New Product:

ZETIA™  (ezetimibe) is the first of a whole new class of drugs for lowering cholesterol.  Expected FDA approval within 30-60 days.  

The addition of ezetimibe (Zetia) in patients undergoing statin treatment, who have LDL-cholesterol levels above current NCEP goals, can result in a significant improvement in both LDL-cholesterol and triglyceride (TG) profiles. 

Zetia works differently than the statins, preventing the adsorption of cholesterol in the intestine.  It works very well for patients with Homozygous Familial Hypercholesterolemia. 

Results from two Phase III clinical trials, showed that ZETIA™ 10 mg (ezetimibe), provided additional reductions in LDL-C ("bad" cholesterol) when co-administered with either pravastatin or lovastatin.

Another result in these studies showed that when ZETIA 10 mg was administered with pravastatin 10 mg it reduced LDL-C by 34 percent as compared to the 29 percent LDL-C reduction achieved by pravastatin 40 mg alone. As for lovastatin, when ZETIA 10 mg was administered with lovastatin 10 mg, it reduced LDL-C by 33 percent as compared to the 29 percent reduction in LDL-C achieved by lovastatin 40 mg alone.

The primary endpoint of both studies was percent of LDL-C reduction from baseline to study endpoint for the pooled ZETIA plus statin arms vs. the pooled statin monotherapy arms. At the conclusion of these 12-week studies, researchers found significant additional reductions in LDL-C among those receiving ZETIA plus a statin compared to statin alone. The mean baseline in LDL-C was between 145 mg/dl and 250 mg/dl.

In the pravastatin co-administration study, patients administered ZETIA plus pravastatin, pooled across statin doses had greater decreases in LDL-C (37.7 percent vs. 24.3 percent) than pravastatin or ZETIA alone. In this study, significantly greater decreases in triglycerides (17.6 percent vs. 7.6 percent, p<0.01) were observed as were increases in HDL-C (8.1 percent vs. 6.7 percent) that did not reach statistical significance. In the lovastatin co-administration study, patients administered ZETIA plus lovastatin, pooled across statin doses, had significantly greater decreases in LDL-C (39.0 percent vs. 24.7 percent) and triglycerides (21.7 percent vs. 11.2 percent) as well as significantly greater increases in HDL-C (8.6 percent vs. 4.0 percent) than lovastatin or ZETIA alone (p<0.01 for all endpoints). The additional reductions in LDL-C demonstrated with ZETIA co-administration were significant with each individual statin dose.

The drug, ezetimibe, lowered total cholesterol in patients by 15 percent, doctors said at the annual meeting of the American College of Cardiology.

"The stains and ezetimibe use different modes of action to reduce cholesterol," Lipka said. Ezetimibe -- nicknamed "E-Z" by researchers -- is a novel inhibitor of intestinal absorption of cholesterol, she said. The statins work through liver mechanisms.

  "Ezetimibe has a lot of potential," said Dr. Chirstie Ballantyne, associate professor of medicine  at the Baylor College of Medicine, Houston. "This is a new class of lipid lowering drugs and it seems to be very well tolerated."

  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 plateau in treatment with the statins.

   Lipka said the drug was easy for the patients to take. She said the side effects in the patients on the drug were similar to subjects who were taking dummy pills -- placebo -- in the clinical trials. "Ezetimibe is taken once-a-day and it can be taken any time of day, with meals or by itself," she said.  When it becomes available it will be in a 10mg. dosage only.

These results, were presented  at the XIVth Meeting of the World Congress of Cardiology and at the 51^st meeting of the American College of Cardiology (ACC).

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