Biggest Reduction in Bad Cholesterol Ever Achieved in a Clinical Trial

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Research conducted at the Methodist DeBakey Heart Center in Houston shows a 70 percent reduction in LDL-c, or bad cholesterol, using a combination therapy of two statin drugs. This is the largest reduction in bad cholesterol ever seen in a statin clinical trial.

The EXPLORER trial, which studied the use of rosuvastatin (Crestor™) and ezetimibe together, can help even the most difficult to treat patients achieve optimal cholesterol targets, said Dr. Christie Ballantyne, director of the Center for Cardiovascular Disease Prevention at the Methodist DeBakey Heart Center in Houston.

“Dangerously high LDL cholesterol has been notoriously difficult to treat,” said Ballantyne, international principal investigator of the trial. “Cardiologists have long recognized the challenge in helping these high-risk patients reach their target cholesterol levels, to ultimately prevent heart attack and stroke.”

Cholesterol is a waxy fat found in the blood. High levels of bad LDL cholesterol can lead to heart attack and stroke, the number one killer of Americans. Combination therapy may be required for patients whose LDL cholesterol levels are very high (190 mg/dl or more), or who have elevated cholesterol and are considered to be at high risk for heart attack because of risk factors such as diabetes, hypertension, obesity, or underlying vascular disease, and whose High cholesterol levels are difficult to control.

EXPLORER showed that a combination treatment regimen of rosuvastatin (40 mg) and ezetimibe (10 mg) achieved a 70 percent reduction in LDL-c, Ballantyne said. In just six weeks, this combination treatment also helped more high-risk patients (94 percent) - those whose LDL-c needs to be reduced to 100mg/dL - achieve their target cholesterol level than those treated with rosuvastatin alone (79 percent)(1). Results from the EXPLORER study will be presented for the first time Thursday, June 22, 2006, at the International Symposium on Atherosclerosis.

Key findings from EXPLORER:

• At six weeks, CRESTOR and ezetimibe reduced mean LDL-c levels at baseline from 4.89 mmo/L (189.2 mg/dL) to 1.47 mmol/L (56.9 mg/dL) compared to CRESTOR monotherapy which reduced mean LDL-c levels from 4.93 mmol/L (190.8 mg/dL) to 2.11 mmol/L (81.5 mg/dL)

• Consequently, CRESTOR and ezetimibe reduced various lipid parameters from baseline significantly (p<0.001) more than CRESTOR monotherapy: LDL-c (69.8% vs 57.1%), LDL-C/HDL-c (72.2% vs 59.6%) and ApoB/ApoA-I (56.7% cent vs 45.6%)

• Significantly (p<0.001) more patients achieved LDL-c <100 mg/dL (94% vs 79%) and European LDL-c goals (94% vs 74%) at six weeks with CRESTOR and Zetia compared with CRESTOR monotherapy

• Both CRESTOR monotherapy and CRESTOR combined with ezetimibe brought about similar increases in HDL-c ("good" cholesterol) (8.5%vs 10.8%)

• CRESTOR and ezetimibe were both well tolerated

EXPLORER was a 12-week, randomized trial of 469 patients with LDL-C 160-<250 mg/dL (4.1-<6.5 mml/L) designed to evaluate whether adding ezetimibe to rosuvastatin would enable more patients with severely High cholesterol to achieve guideline lipid goals compared with rosuvastatin monotherapy. Patients participated in a six-week dietary lead-in followed by six weeks of randomized treatment with rosuvastatin 40 mg alone or in combination with ezetimibe 10 mg.

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