The FINANCIAL — Data from a new study showed that Abbott's (NYSE: ABT) TRILIPIX (fenofibric acid) delayed-release capsules in combination with CRESTOR (rosuvastatin calcium) met all of the study's primary endpoints.
TRILIPIX 135 mg in combination with CRESTOR 5 mg significantly improved HDL cholesterol and triglycerides compared to CRESTOR 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 CRESTOR was generally well-tolerated with reported safety similar to CRESTOR 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 CRESTOR 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 CRESTOR 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.