Treatment with evolocumab (Repatha, Amgen) has shown comparative benefit in high-risk patients who have had recent myocardial infarction (MI), according to a new analysis presented at the annual meeting of the American Association of Cardiology in Philadelphia, PA.
The analysis includes the results of a Phase 3 Evolocumab Cardiovascular System (CV) study (FOURIER).
Evolocumab is currently approved for dietary supplementation, alone or in combination with other lipid-lowering therapies for adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia to lower cholesterol low density lipoproteins (LDL-X). In adults with established cardiovascular disease, evolocumab has been shown to reduce the risk of myocardial infarction, stroke, and coronary revascularization.
In the analysis, 5711 patients who underwent MI during 1–12 months of randomization were compared with 16,609 patients with a more distant event (more than 12 months before randomization). The primary endpoint was cardiovascular death, myocardial infarction, stroke, unstable angina pectoris or coronary revascularization.
In phase 3 of the study, participants received either subcutaneous evolocumab 140 mg every 2 weeks, 420 mg monthly plus an effective dose of statin, placebo subcutaneously every 2 weeks, or monthly plus an effective dose of statin. Optimized statin therapy has been defined as a minimum of atorvastatin 20 mg or equivalent per day with a recommendation of at least 40 mg atorvastatin or equivalent per day if approved.
According to the results, the reduction in the risk of heart attack, stroke, or cardiovascular death in patients who received evolokumab therapy within 1 year after MI was 25% compared with 15% in patients with more distant MI.
“Nearly one in five patients will have recurrent cardiovascular disease during the first year after a heart attack, making this year a critical time for high-risk patients,” says senior researcher Robert Giuliano, MD, executive committee member of FOURIER TIMI Research . A group at Brigham and the Women’s Hospital and a 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 after a heart attack and provide additional evidence that evolocumab significantly reduces the risk of cardiovascular disease and improves outcomes for high-risk patients.”
In an additional analysis of FOURIER data, the addition of evolocumab to statin therapy did not affect reported daily cognitive function, including in patients with very low LDL-C levels, in patients with stable CVD.
PCSK9 inhibitors, such as evolocumab, are effective, but have too high cost. In an effort to expand access to patients, Amgen recently announced that soon evolocumab will be available exclusively at a 60% price compared with its original list price of $ 14,100.