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This study of more than 1,400 patients is part of the largest clinicalprogram to date designed to evaluate the efficacy and safety of a fibrate incombination with statins. Data from the study showed that TriLipix incombination with rosuvastatin met its primary endpoints with significantlygreater improvements in HDL and triglycerides compared to rosuvastatin alone,and significantly greater improvements in LDL compared to TriLipix alone.Both the combinations and rosuvastatin alone resulted in clinically meaningfulreductions in LDL. In the clinical trial, TriLipix in combination withrosuvastatin was generally well tolerated, with reported safety similar to themonotherapies. No rhabdomyolysis (a rare muscle disorder) or unexpectedliver, kidney or muscle safety issues were identified in this study.
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"Patients with mixed dyslipidemia may need treatment options that helpaddress these three key lipids," said Peter H. Jones, M.D., FACP, MethodistDeBakey Heart and Vascular Center, Houston, and a lead investigator of thetrial. "Results from this study showed that TriLipix in combination withrosuvastatin significantly increased HDL, and decreased both LDL andtriglycerides."
According to the American Heart Association (AHA), more than 100 millionAmerican adults have elevated total cholesterol. Of the 30 million Americanscurrently on lipid-altering therapies, the majority are not reaching treatmentgoals. Treatment guidelines endorsed by the National Cholesterol EducationPanel, the American College of Cardiology and the AHA have called for moreaggressive management of lipids, including a lower LDL goal for many patients,as well as more aggressive management of HDL and triglycerides.
About the Study
The efficacy and safety of TriLipix in combination with rosuvastatin wasevaluated in a randomized, double-blind, controlled, 12-week, Phase III studyof 1,445 patients with mixed dyslipidemia. Patients included in the study hadmultiple 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/dLfor men and less than 50 mg/dL for women.
Patients were randomized to receive TriLipix (135mg) combined with either10mg or 20mg of rosuvastatin, TriLipix monotherapy (135mg) or rosuvastatinmonotherapy (10mg, 20mg or 40mg). The 40mg rosuvastatin monotherapy arm wasincluded in the study to assess safety and adverse events, but was notincluded in the statistical analysis.
The primary efficacy comparisons were mean percent change in HDL andtriglycerides in the combination compared to rosuvastatin monotherapy, andmean percent change in LDL in the combination compared to TriLipixmonotherapy. The study met all of its primary endpoints. Patients treatedwith the combination of TriLipix 135mg and rosuvastatin 10mg had an increasein HDL of 20.3 percent and decrease in triglycerides of 47.1 percent comparedto an HDL increase of 8.5 percent and triglyceride decrease of 24.4 percentwith rosuvastatin 10mg alone. LDL decreased 37.2 percent with the combinationcompared to 6.5 percent with TriLipix 135mg monotherapy.
Patients treated with the combination of TriLipix 135mg and rosuvastatin20mg had an increase in HDL of 19.0 percent and decrease in triglycerides of42.9 percent compared to 10.3 percent and 25.6 percent, respectively, withrosuvastatin 20mg monotherapy. LDL decreased 38.8 pe
