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Statin Alternative Looks Promising in Early Trials
Date:3/21/2012

By Maureen Salamon
HealthDay Reporter

WEDNESDAY, March 21 (HealthDay News) -- A new anti-cholesterol drug appears safe and effective in people already taking statins such as Lipitor, making it a potential addition to statin therapy or an alternative, a preliminary new study suggests.

Two single-dose trials in healthy volunteers and a multiple-dose trial in a group with high cholesterol showed that the drug, known as a monoclonal antibody, reduced low-density lipoprotein (LDL, or "bad") cholesterol levels an average of 40 percent. The injectable drug was also well-tolerated by all participants, with headache the most commonly reported side effect.

The drug works by attacking a destructive enzyme in the liver, keeping LDL cholesterol from spilling into the bloodstream, according to the report published in the March 22 issue of the New England Journal of Medicine.

"It was entirely safe, as best they could tell, and LDL levels plummeted within a matter of a few days and remained low for three months," said Dr. Kirk Garratt, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City, who was not involved in the study. "If this antibody turns out to be as safe and effective as it appears, this may very well be a very important method for controlling LDL cholesterol, particularly in patients with [drug-resistant] cases."

The study, by Dr. Evan Stein, of the Metabolic and Atherosclerosis Research Center in Cincinnati, and colleagues, was funded by Sanofi and Regeneron Pharmaceuticals -- makers of the antibody.

About one in four Americans aged 45 and older takes statins, which interfere with the production of cholesterol in the liver, to control their high cholesterol levels and improve their odds against heart disease, according to the U.S. Centers for Disease Control and Prevention. While widely effective, some patients experience intolerable side effects --
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