Amgen drug cuts bad cholesterol up to 66 pct in statin patients -trial

Tue Nov 6, 2012 11:50am EST

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* AMG145 reduced LDL up to 66 percent in trial

* Largest PCSK9 trial so far

By Deena Beasley and Bill Berkrot

LOS ANGELES, Nov 6 (Reuters) - Amgen Inc's experimental cholesterol-lowering drug, AMG145, reduced levels of "bad" cholesterol up to 66 percent in patients already taking statin drugs, according to results from a mid-stage trial that were presented on Tuesday.

The trial results were in line with two other studies showing significant reductions in LDL cholesterol that were unveiled on Monday at the American Heart Association scientific meeting in Los Angeles.

The latest study of 629 patients is the largest trial so far of a drug in a new class, known as PCSK9 inhibitors, designed to target a protein that prevents the body from removing artery blocking LDL cholesterol from the bloodstream.

The Phase 2 trial showed a mean reduction in LDL versus a placebo of 42 percent for patients injected with 70 mg of AMG145 every two weeks, 60 percent in the 105 mg group and 66 percent in the 140 mg group.

When the drug was administered every two weeks, the mean reduction in LDL was 42 percent for the 280 mg group, 50 percent for the 350 mg group and 50 percent in the 420 mg group.

"We had some patients with entry LDLs as low as 85," said Dr. Robert Giugliano, associate professor at Brigham and Women's Hospital in Boston, and the study's lead investigator, "At the end, some had LDLs measured in the teens."

Current guidelines from the American Heart Association call for LDL levels to be 100, but some cardiologists believe even lower levels would be beneficial.

The most common side effects seen in the trial were cold-like symptoms, cough and nausea.

The results were presented at the AHA meeting and published in the Lancet medical journal. (Editing by Ken Wills)

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