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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

reatment guidelines recommend aggressive treatment of lipids in patients with mixed dyslipidemia and type 2 diabetes," said Peter H. Jones, M.D., FACP, Methodist DeBakey Heart and Vascular Center, Houston, and a lead investigator of the trial. "A comprehensive approach may be necessary to help these patients manage their lipids."

About the Study

This 12-week, multi-center, double blind, controlled Phase III study of 1,400 patients evaluated the efficacy and safety of TriLipix in combination with rosuvastatin on multiple lipid parameters. Patients enrolled in the study had multiple lipid problems, with baseline LDL greater than or equal to 130 mg/dL, HDL less than 40 mg/dL for males and less than 50 mg/dL for females and triglycerides greater than or equal to 150 mg/dL.

Patients were randomized to receive TriLipix (135mg) combined with either 10mg or 20mg of rosuvastatin, TriLipix alone (135mg) or rosuvastatin alone (10mg, 20mg or 40mg). The 40mg rosuvastatin arm was included in the study to assess safety and adverse events, but was not included in the statistical analysis.

The primary comparisons were mean percent change in HDL and triglycerides for TriLipix combined with rosuvastatin compared to rosuvastatin alone, and mean percent change in LDL for TriLipix combined with rosuvastatin compared to TriLipix alone. The combination of TriLipix and rosuvastatin significantly improved LDL compared to TriLipix alone, and significantly improved HDL and triglycerides compared to rosuvastatin alone.

A total of 276 patients included in the primary efficacy analysis had type 2 diabetes and were included in a sub-group analysis. Diabetic patients treated with the combination of TriLipix 135mg and rosuvastatin 10mg had an increase in HDL of 21.0 percent and decrease in triglycerides of 44.7 percent compared to an HDL increase of 6.6 percent and triglyceride decrease of 28.8 percent with rosuvastatin 10mg alone. LDL decreased 37.1 percent with t
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SOURCE Abbott
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