New Cholestin, Overview
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Transcript of New Cholestin, Overview
![Page 1: New Cholestin, Overview](https://reader035.fdocuments.in/reader035/viewer/2022080916/56812a43550346895d8d69db/html5/thumbnails/1.jpg)
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.
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Overview of Health Benefits
Promotes Complete Blood Lipid Balance already within the normal range*
– 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.
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Cholestin Composition
Primary Active Constituent:• 15 mg policosanol from PolicorTM extract
• Policor is:– 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
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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
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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!
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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.
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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
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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
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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
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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
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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.