Treatment with evolocumab (Repatha, Amgen) showed comparative benefit in high-risk patients who have experienced a recent myocardial infarction (MI), according to a new analysis presented at the American Heart Association Annual Scientific Sessions held in Philadelphia, Pennsylvania.

The analysis includes findings from the phase 3 evolocumab cardiovascular (CV) outcomes (FOURIER) study.

Evolocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, is currently approved for use as an adjunct to diet, alone, or in combination with other lipid-lowering therapies for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia, to reduce low-density lipoprotein cholesterol (LDL-C). In adults with established CVD, evolocumab is indicated to reduce the risk of MI, stroke, and coronary revascularization.

In the analysis, 5711 patients who experienced an MI within 1 to 12 months of randomization were compared with 16,609 patients with a more distant event (more than 12 months prior to randomization). The primary endpoint was CV death, MI, stroke, unstable angina, or coronary revascularization.

As part of the phase 3 trial, participants received either evolocumab subcutaneous 140 mg every 2 weeks, 420 mg monthly plus effective statin dose, placebo subcutaneous every 2 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.

According to the results, the risk reduction for experiencing a heart attack, stroke, or CV death in evolocumab-treated patients administered therapy within 1 year post MI was 25% compared with 15% in those patients with a more distant MI.

“Nearly 1 in 5 patients will have a recurrent CV event during the first year after a heart attack which makes that year a critical time for high-risk patients,” senior investigator Robert Giugliano, MD, FOURIER executive committee member, from the TIMI Study Group at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School, said in a statement. “These results demonstrate the importance of intensive lipid-lowering therapy in the first year following a heart attack and provide additional evidence that evolocumab significantly reduces CV risk and improves outcomes for high-risk patients.”

In an additional analysis of FOURIER data, the addition of evolocumab to statin therapy had no impact on reported everyday cognition function, including in those with very low LDL-C levels, in patients with stable CVD.

PCSK9 inhibitors, such as evolocumab, are effective but the high cost of these medications often results in barriers to access. In an effort to broaden access to patients, Amgen recently announced that evolocumab will soon be available exclusively at a 60% price reduction from its original list price of $14,100.

Reference

Amgen Announces New FOURIER Analysis Showing Benefit of Repatha (evolocumab) In High-Risk Patients Who Have Experienced A Recent Heart Attack [news release]. Amgen’s website. 2019. https://www.amgen.com/media/news-releases/2019/11/amgen-announces-new-fourier-analysis-showing-benefit-of-repatha-evolocumab-in-highrisk-patients-who-have-experienced-a-recent-heart-attack/. Accessed November 18, 2019.