Data from the study showed that TriLipix in combination with rosuvastatin met its primary endpoints with significantly greater improvements in HDL and triglycerides compared to rosuvastatin alone, and significantly greater improvements in LDL compared to TriLipix alone.
The efficacy and safety of TriLipix in combination with rosuvastatin was evaluated in a randomized, double-blind, controlled, 12-week, Phase III study of 1,445 patients with mixed dyslipidemia. Patients included in the study had multiple 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/dL for men and less than 50 mg/dL for women.
Patients were randomized to receive TriLipix (135mg) combined with either 10mg or 20mg of rosuvastatin, TriLipix monotherapy (135mg) or rosuvastatin monotherapy (10mg, 20mg or 40mg). The 40mg rosuvastatin 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 compared to rosuvastatin monotherapy, and mean percent change in LDL in the combination compared to TriLipix monotherapy. Patients treated with the combination of TriLipix 135mg and rosuvastatin 10mg had an increase in HDL of 20.3% and decrease in triglycerides of 47.1% compared to an HDL increase of 8.5% and triglyceride decrease of 24.4% with rosuvastatin 10mg alone. LDL decreased 37.2% with the combination compared to 6.5% with TriLipix 135mg monotherapy.
Patients treated with the combination of TriLipix 135mg and rosuvastatin 20mg had an increase in HDL of 19% and decrease in triglycerides of 42.9% compared to 10.3% and 25.6%, respectively, with rosuvastatin 20mg monotherapy. LDL decreased 38.8% with the combination compared to 6.5% with TriLipix 135mg monotherapy.