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Abbott's TRILIPIX(R) (Fenofibric Acid) in Combination With Rosuvastatin Calcium Helps Patients With Mixed Dyslipidemia and Type 2 Diabetes Meet American Diabetes Association Lipid Targets
Date:6/8/2009

p>TRILIPIX is the first and only fibrate to be approved for use in combination with a statin. In certain patients, treatment guidelines recommend the combination of a fibrate with a statin to improve lipid levels.

TRILIPIX should not be taken by people with liver, gallbladder, or severe kidney disease or by nursing mothers. Blood tests should be performed before and during treatment with TRILIPIX to check for liver problems. A healthcare provider should be contacted if serious side effects such as unexplained muscle pain, tenderness, or weakness develop. The risk of these side effects may be higher when TRILIPIX is used with a statin.

About the Phase 3 Clinical Trials

A total of 2,197 patients with mixed dyslipidemia were enrolled in two phase 3 clinical studies evaluating TRILIPIX in combination with rosuvastatin 5 mg, 10 mg, or 20 mg compared to either TRILIPIX alone or rosuvastatin alone. Both studies met their primary endpoints, with combination therapy significantly improving HDL and triglycerides compared to rosuvastatin alone, and significantly improving LDL compared to TRILIPIX alone. The combination of TRILIPIX with the highest dose of rosuvastatin (40 mg) has not been studied. These studies are part of the largest clinical program to date designed to evaluate the safety and efficacy of a fibrate in combination with statins.

About the Post Hoc Analysis

This post-hoc analysis of two 12-week, randomized phase 3 studies of patients with mixed dyslipidemia examined a subgroup of 480 patients with type 2 diabetes. These patients were required to have an LDL greater than or equal to 130 mg/dL, triglycerides greater than or equal to 150 mg/dL and HDL less than 40 mg/dL for men and less than 50 mg/dL for women to be included in the study.

The analysis compared the proportion of patients reaching American Diabetes Association (ADA) lipid targets who recei
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SOURCE Abbott
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