Inositol Hexanicotinate

1.http://www.sajpc.org/vol6/vol6_1_2/whocardiological.htm 2.Background Papers—Burden of Disease in India (New Delhi, India), September 2005 3.Clinical Implications: Dyslipidemia in Asian Indians. Chicago:

American Association of Physicians of Indian Origin (AAPI); 2002:1-10. 4.Altschul R, Hoffer A, Stephen JD: Influence of nicotinic acid on serum cholesterol in man. Arch Bioch Biophys 1955, 54: 558-559. 5.Inositol Hexanicotinate Monograph. Alt Med Rev. 1998;3(3):222-223 6.Head, KA. Inositol Hexanicotinate: A Safer Alternative to Niacin. Alt Med Rev. 1996;1(3):176-184.

Total Cholesterol

Lipids

HDL

Lp(a)

Apolipoprotein

Triglycerides

Moving Beyond LDL

Inositol Hexanicotinate

IHN lowers LDL and triglyceride levels by decreasing VLDL synthesis in the liver. The decrease in VLDL

and LDL then leads to a decrease in serum triglycerides, phospholipids and cholesterol.

IHN is slowly metabolized, not reaching maximum serum levels for approximately 10 hours after

ingestion. IHN is absorbed intact and hydrolyzed in the body with release of free niacin and inositol.

Once in the bloodstream, niacin effectively :

Reduces total cholesterol, LDL cholesterol, Lp (a) levels, Triglycerides

Increases HDL levels

6Clinical studies have proved IHN to be safe and free of side effects at doses up to 4 grams.

IHN offers an excellent alternative for combination with statins in Indian dyslipidemic patients. The

benefits of adding IHN with statin would include

Expanding statin effects on LDL, HDL, TG, and LDL particle size/density

Reducing cardiovascular mortality

Pharmacokinetics

Clinical efficacy

Safety Of Inositol Hexaniacinate

Combination therapy

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Puneet Laboratories Pvt. Ltd.605 Raheja Plaza-B, L.B.S Marg, Ghatkopar (W), Mumbai 400086, INDIA.

Tel : +91-22-61367000 Fax : +91-22-61367067 Email : info@puneetlabs.com Web : www.puneetlabs.com

The Mark of Innovative Chemistry

Inositol Hexanicotinate

The therapy for addressing dyslipidemia in Indian patients

should aim at not only decreasing the high LDL levels but, also

reducing the high triglycerides and Lp(a) levels and increasing

low HDL levels. Currently, only a small percentage of patients,

including those with CHD, are reaching this goal. Early

aggressive use of the effective lipid-lowering agents is critical

to achieve target lipid levels.

Contributes of various risk factors forCAD among Asian Indians

Other10%

Tobacco10%

HTN10%

Diabetes10%

TC/LDL15%

TG/HDL15%

Lp(a)25%

Hcy5%

HTN-hypertension, TC-total cholesterol,TG-triglycerides,Hcy-homocystein

20

30

40

50

0

10

India

China

SSA

Mexico

QAI

LAC

EME

PSE

1990 2000 2010 2020

DA

LYs

(mill

ions

)

4

6

8

10

12

0

2

2.5

10.29.8 10 9.6

11

Prevalence of CHD in Asian Indians in the United Statescomparison with Boston, Delhi, and Chennai

BostonUSA

CADIUSA

Non-veg DelhiIndia

Veg ChennaiIndia

Inositol HexanicotinateIHNIHNIHN

1Indians are at highest risk of developing CAD – Alarming Statistics

2Accelerating factors for Coronary artery disease

India is in the middle of a Coronary artery disease (CAD) epidemic

Over 10% of urban Indians have CAD

Rural areas- Increase from 2% in 1970's to 4% at present

50% of all heart attacks occur under the age of 55 and 25% under the age of 40

Epidemiological transition

Demographic shifts in population age-profile

Lifestyle related increases in the levels of cardiovascular risk factors

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Why is the scenario different in India?

Studies performed worldwide and in India confirm that in spite of a fairly healthy lifestyle 3

(vegetarian diet), many Indians possess a different risk factor profile characterized by:

High triglycerides

Low HDL

Glucose intolerance

Insulin resistance

Abdominal obesity and increased lipoprotein(a) levels [Lp(a)]

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In both South India and North India, Coronary artery disease

occurred at much lower levels of total cholesterol and low-density

lipoprotein cholesterol.

Pattern of Dyslipidemia among AsianIndians Relative to American Whites

TC Similar

Lipid

LDL

Small Dense LDL

Triglycerides

HDL

Lp(a)

Relative Serum Concentrations

Similar

Similar

Higher

Lower

HigherNiacin - The natural hypolipidemic

Niacin, an essential B vitamin has favorable effects on all major lipid subfractions at 4

pharmacological doses. Niacin plays a role in lowering

Total cholesterol (TC),

Low-density lipoprotein (LDL) cholesterol,

Very low-density lipoprotein (VLDL) cholesterol,

Apolipoprotein B and

Triglycerides

Niacin is also effective in

Increasing levels of HDL better than any other medication

Switching subclasses of LDL from small dense to large buoyant

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0

10

20

30

40

20

10

30

40

22%-26%

14%-17%

28%-35%

24%-27%

16%

22%-29%

Cha

nge

in li

pid

leve

l (%

)

LDL-C HDL-C Lp(a) Apo B TC/HDL-CTG

Lipid parameters

Lipid lowering properties of Niacin

Inositol Hexanicotinate

Inositol hexanicotinate is a well tolerated high strength niacin

with minimal side effects generally associated with

conventional niacin therapy. Inositol hexanicotinate is

metabolises over time, providing an extended release of free 5,6

niacin.

N

NN

NN

N

O

CO

O

CO

COOH

OCO OCO

OCOHOEsterase

NIACIN

Inositol Hexanicotinate- Structure

Each Film Coated Tablet contains :

Inositol Nicotinate BP 500mg

Excipients q.s.

Mode of Action

Inositol hexanicotinate is the hexanicotinate acid ester of meso-inositol, consisting of 6 molecules of

nicotinic acid and one molecule of inositol. The compound is metabolized in the liver to produce niacin 6& inositol.