TUESDAY, Nov. 15 (HealthDay News) -- Patients with
cardiovascular disease who add niacin to the statin drug Zocor
(simvastatin) to help lower their cholesterol get no additional
clinical benefit, a new study finds.
Even though niacin appeared to increase HDL cholesterol -- the
good cholesterol -- and decrease triglycerides, another type of fat
in the blood, it did not reduce the risk of heart attack, stroke or
death, the researchers found.
"The data we had previously on niacin was not very strong and mostly came from one very old study," said Dr. Robert Giugliano, from the cardiovascular medicine division at Brigham and Women's Hospital and Harvard Medical School in Boston, who was not involved with the study.
The report was published online Nov. 15 in the
New England Journal of Medicine to coincide with the
presentation of the findings at an American Heart Association
meeting in Orlando, Fla.
Giugliano, who is author of an accompanying journal editorial,
said the trial showed no benefit, but unexpectedly showed an
increase in stroke. "Although that signal is not definite," he
The trial, called the Aim-High trial, was stopped in May, 18
months early because there was no proven benefit to niacin -- also
known as vitamin B3 -- and an increased risk of stroke.
For the study, a team led by Dr. William Boden, a professor of
medicine at the University of Buffalo in New York, randomly
assigned more than 3,400 patients to receive high-dose,
time-released niacin or a placebo. Patients in both groups took
During an average follow-up period of three years, 16.4 percent
of patients taking niacin had a heart attack, stroke, died from
heart disease, were hospitalized or needed blocked arteries opened,
compared with 16.2 percent of the patients receiving a placebo, the
However, 1.6 percent of the patients taking niacin suffered a
stroke, compared with 0.9 percent of patients taking the
Giugliano noted that another, larger trial of niacin is in
progress, results of which are expected in 2013.
Niacin might be useful for patients who cannot take statins, he
said. "So niacin may still have a role," he added.
However, Giugliano does not recommend patients start taking
niacin. "One brand, Niaspan, sold almost $800 million worth last
year. But, it's hard to support high-volume sales for a drug that
doesn't have any good recent data to support it," he said.
The trial was funded by the U.S. National Heart, Lung, and Blood
Institute with support from Abbott Laboratories, which provided the
Niaspan. Drug maker Merck Pharmaceuticals provided the Zocor.
Another expert, Dr. Gregg Fonarow, a professor of cardiology at
the University of California, Los Angeles, and a spokesman for the
American Heart Association, commented that "LDL-lowering with
statin therapy dramatically lowers the risk of cardiovascular
events in patients with established coronary heart disease."
It has been commonly held that raising HDL and lowering
triglyceride levels would be beneficial, even among patients who
have achieved optimal levels with statin therapy, he said. LDL is
known as "bad cholesterol."
"AIM-High has demonstrated that among patients with established cardiovascular disease, there was no clinical benefit with the addition of extended release niacin to statin therapy despite increases in HDL and decreases in triglyceride. Further there was an unexpected increase in stroke risk with niacin," Fonarow said.
"These findings challenge the commonly held hypothesis that HDL raising and triglyceride lowering is of benefit to patients with coronary heart disease, though further studies are needed," he added.
Aggressive LDL-lowering with statin therapy remains the
evidence-based, guideline-recommended, gold standard for benefiting
patients with and at risk for cardiovascular disease, Fonarow
For more on cardiovascular disease, visit the
American Heart Association.
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