The investigational drug ‘evolocumab’ reduces low-density lipoprotein (LDL) ‘bad’ cholesterol by 50 percent in patients with severe hypercholesterolemia, researchers said.
Hypercholesterolemia, also called high cholesterol, is the presence of high levels of cholesterol in the blood, the study, published in the New England Journal of Medicine, reported.
According to the researchers, evolocumab is a fully human monoclonal antibody that works through a different mechanism than existing drugs to bring dangerously high cholesterol to normal levels.
“Our study assessing the safety and efficacy of evolocumab shows that it can lower LDL cholesterol by half in patients unable to attain target guidelines despite maximally tolerated lipid-lowering therapy,” said study author Robert Rosenson from Mount Sinai Hospital in the US.
Evinacumab is a fully human monoclonal antibody that inhibits angiopoietin-like protein 3 (ANGPLT3) and lowers LDL cholesterol through an LDL receptor-independent pathway.
Genetic studies have shown that people who are missing or have low levels of ANGPTL3 are known to have very low lifelong levels of LDL cholesterol and rarely suffer from atherosclerotic cardiovascular disease.
Phase two, double-blinded, placebo-controlled study of evolocumab included 272 patients with primary high cholesterol including a majority having a diagnosis of heterozygous familial hypercholesterolemia (HeFH).
HeFH is an inherited form of hypercholesterolemia most often caused by mutations in the LDL receptor gene.
The research team found that subcutaneous administration of the agent at 450 mg weekly resulted in LDL cholesterol lowering of 56 percent, and 52.9 percent at 300 mg weekly compared to the placebo group.
With monthly intravenous administration of evolocumab at 15 mg/kg, LDL cholesterol reduction was 50.5 percent compared to the placebo group.
“Our study demonstrates that a regimen of either subcutaneous or intravenous evolocumab can have a significant impact on LDL cholesterol,” said Rosenson.
“If approved for use in this setting, evolocumab could potentially arm cardiologists with a major new add-on therapy to bring patients with HeFH to or closer to their cholesterol-lowering goal,” Rosenson noted.
