Health Canada Approves Natural Supplement for Management of Cholesterol

MONTREAL, Nov. 6 /CNW Telbec/ - Cholestol(TM) with HEP-40(TM), a
scientifically studied and clinically proven natural supplement that reduces
'bad' cholesterol, is now available across Canada. Marketed by Santé Naturelle
A.G. Ltd., Cholestol has been approved by Health Canada as a natural health
product to help in the management of cholesterol. Cholestol will be available
in retail pharmacies across Canada in November 2007.

A Canadian study recently published in the peer-reviewed journal,
Alternative Medicine Review, examined the effect of Cholestol on reducing bad
cholesterol (LDL-C) levels in patients who were healthy but had
mild-to-moderately increased levels of LDL-C. Study results showed that
Cholestol significantly decreased bad cholesterol by 17 per cent in four

"Diet and exercise alone may not be enough to help patients achieve
cholesterol targets" comments Dr. Shahin Jaffer, Internal Medicine, Delta,
B.C., study investigator and co-author. "The results of this study showed that
Cholestol plus diet and lifestyle changes, was effective in reducing
cholesterol levels in patients with low-to-moderate risk for heart disease."

In the 16 week clinical trial, patients with mild-to-moderately increased
levels of LDL-C (less than (less than) 4.0 mmol/L), who had not been treated
with cholesterol lowering medications, were enrolled from 15 cross Canada
healthcare sites. The goal of the study was to compare the efficaciousness of
different doses of Cholestol versus placebo in reducing cholesterol levels
after four weeks of treatment. The study also looked at the most effective
dose of Cholestol on overall changes to total cholesterol levels as well as
safety and tolerability.(1)

Results showed that Cholestol, 2,400 mg/day (three capsules taken before
the evening meal) produced the greatest reduction in LDL-C (17 per cent)
versus placebo. The study also demonstrated a reduction in total cholesterol
with Cholestol, 2,400 mg/day at four weeks (12.3 per cent versus placebo).(1)

Side effects of treatment were low for patients in both the treatment and
placebo arms of the study. Most commonly reported side effects were
constipation (three per cent) and diarrhea (three per cent).(1)

"We need to consider additional and better tolerated options to manage
cholesterol," says Audrey Couture, Scientific and Regulatory Affairs Manager,
Santé Naturelle A.G. Ltd. "Approaches that include scientifically proven
natural health products in addition to lifestyle changes, can help patients
achieve their targets," she adds.

Heart disease continues to be a leading cause of disability and death in
Canada and other western countries. For patients over 40, heart disease
affects approximately one in two men and one in three women.(2)(3)

In both Canada and the USA, clinical guidelines recommend treatment with
statin therapy to lower LDL-C levels for those patents at moderate-to-high
risk for heart disease.(2)(3) Based on newly published clinical evidence,
Cholestol, in conjunction with lifestyle modification, may provide an option
for patients with low cardiovascular risk profile who may not qualify for drug
therapy or who are seeking non-drug alternatives.

About Cholestol(TM) with HEP-40(TM)

Cholestol with HEP-40 (Enzymatic Polychitosamine Hydrolysate) is sourced
from chitosan, a natural compound found in the exoskeleton of crustaceans.
Discovered at the University of Sherbrooke, Québec, in the 1990's, and
commercially developed by Diversified Natural Products, Inc., Cholestol
affects serum lipid concentrations by binding to acid bile, dietary fats and
cholesterol in the gastrointestinal tract, reducing their absorption.
Cholestol with HEP-40 is a second generation of Cholestol with HEP-30, and has
demonstrated scientific and clinical effectiveness in reducing serum LDL-C

Studies conducted on healthy volunteers have shown that Cholestol is
safe, well-tolerated, has no known drug interactions and reduces total
cholesterol (TC) and LDL-C. Additional clinical trials are underway to
investigate the role of Cholestol in combination with statins and other lipid
lowering agents in patients who have significantly increased cholesterol and
are high risk for heart disease.

About Santé Naturelle A.G. Ltd.

Santé Naturelle A.G. Ltd. is one of Quebec's oldest natural health
companies. Started by the Canadian pioneer and visionary naturopath,
Adrien Gagnon, ND, the company has become a leader in science-based, high
quality, effective natural health products and is now the fourth largest
natural health company in Canada. For over 60 years, Santé Naturelle A.G. Ltd.
has committed itself to providing consumers with trusted, natural and
effective health solutions to manage their health and wellness needs. With
more than 150 products, Santé Naturelle A.G. Ltd. continues to be a leader in
selection, value, and brand recognition for natural source vitamins, minerals
and herbal supplements.


(1) Jaffer S, Sampalis JS. Efficacy and Safety of Chitosan HEP-40(TM) in
the Management of Hypercholesterolemia: A Randomized, Multicenter,
Placebo-controlled Trial. Altern Med Rev 2007; 12(3):265-273.

(2) Expert Panel on Detection, Evaluation, and Treatment of High Blood
Cholesterol in Adults. Executive summary of the 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). JAMA 2001;285:2486-2497.

(3) McPherson R, Frohlich J, Fodor G, Genest J. Canadian Cardiovascular
Society position statement -Recommendations for the diagnosis and
treatment of dyslipidemia and prevention of cardiovascular disease.
Can J Cardiol 2006;22(11):913-927.

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