The Food and Drug Administration approved a new cholesterol drug Friday — to be named Liptruzet — which is a combination of Merck's Zetia, along with the generic form of Lipitor.
Merck developed the new drug that has shown to lower cholesterol but not reduce the risk of cardiovascular disease or death, according to the pharmaceutical company.
Liptruzet is a combination of Zetia, a medication designed to lower low-density lipoprotein, and the generic form of Pfizer's Lipitor that lost its patent protection in 2011.
While the new cholesterol drug did not reduce the risk of heart disease in clinical trials, Liptruzet did reduce LDL cholesterol, or "bad cholesterol," more effectively in patients who solely took Lipitor.
The fact that the new drug does not show to reduce the risk of cardiovascular disease has some cardiologists wondering why the FDA approved it.
"This is extremely surprising and disturbing," said Dr. Steven E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic.
But FDA spokeswoman, Morgan Liscinsky, said that targeting LDL is important because it is known to be a risk factor for heart disease.
"Liptruzet is a combination of two currently marketed drugs that effectively lower elevated levels of cholesterol," she said.
Merck says that their new medication is a suitable drug for patients who are unable to lower their LDL cholesterol.
"A significant percentage of patients are unable to lower their LDL cholesterol to recommend levels despite treatment," said Dr. Peter H. Jones, a Merck adviser and associate professor of medicine at Baylor College of Medicine.
Liptruzet is set at $5.50 a pill and is intended to be administered once daily. Whether insurance companies will cover the new drug is unknown, but a Merck spokeswoman said that the pharmaceutical company "intends to be competitive in managed care to ensure wide access to Liptruzet."
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