Amgen has reported new data from the cardiovascular outcomes FOURIER study of Repatha (evolocumab) in patients who have experienced a recent myocardial infarction (MI) or heart attack.
Repatha is a human monoclonal antibody designed to attach to proprotein convertase subtilisin/kexin type 9 (PCSK9) and inhibit its binding to the low-density lipoprotein (LDL) receptor (LDLR).
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The mechanism of action is said to increase the availability of LDLRs to clear LDL from the blood, reducing LDL-C levels.
FOURIER was a randomised, double-blind, placebo-controlled Phase III trial that assessed a 140mg dose of Repatha every two weeks or 420mg monthly in combination with statin therapy to mitigate cardiovascular (CV) events.
The primary endpoint was the time to CV death, MI, stroke, hospitalisation for unstable angina, or coronary revascularisation.
The trial’s key secondary endpoint was the time to cardiovascular death, MI or stroke.
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By GlobalDataAccording to the results, patients treated with Repatha combination within one year post-MI experienced a 25% reduction in risk for having a heart attack, stroke or CV death.
In the placebo plus statin therapy group of participants with a more distant MI, the risk reduction was observed to be 15%.
The data was obtained from a comparison of 5,711 participants who experienced an MI within one to 12 months of randomisation in the trial to 16,609 subjects with a more distant event.
Amgen Global Medical senior vice-president and chief medical officer Darryl Sleep said: “Far too many patients remain at risk of another CV event because they are not managing one of the most important modifiable risk factors for a heart attack, high LDL-C.
“These data demonstrate the important role cardiologists play in closely monitoring and managing LDL-C in high-risk patients, and support recent professional guideline recommendations that call for more intensive reduction of LDL-C to lower the risk of future CV events in high-risk patients.”
Further analysis showed that Repatha plus statin therapy did not have any impact on reported everyday cognition function in high-risk cardiovascular disease (CVD) patients.
