Abbott's Phase III Sub-Group Analysis Shows Investigational TriLipix™ In Combination With CRESTOR® Improves Key Lipids

Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 08 Jun 2008 - 1:00 PDT

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New data from a sub-group analysis of patients with mixed dyslipidemia and type 2 diabetes that were enrolled in a Phase III study showed that the use of Abbott's ( NYSE: ABT) investigational TriLipix™ (ABT-335) in combination with AstraZeneca's CRESTOR® (rosuvastatin calcium), demonstrated similar improvements in LDL "bad" cholesterol, HDL "good" cholesterol and triglycerides compared to the overall study population. These data were presented at the American Diabetes Association's (ADA) 68th Annual Scientific Sessions in San Francisco.

Abbott evaluated the efficacy and safety of TriLipix in combination with rosuvastatin in a Phase III study of more than 1,400 patients with mixed dyslipidemia. This study, presented at the National Lipid Association annual meeting on May 31, 2008, met its primary endpoints. TriLipix in combination with rosuvastatin significantly improved HDL and triglycerides compared to rosuvastatin alone, and significantly improved LDL compared to TriLipix alone.

Of the patients enrolled in this study, a sub-group of 276 patients were identified as having type 2 diabetes. Data from this sub-group demonstrated that the comprehensive effect of TriLipix in combination with rosuvastatin was similar to that seen in the overall study population. Compared to corresponding monotherapies, patients receiving TriLipix in combination with rosuvastatin had significant decreases in triglycerides and LDL, in addition to clinically meaningful improvements in HDL.

Dyslipidemia affects millions of Americans living with diabetes. These patients often have mixed dyslipidemia, a complex combination of lipid problems commonly characterized by high triglycerides, low HDL and moderately high LDL.

"Treatment 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 the combination compared to 6.1 percent with TriLipix 135mg monotherapy.

Patients treated with the combination of TriLipix 135mg and rosuvastatin 20mg had an increase in HDL of 17.6 percent and decrease in triglycerides of 42.4 percent compared to an HDL increase of 12.2 percent and triglyceride decrease of 26.8 percent with rosuvastatin 20mg alone. LDL decreased 37.4 percent with the combination compared to 6.1 percent with TriLipix 135mg monotherapy.

"New treatment options are critical given that a substantial number of patients are not achieving treatment goals for their three key lipids," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "Abbott has built a robust clinical program to support TriLipix to provide physicians and patients with as much data as possible to help them evaluate this potential new therapy."

About the TriLipix Clinical Trial Program

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.

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

The primary data for TriLipix combined with statins were presented at scientific forums earlier this year.

About TriLipix (ABT-335)

TriLipix is an investigational new fenofibric acid molecule, currently in clinical development for treating patients with unhealthy lipid levels, including LDL cholesterol, triglycerides and HDL cholesterol. A New Drug Application (NDA) for TriLipix for use as monotherapy and in combination with statins has been submitted to the U.S. Food and Drug Administration (FDA). Abbott and AstraZeneca are working together to co-develop and market a fixed-dose combination of TriLipix and CRESTOR, for which the companies plan to submit an NDA to the FDA in 2009.

About Abbott

Abbott ( NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 68,000 people and markets its products in more than 130 countries.

Abbott
http://www.abbott.com

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