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Abbott Receives FDA Approval For SIMCOR(R) (Niaspan(R) / Simvastatin), A Novel Combination Medicine For Comprehensive Cholesterol Management
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.
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.
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.
Abbott
http://www.abbott.com
View drug information on Niaspan.
Abbott a primit aprobare pentru SIMCOR FDA (R) (Niaspan (R) / Simvastatina), un roman Combinaþia de Medicina Pentru Complet de gestionare Colesterol - Abbott Receives FDA Approval For SIMCOR(R) (Niaspan(R) / Simvastatin), A Novel Combination Medicine For Comprehensive Cholesterol Management - articole medicale engleza - startsanatate