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