Abbott’s dyslipidemia trial meets primary endpoints

Abbott has announced that data from a new study showed that Trilipix delayed-release capsules in combination with rosuvastatin calcium met all of the study’s primary endpoints.

Trilipix 135mg in combination with rosuvastatin calcium 5mg significantly improved high-density lipoprotein (HDL) cholesterol and triglycerides compared to rosuvastatin calcium 5mg alone, and significantly improved low-density lipoprotein (LDL) cholesterol compared to Trilipix 135mg alone in patients with multiple lipid problems, said Abbott.

The efficacy and safety of Trilipix in combination with rosuvastatin calcium was evaluated in a multicenter, randomized, double-blind, parallel group, 12-week, Phase III study of 760 patients with mixed dyslipidemia. Patients included in the study had multiple lipid problems, with an LDL greater than or equal to 130mg/dl, triglycerides greater than or equal to 150mg/dl and HDL less than 40mg/dl for men and less than 50mg/dl for women.

Following a six-week period in which patients were not allowed to take cholesterol medications, patients were randomized to receive Trilipix 135mg alone, rosuvastatin calcium 5mg alone or Trilipix 135mg in combination with rosuvastatin calcium 5mg. The primary efficacy comparisons were mean percent changes in triglycerides and HDL with the combination versus rosuvastatin calcium alone and mean percent change in LDL with the combination versus Trilipix alone.

Patients treated with the combination of Trilipix 135mg and rosuvastatin calcium 5mg had an increase in HDL of 23% compared to 12.4% increase with rosuvastatin calcium 5mg alone (p<0.001), and decrease in triglycerides of 40.3% compared to a reduction of 17.5% with rosuvastatin calcium 5mg alone (p<0.001). LDL was reduced by 28.7% with the combination compared to a 4.1% reduction with Trilipix 135mg alone (p<0.001).

The results of this study were consistent with those of the previous studies of Trilipix in combination with the other two most commonly used doses of rosuvastatin calcium (10mg and 20mg), said Abbott. The combinations both showed greater improvement in HDL and triglycerides compared to rosuvastatin calcium alone and greater improvements in LDL than Trilipix alone. The combination of Trilipix with the highest dose of rosuvastatin calcium (40mg) has not been studied. In the clinical trial, Trilipix in combination with rosuvastatin calcium was generally well-tolerated with reported safety similar to rosuvastatin calcium alone and Trilipix alone.

Eugene Sun, vice president of global pharmaceutical clinical development at Abbott, said: The recent approval of Trilipix and the results of this combination study further support Abbott’s clinical program and demonstrate how this combination therapy improves lipid levels.