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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

re than 100 million American adults have elevated total cholesterol. Of the 30 million Americans currently on lipid-altering therapies, the majority are not reaching treatment goals. Treatment guidelines endorsed by the National Cholesterol Education Panel, the American College of Cardiology and the AHA 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 Study

The efficacy and safety of TriLipix in combination with rosuvastatin was evaluated in a randomized, double-blind, controlled, 12-week, Phase III study of 1,445 patients with mixed dyslipidemia. Patients included in the study had multiple lipid problems, with 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.

Patients were randomized to receive TriLipix (135mg) combined with either 10mg or 20mg of rosuvastatin, TriLipix monotherapy (135mg) or rosuvastatin monotherapy (10mg, 20mg or 40mg). The 40mg rosuvastatin 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 compared to rosuvastatin monotherapy, and mean percent change in LDL in the combination compared to TriLipix monotherapy. The study met all of its primary endpoints. Patients treated with the combination of TriLipix 135mg and rosuvastatin 10mg had an increase in HDL of 20.3 percent and decrease in triglycerides of 47.1 percent compared to an HDL increase of 8.5 percent and triglyceride decrease of 24.4 percent with rosuvastatin 10mg alone. LDL decreased 37.2 percent with the combination compared to 6.5 percent with TriLipix 135mg monotherapy.

Patients treated with the combination of TriLipix 135mg and rosuvastatin 20
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SOURCE Abbott
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