FDA Approves New Lipid Lowering Combination Tablet

The Food and Drug Administration (FDA) has approved a new lipid-lowering combination tablet (Liptruzet) that includes atorvastatin, which went off patent in 2011, and ezetimibe.

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The tablet, which is available as a once-daily tablet containing 10 mg of ezetimibe combined with 10, 20, 40, or 80 mg of atorvastatin, can be used to treat elevated LDL-cholesterol levels in patients with primary or mixed hyperlipidemia as an adjunct to dietary changes, as well as for reducing cholesterol levels in patients with homozygous familial hypercholesterolemia (FH). Dosage range is 10/10 mg/day through 10/80 mg/day, with a recommended starting dose of 10/10 mg/day or 10/20 mg/day. For patients requiring a >55% reduction in LDL-C, the recommended starting dose is 10/40 mg/day. In addition, dosing should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant, according to the label.

This is the third time that the FDA has considered Liptruzet. The agency rejected Merck's application for the drug in 2009. In 2012, it issued a complete-response letter stating it would not approve the combination tablet and that more data were needed. To date, no incremental benefit of the new combination drug on cardiovascular morbidity and mortality over and above that demonstrated for atorvastatin has been established to date. A combination tablet (Vytorin) that includes simvastatin and ezetimibe is already available in the US.

Keywords: Pyrroles, Cholesterol, Drug Combinations, United States Food and Drug Administration, Azetidines, Hyperlipoproteinemia Type II, Bile, Heptanoic Acids, Simvastatin

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