-- Robert Preidt
SATURDAY, March 9 (HealthDay News) -- Combining the vitamin
niacin with a cholesterol-lowering statin drug appears to offer
patients no benefit and may also increase side effects, a new study
It's a disappointing result from the largest-ever study of
niacin for heart patients, which involved almost 26,000 people.
In the study, patients who added the B-vitamin to the statin
drug Zocor saw no added benefit in terms of reductions in
heart-related death, non-fatal heart attack, stroke, or the need
for angioplasty or bypass surgeries.
The study also found that people taking niacin had more
incidents of bleeding and/or infections than those who were taking
an inactive placebo, according to a team reporting Saturday at the
annual meeting of the American College of Cardiology, in San
"We are disappointed that these results did not show benefits for our patients," study lead author Jane Armitage, a professor at the University of Oxford in England, said in a meeting news release. "Niacin has been used for many years in the belief that it would help patients and prevent heart attacks and stroke, but we now know that its adverse side effects outweigh the benefits when used with current treatments."
Niacin has long been used to boost levels of "good" HDL
cholesterol and decrease levels of "bad" LDL cholesterol and
triglycerides (fats) in the blood in people at risk for heart
disease and stroke. However, niacin also causes a number of side
effects, including flushing of the skin. A drug called laropiprant
can reduce the incidence of flushing in people taking niacin.
This new study included patients with narrowing of the arteries.
They received either 2 grams of extended-release niacin plus 40
milligrams of laropiprant or matching placebos. All of the patients
also took Zocor (simvastatin).
The patients from China, the United Kingdom and Scandinavia were
followed for an average of almost four years.
Besides showing no helpful effect on heart health outcomes, the
team noted that people taking niacin had about the same amount of
heart-related events (13.2 percent) as those who took a placebo
instead (13.7 percent).
Side effects were common. As already reported online Feb. 26 in
European Heart Journal, by the end of the study, 25 percent
of patients taking niacin plus laropiprant had stopped their
treatment, compared with 17 percent of the patients taking a
"The main reason for patients stopping the treatment was because of adverse side effects, such as itching, rashes, flushing, indigestion, diarrhea, diabetes and muscle problems," Armitage said at the time in a journal news release. "We found that patients allocated to the experimental treatment were four times more likely to stop for skin-related reasons, and twice as likely to stop because of gastrointestinal problems or diabetes-related problems."
Patients taking niacin and laropiprant had a more than fourfold
increased risk of muscle pain or weakness compared to the placebo
group, the team noted.
Did the fault lie with the laropiprant and not niacin? Armitage
She pointed to a prior trial, called AIM-HIGH, which was
discontinued early in 2011 when researchers found no benefit to
niacin treatment. At the time, some experts said that the smaller
population in AIM-HIGH masked any sign of benefit, but Armitage
said the new trial's much bigger study group confirms that niacin
probably does not help.
Speaking in February at the time of the journal's release of
niacin's safety profile, one U.S. expert was less than impressed by
The trial "confirms that, for the present moment, there may be
little additional benefit with the use of niacin when patients are
well treated with the lipid-lowering statin drugs," said Dr. Kevin
Marzo, chief of cardiology at Winthrop-University Hospital in
He said that the results of the new trial, along with those from
a prior large study, "now may put the final nail in the coffin on
niacin-based strategies to raise HDL and lower cardiovascular
Other tried-and-true approaches may work best, Marzo added. "In
addition to statins, our focus should be on continued lifestyle
changes such as a Mediterranean diet, complemented with daily
exercise," he said.
The U.S. Food and Drug Administration had been waiting on the
new trial results to decide whether to approve niacin/laropiprant
for use against heart disease. But in December 2012, responding to
preliminary findings, drug maker Merck said it no longer planned to
press for approval from the FDA and in January suspended
niacin/laropiprant from markets worldwide.
The U.S. National Institutes of Health outlines steps you can
reduce heart risks.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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