Glossary

 

Artery - A blood vessel that carries blood away from the heart.

Atherosclerosis - The build up of fats, cholesterol and plaque on the artery walls, which leads to narrowing or blockage in arteries.

Bile acids - A digestive juice secreted by the liver and stored in the gallbladder that helps digest fats.

Cholesterol - A substance found in animal cells and body fluids that is involved in cell function.

Coronary heart disease - The narrowing of the blood vessels that supply blood and oxygen to the heart. Angina can be a symptom of coronary heart disease.

Diabetes type 2 - A chronic disease in which blood sugar levels are too high because the body can not use insulin effectively (a problem called insulin resistance).

Dyslipidemia - A general term for an imbalance in the types of fats (lipids) in the blood. High TG is a form of dyslipidemia.

Enzyme - A protein in cells that stimulates chemical reactions in the body.

Fredrickson’s Classification of Hyperlipidemia - A model used to identify dyslipidemias, based on high levels of total cholesterol (TC) and triglycerides (TGs).

Heart attack - Damage to the heart muscle caused by a lack of blood supply to the heart for an extended time period.

HDL-C – HDL-C is often called the “good” cholesterol. HDL-C is carried from the blood vessels to the liver where the body can break it down. A high level of HDL-C may decrease your risk of having a heart attack or stroke, while a low level may increase your risk.

Hormones - A chemical produced by the body that travels the bloodstream delivering messages between organs and glands.

Hypertension - High blood pressure.

Hyperlipidemia - High levels of fats (lipids) in the blood. Insulin resistance-a condition in which blood glucose (sugar) levels rise because the body cannot use insulin effectively.

LDL-C - The “bad” cholesterol. LDL-C is the major transporter of cholesterol in the bloodstream. Too much LDL can cause build up on the artery walls, causing atherosclerosis, which may increase the risk of heart attack.

Lipid - A type of molecule that includes fats. Triglycerides and cholesterol are both lipids.

Monounsaturated fat - An unsaturated fat found in canola, olive, and peanut oils, and avocados.

Plaque - Deposits of fats, inflammatory cells, proteins, and calcium along the artery walls.

Polyunsaturated fat - An unsaturated fat found in safflower, sesame, and sunflower seeds, corn and soybeans, many nuts and seeds, and their oils.

Saturated fat - The main dietary cause of high blood cholesterol, saturated fat is found in foods from animals and some plants.

Transfatty acids - A type of unsaturated fatty acid found in partially hydrogenated vegetable oils and in very small amounts in animal products (beef, pork, lamb, butter, and milk). Also known as TFA or hydrogenated fats, they help food stay fresh longer. However, the body is not efficient in breaking down these fats and therefore they contribute to increasing the risk of atherosclerosis.

Triglycerides - The most common storage form for lipids in the body.


Reference: 1. Fredrickson DS, Lees RS. A system for phenotyping hyperlipidemia.
Circulation. 1965; 31(3):321-327.

 

INDICATIONS

Primary Hypercholesterolemia and Mixed Dyslipidemia: ANTARA® is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hyperlipidemia or mixed dyslipidemia.

Hypertriglyceridemia: ANTARA® is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (eg, >2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.

Important limitations of use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus.

IMPORTANT SAFETY INFORMATION

ANTARA® is contraindicated in patients with severe renal impairment; active liver disease, including unexplained persistent liver function abnormalities; preexisting gallbladder disease; nursing mothers; and hypersensitivity to fenofibric acid, choline fenofibrate or fenofibrate.

The effect of ANTARA® on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established.

Fibrates increase the risk for myopathy and are associated with rhabdomyolysis. The risks for myopathy and rhabdomyolysis are increased when fibrates are co-administered with a statin, particularly in the elderly and in patients with diabetes, renal failure, or hypothyroidism. The combined use of fibrates and statins should be avoided unless the benefit of further alterations in lipid levels is likely to outweigh the increased risk.

Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness. Discontinue ANTARA® if myopathy/myositis is suspected or diagnosed or if CPK levels are markedly elevated.

Fenofibrate at doses equivalent to 90 mg ANTARA® per day can increase serum transaminases. Monitor liver function regularly and discontinue treatment if enzyme levels persist above 3 times the normal limit.

Fenofibrate can reversibly elevate serum creatinine. Monitor renal function in patients with renal impairment.

Fenofibrate may lead to cholelithiasis. Discontinue ANTARA® if gallstones are found.

ANTARA® can potentiate the activity of oral anticoagulants. Monitoring and dosage adjustment of anticoagulants as needed are recommended.

Other precautions include pancreatitis, hematologic changes, hypersensitivity reactions, and venothromboembolic events.

The most common adverse reactions (>2% and ≥1% greater than placebo) are abnormal liver function tests, increased AST, increased ALT, increased CPK, and rhinitis.

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