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 Indications
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. About Abbott
Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 72,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's Web site at www.abbott.com.