

Repatha cardiovascular outcomes (FOURIER) study design

FOURIER (further cardiovascular outcomes research with pcsk9 inhibition in subjects with elevated risk), a multinational Phase 3 randomized, double-blind, placebo-controlled trial, is designed to evaluate whether treatment with Repatha in combination with statin therapy compared to placebo plus statin therapy reduces cardiovascular events. The primary endpoint is the time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary endpoint is the time to cardiovascular death, myocardial infarction or stroke.

Eligible patients with high cholesterol (LDL-C ≥70 mg/dL or non-high-density lipoprotein cholesterol [non-HDL-C] ≥100 mg/dL) and clinically evident atherosclerotic cardiovascular disease at more than 1300 study locations around the world were randomized to receive Repatha subcutaneous 140 mg every two weeks or 420 mg monthly plus effective statin dose; or placebo subcutaneous every two weeks or monthly plus effective statin dose. Optimized statin therapy was defined as at least atorvastatin 20 mg or equivalent daily with a recommendation for at least atorvastatin 40 mg or equivalent daily where approved. The study was event-driven and continued until at least 1630 patients experienced a key secondary endpoint. – Medical Buyer Bureau