Statin Patients Clear Arteries Better Building Good
Cholesterol with Niacin than Reducing Bad with Zetia
Plaque buildup in the lining of the neck arteries was
significantly reduced only in the niacin group
Nov.
16, 2009 - In combination with statins, adding a medication that raises
high-density lipoprotein (HDL) cholesterol was more effective in
reversing artery wall plaque buildup and in reducing heart disease risk
than adding a drug that lowers low-density lipoprotein (LDL)
cholesterol, researchers reported today at the American Heart
Association Scientific Sessions 2009.
In the study titled "The Effect of Extended-release
Niacin or Ezetimibe Added to Chronic Statin Therapy On Carotid Intima
Media Thickness (ARBITER 6-HALTS)," researchers found:
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● Adding the cholesterol drug niacin to a statin
improved HDL (“good”) cholesterol levels and significantly reduced
arterial plaque buildup within 8 months, with further improvement seen
at the end of the study (14 months).
● A second approach, adding ezetimibe
(generic for Zimbia) to a
statin, lowered LDL (“bad”) cholesterol to a greater extent, but did not
raise HDL. With it, there was no overall effect on arterial build up in
the neck arteries.
● With ezetimibe, greater reductions in LDL
cholesterol paradoxically were associated with more arterial buildup, a
result opposite to that expected.
● The incidence of major cardiovascular events
such as fatal and non-fatal heart attack was higher in the ezetimibe
group as compared to the niacin group (5 percent vs. 1 percent).
HDL And LDL Treatment Strategies (HALTS) was a
prospective, randomized, parallel group, open-label, blinded endpoint
study conducted at Walter Reed Army Medical Center in Washington, D.C.,
and Washington Adventist Hospital in Tacoma Park, Md. It included 363
adults (80 percent male, average age 68 years) with or at high risk for
atherosclerotic cardiovascular disease.
All participants were on cholesterol-lowering
statin drugs, and their LDL cholesterol was at the treatment goal of
under 100 milligrams per deciliter (mg/dL) of blood. Their HDL
cholesterol was lower than 50 mg/dL for men and 55 mg/dL for women.
The researchers randomly assigned the subjects to
receive either niacin or ezetimibe in addition to their usual statin.
The primary endpoint was the change in the wall
thickness of the carotid artery in the neck between the two groups of
patients.
In June, researchers halted the trial early because
the primary endpoint was met.
Specifically, 14-month follow-up data on 208
patients showed that in the niacin group, average HDL cholesterol
rose from 42 mg/dL to 50 mg/dL and there was a significant regression in
artery wall thickness.
In the ezetimibe (Zetia) group, average LDL
cholesterol levels dropped from 83 mg/dL to 66 mg/dL; however no overall
change was found in average artery wall thickness.
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. Read
more...
LDL cholesterol is generally linked to the buildup
of plaque in the arteries, which makes them more likely to become
narrowed, and can lead to heart attack or stroke. HDL cholesterol helps
clear LDL cholesterol from the blood in a process called reverse
cholesterol transport.
“These findings for ezetimibe are counter to the
prevailing understanding of LDL cholesterol - that lowering LDL
cholesterol results in slowing of the atherosclerotic process as has
been convincingly shown for other classes of lipid modifying drugs, such
as statins and bile acid resins,” said Allen J. Taylor, M.D. FAHA,
principal investigator of the study and director of Advanced
Cardiovascular Imaging and the Lipid/Prevention Clinic in the Department
of Medicine (Cardiology) at Washington Hospital Center in Washington,
D.C.
In earlier studies demonstrating the protective
effects of statins, researchers found strong associations between LDL
cholesterol reduction and the prevention of cardiovascular disease.
Consequently, many people now view LDL cholesterol reduction as a way to
measure whether a treatment will be useful.
But HALTS researchers’ findings “challenge the use
of LDL reduction as a guaranteed surrogate for clinical performance,
particularly for new clinical compounds, and in this particular case,
ezetimibe,” Taylor said.
Patients should know their HDL numbers and, if they
are low, ask their doctors if adding a treatment such as niacin is right
for them once their LDL is treated to goal with a statin drug, he said.
Co-authors of the study are: Todd C. Villines,
M.D.; Patrick J. Devine, M.D.; Mark Turco, M.D.; Len Griffen, M.D.;
Michael Miller, M.D.; Eric J Stanek, Pharm. D.; and Neil J Weissman,
M.D.
Study sponsor: Abbott Inc. (initially Kos
Pharmaceuticals, Inc., Cranbury, N.J.) provided an unrestricted,
investigator-initiated research grant administered by the Henry M.
Jackson Foundation for the Advancement of Military Medicine in
Rockville, Md. The investigators were solely responsible for all aspects
of the study and the final decisions on manuscript content.
Disclosures: Dr. Taylor reports receiving
lecture fees from Abbott. Dr. Turco reports receiving consulting and
lecture fees from Abbott Cardiovascular. Dr. Miller reports receiving
lecture fees and grant support from Merck-Schering Plough. Dr. Villines
reports receiving lecture fees from Novartis Pharmaceuticals. Dr. Devine
reports receiving consulting fees from Medacorp, MDLinx, and Guidpoint
Global, equity ownership in Evergreen solar, Openwave, Unifi, Novavax,
Genaera Pharm, and Generex Biotech. Dr. Stanek is senior director of
research in Personalized Medicine Research and Development at Medco
Health Solutions, Inc. (Franklin Lakes, N.J.), but all work performed on
this trial was independent of this relationship. No other potential
conflict of interest was reported.
About Niacin from MedlinePlus
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.
Nov.
16, 2009 - In combination with statins, adding a medication that raises
high-density lipoprotein (HDL) cholesterol was more effective in
reversing artery wall plaque buildup and in reducing heart disease risk
than adding a drug that lowers low-density lipoprotein (LDL)
cholesterol, researchers reported today at the American Heart
Association Scientific Sessions 2009.