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Issue 106 Item 1 New Drug “Zetia” Boosts Statins’ Effect and Adds Safety

Apr 22, 2002

“These are truly amazing results,” says study author Claude Gagné, MD. >An experimental drug greatly increases the cholesterol-lowering effect of the most powerful drugs now available, according to new studies reported last spring at the annual meeting of the American College of Cardiology. Gagné is affiliated with the CHUL Medical Research Center, Sainte-Foy, Quebec, Canada

Statins are currently the most potent anticholesterol drugs now available. But normal doses of statins don’t work for everybody. Doctors don’t like to give high doses of statins because of the risk of heart and liver toxicity. Combining statins with other drugs that lower levels of fats in the blood also increases the risk of dangerous side effects.

The new drug is called Zetia. Unlike statins, it does not slow down cholesterol production. Instead, it keeps the body from absorbing cholesterol that’s already in the bloodstream. The new studies show that Zetia adds to the anticholesterol effect of statins. And it does so without any new side effects.

The safety profile is really impressive," Gagné says. "We have not observed any difference between the placebo and the treated group. More than 1,500 patients have received this drug, and the safety profiles are similar in all of the studies."

Gagné’s study yielded particularly impressive results, because it looked at the hardest-to-treat group of patients. These are people who inherit from both their parents a genetic defect that gives them extremely high cholesterol levels. People with this condition — homozygous familial hypercholesterolemia — tend to get clogged arteries and die prematurely from heart disease. Statins usually only reduce cholesterol levels in these patients by 6% or 7%.

When the researchers added Zetia to statin treatment, the anticholesterol effect tripled — a 20.7% reduction in LDL cholesterol, the "bad" kind of cholesterol. Patients who took high-dose statins had a 27.5% decrease in LDL cholesterol. And all patients who received Zetia had a slight but significant increase in "good" HDL cholesterol.

Other studies presented at the conference showed that Zetia significantly adds to the cholesterol- and triglyceride-lowering effects of Lipitor. Adding the new drug to normal doses of the statin was more effective than high doses of Lipitor alone.

Gagné says that the studies may actually underestimate the effects of Zetia. This is because they call for cholesterol to be measured only after a patient hasn’t eaten overnight. He says the drug has a more important effect in limiting the amount of cholesterol that gets into the blood right after a meal.

"For any patient with an LDL cholesterol level higher than you would like it to be, I think this drug will be very useful," Gagné says. "I think that the sooner we will be able to prescribe and use the drug, it will be better for many patients." Zetia manufacturer Schering-Plough sponsored the studies