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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
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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 PromotesComplete Blood Lipid Balancealready 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.
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 Exclusivitygranted 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 • PromotesComplete Blood Lipid Balancealready 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.