A new drug called evolocumab, given along with statin therapy to patients with existing heart or vascular disease, significantly reduces the risk of a cardiovascular event, including heart attack, stroke, the need for angioplasty or bypass surgery, and death. This finding was presented at the American College of Cardiology’s (ACC) Annual Scientific Session in March.
Evolocumab is one of a new class of drugs called PCSK9 inhibitors. They block the activity of the PCSK9 molecule, which, in turn, increases the body’s natural ability to remove cholesterol from the blood stream. PCSK9 inhibitors work independently of the commonly prescribed statin drugs to reduce LDL cholesterol. Patients from 49 countries who enrolled in the FOURIER clinical trial had blood cholesterol levels that put them at risk for cardiovascular events despite taking an optimal dose of a statin. More than 80% had already experienced a heart attack.
Over an average of about two years, patients who received evolocumab injections plus a statin in the trial had a 15% lower risk of any cardiovascular event compared with patients receiving a statin plus placebo injections. Evolocumab also reduced LDL cholesterol levels by an average of 59% and did not cause additional side effects compared with statin therapy alone.
Although longer-term follow up is needed, “We now have definitive data that by adding evolocumab to a background of statin therapy, we can significantly improve cardiovascular outcomes and do so safely,” said Marc Sabatine, MD, the study’s lead author in a press release from the ACC. This improvement comes at a steep price, however: evolocumab, approved by Health Canada in 2015, costs more than $7,000 to $9,000 per patient per year in Canada, and substantially more in the US.