New Data for Abbott's TRILIPIX(R) (fenofibric acid) in Combination with Rosuvastatin...

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Sun Mar 29, 2009 3:30pm EDT

New Data for Abbott's TRILIPIX(R) (fenofibric acid) in Combination with
Rosuvastatin Calcium Shows Improvement on Key Lipids for Cholesterol
Management

TRILIPIX has now been studied in combination with the most commonly used doses
of rosuvastatin calcium (5 mg, 10 mg, 20 mg) in patients with mixed
dyslipidemia

ORLANDO, Fla., March 29 /PRNewswire-FirstCall/ -- Data from a new study showed
that Abbott's TRILIPIX(R) (fenofibric acid) delayed-release capsules in
combination with rosuvastatin calcium met all of the study's primary
endpoints.  TRILIPIX 135 mg in combination with rosuvastatin calcium 5 mg
significantly improved HDL cholesterol and triglycerides compared to
rosuvastatin calcium 5 mg alone, and significantly improved LDL cholesterol
compared to TRILIPIX 135 mg alone in patients with multiple lipid problems. 
Results from this new Phase III study were presented today at the American
College of Cardiology's 2009 Scientific Sessions in Orlando.

TRILIPIX is a prescription medicine that can be used along with diet to lower
triglycerides and LDL (bad) cholesterol, and increase HDL (good) cholesterol.
TRILIPIX can also be used along with diet to lower triglycerides and increase
HDL cholesterol in people who are at high risk of heart disease and are taking
a statin medicine to control their LDL cholesterol. TRILIPIX has not been
shown to prevent heart attacks or stroke more than a statin alone. 

TRILIPIX is the first and only fibrate to be approved for use in combination
with a statin.  In certain patients, treatment guidelines recommend the
combination of a fibrate with a statin to improve lipid levels.    

In the clinical trial, TRILIPIX in combination with rosuvastatin calcium was
generally well-tolerated with reported safety similar to rosuvastatin calcium
alone and TRILIPIX alone.  No unexpected liver, kidney or muscle safety issues
were identified in this study.  Muscle related problems can occur with
TRILIPIX and rosuvastatin calcium alone.  The risk of these side effects may
be increased when TRILIPIX is used with a statin. 

"More comprehensive treatment is often needed in certain patients with mixed
dyslipidemia to help reach targets for all three key lipids," said Eli Roth,
M.D., University of Cincinnati College of Medicine, and Sterling Research
Group, Cincinnati, Ohio.  "The results from this study are encouraging because
TRILIPIX combined with the lowest available dose of rosuvastatin calcium
improved LDL cholesterol, HDL cholesterol and triglycerides."  
 
More than 100 million American adults have lipid problems, and 35 percent
reported being treated with lipid-altering medications.  Of the patients being
treated, fewer than one in three (30 percent) were at recommended levels for
all three key lipids.  Treatment guidelines endorsed by the National
Cholesterol Education Panel, the American College of Cardiology 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 Study Design
The efficacy and safety of TRILIPIX in combination with rosuvastatin calcium
was evaluated in a multicenter, randomized, double-blind, parallel group,
12-week, Phase III study of 760 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.

Following a six-week period in which patients were not allowed to take
cholesterol medications, patients were randomized to receive TRILIPIX 135 mg
alone, rosuvastatin calcium 5 mg alone or TRILIPIX 135 mg in combination with
rosuvastatin calcium 5 mg.  The primary efficacy comparisons were mean percent
changes in triglycerides and HDL with the combination versus rosuvastatin
calcium alone and mean percent change in LDL with the combination versus
TRILIPIX alone.  

About the Study Results
Patients treated with the combination of TRILIPIX 135 mg and rosuvastatin
calcium   5 mg had an increase in HDL of 23 percent compared to 12.4 percent
increase with rosuvastatin calcium 5 mg alone (p<0.001), and decrease in
triglycerides of 40.3 percent compared to a reduction of 17.5 percent with
rosuvastatin calcium 5 mg alone (p<0.001).  LDL was reduced by 28.7 percent
with the combination compared to a 4.1 percent reduction with TRILIPIX 135 mg
alone (p<0.001). 

The results of this study were consistent with those of the previous studies
of TRILIPIX in combination with the other two most commonly used doses of
rosuvastatin calcium (10 mg and 20 mg).  The combinations both showed greater
improvement in HDL and triglycerides compared to rosuvastatin calcium alone
and greater improvements in LDL than TRILIPIX alone.  The combination of
TRILIPIX with the highest dose of rosuvastatin calcium (40 mg) has not been
studied.

"The recent approval of TRILIPIX and the results of this combination study
further support Abbott's clinical program and demonstrate how this combination
therapy improves lipid levels," said Eugene Sun, M.D., vice president, Global
Pharmaceutical Clinical Development, Abbott. 

TRILIPIX Clinical Development Program
The TRILIPIX clinical program studied 3,458 patients with mixed dyslipidemia
in four controlled studies where patients received TRILIPIX alone, TRILIPIX in
combination with one of the three most commonly prescribed statins
(atorvastatin, simvastatin or rosuvastatin) or statin alone.  The clinical
program also included a 52-week, long-term, open-label extension study.  

TRILIPIX Indications 
TRILIPIX(R) is a prescription medicine that can be used along with diet to
lower triglycerides and LDL (bad) cholesterol, and increase HDL (good)
cholesterol. TRILIPIX can also be used along with diet to lower triglycerides
and increase HDL cholesterol in people who are at high risk of heart disease
and are taking a statin medicine to control their LDL cholesterol. TRILIPIX
has not been shown to prevent heart attacks or stroke more than a statin
alone.

Important Safety Information About TRILIPIX
TRILIPIX should not be taken by people with liver, gallbladder, or severe
kidney disease, nursing mothers, or those allergic to any product ingredient.
Unexplained muscle pain, tenderness, or weakness, particularly when occurring
with tiredness and fever, may be a sign of a serious side effect and should be
reported to a healthcare provider right away.  Rarely, muscle-related problems
can cause kidney damage and can be fatal. The risk of these side effects may
be increased when TRILIPIX is used with a statin.  Patients should tell their
healthcare provider about all the medicines they take to help avoid serious
side effects.  Blood tests may be performed before and during treatment with
TRILIPIX to check for liver or kidney problems. Patients should contact their
healthcare provider if they experience abdominal pain, nausea, or vomiting
while taking TRILIPIX.  These may be signs of inflammation of the gallbladder
or pancreas. Women who are pregnant should not take statins and should talk
with their healthcare provider about TRILIPIX if they are pregnant or may
become pregnant.  The most common side effects with TRILIPIX include headache,
heartburn, nausea, muscle aches, and increases in muscle or liver enzymes that
are measured by blood tests.  Full Prescribing Information is available at
www.rxabbott.com/pdf/trilipix_pi.pdf.  Visit www.trilipix.com or call Abbott
Medical Information at 1-800-633-9110 for more information about TRILIPIX.

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 72,000 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
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