About Diabetes, Excess Weight,
and Triglycerides (TGs)


People who have Type 2 diabetes often have high TG levels. This is because the body’s mechanisms for using and storing energy (calories) are interconnected.1

In Type 2 diabetes, cells have a problem using insulin. This insulin resistance can lead to the breakdown of “good” HDL cholesterol and an increase in TGs. This is why managing diabetes helps to bring down high TGs.1

In a similar way, having too much body fat around the waist and belly can cause TGs to rise. That is because it contains fat-storage cells that release chemicals that break down lipids. These metabolic changes can cause lower HDL cholesterol and higher TGs.1

Most importantly, diabetes, excess weight, and TGs can all increase the buildup of plaque in the blood vessels and lead to heart disease.1


Reference: 1. Athyros VG, Tziomalos K, Karagiannis A, Mikhailidis DP. Dyslipidaemia of obesity, metabolic syndrome and type 2 diabetes mellitus: the case for residual risk reduction after statin treatment. Open Cardiovasc Med J. 2011;5:24-34.

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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