These findings were based on 4,465 patients who were studied for one year after completing an earlier phase of the drug’s safety and efficacy testing.
The results could offer an alternative to the estimated one in three Americans with high low-density lipoprotein (LDL) cholesterol who have been unable to manage their condition with diet, exercise and statin drugs which are currently on the market.
Patients were divided into groups to either receive evolocumab, made by the pharmaceutical company Amgen, which was injected under the skin in addition to standard care, or standard care alone, which meant taking the cholesterol-lowering statin drug recommended by their physician.
Evolocumab works quite differently than traditional statins. It is a human monoclonal antibody that blocks a harmful protein in the liver, freeing the organ up to remove LDL cholesterol from the blood.
This new class of drug is known as PCSK9 inhibitors, which consists of three different kinds, including evolocumab, are being studied in large clinical trials.
The drug has yet to be approved by the US Food and Drug Administration, and more years of study are planned to test its longer term outcomes.