Amid a hail of publicity, pharmaceutical giant Merck received FDA approval last week for a new cholesterol-lowering drug. But a top cardiologist says he won’t be recommending it to his patients.

 

Liptruzet appears to be all about generating profits for Merck, but it doesn’t seem to add much to the arsenal of weapons in the fight against heart disease, says Chauncey Crandall, M.D.

 

“This is another smokescreen for the drug companies to make money for duplicating another drug,” says Dr. Crandall, head of preventive medicine and cardiology services at the world-renowned Palm Beach Cardiovascular Clinic.

 

Liptruzet doesn’t have any new ingredients. It is a combination of Merck’s existing medication, Zetia, combined with a generic version of Lipitor, the best-selling statin from Pfizer that is no longer patent protected. Liptruzet is expected to become available later this year.

 

“Lipitor went off patent so the drug companies are trying to cash in,” said Dr. Crandall. “This drug does lower cholesterol, but not by a mechanism that reduces risk of heart disease.

 

“Too often drugs are approved that benefit the drug companies, and not the patients.”

 

Research on the combination drug did show that it reduces LDL-cholesterol, the so-called “bad” cholesterol, but the new drug has not been shown to actually lower heart disease or stroke. Liptruzet will be patent-protected, which means Merck will be able to charge more for it than a generic drug.

 
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The new formula comes at a time when Merck has been fighting low sales for its other cholesterol medications. Sales for Zetia and Vytorin (a combination of Zetia and the statin drug Zocor) have not recovered since falling in 2008. That’s when a major study found that they did not stem the progression of heart disease in people with familial hyperlipidemia, an inherited condition in which the body manufactures too much cholesterol.

 

The FDA’s approval last week of Liptruzet came as a surprise because experts expected regulators to wait until a major clinical trial assessing Vytorin, another combo cholesterol drug, is concluded at the end of 2014. However, an FDA spokeswoman said the Liptruzet was approved because it is effective in lowering LDL-cholesterol, which is a known heart disease risk factor.

 

“I prescribed Zetia early on until the studies showed that it was not an effective medication to lower heart disease, and then I switched. So I have no intention of recommending this new combination drug, and I doubt many of my colleagues will either,” Dr. Crandall said.