Evolocumab appears to be equally effective at reducing LDL cholesterol and preventing cardiovascular events regardless of a patient’s kidney function, according to a new subanalysis of the FOURIER outcomes study presented at the American Society of Nephrology’s annual Kidney Week in San Diego.
For patients already on background statin therapy, treatment with the PCSK9 inhibitor was associated with LDL-C reductions of 58.7 percent among those with stage 3 chronic kidney disease (CKD) and 58.2 percent among those with preserved kidney function.
The absolute risk reduction for the secondary composite endpoint of cardiovascular death, heart attack or stroke at three years was 2.5 percent for patients with CKD of stage 3 or worse, compared to 1.7 percent in patients with preserved kidney function. The subanalysis included 4,443 patients with CKD.
“Patients with chronic kidney disease are considered a high-risk population due to increased rates of cardiovascular events associated with impaired kidney function," lead investigator Robert P. Giugliano, MD, SM, with Brigham and Women’s Hospital and Harvard Medical School, said in a press release. “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.”
Despite evolocumab being associated with a 15 percent reduction in the primary efficacy endpoint of cardiovascular death, MI, stroke, hospitalization for unstable angina or coronary revascularization when FOURIER was first published, sales of the medication haven’t met expectations due in part to its high price point and burdensome pre-authorization requirements.
Amgen, the maker of evolocumab (brand name: Repatha), addressed one of those barriers last week—announcing it would slash the list price of the drug by almost 60 percent, from $14,100 per year to $5,850.