Navigation Links
Abbott's Phase III Studies of Investigational TriLipix(TM) (ABT-335), in Combination With Statins, Meets Primary Endpoints on Improving LDL, Triglycerides and HDL
Date:3/31/2008

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 lipid problems."

Treatment guidelines endorsed by the National Cholesterol Education Panel (NCEP), the ACC 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 TriLipix Clinical Program

The two studies being presented at the ACC conference are part of a broad clinical program to evaluate the efficacy and safety of TriLipix combined with statins. 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. Patients included in the studies had multiple lipid problems, with an LDL greater than 130 mg/dL, triglycerides greater than 150 mg/dL and HDL less than 40 mg/dL for men and less than 50 mg/dL for women.

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

In the atorvastatin and simvastatin studies, presented at the ACC conference, 613 and 657 patients, respectively, were randomized to receive either TriLipix (135mg) combined with either 20mg or 40mg of the corresponding statin, TriLipix monotherapy (135mg) or statin monotherapy (20mg, 40mg or 80mg). The 80mg statin monotherapy arm was included in the study to assess safety and adverse events, but was not included in the statistical analysis.

The primary efficacy comparisons were mean percent change in HDL and triglycerides in the combination versus a statin alone, and mean percent change in LDL in the combination versus TriLipix alone. Both studies met all of their primary endpoints, with the combinations resulting in significant improvements over the pre-specified monotherapies for all three key lipids -- LDL, triglycerides and HDL.

Additional data supporting TriLipix, including data from the Phase III trial evaluating TriLipix in combination with rosuvastatin in over 1,400 patients with mixed dyslipidemia, are planned for presentation at scientific forums throughout the year.

"Through our investment in a broad clinical development program for TriLipix, Abbott is providing physicians with data to help support a potential new treatment option for their patients," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott.

About TriLipix (ABT-335)

TriLipix is an investigational new fenofibric acid molecule, currently in clinical development for treating unhealthy lipid levels, including LDL cholesterol, triglycerides and HDL cholesterol. A New Drug Application for TriLipix for use as monotherapy and in combination with statins has been submitted to the U.S. Food and Drug Administration.

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 http://www.abbott.com.


'/>"/>
SOURCE Abbott
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. DSMB Supports Continuation of Phase 3 AGENDA Trial of Genasense(R) in Advanced Melanoma
2. Lilly Launches Its First Phase III Trial for Treatment of Alzheimers Disease
3. Keryx Biopharmaceuticals Announces Termination of SUN-MACRO Phase 4 Trial
4. Trubion Initiates Phase 1/2 Study of TRU-016 in CLL, Announces Next-Generation Product Candidate for RA and Provides Product Pipeline Update
5. Cystic Fibrosis Foundation Announces Positive Early Results for Phase 2 Clinical Trial of VX-770 - an Oral Compound to Treat CF
6. Repligen Initiates Phase 3 Clinical Trial of RG1068 for Pancreatic MRI Imaging
7. Metabolex Initiates Phase 1 Trial of MBX-2982
8. Nventa Announces Positive Interim Immunological Data From HspE7 Phase 1 Cervical Dysplasia Trial
9. Anesiva Commences Phase 3 Clinical Trial of Adlea(TM) for Reducing Post-Surgical Pain Following Bunionectomy
10. Anacor Pharmaceuticals Announces Positive Results from Phase 2a Clinical Trial of AN2728 in Psoriasis Patients
11. Cell Therapeutics, Inc. (CTI) Announces Enrollment Complete in Phase III EXTEND (PIX301) Clinical Trial of Pixantrone in Patients With Second or Greater Relapse of Diffuse Large B Cell NHL
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... Mylan N.V. (NASDAQ, TASE: MYL) today announced ... December 31, 2015. --> --> ... revenues of $9.45 billion, up 28% on a constant ... of $9.43 billion. Excluding the impact of the acquisition ... generics business (the "EPD Business"), full year adjusted total ...
(Date:2/10/2016)... , Feb. 10, 2016  Resolve Therapeutics, LLC, ... new approaches to the treatment of lupus and ... a multiple ascending dose study in patients with ... RSLV-132. --> --> ... multiple ascending dose study of RSLV-132 in 32 ...
(Date:2/10/2016)... , Feb. 10, 2016  Rich Pharmaceuticals, Inc. (OTC ... a 1-for-100 reverse split of its issued and outstanding ... trading on Thursday, February 11, 2016. The Company,s common ... CUSIP number 76303T308 and temporary ticker symbol "RCHAD". After ... under the ticker symbol (RCHA).  --> ...
Breaking Medicine Technology:
(Date:2/10/2016)... ... February 10, 2016 , ... Western University ... health services to the developmentally disabled in the Coachella Valley. , The two ... new facility at 71-949 Highway 111, Suite 100-B, in Rancho Mirage, California. The ...
(Date:2/10/2016)... ... February 10, 2016 , ... As part of its ongoing ... February 2016. Each webinar features a dynamic expert and thoughtful presentation to give ... patients and facilities. Both events are free to attend, but registration is ...
(Date:2/10/2016)... (PRWEB) , ... February 10, 2016 , ... ... American Academy of Emergency Medicine , an emergency medicine professional association, ... practice management services . , The American Academy of Emergency Medicine, or AAEM, ...
(Date:2/10/2016)... ... 2016 , ... The Wickman Agency in Garland, TX has ... community. Pledging to select a new beneficiary every 60 days, the agency will ... is to bring community awareness to important local causes by forming campaigns which ...
(Date:2/10/2016)... ... February 10, 2016 , ... 10 Best Water ... were three leading bottled water brand owners that topped the list as a result ... and optimize conversion. The premier brand was Tibet 5100, a top notch water company ...
Breaking Medicine News(10 mins):