The Food and Drug Administration approved on Friday a combination drug developed by Merck that lowers a patient's cholesterol but has not been shown to reduce the risk of cardiovascular disease or death, the company said.
The drug pairs Merck's Zetia, which lowers low-density lipoprotein (LDL or "bad cholesterol") with the generic version of Lipitor, the best-selling statin made by Pfizer that lost its patent protection in 2011.
Although the combination drug, to be called 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. That fact troubled some cardiologists, who questioned why it was approved.
"This is extremely surprising and disturbing," said Dr. Steven E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic.
Cardiologists have long questioned the value of Zetia and Vytorin, which combined Zetia with an older statin, Zocor. They had been on the market for a decade, but had not been shown to reduce the risk of heart disease.
A clinical trial of more than 18,000 patients is assessing whether Vytorin significantly reduces heart attacks, strokes and heart-related deaths and is expected to conclude in 2014. In March, an independent monitoring board let the trial continue, suggesting that no significant safety concerns had come up. Still, Dr. Nissen said he was skeptical that the trial would show that the drugs were effective.
Morgan Liscinsky, an F.D.A. spokeswoman, said high levels of LDL cholesterol were a known risk factor for heart disease. "Liptruzet is a combination of two currently marketed drugs that effectively lower elevated levels of LDL cholesterol," she said. The F.D.A. rejected Merck's application for the drug last year, and the company said at the time that the agency requested more information.
Merck said Liptruzet was a good option for patients who were not successful in lowering their bad cholesterol. "A significant percentage of patients are unable to lower their LDL cholesterol to recommended levels despite treatment," Dr. Peter H. Jones, an adviser to Merck and an associate professor of medicine at Baylor College of Medicine, said in a news release.
Liptruzet is meant to be taken once a day and will be sold in doses of 10 milligrams of Zetia, in addition to 10, 20, 40 or 80 milligrams of Lipitor, known as atorvastatin. Merck's list price will be $5.50 a pill. A company spokeswoman did not say whether insurance companies were planning to cover the drug, but said Merck "intends to be competitive in managed care to ensure wide access to Liptruzet."
Sales of Vytorin and Zetia have fallen since 2007, when they brought in a combined $5 billion, but they are still among Merck's top-selling drugs. In 2012, Zetia brought in $2.6 billion and Vytorin $1.8 billion, according to company filings.
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