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Abbott's Phase III Studies of Investigational TriLipix(TM) (ABT-335), in Combination With Statins, Meets Primary Endpoints on Improving LDL, Triglycerides and HDL
Date:3/31/2008

lipid problems."

Treatment guidelines endorsed by the National Cholesterol Education Panel (NCEP), the ACC and the American Heart Association have called for more aggressive management of lipids, including a lower LDL goal for many patients, as well as more aggressive management of HDL and triglycerides.

About the TriLipix Clinical Program

The two studies being presented at the ACC conference are part of a broad clinical program to evaluate the efficacy and safety of TriLipix combined with statins. 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. Patients included in the studies had multiple lipid problems, with an LDL greater than 130 mg/dL, triglycerides greater than 150 mg/dL and HDL less than 40 mg/dL for men and less than 50 mg/dL for women.

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

In the atorvastatin and simvastatin studies, presented at the ACC conference, 613 and 657 patients, respectively, were randomized to receive either TriLipix (135mg) combined with either 20mg or 40mg of the corresponding statin, TriLipix monotherapy (135mg) or statin monotherapy (20mg, 40mg or 80mg). The 80mg statin monotherapy arm was included in the study to assess safety and adverse events, but was not included in the statistical analysis.

The primary efficacy comparisons were mean percent change in HDL and triglycerides in the combination versus a statin alone, and mean percent change in LDL in the combinati
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SOURCE Abbott
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