FDA Approves Liptruzet (ezetimibe and atorvastatin), a to Help Lower LDL Cholesterol

Liptruzet approved for patients with primary or mixed hyperlipidemia, as an adjunct to diet when diet alone is not enough

 

May 16, 2013
Merck FDA Approval Liptruzet

Liptruzet (pronounced LIP-true-zett) contains ezetimibe, an efficacious LDL cholesterol lowering therapy, and atorvastatin, currently one of the most widely prescribed statins in the United States. Once-daily Liptruzet 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 benefit of Liptruzet on cardiovascular morbidity and mortality over and above that demonstrated for atorvastatin has been established.

Liptruzet is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides and non-high-density lipoprotein cholesterol and to increase high-density lipoprotein (HDL) cholesterol in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. Liptruzet (ezetimibe and atorvastatin) is also indicated for the reduction of elevated total cholesterol and LDL cholesterol in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. No incremental benefit of Liptruzet on cardiovascular morbidity and mortality over and above that demonstrated for atorvastatin has been established.

Liptruzet is a prescription medicine and should not be taken by anyone who has active liver disease or unexplained persistent elevations in hepatic transaminases or who is hypersensitive to any component of Liptruzet. Women who are pregnant, nursing or who may become pregnant should not take Liptruzet.

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, 10/80 mg, respectively). The dosage range is 10/10 mg/day through 10/80 mg/day.

Liptruzet 10/10 and 10/80 mg tablets have been shown to be bioequivalent to coadministration of corresponding doses of ezetimibe and atorvastatin tablets.

Liptruzet 10/20 and 10/40 mg tablets have been shown to be clinically equivalent in LDL-C response to the corresponding coadministered doses of ezetimibe and atorvastatin tablets.

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

Liptruzet received FDA approval in May 2013

For more information: www.merck.com