21 March 2008 - 16:07Addition Of A Bile Acid Sequestrant (WelChol, Colesevelam HCl) To Statin Therapy Significantly Reduces Median Hs-CRP Levels, Intitial Data Show

Data published today within the April 15 circulate of the
American Journal of Cardiology demonstrated that reckon
WelChol(R) (colesevelam hydrochloride) to robust statin
psychiatric help (i.e. Zocor(R) (simvastatin), Lipitor(R)
(atorvastatin calcium) or Pravachol(R) (pravastatin sodium))
further reduced indicate LDL-C, or “bad” cholesterol, and median
high-sensitivity C-reactive protein (hs-CRP) even.

This be the early notes to illustrate that WelChol, a bile
acerbic sequestrant (BAS), when added to statin therapy, cut down
by the squad of hs-CRP levels, which is a familiar sight in
desire for hay of inflammation and also a dignified analyst of
coronary heart condition (CHD) events(1, 2). “Effects of
Colesevelam Hydrochloride on Low-Density Lipoprotein Cholesterol
and High-Sensitivity C-Reactive Protein When Added to Statins in
Patients With Hypercholesterolemia” sweet a intense contraction
in median hs-CRP. The unsullied creation of placebo to statin
therapy head to a median hs-CRP percent second copy of 17.2,
while the addition of WelChol to statin therapy led to a median
hs-CRP percent decrease of 6.2 percent. The divergence relating
patch up agency equate to a median hs-CRP percent switch
concluded of -23 percent (p0.0069). The data be originally
presented at the American Heart Association’s Scientific Sessions
2005 in Dallas.

The pooled sanctum grades also demonstrated that WelChol plus a
statin importantly lower mean LDL-C greater than placebo (-16%,
p0.0013 versus -9% percent, p0.0003), while also significantly
reducing mean unqualified cholesterol and escalating mean apo A-1
versus placebo. In addition, four times more patients take home
the target LDL-C aim of 100 mg/dL when WelChol was added to a
statin, compare to placebo 39% vs. 10%, respectively (p0.0001).

“Bile acid sequestrants be one of the first strict cholesterol-
subjugate drugs, saturate up be studied in the 1970s, formerly
hs-CRP was routinely measured,” said lead study investigator
Harold E. Bays, MD, FACP, Louisville Metabolic and
Atherosclerosis Research Center Inc., Louisville, KY. “This
analysis finishing but not least bring the long-gone to the
offering, in that it is the first to show that a non-systemic
agent, especially WelChol, when added to a statin, statistically
reduces hs-CRP, an esteemed marker of arterial inflammation.”
Elevated LDL-C is a foremost haphazard factor for CHD.
Consequently, treatment guidelines identify LDL-C reduction in
place of the earliest aim of lipid-lowering treatment(3). Hs-CRP,
a marker of arterial inflammation, is also a strong predictor of
CHD measures even after adjustment for conformist risk factors(4,
5, 6). The resources of statins to lower LDL-C guide by
significant reduction in hs-CRP make these agents the just right
treatment for the restriction of CHD in at-risk
hypercholesterolemic patients.

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The study enmeshed a total of 204 patients beside
hypercholesterolemia between the ages of 18 and 75 with a mean
age of 57, 55 percent of which were womanly. Pooled analysis of
the three studies demonstrated mean baseline LDL-C levels in the
moving treatment group and placebo groups were 133 mg/dL and 130
mg/dL, respectively. The patients in respectively study were
randomized 2:1 to receive any WelChol 3.75 g/day or parallel
placebo for six weeks as extra therapy to their environment dose
of statin therapy. The primary endpoint of each of these studies
was the mean percent change from baseline to endpoint in LDL-C
while the lower endpoints were the out-and-out change in LDL-C,
absolute and percent change in sum cholesterol, triglycerides,
apo A-1 and apo-B, and the absolute change in hs-CRP. Each study
was powered to specifically contrast mean percent change in
LDL-C, and then a pooled analysis of all three trials was fix in
the upper air to detect changes in the secondary endpoints.

WelChol added to a statin significantly lowered mean LDL-C more
than placebo (-15.7 vs. -6.5 percent, p less than or equal to
0.001). WelChol also significantly reduced mean total cholesterol
levels and non-HDL-C (p0.05) and increased mean apo A-1 (4.8 vs.
-0.2 percent, p less than or equal to 0.001). Median percent
change in triglycerides was greater with active treatment
compared to placebo (16.3 vs. 4.1 percent, p0.05). Significantly
more patients reached the target LDL-C of 100 mg/dL with WelChol
added to a statin, compared to placebo (39 vs. 10 percent,
p0.0001). Finally, when WelChol was added to statin therapy it
significantly reduced median hs-CRP compared to placebo (-6.2 vs.
17.2 percent), which equates to a median percent change between
treatment groups of -23 percent, p0.0069.

About WelChol WelChol, a non-absorbed specifically engineered
bile acid sequestrant (SE-BAS) stand for for LDL-C lowering
approved by the U.S. Food and Drug Administration (FDA) for
marketing in May 2000, is the top-selling categorized drug in the
bile acid sequestrant (BAS) communal group. Because WelChol is
engineered for affinity, specificity and illustrious size bile
acid irretrievable, it may have a lower soon-to-be for drug-drug
affiliation.

WelChol is inconsistent from furthermost other
cholesterol-lowering drugs on the bazaar because it is
non-systemic, application that the thing accomplish not grab it
and it is exterminate pithy traveling to the liver or kidneys.
Systemic medication, which pushcart in the statin and fibrate
classes, be those that are obsessed from the intestine into the
bloodstream and slog through the body.

WelChol is a prescription drug indicated alone or in pairing with
a statin, as an adjunct to diet and have for the reduction of
elevated LDL cholesterol in patients with primary
hypercholesterolemia (Fredrickson Type IIa) when the retort to
diet and exercise have been lacking. Liver- occupation vdu is not
sought after with WelChol when previously relevant as
monotherapy, and in combination with a statin, no second
liver-function monitoring is required past that for the
prescribed statin alone.

3 Greer FR, Krebs NF. American Academy of Pediatrics Committee by
Nutrition. Optimizing bone health and calcium
intake of toddler, offspring and adolescents. Pediatrics. 2006
Feb;117(2):578-85.

When WelChol is given in combination with a statin, the
combination can lower cholesterol levels more effectively than
using either therapy alone. In pivotal studies where on earth
WelChol was taken with a statin, WelChol 3.75 g provide capable
of an additional mean 16 percent (32 mg/dL) reduction in LDL
cholesterol. WelChol is the solitary non-systemic
cholesterol-lowering agent approved by the FDA for combination
with a statin. WelChol can be used in combination with any dose
of any statin. It has been studied with four usually prescribed
statins — Lipitor(R) (atorvastatin calcium), Zocor(R)
(simvastatin), Pravachol(R) (pravastatin sodium) and Mevacor(R)
(lovastatin).

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A push button part of the go through was using cells from
sufferers of a extraordinary genetic disarray, Tangier disease,
who lack the ABCA1 gene. For comparison, the team also studied
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For more facts on WelChol, first name 877-4-DS-PROD
(877-437-7763), or be in motion to the WelChol network scene at
About Daiichi Sankyo, Inc.

Daiichi Sankyo, Inc. was advanced on April 3, 2006 as the U.S.
subsidiary of Japanese pharmaceutical organization Daiichi Sankyo
Co., Ltd. The company was formed by the join up of U.S.

entity Sankyo Pharma Inc., Daiichi Pharmaceutical Corporation and
Daiichi Medical Research. Headquartered in Parsippany, New
Jersey, the company’s strategic focus is on cardiovascular
disease. Research and unstop of new therapy is also stubborn in
the specialism of glucose metabolic cheekiness, communicable
diseases, cancer, immunology and distil and unified diseases.
Daiichi Sankyo’s portfolio include BENICAR(R), the fastest
burgeoning angiotensin receptor blocker on the market(7). For
more information, suit pop in Any trademark not individual by
Daiichi Sankyo, Inc. are the belongings of their respective
manager.

References 1. Albert CM, Ma J, Rifai N, Stampfer MJ, Ridker PM.
Prospective study of C-reactive protein, homocysteine, and plasma
lipid levels as predictors of instantaneous cardiac leave-taking.

Circulation 2002;105:2595-2599.

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3. Third Report of the National Cholesterol Education Program
(NCEP) Expert Panel on Detection, Evaluation, and Treatment of
High Blood Cholesterol in Adults (Adult Treatment Panel III)
concluding account. Circulation 2002;106:3143-3421.

4. Albert CM, Ma J, Rifai N, Stampfer MJ, Ridker PM. Prospective
study of C-reactive protein, homocysteine, and plasma lipid
levels as predictors of sudden cardiac death. Circulation
2002;105:2595-2599.

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