Statement
Abbott Statement on ARBITER 6 - HALTS Results and Abbott's Niaspan (niacin extended-release)
Study results released today by the American Heart Association and the New
England Journal of Medicine
November 15, 2009
Orlando, Florida — Results from the investigator-initiated ARBITER 6 - HALTS
study showed patients at high cardiovascular risk had significant regression of
atherosclerosis after 8 and 14 months of therapy with Abbott's Niaspan® (niacin
extended-release tablets) plus a statin, the study's primary endpoint. In a
pre-specified secondary endpoint of the study, treatment with Niaspan plus
statin also resulted in significantly fewer major adverse cardiac events, (or
MACE, a composite endpoint consisting of heart attack, myocardial
revascularization, admission to the hospital for an acute coronary syndrome,
and death from coronary heart disease), as compared to ezetimibe plus a
statin.
The study was stopped early after a pre-specified interim analysis was
conducted on 208 patients who had completed treatment and had undergone final
ultrasound imaging of the carotid artery to measure the impact of treatment on
atherosclerosis. Atherosclerosis is fat build-up in the arteries and in the
early stages it can be found inside the lining of the arteries, known as intima
media thickness (IMT). HALTS measured IMT in the carotid artery.
"The ARBITER 6 - HALTS study is the first study showing that HDL-raising
with Abbott's Niaspan on top of statin regresses atherosclerosis compared to an
LDL-lowering strategy," said Eugene Sun, M.D, vice president, Global
Pharmaceutical Development, Abbott. "These data reinforce the importance of
looking beyond LDL treatment targets to address other lipid
parameters."
Niaspan is not indicated to promote regression of atherosclerosis in
combination with a statin. In patients taking Niaspan, the most commonly
reported adverse event was flushing of the skin, a transient effect associated
with niacin therapy. Adverse drug effects were cited as the reason for
withdrawal in three ezetimibe patients and 17 niacin patients. The difference
between treatment groups was not statistically significant.
ARBITER 6 - HALTS
The ARBITER 6 - HALTS study explored treatment approaches in patients at
high cardiovascular risk already taking statins to control bad LDL cholesterol.
The primary endpoint of the study compared the effect on atherosclerosis of
raising good HDL cholesterol with the addition of Abbott's Niaspan to a statin
versus LDL-lowering with the addition of ezetimibe. There were four secondary
endpoints: change in lipid values; a composite endpoint consisting of MACE;
drug discontinuation due to adverse effects; and health-related quality of
life. ARBITER 6 - HALTS, led by Allen Taylor, M.D., of Washington Hospital
Center, was conducted and analyzed independent of Abbott. Abbott provided
funding and medication to support the study.
ARBITER 6 - HALTS Study Design and Patient
Population
ARBITER 6 - HALTS is a prospective, randomized, parallel group, open-label,
blinded endpoint study, which means the treatment was not blinded to patients
or the investigators, but the analyses of scans were blinded. The study
included 362 patients with coronary heart disease or risk equivalents, LDL less
than 100 mg/dL and HDL less than 50 for men or 55 mg/dL for women receiving
chronic statin therapy. Baseline mean HDL in the study was 43 mg/dL and mean
LDL was 82 mg/dL. At the time of the pre-specified interim analysis, the 208
patients who completed treatment and final imaging were included in the
analysis.
NIASPAN Indications
NIASPAN is a prescription medication, used along with diet and exercise, to
improve cholesterol levels. NIASPAN raises HDL ("good") cholesterol and
lowers LDL ("bad") cholesterol and triglycerides. Niacin is also used
to reduce the risk of recurrent heart attacks in patients with high
cholesterol. In patients with coronary artery disease and high cholesterol,
niacin, in combination with a bile acid binding resin, has been shown to slow
down or reduce atherosclerosis, the hardening of coronary arteries due to
plaque build-up. NIASPAN has not been shown to prevent the development of heart
disease.
Important Safety Information About NIASPAN
NIASPAN is contraindicated in patients with liver problems, stomach ulcers,
or serious bleeding problems; and those allergic to any product ingredient.
NIASPAN is the only prescription extended-release form of niacin. Liver damage
has been reported when NIASPAN has been substituted for equivalent doses of
immediate-release niacin.
Patients should check with their healthcare provider before changing their
medication. NIASPAN should be used with caution in patients who consume large
amounts of alcohol. Blood tests may be performed before and during treatment
with NIASPAN to check for liver problems. Patients treated with NIASPAN in
combination with a statin should be monitored for any unusual muscle pain,
tenderness, or weakness, as this could be a sign of a rare but serious side
effect. Diabetic patients should be observed closely as NIASPAN may cause a
dose-related increase in blood sugar levels. Flushing (warmth, redness,
itching, and/or tingling of the skin) is the most common side effect. This
sensation usually occurs when starting NIASPAN or during dose increases and may
become less frequent over time. In most patients, flushing is mild to moderate.
Some people may experience more severe and intense flushing. Additional
symptoms may include rapid or pronounced heartbeat, shortness of breath,
swelling, sweating, chills, dizziness, and in rare cases, fainting. NIASPAN
should be used with caution in patients with a history of gout or kidney
problems. Some medicines should not be taken with NIASPAN. Patients should tell
their healthcare provider about all the medicines they take. Other common side
effects with NIASPAN may include headache, pain, diarrhea, indigestion, nausea,
vomiting, itching, and rash.
For full prescribing information, please visit
http://www.rxabbott.com/pdf/niaspan.pdf or www.niaspan.com.
About Abbott
Abbott (NYSE: ABT)
is a global, broad-based health care company devoted to the discovery,
development, manufacture and marketing of pharmaceuticals and medical products,
including nutritionals, devices and diagnostics. The company employs more than
72,000 people and markets its products in more than 130 countries.
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