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Study Raises New Questions About Cholesterol Drug Zetia

(HealthDay News) -- A new study raises more questions about ezetimibe (Zetia), a drug used by millions of Americans in tandem with statins to lower LDL, or "bad," cholesterol.

The trial, known as ARBITER-6 HALTS, was stopped early in June after it was discovered that LDL-cholesterol-lowering Zetia was less effective than extended-release niacin (Niaspan), which raises HDL, or "good," cholesterol levels, in reducing plaque build-up in the arteries.

Clinical trials are generally terminated early if a safety issue arises, less so when a measure of success is achieved.

The niacin combination also reduced the number of heart attacks and deaths.

"This trial provides a clear and undeniable statement on the superior clinical effectiveness of niacin over ezetimibe," study principal investigator Dr. Allen Taylor, director of Advanced Cardiovascular Imaging and the Lipid/Prevention Clinic at Washington Hospital Center in Washington, D.C., said at a Sunday afternoon news conference.

The study was funded by the pharmaceutical company Abbott Laboratories, which makes Niaspan, and Taylor and other study authors have received consulting fees from the company. Merck & Co. makes Zetia.

Taylor presented the findings at the American Heart Association's annual meeting in Orlando, Fla. The report was also released early online Nov. 16 in the New England Journal of Medicine.

"This trial showed the clear superiority of niacin over ezetimibe. I would say that the combination of LDL-lowering and HDL-increasing with niacin was associated with a greater regression of atherosclerosis," added Dr. John J.P. Kastelein, author of one of two editorials accompanying the paper. Kastelein is with the department of vascular medicine, Academic Medical Center, Meibergdreef, the Netherlands.

The current evidence on Zetia and a related drug, Vytorin, both made by Merck, have not been overwhelmingly positive. One study found that the combination of Vytorin and a statin was no better than the statin on its own.

Although statins -- drugs such as Crestor, Lipitor and Zocor -- reduce LDL cholesterol levels in a great many patients, some people need additional therapy.