WASHINGTON — A popular cholesterol-lowering drug failed to help slow the build-up of artery-clogging plaque in a long-awaited study, the companies that market the medication said Monday, raising questions about whether its use should be limited.
The drug, Vytorin (a combination of Zetia and Zocor), also did not reduce the thickness of plaque lining artery walls, a significant disappointment for the manufacturers.
“Obviously we would have preferred a more favorable results,” said Skip Irvine, a spokesman for Merck/Schering-Plough Pharmaceuticals, a joint venture between the two companies that markets both Zetia and Vytorin.
Other experts said the findings mark a major blow for the medications.
“This is stunning,” said Steven Nissen, a Cleveland Clinic cardiologist who was not involved in the research. “I do not believe it should be used as a first line therapy. It should only be used as a last resort. That’s a stunning reversal for what was previously one of the fastest growing cholesterol-lowering medications being used.”
Zetia was approved in 2002, and Vytorin was approved in 2004. Both quickly became popular. Doctors wrote about 18 million prescriptions for Vytorin and about 14 million for Zetia in 2006, making them among the most commonly prescribed cholesterol-lowering drugs, and their popularity has continued to grow, according to IMS Health, a health care information company.
Previous studies have shown Zetia and Vytorin are effective at lowering cholesterol, but other medications that do this have been shown to have additional benefits, such as slowing the build-up of plaque or sometimes even shrinking it, as well as reducing the risk of heart attacks and strokes and lowering mortality rates.
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