Niacin Added to Statin Therapy Fails to Clear Plaque
in Senior Citizens Like Earlier Study
Cholesterol levels did improve, but arteries of
seniors with coronary artery disease do not show it
Nov. 18, 2009 Research focusing on senior
citizens that is being presented today challenges a study released only
days ago that found adding the cholesterol drug niacin to a statin
improved HDL (good) cholesterol levels and significantly reduced
arterial plaque. The newest study says niacin with statins does not
significantly diminish plaque buildup in seniors who already have
coronary artery disease.
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The routine prescription of extended-release
niacin, a B vitamin (1,500 milligrams daily), in combination with
traditional cholesterol-lowering therapy offers no extra benefit in
correcting arterial narrowing and diminishing plaque buildup in seniors
who already have coronary artery disease, this new vascular imaging
study from Johns Hopkins experts shows.
(For details on the earlier study, see Statin
Patients..., at
top of sidebar on left.)
In tests on 145 Baltimore-area men and women with
existing atherosclerosis, all over age 65, researchers found that after
18 months of drug therapy, reductions in arterial wall thickness were
measurably no different between the half who took dual niacin-statin
therapy and the rest who remained on statin therapy alone.
The results were the same whether they took any one
of the three leading statin medications: atorvastatin (Lipitor),
simvistatin (Zocor) or rosuvastatin (Crestor).
Seniors on dual drug therapy had an average 5.4
cubic millimeter per month scale back in plaque buildup in the main neck
artery, while those taking just a cholesterol-lowering statin medication
came down by 4 cubic millimeters per month - a difference that
researchers say is not statistically significant.
The team will present its findings today at the
American Heart Association's (AHA) annual Scientific Sessions in
Orlando.
According to senior study investigator and Johns
Hopkins cardiologist Joγo Lima, M.D., the lack of any discernible
advantage occurred despite promising gains in bad (LDL) and good (HDL)
blood cholesterol levels in those taking vitamin B niacin.
Results showed that in the group taking both niacin
and a statin, blood levels of LDL-cholesterol fell 5 percent more than
in the group taking only statin medications. And levels of HDL jumped 14
percent more than in the statin-only group.
"Our findings tell us that improved cholesterol
levels from taking combination vitamin B niacin and statin therapy do
not necessarily translate into observable benefits in reversing and
stalling carotid artery disease," says Lima, a professor of medicine and
radiology at the Johns Hopkins University School of Medicine and its
Heart and Vascular Institute.
"This does not mean that niacin therapy may not
have other cardiovascular benefits, but any such benefits are
independent of reducing the amount of plaque buildup and patients should
be aware of that."
"Our recommendation to physicians is that current
national treatment guidelines, which recommend mainly statin therapy
tailored to the severity of atherosclerosis for preventing arteries from
reclogging and narrowing, appear to be sufficient and accurate for
physicians and patients to follow," says Lima.
However, Lima cautions that an ongoing national
study of the long-term vascular benefits of dual therapy and whether
extended-release niacin, also known as nicotinic acid, lowers death
rates from heart disease should provide more definitive data. Hopkins is
participating in that research, as well. He also notes that
extended-releases niacin used in this study is a prescription
medication, and that it is not sold over the counter like many other
vitamin B products.
About Niacin
Why is Niacin prescribed?
Niacin is used with diet changes (restriction of
cholesterol and fat intake) to reduce the amount of cholesterol and
certain fatty substances in your blood. Niacin is also used to prevent
and treat pellagra (niacin deficiency), a disease caused by inadequate
diet and other medical problems. Niacin is a B-complex vitamin.
How should this medicine be used?
Niacin comes as a tablet and an extended-release
(long-acting) tablet to take by mouth. The regular tablet usually is
taken two to three times a a day with meals, and the extended-release
tablet is taken once a day, at bedtime, with food.
Follow the directions on your prescription label or
package label carefully, and ask your doctor or pharmacist to explain
any part you do not understand. Take niacin exactly as directed. Do not
take more or less of it or take it more often than prescribed by your
doctor.
Swallow the extended-release tablets whole; do not
split, chew, or crush them.
Your doctor will probably start you on a low dose
of niacin and gradually increase your dose.
Continue to take niacin even if you feel well. Do
not stop taking niacin without talking to your doctor.
Also called: CAD, Coronary arteriosclerosis,
Coronary atherosclerosis
Coronary artery disease (CAD) is the most common
type of heart disease. It is the leading cause of death in the United
States in both men and women.
CAD happens when the arteries that supply blood
to heart muscle become hardened and narrowed. This is due to the buildup
of
cholesterol and other material, called plaque, on their inner walls.
As the buildup grows, less blood can flow through the arteries. As a
result, the heart muscle can't get the blood or oxygen it needs. This
can lead to chest pain (angina)
or a
heart attack. Most heart attacks happen when a blood clot suddenly
cuts off the hearts' blood supply, causing permanent heart damage.
Over time, CAD can also weaken the heart muscle
and contribute to
heart failure and
arrhythmias. Heart failure means the heart can't pump blood well to
the rest of the body. Arrhythmias are changes in the normal beating
rhythm of the heart.
"The real value in initially studying this
particular group of people is that these seniors are the ones who I am
most likely to see in the hospital, the group most vulnerable to
coronary artery disease and most at risk of suffering an arterial
blockage, heart attack, or stroke," says lead study investigator
Christopher Sibley, M.D. Nearly 17 million American adults are estimated
to have some form of coronary artery disease, resulting in more than
400,000 deaths each year.
"Practically speaking, carotid MRI scans are an
option to assess the risk of patients based on the amount of plaque in
their arteries, to better determine who needs aggressive statin therapy
and to monitor how well they respond to treatment," says Sibley, an
adjunct assistant professor at Johns Hopkins, as well as a staff
clinician at the National Institutes of Health Clinical Center.
All study participants had one or more preexisting
cardiovascular health issues, such as a previous heart attack, stroke,
coronary artery bypass grafting to resupply blood to the heart, severe
chest pain, or angioplasty with the placement of wire stents to keep
arteries open.
At the start of the study, participants received an
MRI scan of their carotid artery, and again every six months thereafter.
The four sets of carotid images provided what Sibley says is "an
important window" into what is going on in the body's network of veins
and arteries. He notes that the neck artery is important not just
because it serves as the main blood supply to the brain, but also
because narrowing in the carotid artery reflects the risk of future
heart attack.
Sibley says that the team has begun to analyze
blood samples collected as part of the study, searching for chemicals
that might also signal a change in arterial plaque buildup and
progressive arterial narrowing.
Background Information
Funding support for the study, conducted solely at
Johns Hopkins, was provided by the National Institute on Aging, a member
of the National Institutes of Health. The nicotinic acid (Niaspan) used
in the study was provided by its manufacturer, Abbott Laboratories,
based in Abbott Park, Ill.
Other Hopkins researchers involved in this study
were Ilan Gottlieb, M.D.; Christopher Cox, Ph.D.; Gustavo Gudoy, M.D.;
Amy Spooner, M.D.; and David Bluemke, M.D., Ph.D., who is now at the
National Institutes of Health. (Presentation title: Comparative effect
of statin versus niacin on MRI-measured regression of carotid
atherosclerosis in a randomized clinical trial, the National Institute
on Aging Plaque Study.)
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