1 INDICATIONS AND USAGE
Trilipix is a peroxisome proliferator receptor alpha (PPAR) activator indicated:
In combination with a statin to reduce TG and increase HDL-C in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL-C goal (1.1).
As monotherapy to reduce TG in patients with severe hypertriglyceridemia (1.2).
As monotherapy to reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in patients with primary hyperlipidemia or mixed dyslipidemia (1.3).
Important Limitations of Use:
No incremental benefit of Trilipix on cardiovascular morbidity and mortality over and above that demonstrated for statin monotherapy has been established. Fenofibrate at a dose equivalent to 135 mg of Trilipix was not shown to reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus.
1.1 Co-administration Therapy with Statins for the Treatment of Mixed Dyslipidemia
Trilipix is indicated as an adjunct to diet in combination with a statin to reduce TG and increase HDL-C in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL-C goal.
CHD risk equivalents comprise:
Other clinical forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease);
Diabetes;
Multiple risk factors that confer a 10-year risk for CHD > 20%
1.2 Treatment of Severe Hypertriglyceridemia
Trilipix is indicated as adjunctive therapy to diet to reduce TG in patients with severe hypertriglyceridemia.
Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention.
Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of Trilipix therapy on reducing this risk has not been adequately studied.
1.3 Treatment of Primary Hyperlipidemia or Mixed Dyslipidemia
Trilipix is indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, TG, and Apo B, and to increase HDL-C in patients with primary hyperlipidemia or mixed dyslipidemia.
1.4 Important Limitations of Use
No incremental benefit of Trilipix on cardiovascular morbidity and mortality over and above that demonstrated for statin monotherapy has been established. Fenofibrate at a dose equivalent to 135 mg of Trilipix was not shown to reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus.
1.5 General Considerations for Treatment
Laboratory studies should be performed to establish that lipid levels are abnormal before instituting Trilipix therapy.
Every reasonable attempt should be made to control serum lipids with non-drug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride-lowering drug therapy is considered. If the decision is made to use lipid-altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.
Drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL.