TG Reduction in a Small Capsule.

Demonstrated in patients with the metabolic syndrome and elevated TGs…

  • In the TRIMS Study, ANTARA® reduced TGs, non-HDL-C, and VLDL-C
    by Week 81*†‡
  • Approximately 70% of patients had hypertension and 32% had diabetes2

* Results from a randomized, placebo-controlled, double-blind, double-dummy, parallel-group, multicenter study for 8 weeks to assess the food-related efficacy of ANTARA® for the treatment of hypertriglyceridemia in patients exhibiting the metabolic syndrome; patients evaluated received = 1 dose of study drug and had = 1 postrandomization lipid measurement

Patients were required to have fasting TG levels of 300 mg/dL to < 1000 mg/dL and to have 3 risk factors for the metabolic syndrome.

Baseline was the mean of Weeks -2, -1, and 0. End of treatment is the average of Weeks 6 and 8.



And in a subset of high-risk patients…

  • ANTARA® produced significant results in high-risk patients with TG levels >500 mg/dL2

…With rapid increases in HDL-C

  • ANTARA produced a significant increase in HDL-C in just 2 weeks1*†‡

  • ANTARA® treatment resulted in a significant increase in HDL-C of 14% at 8 weeks vs placebo (P=<0.001)1

 

* Results from a randomized, placebo-controlled, double-blind, double-dummy, parallel-group study for 8 weeks, to assess the food-related efficacy of a new formulation of micronized fenofibrate coated on inert microgranules (ANTARA®) for the treatment of hypertriglyceridemia in patients exhibiting the metabolic syndrome. ANTARA® 130-mg arms were pooled with or without meals, and the end of treatment is average of 6 and 8 weeks.
In patients with a mean TG baseline of 300 to 999 mg/dL; average of weeks -2, -1, 0.
In patients with an average HDL-C baseline of 36 mg/dL for weeks -2, -1, 0.

References: 1. Davidson MH, Bays H, Rhyne J, et al. Efficacy and safety profile of fenofibrate-coated microgranules 130 mg, with and without food, in patients with hypertriglyceridemia and the metabolic syndrome: an 8-week, randomized, double-blind, placebo-controlled study. Clin Ther. 2005;27(6):715-727. 2. Data on file. Lupin Pharmaceuticals, Inc.

 

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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