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Simvastatin/Ezetimibe Combination Outperforms High Dose Atorvastatin in Lowering Cholesterol: Presented at ACC

By Ed Susman

NEW ORLEANS, LA -- March 9, 2004 -- The combination of simvastatin and ezetimibe reduces low-density lipoprotein (LDL) cholesterol to greater levels that even high dose atorvastatin.

"The coadministration of ezetimibe plus simvastatin provided additional improvements in lipid profiles across a wide range of doses compared with titration of atorvastatin monotherapy," said Christie Ballantyne, MD, Professor of Medicine, Baylor College of Medicine, Houston, Texas.

In his poster presentation here on March 8^th at the American College of Cardiology 53^rd Annual Scientific Sessions, Dr. Ballantyne noted that patients titrated to receive 80 mg of atorvastatin achieved a mean LDL reduction of 52.5%. However, those titrated to received high dose simvastatin at 80 mg plus 10 mg of ezetimibe achieved a mean LDL reduction of 59.4% (P < .01).

"It is very helpful to add ezetimibe to almost any dose of statin," said Anne Goldberg, MD, Associate Professor of Medicine, Washington University, St. Louis, Missouri. "I usually see a 15% or greater [cholesterol] decrease in my patients when ezetimibe is added."

In the study, Dr. Ballantyne and colleagues recruited 788 patients with high LDL cholesterol levels and randomized them to receive a starting dose of atorvastatin 10 mg, 10 mg of simvastatin plus 10 mg of ezetimibe; or 20 mg simvastatin plus 10 mg of ezetimibe. Doses were titrated over 24 weeks to final doses of 80 mg atorvastatin or 40 mg simvastatin plus 10 mg ezetimibe or 80 mg simvastatin plus 10 mg of ezetimibe.

"We now know it is important to go very low [with levels of] LDL cholesterol," Dr. Ballantyne said, suggesting that the addition of ezetimibe allows physicians to get levels below the threshold at which atherosclerosis appears to begin -- around 70 mg of LDL cholesterol.

The study did not look at clinical outcomes, however. The primary end point was the difference in LDL cholesterol reductions seen after 6 weeks with the starting doses. During that period the combination doses produced decreases in LDL of 46% to 50% while the atorvastatin monotherapy achieved a 37% reduction.

"However, we continued to see a greater cholesterol lowering benefit with the combination at every dose of atorvastatin," Dr. Ballantyne said. In addition, he reported that at the highest dose levels, there was a 12.3% increase in high-density lipoprotein (HDL) cholesterol levels with the combination compared with a 6.5% increase with atorvastatin (P < .01).

Merck/Schering-Plough Pharmaceuticals is developing the simvastatin/ezetimibe combination under the brand name Vytorin and funded Dr. Ballantyne's study, is awaiting Food and Drug Administration approval for the drug in the United States, which is expected by the end of 2004, according to company spokespersons.


[Study title: Efficacy of Ezetimibe Coadminstered With Simvastatin Versus Atorvastatin in Patients With Hypercholesterolemia. Abstract 1084-176]

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