Abbott Receives FDA Approval for SIMCOR(R) (Niaspan(R) / simvastatin), a Novel Combination Medicine for Comprehensive Cholestero
15 Février 2008 - 10:55PM
PR Newswire (US)
SIMCOR Is a New Single-Pill Combination of Two Proven Therapies
that Significantly Raises HDL "Good" Cholesterol and Lowers LDL
"Bad" Cholesterol ABBOTT PARK, Ill., Feb. 15 /PRNewswire-FirstCall/
-- Today, Abbott received U.S. Food and Drug Administration (FDA)
approval for SIMCOR(R), the first fixed-dose combination of two
widely prescribed cholesterol therapies, Niaspan(R) (Abbott's
proprietary niacin extended-release) and simvastatin. SIMCOR is
approved for use along with diet to lower levels of elevated total
cholesterol, LDL "bad" cholesterol and triglycerides, and to raise
HDL "good" cholesterol in patients with complex lipid disease when
treatment with simvastatin or Niaspan monotherapies are not
considered adequate. "Managing cholesterol encompasses many
factors, not just lowering LDL. There is a clear need for medicines
that both raise good and comprehensively lower the bad components
of cholesterol," said Christie Ballantyne, M.D., the Methodist
DeBakey Heart and Vascular Center, Houston, and lead SIMCOR
investigator. "SIMCOR represents an important new option to help
patients reach healthy lipid levels." An estimated 80 million
Americans have high levels of the bad LDL cholesterol, and more
than 44 million have low levels of the good HDL cholesterol, which
the body uses to remove bad cholesterol from the bloodstream.
Studies have shown that along with diet, SIMCOR can help patients
with lipid disorders reach their treatment goals by addressing more
than just bad cholesterol, targeting multiple lipids with one pill.
The FDA's approval was based on SIMCOR safety and efficacy trial
data from more than 640 patients with mixed dyslipidemia and type
II hyperlipidemia. In the SEACOAST clinical trial, patients
receiving SIMCOR 1000/20mg achieved significant cholesterol
improvements over and above what simvastatin 20mg alone provided.
Patients treated with SIMCOR 1000/20mg had additional lipid
improvements beyond simvastatin 20-mg treated baseline, with
additional LDL reductions of 12 percent and an additional 21
percent HDL increase compared to a 7 percent decrease in LDL and an
8 percent increase in HDL with simvastatin 20mg alone. Furthermore,
SIMCOR reduced triglycerides by an additional 27 percent compared
to 15 percent with simvastatin 20mg alone. SIMCOR was generally
well tolerated by patients in clinical studies. Six percent of
patients discontinued therapy due to flushing, the most commonly
reported side effect of SIMCOR and niacin-based therapies. Flushing
can be minimized by taking aspirin or an NSAID 30 minutes prior to
taking the medication at bedtime. Flushing may subside over several
weeks of consistent SIMCOR use. "With SIMCOR, doctors now have a
new option for helping patients reach their LDL and HDL cholesterol
treatment goals with a combination of two proven therapies," said
Eugene Sun, M.D., vice president of Global Clinical Development for
Abbott. "Abbott is committed to bringing forward new cholesterol
therapies, and SIMCOR represents a new treatment option for
patients in Abbott's rapidly expanding portfolio of cholesterol
treatments for lipid disorders." The American Heart Association,
National Cholesterol Education Program (NCEP) and American College
of Cardiology recommend more aggressive treatment of HDL to reduce
cardiovascular risk. Cholesterol and other lipids can build up in
the bloodstream forming plaque and restricting blood flow, which
can lead to heart disease. According to NCEP guidelines, a
reduction in LDL of 1 percent is associated with a 1 percent
reduction in heart disease risk. Additionally, raising HDL by 1
point is associated with a 2 percent heart disease risk reduction.
Abbott is committed to the continued research of its products and
has sponsored the National Heart Lung and Blood Institute's
AIM-HIGH outcomes study. The study is designed to evaluate the
effects of niacin extended- release and simvastatin in reducing
cardiovascular events in patients with existing heart disease.
AIM-HIGH began enrolling patients in 2005 with final results
expected to be reported in 2011. SIMCOR Indications SIMCOR is the
combination of two cholesterol-lowering medications: niacin
extended-release (Niaspan(R)) and simvastatin. SIMCOR is used along
with diet to lower levels of total cholesterol, LDL "bad"
cholesterol and triglycerides, and to increase HDL "good"
cholesterol. SIMCOR is used when treatment with simvastatin
monotherapy or niacin extended-release monotherapy is considered
inadequate, and when diet and other non-drug measures alone have
not been successful. Patients should stay on a diet low in
saturated fat and cholesterol while taking this medicine. No
additional benefit of SIMCOR on heart disease over and above that
shown for niacin alone and simvastatin alone has been demonstrated.
Important Safety Information About SIMCOR SIMCOR should not be used
by people with liver problems, stomach ulcers, or serious bleeding
problems; in women who are pregnant, may become pregnant, or
nursing; and in people allergic to any product ingredient. Patients
should contact their health care provider if symptoms of
unexplained muscle pain, tenderness, or weakness occur, as this may
be a sign of a serious but rare muscle disorder, from which rare
cases of death have occurred. Health care provider should be
informed about any other medications, vitamins, or nutritional
supplements people are taking to avoid possible serious drug
interactions. SIMCOR should not be substituted for equivalent doses
of immediate-release niacin. Liver damage has been reported when
substituting sustained-release niacin products with
immediate-release niacin at equivalent doses. Always check with a
health care provider before changing medication. SIMCOR should be
used with caution by patients who consume large amounts of alcohol.
Health care providers may do simple blood tests before and during
treatment with SIMCOR to check for liver problems. SIMCOR may cause
an increase in blood sugar levels. Patients with diabetes should
report any changes in blood sugar levels to their health care
provider. Women of childbearing age should use an effective method
of birth control to prevent pregnancy while using SIMCOR. Flushing
(warmth, redness, itching, and/or tingling of the skin) is the most
common side effect and may become less frequent over time.
Additional symptoms may include rapid or pronounced heartbeat,
shortness of breath, sweating, chills, dizziness, fainting, and/or
swelling. Flushing may vary in severity and is more likely to occur
when starting therapy or during dose increases. By taking SIMCOR at
bedtime, flushing will most likely occur during sleep. If awakened
by flushing, patients should take their time getting up, especially
if feeling dizzy, faint, or taking blood pressure medications.
Other common side effects may include headache, itching, nausea,
back pain, and diarrhea. More information about SIMCOR, including
full prescribing information, is available on the Web site
http://www.rxabbott.com/pdf/simcor_pi.pdf, or by calling Abbott
Medical Information at 1-800-633-9110. About Niaspan Available
since 1997, Niaspan is the only FDA-approved, once-daily
extended-release prescription formulation of niacin for treating
abnormal cholesterol levels. Niaspan Indications Niaspan is
indicated as an adjunct to diet when the response to a diet
restricted in saturated fat and cholesterol and other
nonpharmacologic measures alone has been inadequate, to reduce
elevated total cholesterol, LDL- C, Apo B, and triglyceride levels,
and to increase HDL-C in patients with primary hypercholesterolemia
and mixed dyslipidemia. In patients with a history of myocardial
infarction and hypercholesterolemia, niacin is indicated to reduce
the risk of recurrent non-fatal myocardial infarction. In patients
with coronary artery disease and hypercholesterolemia, niacin, in
combination with a bile acid binding resin, is indicated to slow
progression or promote regression of atherosclerotic disease.
Important Safety Information About Niaspan Niaspan is
contraindicated in patients with allergies to any of its
ingredients, active peptic ulcer disease, significant or
unexplained persistent liver dysfunction, or arterial bleeding.
Niaspan should not be substituted for equivalent doses of
immediate-release niacin. Niaspan should be prescribed with caution
in patients who consume substantial amounts of alcohol and/or have
a past history of liver disease. Liver function tests should be
performed on all patients during therapy with Niaspan. Use of
Niaspan with other lipid-altering medications called statins may
increase the risk of rhabdomyolysis, a rare condition that causes
muscles to breakdown. The most common side effect with Niaspan is
flushing of the skin. Patients with diabetes should carefully
monitor their blood sugar and report changes to their doctor. Other
commonly reported side effects include indigestion, headache, pain,
abdominal pain, nausea, itching, diarrhea, runny nose, vomiting and
rash. More information about Niaspan, including full prescribing
information, is available on the Web sites
http://www.rxabbott.com/pdf/niaspan.pdf and
http://www.niaspan.com/, or by calling Abbott Medical Information
at 1-800-633-9110. Important Safety Information About Simvastatin
Simvastatin is a prescription tablet and isn't right for everyone,
including women who are nursing or pregnant or who may become
pregnant, and anyone with liver problems. Unexplained muscle pain
or weakness could be a sign of rhabdomyolysis, a rare but serious
side effect and should be reported to a doctor right away.
Simvastatin may interact with certain foods or other medicines
including lipid-lowering medications called fibrates or niacin,
increasing the risk of getting this serious side effect. Patients
should tell their doctor about any other medications they are
taking. The most common side effects are headache, abdominal pain,
and constipation. About Abbott Abbott 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 65,000 people and markets its products in more than 130
countries. Abbott's news releases and other information are
available on the company's Web site at http://www.abbott.com/.
DATASOURCE: Abbott CONTACT: Media, DeAnna DuBose, +1-847-938-9002,
or Elizabeth Hoff, +1-847-935-4236, or Financial, Lawrence Peepo,
+1-847-935-6722, all for Abbott Web site: http://www.abbott.com/
http://www.niaspan.com/
Copyright