Data from a new study showed that Abbott's TRILIPIX (fenofibric acid) delayed-release capsules in combination with rosuvastatin calcium met all of the study's primary endpoints.
TRILIPIX 135 mg in combination with rosuvastatin calcium 5 mg significantly improved HDL cholesterol and triglycerides compared to rosuvastatin calcium 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 rosuvastatin calcium was generally well-tolerated with reported safety similar to rosuvastatin calcium 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 rosuvastatin calcium 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 rosuvastatin calcium 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.
About the Study Design
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 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.
Following a six-week period in which patients were not allowed to take cholesterol medications, patients were randomized to receive TRILIPIX 135 mg alone, rosuvastatin calcium 5 mg alone or TRILIPIX 135 mg in combination with rosuvastatin calcium 5 mg. 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.
About the Study Results
Patients treated with the combination of TRILIPIX 135 mg and rosuvastatin calcium 5 mg had an increase in HDL of 23 percent compared to 12.4 percent increase with rosuvastatin calcium 5 mg alone (p<0.001), and decrease in triglycerides of 40.3 percent compared to a reduction of 17.5 percent with rosuvastatin calcium 5 mg alone (p<0.001). LDL was reduced by 28.7 percent with the combination compared to a 4.1 percent reduction with TRILIPIX 135 mg 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 (10 mg and 20 mg). 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 (40 mg) has not been studied.
"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," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott.
TRILIPIX Clinical Development Program
The TRILIPIX clinical program studied 3,458 patients with mixed dyslipidemia in four 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.
TRILIPIX(R) 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.
Important Safety Information About TRILIPIX
TRILIPIX should not be taken by people with liver, gallbladder, or severe kidney disease, nursing mothers, or those allergic to any product ingredient. Unexplained muscle pain, tenderness, or weakness, particularly when occurring with tiredness and fever, may be a sign of a serious side effect and should be reported to a healthcare provider right away. Rarely, muscle-related problems can cause kidney damage and can be fatal. The risk of these side effects may be increased when TRILIPIX is used with a statin. Patients should tell their healthcare provider about all the medicines they take to help avoid serious side effects. Blood tests may be performed before and during treatment with TRILIPIX to check for liver or kidney problems. Patients should contact their healthcare provider if they experience abdominal pain, nausea, or vomiting while taking TRILIPIX. These may be signs of inflammation of the gallbladder or pancreas. Women who are pregnant should not take statins and should talk with their healthcare provider about TRILIPIX if they are pregnant or may become pregnant. The most common side effects with TRILIPIX include headache, heartburn, nausea, muscle aches, and increases in muscle or liver enzymes that are measured by blood tests. Full Prescribing Information is available at www.rxabbott.com/pdf/trilipix_pi.pdf. Visit www.trilipix.com or call Abbott Medical Information at 1-800-633-9110 for more information about TRILIPIX.