About the TRILIPIX Clinical Trial Program
The FDA's approval of TRILIPIX was based on the largest clinical trial program to date designed to evaluate the efficacy and safety of a fibrate in combination with various statins. The efficacy and safety of TRILIPIX in combination with the three most commonly prescribed statins -- rosuvastatin, atorvastatin and simvastatin -- was evaluated in three randomized, multicenter, 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 > 130 mg/dL, triglycerides > 150 mg/dL and HDL less than 40 mg/dL for men and less than 50 mg/dL for women. A total of 1,911 patients who completed one of the 12-week studies subsequently enrolled in a 52-week long-term, open-label extension study.
The Phase III combination studies all met their primary endpoints. Combination therapy significantly improved HDL and triglycerides compared to statin therapy alone, and significantly improved LDL compared to TRILIPIX alone. All of the combinations and the statins had clinically meaningful reductions in LDL.
"Physicians told us that they needed data supporting the use of a fibrate with statins to help them more aggressively manage their patients' lipid problems," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "Abbott built a robust clinical program to support the use of TRILIPIX, and its approval adds a new option to Abbott's growing dyslipidemia portfolio which provides treatments to comprehensively help address all three key lipids."
Abbott and AstraZeneca are working together to develop a fixed-dose
combination of Abbott's TRILIPIX and AstraZeneca's CRESTOR(R) (rosuvastatin
calcium) with plans to submit a new drug application to t
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