Fibrate approved for use with a statin
Pharmacologic class: Fibrate
Active ingredient: Fenofibric acid (as choline fenofibrate) 45 mg, 135 mg; delayed-release caps.
Indications: Adjunct to diet: In combination with a statin, to reduce triglycerides (TG) and increase high-density lipoprotein cholesterol (HDL-C) in patients with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent who are on optimal statin therapy to achieve low-density lipoprotein cholesterol (LDL-C) goal; as monotherapy to reduce TG in severe hypertriglyceridemia, and to reduce elevated LDL-C, total cholesterol (total-C), TG, and apolipoprotein B (Apo B), and to increase HDL-C in primary hyperlipidemia or mixed dyslipidemia.
Pharmacology: Elevated blood levels of total-C, LDL-C, and Apo B and decreased levels of HDL-C have been shown to increase the risk for atherosclerosis. Fenofibric acid, the active moiety of fenofibrate, is a lipid-modifying agent that increases lipolysis and the elimination of TG-rich particles from plasma by activating lipoprotein lipase and reducing the production of apolipoprotein CIII.
Trilipix can be used in combination with a statin in patients with mixed dyslipidemia and CHD or a CHD risk equivalent, which includes other forms of atherosclerotic disease, diabetes, and multiple risk factors that confer a 10-year risk for CHD >20%. It has not been established that the use of Trilipix reduces morbidity and mortality more than the use of a statin alone.
Clinical trials: Three 12-week Phase 3 studies and one 52-week, open-label extension study were conducted to evaluate safety and efficacy of this product. In the Phase 3 studies, Trilipix was studied in combination with rosuvastatin, atorvastatin, or simvastatin. A total of 1,895 patients who completed one of the Phase 3 studies were then treated in the open-label study in which 568 patients completed 52 weeks of treatment with Trilipix plus a statin. The primary end points for each of the studies was the mean percent change from baseline to final value in HDL-C, TG, and LDL-C. The results of these studies indicated that combination therapy with low-dose and moderate-dose statins significantly improved HDL-C and TG compared with statin therapy alone, and significantly improved LDL-C compared with Trilipix alone. The use of each of the combinations and the statins resulted in significant reductions in LDL-C.
Adults: Mixed dyslipidemia, primary hyperlipidemia: 135 mg once daily. Hypertriglyceridemia: 45-135 mg once daily. Titrate at four- to eight-week intervals; maximum 135 mg/day. Mild-to-moderate renal impairment: initially 45 mg once daily.
Children: Not recommended.
Contraindications: Severe renal dysfunction (including dialysis). Active liver disease. Primary biliary cirrhosis. Gallbladder disease. Nursing mothers.
Precautions: Renal failure, diabetes, hypothyroidism, elderly: increased risk of myopathy with concomitant statins. Monitor liver function; discontinue if liver function tests (LFTs) greater than three times the upper limit of normal persist. Discontinue if markedly elevated creatine phosphokinase levels, myopathy, or gallstones occur. Pregnancy (Cat. C).
Interactions: Avoid with maximum doses of a statin (myopathy). Potentiates warfarin (monitor). Separate dosing of bile acid sequestrants. Caution with cyclosporine.
Adverse reactions: Headache, back pain, nasopharyngitis, myalgia, GI upset, upper respiratory infection, elevated LFTs, serum creatinine; myopathy, rhabdomyolysis, hematologic changes (e.g., hemoglobin, hematocrit), cholelithiasis, pancreatitis.
How supplied: Caps—90
For more information, call 800.633.9110 or visit www.Trilipix.com.