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
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-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 investigational
TriLipix(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 overall
study population. These data were presented today 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's news releases and other information are available on the
company's Web site at www.abbott.com.
SOURCE Abbott
Media: Elizabeth Hoff, +1-847-935-4236, or Financial: Lawrence Peepo,
+1-847-935-6722, both of Abbott
