TriLipix in Combination with CRESTOR (rosuvastatin calcium) Demonstrates Similar Lipid Effects in Patients with Diabetes and Overall Study Population
SAN FRANCISCO, June 7 /PRNewswire-FirstCall/ -- New data from a sub-groupanalysis of patients with mixed dyslipidemia and type 2 diabetes that wereenrolled in a Phase III study showed that the use of Abbott's investigationalTriLipix(TM) (ABT-335) in combination with AstraZeneca's CRESTOR(R)(rosuvastatin calcium), demonstrated similar improvements in LDL 'bad'cholesterol, HDL 'good' cholesterol and triglycerides compared to the overallstudy population. These data were presented today at the American DiabetesAssociation's (ADA) 68th Annual Scientific Sessions in San Francisco.
Abbott evaluated the efficacy and safety of TriLipix in combination withrosuvastatin in a Phase III study of more than 1,400 patients with mixeddyslipidemia. This study, presented at the National Lipid Association annualmeeting on May 31, 2008, met its primary endpoints. TriLipix in combinationwith rosuvastatin significantly improved HDL and triglycerides compared torosuvastatin alone, and significantly improved LDL compared to TriLipix alone.
Of the patients enrolled in this study, a sub-group of 276 patients wereidentified as having type 2 diabetes. Data from this sub-group demonstratedthat the comprehensive effect of TriLipix in combination with rosuvastatin wassimilar to that seen in the overall study population. Compared tocorresponding monotherapies, patients receiving TriLipix in combination withrosuvastatin had significant decreases in triglycerides and LDL, in additionto clinically meaningful improvements in HDL.
Dyslipidemia affects millions of Americans living with diabetes. Thesepatients often have mixed dyslipidemia, a complex combination of lipidproblems commonly characterized by high triglycerides, low HDL and moderatelyhigh LDL.
'Treatment guidelines recommend aggressive treatment of lipids in patientswith mixed dyslipidemia and type 2 diabetes,' said Peter H. Jones, M.D., FACP,Methodist DeBakey Heart and Vascular Center, Houston, and a lead investigatorof the trial. 'A comprehensive approach may be necessary to help thesepatients manage their lipids.'
About the Study
This 12-week, multi-center, double blind, controlled Phase III study of1,400 patients evaluated the efficacy and safety of TriLipix in combinationwith rosuvastatin on multiple lipid parameters.
