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FDA Approves Liptruzet (Ezetimibe/Atorvastatin) to Lower Cholesterol

Drug indicated as adjunct to dietary measures (May 3)

The FDA has approved Liptruzet (ezetimibe and atorvastatin; Merck) tablets for the treatment of elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough.

Liptruzet contains ezetimibe, an LDL-C–lowering drug, and atorvastatin, a widely prescribed statin. The product, administered once daily, treats two sources of cholesterol by inhibiting both the absorption of cholesterol in the digestive tract (through ezetimibe) and the production of cholesterol in the liver (through atorvastatin).

No incremental beneficial effect of Liptruzet on cardiovascular morbidity and mortality beyond that demonstrated for atorvastatin has been established.

Liptruzet (ezetimibe and atorvastatin) is indicated as adjunctive therapy to diet to reduce elevated total cholesterol, LDL-C,apolipoprotein B, triglycerides, and non–high-density lipoprotein cholesterol (HDL-C), and to increase HDL-C in patients with primary (heterozygous familial and nonfamilial) hyperlipidemia or mixed hyperlipidemia. Liptruzet is also indicated for the reduction of elevated total cholesterol and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

Liptruzet is available as a once-daily tablet containing 10 mg of ezetimibe combined with 10, 20, 40, or 80 mg of atorvastatin (Liptruzet 10/10, 10/20, 10/40, or 10/80 mg, respectively). The dosage range is 10/10 mg/day through 10/80 mg/day.

The drug’s recommended starting dose is 10/10 mg or 10/20 mg taken once daily, or 10/40 mg once daily for patients who require a larger reduction (greater than 55%) in LDL-C. The product can be taken at any time of day, with or without food.

In a 12-week, double-blind, placebo-controlled clinical study involving 628 patients with hyperlipidemia, co-administration of ezetimibe and atorvastatin provided LDL-C reductions of 53% at the lowest dose (10/10 mg; mean baseline LDL-C: 177 mg/dL); 54% at the 10/20 mg dose (mean baseline LDL-C: 184 mg/dL); 56% at the 10/40 mg dose (mean baseline LDL-C: 184 mg/dL); and 61% at the maximum dose (10/80 mg; mean baseline LDL-C: 183 mg/dL).

Source: Merck; May 3, 2013.

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