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Phase III Study of Abbott's Investigational TriLipix(TM) in Combination With AstraZeneca's CRESTOR(R) Meets Primary Endpoints on Key Lipids
Date:5/31/2008

Data Show TriLipix (ABT-335) in Combination with CRESTOR (rosuvastatin

calcium) Improved LDL, HDL and Triglycerides and Had Reported Safety

Consistent with Monotherapies

SEATTLE, May 31 /PRNewswire-FirstCall/ -- New Phase III data showed that in patients with multiple lipid problems, Abbott's investigational TriLipix(TM) (ABT-335) combined with AstraZeneca's CRESTOR(R) (rosuvastatin calcium) led to greater improvements than the corresponding monotherapy in treating all three key lipids -- LDL "bad" cholesterol, HDL "good" cholesterol and triglycerides. Results from this Phase III study were presented today at the National Lipid Association's 2008 Scientific Sessions in Seattle.

This study of more than 1,400 patients is part of the largest clinical program to date designed to evaluate the efficacy and safety of a fibrate in combination with statins. Data from the study showed that TriLipix in combination with rosuvastatin met its primary endpoints with significantly greater improvements in HDL and triglycerides compared to rosuvastatin alone, and significantly greater improvements in LDL compared to TriLipix alone. Both the combinations and rosuvastatin alone resulted in clinically meaningful reductions in LDL. In the clinical trial, TriLipix in combination with rosuvastatin was generally well tolerated, with reported safety similar to the monotherapies. No rhabdomyolysis (a rare muscle disorder) or unexpected liver, kidney or muscle safety issues were identified in this study.

"Patients with mixed dyslipidemia may need treatment options that help address these three key lipids," said Peter H. Jones, M.D., FACP, Methodist DeBakey Heart and Vascular Center, Houston, and a lead investigator of the trial. "Results from this study showed that TriLipix in combination with rosuvastatin significantly increased HDL, and decreased both LDL and triglycerides."

According to the American Heart Association (AHA), mo
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SOURCE Abbott
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