May 6, 2013
FDA Approves Merck’s New Combination Cholesterol Drug Liptruzet
redOrbit Staff & Wire Reports - Your Universe Online
Liptruzet, a combination drug developed by Merck that has been found to lower a patient´s low-density lipoprotein (LDL) cholesterol levels, has been approved by the US Food and Drug Administration (FDA).
According to MedPage Today Cardiology Editor Chris Kaiser, Liptruzet is a combination of the drugs ezetimibe and atorvastatin and has been approved for the treatment of hyperlipidemia, a condition characterized by abnormally elevated levels of any or all kinds of lipids and/or lipoproteins in the blood.
The FDA authorized the combination drug´s use to treat elevated LDL levels in patients suffering from either primary or mixed hyperlipidemia, and whose diet and lifestyle changes have not lowered their so-called “bad cholesterol” levels to the recommended range, Kaiser added.
Liptruzet combines ezetimibe, which is sold under the brand-name Zetia and decreases the amount of LDL absorbed from the food consumed by the patient, and atorvastatin, which is a generic version of the drug Lipitor that absorbs cholesterol in the liver, the Associated Press (AP) explained on Friday.
While Liptruzet “was shown in a clinical trial to reduce LDL cholesterol more than patients who took Lipitor alone, the company said Liptruzet did not reduce patients´ chances of developing heart disease,” according to Katie Thomas of the New York Times. “That fact troubled some cardiologists, who questioned why it was approved.”
Merck, however, countered that the combination pill was a good option of patients whose previous attempts to lower their bad cholesterol levels had proven unsuccessful, Thomas added. Baylor College of Medicine associate professor Dr. Peter H. Jones, an advisor with the pharmaceutical company, told the Times reporter that “a significant percentage of patients are unable to lower their LDL cholesterol to recommended levels despite treatment.”
Kaiser reports that the drug should be taken once per day with a dosage range of 10/10 mg/day through 10/80 mg/day. That means that 10mg of ezetimibe will be combined with between 10mg and 80mg of atorvastain, Thomas explained. The company´s list price for Liptruzet will be $5.50 per pill, though a spokeswoman would not confirm to Thomas if insurance companies were planning to cover the cost of the medication.