Niacin Tops Zetia in Cutting Artery Plaque

Nov. 16, 2009 (Orlando, Fla.) -- A prescription version of niacin beat out a
blockbuster cholesterol-lowering drug in slowing the buildup of plaque in
artery walls, researchers report.
The study pitted extended-release niacin, sold as Niaspan, which works by
boosting levels of HDL "good" cholesterol, against ezetimibe. Ezetimibe, an
active ingredient in both Zetia and Zocor, lowers levels of LDL "bad"
cholesterol.
The findings are the second recent setback for Zetia.
Last year, another study showed that Vytorin, a combination of ezetimibe
and Zocor, worked no better than Zocor alone.
"The question is whether ezetimibe works at all," says researcher Allen
Taylor, MD, of the Washington Hospital Center in Washington, D.C. "Niacin has
been around for 50 years. It's a well-understood drug, and in this trial it was
clearly superior."
Peter Kim, president of Merck Research Laboratories, which makes ezetimibe,
says the new study was imitated due to its small size and short length. "It
would be very unfortunate if a flawed analysis led patients to discontinue
their cholesterol treatment."
The new findings were released here at the annual
American Heart Association (AHA) meeting and published online by TheNew England Journal of Medicine.
Niacin Slows Plaque Buildup
The new study, funded by Abbott, the maker of Niaspan, involved 363 people
who had heart disease or were at high risk of heart disease. All the patients
were on statin drugs that had brought their LDL below 100 mg/dL. However, they
all had suboptimal HDL levels.
About half of the patients were given Niaspan and the other half were given
Zetia, in addition to their usual statin drugs.
The study was halted in July, about four months early, when investigators
concluded that one group was clearly doing better than the other -- although
they did not say which group was doing better at the time; 208 patients
completed the trial.
At a news conference at the AHA meeting Sunday night, Taylor reported that
the "winner" was Niaspan.
Ultrasound images of neck arteries showed that Niaspan reduced artery plaque
by about 2%. Zetia did not slow plaque buildup, although it did lower
cholesterol.
Patients taking the niacin drug also suffered fewer heart attacks and other
heart problems than those in the ezetimibe group, but that finding could have
been due to chance, Taylor says.
Second Opinion
"This trial doesn't quite put the nail in the coffin for [Zetia], but it
pushes it way down on the list of medications for cholesterol-lowering
therapy," Anthony DeMaria, MD, editor-in-chief of the Journal of the
American College of Cardiology, says in a statement.
Two editorials accompanying the findings in The New England Journal of
Medicine raised questions about the findings.
"Unfortunately, the premature termination of the trial, the small number of
patients studied and the limited duration of follow-up preclude us from
conclusively declaring niacin the adjunctive agent of choice," writes Roger
Blumenthal, MDand Erin Michos, MD, both of Johns Hopkins.
Still, Vytorin and Zetia should probably be reserved for patients whose
cholesterol isn’t controlled with statins and niacin, Blumenthal tells
WebMD.
That said, some patients have trouble tolerating niacin, whose main side
effects are itching and flushing, he says. Thirty-six percent of patients
taking niacin in the trial reported flushing.
Blumenthal adds that several large clinical trials of niacin and Zetia that
are currently in progress shouldoffer more guidance.
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