Amgen Inc. has achieved a significant milestone with its cholesterol-lowering injection, Repatha (evolocumab), demonstrating a 20% reduction in heart attack and stroke risks among patients with heart diseases, according to results from a comprehensive phase 3 cardiovascular outcomes study.

Groundbreaking Results in Cardiovascular Prevention

The study, named FOURIER, involved 27,564 patients who were at risk of major cardiovascular events. Repatha was tested in combination with statin therapy, showing substantial benefits over placebo plus statin therapy in reducing events such as heart attacks, strokes, and coronary revascularizations.

Detailed Study Findings

During the trial, Repatha, administered either 140mg biweekly or 420mg monthly, significantly lowered low-density lipoprotein cholesterol (LDL-C) levels—commonly known as bad cholesterol—beyond what is achievable with current best therapies. This intensive LDL reduction led to the noted decreases in major cardiovascular incidents: heart attacks were reduced by 27%, stroke risk by 21%, and the need for coronary revascularization by 22%.

Safety and Efficacy

Importantly, the study confirmed that the deeper reduction of LDL-C levels with Repatha did not introduce new safety issues. The trial’s primary endpoint included time to cardiovascular death, heart attack, stroke, hospitalization for unstable angina, or coronary revascularization. A key secondary endpoint was time to cardiovascular death, heart attack, or stroke. Both endpoints showed significant improvements with Repatha treatment.

Amgen’s Perspective on the Impact of Repatha

Sean E. Harper, M.D., Executive Vice President of Research and Development at Amgen, commented on the trial’s outcomes, describing them as a “game changer for patients at high risk.” Harper highlighted the importance of the findings, especially given that the patients were already on the most recent therapies and yet an additional reduction in cardiac events was observed. He noted, “It’s remarkable to see such a large impact in reducing cardiac events given that this patient population was only on Repatha for about two years.”

Mechanism of Action

Repatha is a human monoclonal antibody that works by inhibiting the PCSK9 enzyme. This action prevents PCSK9 from binding to LDL receptors (LDLR), allowing more LDLRs to remain on the surface of liver cells to remove LDL from the blood, thereby reducing LDL-C levels.

The FOURIER trial’s results are pivotal, not just for their immediate findings but for their implications in the management of cardiovascular disease. Repatha’s ability to significantly reduce the risk of severe cardiovascular events can transform the treatment paradigm for patients with elevated cardiovascular risk due to high cholesterol levels.

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