Abbott's Phase III Studies of Investigational TriLipix(TM) (ABT-335), in Combination With Statins, Meets Primary Endpoints on Improving LDL, Triglycerid...( TriLipix in Combination With Statins...),Health

TriLipix in Combination With Statins Improved All Three Key Lipids and Had

Reported Safety Consistent With TriLipix or Statin Monotherapies

CHICAGO, March 31 /PRNewswire-FirstCall/ -- New data from two Phase III studies show that in patients with multiple lipid problems, Abbott's ABT-335 combined with two commonly prescribed statins (atorvastatin and simvastatin), significantly improved three key lipids -- LDL "bad" cholesterol, triglycerides and HDL "good" cholesterol -- compared to the corresponding monotherapies. Results were presented today at the American College of Cardiology (ACC) 57th Annual Scientific Sessions in Chicago. ABT-335, an investigational new fenofibric acid molecule, will be known as TriLipix(TM).

Both TriLipix studies are part of the largest clinical program to date designed to evaluate the efficacy and safety of a fibrate in combination with statins. These studies using fenofibric acid combined with atorvastatin and simvastatin met their primary endpoints. Combination therapy significantly improved HDL and triglycerides compared to statin therapy alone, and significantly improved LDL compared to TriLipix alone. Both the combinations and the two statins had clinically meaningful reductions in LDL. In the clinical trials, combination therapy was generally well tolerated, with reported safety similar to the monotherapies. No rhabdomyolysis or unexpected liver, kidney or muscle safety signals were identified.

"With more than 30 million Americans taking lipid-altering therapies and only one quarter of them reaching treatment goals, there is a clear need for more data to support combination treatment options," said Christie Ballantyne, M.D., Methodist DeBakey Heart and Vascular Center, Houston, and investigator in the TriLipix studies. "Data from these two studies show that TriLipix in combination with atorvastatin or simvastatin improved all three key lipids -- LDL, HDL and triglycerides -- in patients with multiple
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