Liptruzet approved by the FDA, everyone questions why

May 7, 2013 | By Márcio Barra

Liptruzet, a cholesterol-lowering pill combo that combines the active ingredient in Pfizer’s bestselling Lipitor (Atorvastatin) with Merck’s own Zetia (Ezetimibe), was just approved yesterday by the FDA, a move that some are calling a mistake.

In Merck’s release statement, the company pointed out that the combo drug was more effective in reducing LDL cholesterol than patients who took Lipitor alone. However, the company declared that Liptruzet did not reduce patients’ chances of developing heart disease. The last statement is driving a debate over why did the FDA approve this drug.

“This is extremely surprising and disturbing,” said Dr. Steven E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic, in declarations to the New York Times.

Zetia works by lowering low-density lipoprotein (LDL), aka the bad cholesterol involved in all kinds of nasty heart diseases like strokes and heart attacks. The thing is, it does so less than other drugs from Merck’s competitors, like Pfizer’s Lipitor and AstraZeneca’s Crestor (two statins, Atorvastatin and Simvastatin respectively). Another aggravating factor here is that there is no evidence that Zetia prevents heart attacks or strokes, unlike the aforementioned drugs. In short, there is no proof that Liptruzet is better than just Atorvastatin or Simvastatin alone.

This is not the first time that Merck combines Zetia with a statin. Vytorin, one of Merck’s top selling drugs who brought $1.8 billion last year, is a combination of Zetia with Merck’s own off-patent statin, Zocor, also known as Simvastatin. The 2008 study Enhance, which used ultrasound images of arteries, showed that the combination of Zetia and simvastatin was no better than simvastatin alone at preventing artery hardening. This made Vytorin and Zetya sales plummet and cardiologists less eager to prescribe both these drugs.

The FDA, in defending their position, stated that high LDL levels are a known risk factor for heart disease, and that “Liptruzet is a combination of two currently marketed drugs that effectively lower elevated levels of LDL cholesterol,” said an agency spokeswoman to the New York Times.


New York Times

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