A Natural Healthcare Company Pharmanex, Inc. Selected by Nature... Proven by Science.

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A Natural Healthcare Company Pharmanex, Pharmanex, Inc. Inc. lected by Nature... Proven by Science

Transcript of A Natural Healthcare Company Pharmanex, Inc. Selected by Nature... Proven by Science.

A Natural

Healthcare Company

Pharmanex, Inc.Pharmanex, Inc.

Selected by Nature... Proven by Science

Cholestin Cholestin

History as a food Manufacture Science behind Cholestin

China U.S.

Red Yeast Rice (Monascus Red Yeast Rice (Monascus purpureus Went)purpureus Went) Food supplement in China Spice for the preparation of fish, meat,

and bean curd Rice wine Traditional Chinese Medicine for blood

circulation and digestion Cholestin = Rice fermented with red

yeast

Red Yeast Rice Preparation Red Yeast Rice Preparation (circa 17th century)(circa 17th century)

History of CholestinHistory of Cholestin 20th Century

Introduced in the US 1970s

Link between cholesterol and heart disease Discovery of cholesterol lowering

properties by Japanese professor 1990s

Development by Chinese company as an alternative to costly drugs

Licensed by Pharmanex to market as dietary supplement

China: 17 clinical studies

Cholestin: Clinical Proof for Cholestin: Clinical Proof for Lowering CholesterolLowering Cholesterol

UCLA study Placebo, double-

blind design 83 patients

Average cholesterol decrease of 16%

U.S. multi-center study Open-label, wash-out

design 187 patients

Average cholesterol decrease of 15.5%

• Exclusive Red yeast rice -over 10 year research

• All natural fermentation

• Standardized

U.S.

0 (weeks) 8

• Age: 50 - 80 years• Total cholesterol: > 200 mg/dL• Triglycerides: 180 - 500 mg/dL

Inclusion Criteria:

Placebo (n=35)

Red yeast rice extract (n=35,1.2 g/day)

Randomized

Study presented at AHAStudy presented at AHA

Patients’ ProfilePatients’ ProfileTreatment group Placebo group

Number of patients 35 35

Sex 22 M, 13 F 22 M, 13 F

Age (years) 62.7 ± 4.2 63.5 ± 5.0

Age range (years) 55 - 79 50 - 74

Disease history (years) 1 - 23 1 - 20

Associated with coronary heart disease 5 7

Associated with hypertension 13 13

Associated with vascular diseases 3 3

American Heart Association, Orlando Florida, March 26, 1999

Red yeast rice extract

150

175

200

225

250

0 4 8 (weeks)

placebo

(mg

/dL

)

-17.4%p=0.002

-25.9%p=0.001

Changes in Total CholesterolChanges in Total Cholesterol

(mg

/dL

)

100

120

140

160

180

Red yeast rice extract

placebo

0 4 8 (weeks)

-17.6%p<0.001

-32.8%p<0.001

Changes in LDL CholesterolChanges in LDL Cholesterol

(mg

/dL

)

160

180

200

220

240

260

280

300

Red yeast rice extract

placebo

0 4 8 (weeks)

-23.0%p=0.05

-19.9%p=0.037

Changes in TriglyceridesChanges in Triglycerides

Placebo/diet

12 week treatment phase

Week 8 Week 9 Week 11 Week 12

Randomization

1 week

Treatment arm

Placebo arm

Combined analysis Combined analysis

UCLA Cholestin study in UCLA Cholestin study in patients with Elevated patients with Elevated cholesterolcholesterol

Treatment group Placebo group

Pre Post Pre Post

Total cholesterol 250±30 210±31* 255±29 250±36

Triglycerides 133±48 124±44* 143±46 146±47

LDL cholesterol 173±27 134±27* 180±30 175±33

HDL cholesterol 50±13 50±14 46±10 46±11

*, p<0.05, compared to baseline.Values are means ± S.D., mg/dL

UCLA Study: Data SummaryUCLA Study: Data Summary

n Pre-treatment post 12-week treatment

ALT (IU/L) 42 22 ± 9 20 ± 8

AST (IU/L) 42 24 ± 5 23 ± 6

BUN (mg/dL) 42 16 ± 4 15 ± 4

-GTP (IU/L) 42 27 ±18 23 ±19

LDH (IU/L) 42 155 ±25 152 ±23

UCLA Study: Liver and UCLA Study: Liver and Kidney functionsKidney functions

0 4 12 14

* American Heart Association Step 1 diet alone

• Total cholesterol: 200 - 240 mg/dL• LDL-cholesterol: 135 - 190

mg/dL

Subjects:

weeks

Cholestin (2.4 g/day) Diet*Diet*

Multi-center Study Presented Multi-center Study Presented at AHAat AHA

100

120

140

160

180

200

220

240

(mg/

dL)

TotalCholesterol

LDLCholesterol

-21.7%

-19.5%

-15.5%

-13.6%

Diet + Cholestin Diet Diet0 4 8 12 14 (weeks)

Cholesterol dataCholesterol data

140

160

180

200

220

240

260

280

0 4 8 12 14 (weeks)Diet + Cholestin Diet

(mg/

dL)

All patients

Patients withbaseline TG >200 mg/dL-21.9%

-15.7%

-4.1%-3.8%

Diet

Triglyceride dataTriglyceride data

Patientswith baseline HDL Male <40 mg/dLFemale <45 mg/dL

All patients

30

35

40

45

50

55

0 4 8 12 14 (weeks)

Diet + Cholestin Diet Diet

(mg/

dL)

+13.6%p<0.01+8.3%

p<0.01

HDL dataHDL data

Multi-center study: SummaryMulti-center study: Summary

Total cholesterol decreased by 15.5% LDL-cholesterol decreased by 21.7% HDL-cholesterol increased by 13.6% * Triglycerides decreased by 21.9% *** Males with baseline HDL-c 40 mg/dL or

females with 45 mg/dL

** Patients with baseline triglycerides >200 mg/dL

How does Cholestin work?How does Cholestin work?

Fatty foods

Acetyl-CoA

HMG-CoA

Cholesterol

Other body fatsHMG-CoA reductase

enzyme Cholestin

ConclusionConclusion

Cholestin is a natural dietary supplement

Safe and highly effective in maintaining normal blood lipids

Effective if taken regularly