DG DISPATCH - ACC: New Drug, Ezetimibe, Lowers Cholesterol With Few Side Effects
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DG DISPATCH - ACC: New Drug, Ezetimibe, Lowers Cholesterol With Few Side Effects

By Edward Susman
Special to DG News

ANAHEIM, CA -- March 14, 2000 -- Phase II studies with ezetimibe, a new class of novel intestinal absorption inhibitors, showed the drug lowers total cholesterol by 15 percent, researchers report.

Leslie Lipka, MD, a researcher with Schering-Plough Research Institute, in Kenilworth, NJ, presented these results at the 49th scientific session of the American College of Cardiology, being held in Anaheim, CA, March 12-15.

She said that of the 242 patients treated with ezetimibe in this study, more than 50 percent were able to achieve a greater than 15 percent reduction in low density lipoprotein (LDL) and 15 percent of patients lowered LDL by 25 percent. She reported on data from two multicenter, placebo-controlled, double-blind, randomized, parallel-group, 12-week studies, which were pooled to evaluate the drug's effect on lipid parameters in subjects with primary hypercholesterolemia

Although the experimental drug was tested as a single agent in these studies, Dr. Lipka said it was likely that ezetimibe would be co-administered with other anti-cholesterol drugs, particularly the statins. "The stains and ezetimibe use different modes of action to reduce cholesterol," Lipka said.

"Ezetimibe has a lot of potential," said Dr. Chirstie Ballantyne, clinical director of atherosclerosis research at the Baylor College of Medicine, in Houston, TX. "This is a new class of lipid lowering drugs and it has very few side effects."

Although it doesn't lower cholesterol as efficiently as the statin drugs, Ballantyne suggested that ezetimibe would be helpful in treating patients who had reached a treatment plateau using the statins.

He said he will be working on an upcoming trial in which ezetimibe is used in combination with the statins. He was not involved in the studies reported at the meeting.

Dr. Lipka said the drug was easy for the patients to take. She said the side effects in the patients taking it were similar to those seen in subjects taking placebo. "Ezetimibe is taken once-a-day and it can be taken any time of day, with meals or by itself," she said.

She said trials are underway that may pave the way for ezetimibe to be approved by the Food and Drug Administration.

Related Link: Schering-Plough.

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