New Cholestin, Overview
New & Improved Cholestin:
• Red yeast rice-free formula
• Equally safe and effective as RYR*
• Contains novel ingredient extracted from
beeswax: Policor™ extract with Policosanol
• Better tolerated - no liver function testing,
muscle weakness issues
• Much more convenient - once a day!
* These statements have not been evaluated the Food and Drug Administration. This
product is not intended to diagnose, treat, cure, or prevent any disease.
Overview of Health Benefits
Promotes Complete Blood Lipid Balance
already within the normal range*
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–
–
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Total & LDL-Cholesterol
HDL-Cholesterol
LDL/HDL Ratio
Triglycerides
Promotes normal blood fluidity (platelet aggregation)*
Helps protect LDL from oxidation by free radicals*
* These statements have not been evaluated the Food and Drug Administration. This
product is not intended to diagnose, treat, cure, or prevent any disease.
Cholestin Composition
Primary Active Constituent:
• 15 mg policosanol from PolicorTM extract
• Policor is:
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Novel ingredient, “Cholesterol Breakthrough”
Extracted from white NF-grade beeswax (GRAS)
Patent pending (use, composition and process)
Global Exclusivity granted to Pharmanex for network
markets
Policosanol’s History
• Originally developed in Cuba as a
natural, cholesterol-lowering agent
– Early 90’s: initially identified
beeswax policosanol as the preferred
source material
– Mid 90’s: Cuban government
‘suggested’ sugarcane policosanol as
a more economical source
– Sugarcane policosanol clinically
tested and commercialized in Cuba
Policosanol’s History
• Inventor, Pedro P. Perez, revived
R&D based on a beeswax source
• worked with a top-quality
extraction company, Hauser
• Pharmanex has Network
Marketing exclusive!
Beeswax Policosanol
Pharmanex Double-Blind Clinical Study
• Double-blind, placebo-controlled clinical study of new
Cholestin (15 mg policosanol) in 90 hypercholesterolemic
subjects.
• Main outcome: Changes in blood lipid profile at 6 & 12 weeks.
• Rippe Lifestyle Institute, Tufts University, Boston, MA.
• Started June 2001; To be finished in 1Q 2002.
Two further double-blind, placebo-controlled clinical studies
testing 10 mg beeswax policosanol planned in 2002.
Summary, Clinical Data
10-20 mg/day policosanol
• Lowers LDL-C by 20-30 %
• Lowers TC by 16-23 %
• Increases HDL-C by 21%
• Lowers TG by 12 % (if TG > 200 mg/dl)
• 8-12 weeks, maximum after 12 months
• Excellent safety & side effect profile
Policosanol Safety
Beeswax policosanol has excellent safety data:
• Clinical data: very few side effects
• post marketing study, only 86 of 27,879 patients
(0.3%) reported minor side effects
• Beeswax policosanol has LD50 > 5 g/kg, with no
adverse effects
• No carcinogenic, mutagenic or teratogenic effects
• Made from purified, white NF-grade beeswax,
GRAS (FDA) for food & drug use
Drug Interactions
• No clinical reports of drug interactions
• However,
– policosanol lowers platelet aggregation
– w/o affecting clotting time
• Conservative precautions:
– high-dose aspirin therapy
– anticoagulants (warfarin, coumadin, etc.)
– within 2 weeks of surgery
PoliSorb™ Proprietary Delivery
• Policosanol delivery can be problematic:
– tablets & capsules: poor dissolution (USP XXIV)
– policosanol, a fat-soluble, waxy substance
– remains solid at body temperature
• Pharmanex PoliSorb™ proprietary delivery:
– overcomes policosanol’s solubility problems
– emulsification with lecithin phospholipids
• natural cell membrane components
– PoliSorb softgels have over 10x better dissolution
than policosanol capsules or tablets
Cholestin, Summary
• Promotes Complete Blood Lipid Balance
already within the normal range*
–
–
–
–
•
•
•
•
Total & LDL-Cholesterol
HDL-Cholesterol
LDL/HDL Ratio
Triglycerides
15 mg policosanol from Policor™ extract
Safe & well tolerated
Proprietary PoliSorb™ softgel delivery
Convenient once-a-day dosage
* These statements have not been evaluated the Food and Drug Administration. This
product is not intended to diagnose, treat, cure, or prevent any disease.