Zetia Fails to Show Benefit Over Niacin for Heart Patients

Results reported here Sunday may not put the nail in the coffin for a once wildly popular cholesterol-lowering drug, but they do put Zetia at the bottom of the list of medications that doctors will be using.

So said Dr. Anthony DeMaria, a leading cardiologist who is also the editor in chief of the Journal of the American College of Cardiology.

He was referring to the results of a study that compared niacin -- a form of vitamin B -- to Zetia in high-risk patients who need more than a drug like Lipitor or Crestor to control their cholesterol.

The niacin used in the study is not variety available in health food stores and drug stores. It is a prescription product that has a special timed-release formulation, which may cut down on the hot flashes that are associated with niacin use.

Zetia, known generically as ezetimibe, is highly effective at reducing LDL, the so-called bad cholesterol. But niacin boosts HDL, or good cholesterol.

In the study reported at the American Heart Association meeting here -- and published online by the New England Journal of Medicine -- good trumped bad.

Niacin had a beneficial effect on the plaque buildup in the walls of the arteries that supply blood to the brain, but despite the fact that Zetia reduced LDL by almost 20 percent in patients who already had LDL cholesterol levels of less than 100 mg/dL, patients taking the drug had a slight worsening of the plaque build-up.

"This trial doesn't quite put the nail in the coffin for ezetimibe, but it pushes it way down on the list of medications for cholesterol-lowering therapy," DeMaria said.

Moreover, nine patients in the Zetia arm had heart attacks, stroke, or died from heart disease, versus just two patients taking niacin.

"Niacin had a superior effect on the artery wall," said Dr. Allan Taylor, a cardiologist at Walter Reed Army Medical Center who headed the study. "The take-home message is clear: niacin should be the choice when considering an add-on therapy."

Taylor pulled no punches at a press conference to discuss the results, pressing the point that at time when the nation is watching the bottom line on healthcare costs, it's time to switch to niacin -- which even in the branded formulation called Niaspan, which was used in the trial, is cheaper than Zetia. Noting that in 2008, 9 million Americans were taking Zetia versus just 2.5 who were taking niacin, Taylor said that switching would reap big potential savings as well as better outcomes.

Yet, Taylor's position was questioned by reporters who noted that he disclosed receiving more than $10,000 in lecture fees from Abbott, which makes Niaspan.

Dr. Jim Stein of the University of Wisconsin put it this way:

"Doctors need to stop using so much ezetimibe," Stein said. "Using this drug is not practicing evidence-based medicine. It is taking a path of least resistance -- the easy way out of getting numbers to targets. But we don't treat numbers, we treat patients, and are obligated to use drugs that are proven in clinical trials to reduce things they care about -- heart attacks, strokes, and death -- and to do so safely."

The trial itself was small; just 208 patients had completed the 14-month study when it was terminated because "the clinical question was answered and having answered it, the trial lost clinical equipoise," Taylor said.

That early termination caused some critics to question the impact of the results.

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