Combination therapy helped more patients reach combined targets for key lipid targets

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Abbott’s Trilipix (fenofibric acid) delayed-release capsules in combination with rosuvastatin calcium achieved individual and combined lipid targets in patients with mixed dyslipidemia and type 2 diabetes. In these patients, the combination of Trilipix and rosuvastatin helped up to three times more patients simultaneously reach all three key lipid targets – HDL, triglycerides and LDL – than the pre-determined monotherapy. Results from this post-hoc analysis were presented at the American Diabetes Association’s 2009 Scientific Sessions.

Trilipix is a prescription medicine used along with diet to lower triglycerides and LDL cholesterol, and increase HDL cholesterol. Trilipix is also 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.


“Because diabetes is a risk factor for heart disease, it is particularly important that patients with diabetes and mixed dyslipidemia manage all three key lipid parameters,” said Robert Rosenson, State University of New York, USA. “The results of this analysis are promising for combination therapy with Trilipix and rosuvastatin.”


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.


Trilipix should not be taken by people with liver, gallbladder, or severe kidney disease or by nursing mothers. Blood tests should be performed before and during treatment with Trilipix to check for liver problems. A healthcare provider should be contacted if serious side effects such as unexplained muscle pain, tenderness, or weakness develop. The risk of these side effects may be higher when Trilipix is used with a statin.


A total of 2,197 patients with mixed dyslipidemia were enrolled in two phase 3 clinical studies evaluating Trilipix in combination with rosuvastatin 5mg, 10mg, or 20mg compared to either Trilipix alone or rosuvastatin alone. Both studies met their primary endpoints, with combination therapy significantly improving HDL and triglycerides compared to rosuvastatin alone, and significantly improving LDL compared to Trilipix alone. The combination of Trilipix with the highest dose of rosuvastatin (40mg) has not been studied. These studies are part of the largest clinical program to date designed to evaluate the safety and efficacy of a fibrate in combination with statins.


This post-hoc analysis of two 12-week, randomised phase 3 studies of patients with mixed dyslipidemia examined a subgroup of 480 patients with type 2 diabetes. These patients were required to have 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 to be included in the study.


The analysis compared the proportion of patients reaching American Diabetes Association (ADA) lipid targets who received Trilipix in combination with rosuvastatin to those who received the corresponding dose of rosuvastatin alone, the pre-determined monotherapy. The ADA lipid targets included LDL less than 100mg/dL, triglycerides less than 150mg/dL and HDL greater than 40mg/dL for men and greater than 50mg/dL for women.


More patients simultaneously achieved all three ADA lipid targets for HDL, triglycerides and LDL when receiving Trilipix in combination with rosuvastatin 10mg (28.3% vs. 8.3%; p=0.012) or 20mg (19.1% vs. 5.9%; p= 0.045) compared to rosuvastatin 10mg or 20mg alone, respectively. Additionally, Trilipix in combination with rosuvastatin 5mg resulted in 21.7% of patients achieving all three ADA lipid targets simultaneously compared to 12.1% of patients receiving rosuvastatin 5mg alone (p=0.137). Trilipix monotherapy resulted in 4.3% of patients obtaining simultaneous achievement of these goals.


The Trilipix clinical program studied 3,458 patients with mixed dyslipidemia in four 12-week controlled studies where patients received Trilipix alone, Trilipix in combination with one of the three most commonly prescribed statins (atorvastatin, simvastatin or rosuvastatin) or statin alone. The clinical program also included a 52-week, long-term, open-label extension study.