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Abbott's Phase III Sub-Group Analysis Shows Investigational TriLipix(TM) in Combination with CRESTOR(R) Improves Key Lipids in Patients with Mixed Dyslipidemia and Type 2 Diabetes
Date:6/7/2008

he combination compared to 6.1 percent with TriLipix 135mg monotherapy.

Patients treated with the combination of TriLipix 135mg and rosuvastatin 20mg had an increase in HDL of 17.6 percent and decrease in triglycerides of 42.4 percent compared to an HDL increase of 12.2 percent and triglyceride decrease of 26.8 percent with rosuvastatin 20mg alone. LDL decreased 37.4 percent with the combination compared to 6.1 percent with TriLipix 135mg monotherapy.

"New treatment options are critical given that a substantial number of patients are not achieving treatment goals for their three key lipids," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "Abbott has built a robust clinical program to support TriLipix to provide physicians and patients with as much data as possible to help them evaluate this potential new therapy."

About the TriLipix Clinical Trial Program

The efficacy and safety of TriLipix in combination with the three most commonly prescribed statins -- rosuvastatin, atorvastatin and simvastatin -- were evaluated in three randomized, multi-center, double-blind, controlled, 12-week Phase III studies, totaling 2,698 patients with mixed dyslipidemia.

These studies, along with a 52-week long-term safety and efficacy open-label extension study of 1,911 patients, represent the largest program to date examining a fibrate in combination with statins. More than 2,200 patients were treated with TriLipix alone and in combination with statins across these four studies.

The primary data for TriLipix combined with statins were presented at scientific forums earlier this year.

About TriLipix (ABT-335)

TriLipix is an investigational new fenofibric acid molecule, currently in clinical development for treating patients with unhealthy lipid levels, including LDL cholesterol, triglycerides and HDL cholesterol. A New Drug Application (NDA) for TriLipix for use as monotherapy and in comb
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SOURCE Abbott
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