Patients with high cholesterol who are on moderate- or high-intensity statin therapy can lower their low-density lipoprotein (LDL) cholesterol levels further by adding the human monoclonal antibody evolocumab to their routine. 

A double-blind study published in the May 14 issue of the Journal of the American Medical Association reports that evolocumab reduced LDL levels in patients on statins. The study included patients in 17 countries and was funded by drugmaker Amgen.

Many patients on such statin therapies cannot reach their ideal LDL cholesterol goal, and many wind up taking nonstatin therapy as a way to lower LDL levels.

Dr. Jennifer G. Robinson, a professor at the University of Iowa, said that about 20 percent of patients taking statins need assistance to bring their LDL levels down. If ongoing trials show that the antibody further reduces the risk of heart disease for people on statins, more people may be candidates for using it.

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How Evolocumab Works

Evolocumab is a highly specific antibody that keeps the body's LDL receptors from breaking down.

“This keeps LDL receptors active on the liver cell surface so they can keep taking LDL [cholesterol] out of the blood,” Robinson said. “This is the body's natural way of getting cholesterol out of the body.”

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Robinson conducted a phase 3 study of 1,826 patients. Initially, each was put into one of five groups and took a daily moderate-intensity statin (atorvastatin [10 mg], simvastatin [40 mg], or rosuvastatin [5 mg]) or a high-intensity statin (atorvastatin [80 mg] or rosuvastatin [40 mg]). After four weeks, patients still enrolled in the study taking simvastatin or rosuvastatin were then randomly assigned to one of four groups: The first two groups took 140 mg of evolocumab or a similar placebo every two weeks, the latter two groups took 420 mg of evolocumab or a similar placebo monthly. Patients originally on atorvastatin took 10 mg of ezetimibe or a placebo daily.

The researchers found those taking evolocumab every two weeks saw a 66 to 75 percent reduction in LDL levels, while those who took the medication monthly saw reductions from 63 to 75 percent. The reduction in LDL cholesterol in those taking evolocumab was 24 percent greater than in those taking ezetimibe.

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Robinson said that the evolocumab lowered LDL cholesterol better than ezetimibe, another common therapy.

“[Ours] is to our knowledge the first study to demonstrate that the addition of evolocumab results in similar percent reductions in LDL and achieved LDL levels regardless of stable baseline statin type, dose, or intensity, across three commonly prescribed statins and a broad range of doses,” the authors wrote.

What’s Next?

The authors say that more studies are needed to measure the long-term outcomes of using evolocumab to lower cholesterol. To bring the therapy to the mainstream, the next step would be applying for U.S. Food and Drug Administration approval.

For now, it’s a promising development for patients on statins who can’t seem to lower their LDL levels—especially those who can’t take the recommended dose of statin medication or have genetically high cholesterol.

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