Popular statins go head to head in new cholesterol trialHouston, TX - 9/4/2007
A new trial at the Methodist DeBakey Heart Center will provide a head-to-head competition between two popular statin therapies to see which does a better job at lowering the levels of bad cholesterol (LDL-C) in patients’ blood.
“High cholesterol leads to heart disease and stroke, two of our nation’s top killers,” said Dr. Christie Ballantyne, international principal investigator for the trial and director of the Center for Cardiovascular Disease Prevention at the Methodist DeBakey Heart Center in Houston. “This trial will help us determine which widely prescribed statins medication has the greatest cholesterol-lowering benefits for our patients.”
Statins Crestor and Zocor are both available today and can be used in combination with a drug called Zetia that inhibits cholesterol absorption. The new study, called GRAVITY (Gauging the lipid effects of rosuvastatin plus ezetimibe versus simvastatin plus ezetimibe therapy), will follow 800 patients worldwide with high cholesterol and heart disease over 12 weeks to determine which of these two combination treatment works best.
In a previous clinical trial called EXPLORER, Zetia (10 mg) added to Crestor (40 mg) achieved unprecedented levels of LDL-C reduction of up to 70 percent, greater than has been reported with the simvastatin/ezetimibe combination. This result showed that for those patients who fail to reach their cholesterol goal using a single medication, a combination treatment regime of Crestor and Zetia, could help achieve desired cholesterol levels.
GRAVITY will examine lower doses of Crestor (10 mg and 20 mg) with Zetia (10 mg) compared to 40 mg and 80 mg does of Zocor with Zetia (10 mg).
GRAVITY is a 12-week, open-label, randomized, parallel-group, multicoated, Phase IIIb study of 800 patients from North America, South America and Europe to compare the efficacy and safety of CRESTOR (rosuvastatin) 10 mg and 20 mg in combination with ezetimibe 10 mg and simvastatin 40 mg and 80 mg in combination with ezetimibe 10 mg in patients with hypercholesterolemia and coronary heart disease (CHD) or a CHD risk equivalent, atherosclerosis or a 10-year CHD risk of >20 percent. Complete results are due in 2009.
For more in formation on the Methodist DeBakey Heart Center, see www.debakeyheartcenter.com