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INDIA

PERIPHERAL ARTERIAL DISEASE, THROMBOANGIITIS OBLITERANS

AND CRITICAL LIMB ISCHEMIA

EPIDEMIOLOGY AND MARKETS

Mary L. YostTHE SAGE GROUP

404-816-0746


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THE SAGE GROUP, LLC993 Coronado DriveAtlanta, GA 30327

Copyright Pending2009

All rights reserved, including the right of reproductionin whole or in part in any form.


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iiiTHE SAGE GROUP

Table of Contents

DEMOGRAPHICS............................................................................................................. 7Rural Population Predominates....................................................................................... 7Age Structure .................................................................................................................. 7

ECONOMY ........................................................................................................................ 8HOUSEHOLD INCOME ................................................................................................... 8Middle Class Projected to Expand Significantly ............................................................ 9Consumer Market Forecast to Become the Fifth Largest in the World........................ 10Household Healthcare Spending Forecast to Grow Rapidly ........................................ 10

GOVERNMENT HEALTHCARE EXPENDITURES.................................................... 11PUBLIC HEALTHCARE SYSTEM................................................................................ 11

Limited Role of Central Government ........................................................................... 11Public CareA State Responsibility............................................................................ 12Three Tier System......................................................................................................... 12Rural Care System ........................................................................................................ 12

Urban System................................................................................................................ 12Problems with the Public Health System...................................................................... 13PRIVATE SECTOR ......................................................................................................... 13

Dominant Service Provider........................................................................................... 13Sole Practitioners, Small Nursing Homes and Small Clinics Predominate.................. 14Inequitable Distribution of Medical Personnel, Resources and Technology................ 15

CORPORATE FOR-PROFIT HOSPITALS .................................................................... 15Pioneered by Apollo Hospital Group............................................................................ 15Types of Hospitals and Services Provided.................................................................... 15International Accreditations.......................................................................................... 16Broadening Customer Base........................................................................................... 16Health Cities.................................................................................................................. 16Public Private Partnerships ........................................................................................... 17

HEALTHCARE INFRASTRUCTURE............................................................................ 17Medical Personnel......................................................................................................... 17Hospitals ....................................................................................................................... 17Infrastructure and Personnel Density............................................................................ 18Healthcare Demand Exceeds Supply ............................................................................ 18Past Underinvestment Resulted in Infrastructure Inadequate for Current Demand ..... 19Magnitude of Projected Infrastructure Investment Creates Opportunities for PrivateSector ............................................................................................................................ 19

INSURANCE.................................................................................................................... 19Majority of Patients Have No Insurance....................................................................... 19Private Health Insurance ............................................................................................... 20Cost of Care is Expensive Relative to Personal Income............................................... 20

Determines Patient Treatment Decisions.................................................................. 20New National Health Insurance Program ..................................................................... 20Medical Tourism........................................................................................................... 21

VASCULAR SURGERY IN INDIA................................................................................ 21Limited Number of Vascular Specialists and Facilities................................................ 21


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A Relatively New Specialty.......................................................................................... 21Low Physician Awareness of Atherosclerotic Vascular Disease ................................. 22

Even Less Consumer Awareness .............................................................................. 22Treatment Patterns ........................................................................................................ 22

DISEASE AND PROCEDURE STATISTICS ................................................................ 22

TOBACCO USE............................................................................................................... 23A Significant Risk Factor for Thromboangiitis Obliterans and Peripheral ArterialDisease .......................................................................................................................... 23Bidis .............................................................................................................................. 23Tobacco Use Highly Prevalent ..................................................................................... 23Tobacco Consumption Increasing................................................................................. 24Health Consequences .................................................................................................... 24

THROMBOANGIITIS OBLITERANS (TAO) ............................................................... 24Related to Smoking....................................................................................................... 24Symptoms ..................................................................................................................... 25Multi-Limb Involvement .............................................................................................. 25

Treatment ...................................................................................................................... 25Amputation ................................................................................................................... 26Prevalence ..................................................................................................................... 26

Hospitalized Patients................................................................................................. 26Population-Based Research ...................................................................................... 26

World Health Organization StudyConsequences of Tobacco Use in Bangladesh ... 27The Number of Indians with TAO................................................................................ 28

TAO MARKET ................................................................................................................ 28CRITICAL LIMB ISCHEMIA CAUSED BY THROMBOANGIITIS........................... 29

Prevalence ..................................................................................................................... 29Critical Limb Ischemia/Thromboangiitis Patient Market ............................................. 30Critical Limb Ischemia/Thromboangiitis Limb Market ............................................... 31

PERIPHERAL ARTERIAL DISEASE (PAD) ................................................................ 31ATHEROSCLEROTIC CRITICAL LIMB ISCHEMIA (CLI)........................................ 31

A Bilateral Disease ....................................................................................................... 32Multilevel Disease ........................................................................................................ 32

RISK FACTORS .............................................................................................................. 32HYPERTENSION ............................................................................................................ 33

Increases Risk of PAD.................................................................................................. 33A Growing Problem...................................................................................................... 33Urban Prevalence .......................................................................................................... 33Rural Prevalence ........................................................................................................... 33Over 100 Million Indian Hypertensives ....................................................................... 33

DYSLIPIDEMIA.............................................................................................................. 34Low Density Lipoprotein (LDL) Increases Risk of Vascular Disease ......................... 34Atherogenic Dyslipidemia ............................................................................................ 34Indian Lipid Profile Similar to Atherogenic Dyslipidemia........................................... 34Urban Prevalence .......................................................................................................... 35Rural Prevalence ........................................................................................................... 35Almost 190 million Indians Have Dyslipidemia .......................................................... 35


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DIABETES ....................................................................................................................... 35Diabetes Defined........................................................................................................... 35A Note on Diabetes Terminology................................................................................. 36Prediabetes Defined ...................................................................................................... 36Risk Factors .................................................................................................................. 36

Mortality ....................................................................................................................... 36Diabetes Prevalence Increases with Age ...................................................................... 36DIABETES AND PERIPHERAL ARTERIAL DISEASE .............................................. 37

PAD Highly Prevalent in Diabetics .............................................................................. 37Diabetics Have Increased Risk for Developing PAD................................................... 37Other Factors That Increase Risk of PAD in Diabetics ................................................ 37

DIABETES AND CRITICAL LIMB ISCHEMIA........................................................... 37Higher Risk of CLI and More Severe Disease.............................................................. 38CLI Develops Suddenly................................................................................................ 38Diabetes Increases the Risk of Amputation .................................................................. 38

Risk of Amputation Related to Severity of Diabetes................................................ 38

Higher Mortality ........................................................................................................... 38Additional Risk Factors Increase Severity.................................................................... 38Diabetes and SmokingA Deadly Combination ..................................................... 39

INDIATHE DIABETIC CAPITAL OF THE WORLD ............................................... 3941 Million Diabetics and 36 Million with Prediabetes................................................. 39Genetic Predisposition and Lifestyle Factors ............................................................... 40Asian Indian Phenotype ................................................................................................ 40

Indians More Susceptible to Adverse Effects of Insulin Resistance ........................ 40Younger Age of Type 2 Diabetes Onset ....................................................................... 40Increasing Diabetes Prevalence .................................................................................... 40

SUMMARY COMPARISON OF PERIPHERAL ARTERIAL DISEASE RISKFACTORS IN INDIA AND UNITED STATES.............................................................. 41PERIPHERAL ARTERIAL DISEASE IN INDIAN DIABETICS.................................. 42

Chennai Urban Population Study (CUPS).................................................................... 42CUPS Peripheral Arterial Disease Prevalence Compared with U.S. and EuropeanPopulations.................................................................................................................... 43Prevalence of PAD Likely Understated........................................................................ 43Research May be Limited Because of Subjects Young Age ........................................ 44Duration of Diabetes ..................................................................................................... 44Bikaner Diabetic Clinic Study ...................................................................................... 45

THE DIABETES METHOD ............................................................................................ 46NUMBER OF INDIANS WITH PERIPHERAL ARTERIAL DISEASE....................... 46

PAD Estimates Based on CUPS Prevalence................................................................. 47PAD Estimates Based on Bikaner Prevalence in Diabetics.......................................... 47Diabetes Prevalence Held Constant .............................................................................. 47

NUMBER OF INDIANS WITH CRITICAL LIMB ISCHEMIA CAUSED BYPERIPHERAL ARTERIAL DISEASE ............................................................................ 47CRITICAL LIMB ISCHEMIA/PERIPHERAL ARTERIAL DISEASE MARKET ....... 48

Patients.......................................................................................................................... 48Limbs ............................................................................................................................ 49


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PERIPHERAL ARTERIAL DISEASE MARKET .......................................................... 50Patients.......................................................................................................................... 50Limbs ............................................................................................................................ 51

CRITICAL LIMB ISCHEMIACOMPARISON OF MARKETS BY CAUSE............ 51Patient Market Overview .............................................................................................. 51

Limb Market Overview................................................................................................. 52IN-HOSPITAL CRITICAL LIMB ISCHEMIA DISEASE PATTERNS ........................ 53AMPUTATION................................................................................................................ 53

Incidence ....................................................................................................................... 53Number of Amputations Under Estimated ................................................................... 53Nontraumatic Amputations by Cause ........................................................................... 54Diabetic Foot Amputations ........................................................................................... 54Critical Limb Ischemia Amputations............................................................................ 55

Atherosclerotic CLI Amputations............................................................................. 55Thromboangiitis CLI Amputations........................................................................... 55

Amputation by Location ............................................................................................... 55

Indian TAO Patients Might Undergo Higher Rates of Amputation ............................. 55APPENDIX: DEDICATED VASCULAR SURGERY CENTERS................................. 56Listed by Geographic Zone........................................................................................... 56

North Zone ................................................................................................................ 56West Zone ................................................................................................................. 56South Zone ................................................................................................................ 57

REFERENCES ................................................................................................................. 58INDEX OF TABLES........................................................................................................ 74INDEX OF FIGURES ...................................................................................................... 76DISCLOSURE STATEMENT ......................................................................................... 77

Stock Ownership........................................................................................................... 77CONTACT INFORMATION........................................................................................... 78

Research........................................................................................................................ 78Marketing...................................................................................................................... 78


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SELECTED SAMPLE PAGES FOLLOW


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8THE SAGE GROUP

DEMOGRAPHICS

India, the second most populous country in the world, has over 1.1 billion citizens. By2020 the population will exceed 1.3billion.1In addition to the majority Hindu faith(81%) the population is comprised of several religious and ethnic groups (Indo-Aryan,

Dravidian, etc.).

2

Rural Population Predominates

Currently 29% of the population is urban and 71% is rural. However, urbanization isoccurring rapidly and by 2025the percentage of urban dwellers is projected to exceed37%.3

The urban rural ratio is important because the prevalence of cardiovascular diseases andtheir risk factors are two to three times higher in the urban areas.4-11

Age Structure

With a median age of 23 the India is one of the younger countries worldwide.12Sinceolder age is a significant risk factor for lower limb atherosclerotic disease, this isimportant to note with regard to our subsequent discussion on peripheral arterial disease(PAD) prevalence.13

Table 1 displays the median age of the population in India, China, the United States,Germany and Japan for the years 2000, 2020 and 2040. With a median age of 41 in 2000Japan was the oldest country in the world.

Table 1

2000, 2020 and 2040Median Age in India and Selected Countries

Country Median Age2000 2020 2040

India 23 28 35China 30 37 45United States 35 38 39Germany 40 47 50Japan 41 49 54

Source: Kinsella12 and THE SAGE GROUP.

Although the Indian population is relatively young when compared to that in the U.S. andEurope, the ageing of India is beginning to occur and is expected to progress rapidly overthe next 30 years.


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In 2008 the percentage of Indians 65 and older was 5% versus 13% in the U.S. and 17%in the European Union.1By 2040 slightly over 13% of the Indian population is expectedto be ages 65 and older. In the U.S. this age group will increase to over 20% of the total.

From a market perspective the actual numbers of people in the 65 and older group are

more important than the percentages. Reflecting its status as the worlds second mostpopulous country, the number of Indian citizens 65 and older vastly exceeds those in theU.S. In 2008 there were 60 million elderly Indians versus 39 million in the U.S. By 2040approximately 222 million Indian elders are forecast.12(See Table 2 below).

Table 2

Population Ages 65 and Older in India and Selected Countries

In 2008, 2010 and 2040

(Numbers in Millions)

Population Age 65

Country 2008 2020 2040

China 106 170 329India 60 89 222United States 39 54 80Japan 28 34 36Germany 17 18 23

Source: Kinsella12and THE SAGE GROUP.

ECONOMY

The Indian economy is one of the largest and most rapidly growing in the world. Fueledby economic reforms Indias recent growth has been exceeded only by that in China.

After increasing 5.8% annually between 1995 and 2000, gross domestic product (GDP)expanded at a 6.8% rate in the 2000-2005 period.15GDP expansion accelerated evenfaster in subsequent years to 9.6%, 9.0% and 6.6% in 2006, 2007, and 2008 respectively.Despite the global economic recession GDP is forecast to increase by approximately 7%in 2009.16

HOUSEHOLD INCOME

In 2008 per capita income was $653.13 (US).2 While this appears low, by 2025 asignificant percentage of the poor and lower income groups are projected to move up theeconomic ladder. As they achieve middle class status, substantial increases indiscretionary expenditures, including healthcare, are projected for the Indian consumermarket. 15**


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GOVERNMENT HEALTHCARE EXPENDITURES

By international standards government spending on healthcare in India is low and thepercentage contribution of private funding is high.7, 17-19

As can be seen in Table 5, India spends 4% of gross domestic product (GDP) on healthcare versus 5% in China. This compares with 9% globally, 15% in the U.S. and 11% inGermany.

Table 5

2006 Comparison of Government and Private Health Expenditure Ratios in

India, China, the United States, Germany and the Global Average

Expenditure Ratio Global

%

India

%

China

%

Germany

%

U.S.

%

Health Spending as % of GDP 9 4 5 11 15

Health Spending as % of Total Government Spending 14 3 10 18 19

Government Spending as % of Total Health Spending 58 25 41 77 46

Private Spending as % of Total Health Spending 42 75 59 23 54

Out-of Pocket Spending as % of Private Spending 50 91 83 57 24

Source: WHO17

Globally the 2006 percentage of total government expenditures on health care was 14%;in contrast healthcare accounted for only 3% of total Indian government spending.

In India private expenditures not government funding represents the majority (75%) ofhealth spending. In contrast the global average is 42% and in the U.S. 54%.

Out-of-pocket spending by individual households accounts for over 90% of the privatespending. Compared with the global average of less than 50% this represents one of thelargest percentages in the world. Out-of-pocket spending for the other countries shown inTable 5 ranges from a low of 24% in the U.S. to a high of 83% in China.

PUBLIC HEALTHCARE SYSTEM

The Indian public healthcare system is highly decentralized.

Limited Role of Central Government

The central government in Delhi finances and administers family welfare and diseasecontrol programs as well as the development of some specialty and tertiary hospitals. TheDelhi government also provides policy guidelines.20


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Public CareA State Responsibility

In the public sector the provision of primary and secondary healthcare is controlled,administered and financed primarily by the individual states and territories.19(India has28 states and 7 Union Territories.)1Since healthcare budget allocations depend on thestates fiscal status, the percentage of gross state domestic product and actual dollaramounts spent on health care vary widely between the states.19, 20The states account for85% of government spending.7, 21

Three Tier System

Government healthcare services are provided through a three-tiered system with the typeand level of services based on population.22, 23

Rural Care System

In rural areas primary health care is provided by a network of 142,655 Subcenters, 23,109

Primary Health Centers (PHC) and 3,222 Community Health Centers (CHC). (The centerstatistics are those as of September 2004.)22, 23

Staffed by 2 health care workers, Subcenters provide the most basic care. Primary HealthCenters act as the referral unit for 6 Subcenters. PHCs staffed by a doctor and otherhealthcare personnel also have between 4 and 6 beds for patients.22

Community Health Centers are the rural specialty referral centers for 4 PHCs. CHCs arestaffed by four specialists; a surgeon, physician, gynecologist and pediatrician. EachCHC has approximately 30 beds, operating facilities, X-ray and laboratory services.22

India has only 50% to 80% of the number of primary and community health care centersneeded.7

Urban System

In urban areas the 871 Urban Health Posts are the focus of care. Generally these facilitieshave a doctor, nurse, midwife and other support staff. Specialist and acute care isprovided by Urban and District Hospitals. In addition to the Health Posts there is also anetwork of Urban Family Welfare Centers that provides family welfare servicesincluding contraceptives.22

Recognizing shortcomings in urban healthcare, the 2002 National Health Policy proposedmodifying the system into a network of Primary Centers and Government Hospitals.20, 22However, to date little has been changed.24

Problems with the Public Health System

The 2005 National Commission on Macroeconomics and Health report concluded thatthe public health system was inadequate and functioned poorly. Reasons cited included


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12THE SAGE GROUP

poor management of resources, centralized decision making, low budgets, irregularsupplies, large scale absenteeism, corruption, absence of performance based monitoringand problems with accountability.20

Physicians and staff for the Primary Health Centers are in short supply resulting in high

vacancy rates. Even when the PHCs are staffed, the doctor and other professionalemployees are often absent with absentee rates ranging from one third to two thirds.Physicians frequently operate their own private clinics while collecting governmentpaychecks.25

Other shortcomings of the public system include uneven physician distribution and lackof national regulation. Although 71% of the population resides in rural locations, two-thirds of physicians are concentrated in urban areas.7, 23 Because there is no nationalregulatory body to administer and enforce minimum quality standards, the quality of carevaries between providers in both private and public sectors.26

PRIVATE SECTOR

Dominant Service Provider

The private sector dominates healthcare services and represents the primary provider ofhealthcare for both rural and urban Indian households.27

Figure 1

India

Provision of Healthcare by Service Provider

Nonprofit 1%

Public 17%

Private 82%

Source: CMAJ 23and THE SAGE GROUP.

**


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13THE SAGE GROUP

DISEASE AND PROCEDURE STATISTICS

There is no central data source for thromboangiitis obliterans or peripheral arterialdisease incidence or prevalence. National data on revascularization procedures andamputations are also unavailable.

Both the Vascular Society of India (VSI) and the Cardiological Society of India (CSI)have begun collecting data on numbers and types of revascularization procedures.However, participation in these surveys is voluntary and while the participation rate isincreasing it is still inadequate. For example, in the 2006 CSI national registry only 29%of the 520 cardiac cath labs submitted data.48, 49

TOBACCO USE

In India an estimated 100 million people smoke bidis and 25 million smoke cigarettes.Over 125 million use smokeless tobacco.50

A Significant Risk Factor for Thromboangiitis Obliterans and Peripheral Arterial Disease

Almost all patients with thromboangiitis obliterans are heavy smokers. Smoking is alsoone of the most significant risk factors for the development of atherosclerotic disease inthe lower limbs.

Smokers have three times the rate of PAD as non-smokers and are diagnosed an averageof 10 years earlier.13The risk of PAD increases with the number of cigarettes smoked.13The disease is more severe and progresses more rapidly in smokers as evidenced by thefinding that smokers with intermittent claudication have three times the risk ofamputation and death.51

The five-year mortality rate in smokers is 60% or greater, with the majority of deathscaused by heart attack or stroke.52This compares with a 10 % rate for age-matchedcontrols and 40% for those with both PAD and CAD.53

Bidis

Bidis or beedies are thin, hand-rolled, unfiltered cigarettes. Sun-dried, processed tobaccoflakes are rolled in a tendu leaf or temburni leaf and held together by cotton thread. Thedark and sun-dried tobacco rolled in bidis is different from that used in cigarettes.54

Known as the poor mans cigarette in India, bidis are smaller and cheaper than cigarettes.Nonporous tendu leaves have relatively low combustibility. Because of this the smokerneeds to take more frequent and deeper puffs to keep the bidi lit. In addition to beingharder on the smokers lungs, bidis also deliver higher levels of carbon monoxide,nicotine and tar than paper wrapped cigarettes.54, 55


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14THE SAGE GROUP

Tobacco Use Highly Prevalent

According to the 2005-2006 National Family Health Survey, 57% of men and 11% ofwomen (ages 15-49 years) use tobacco.27Over 50% of all tobacco consumed is smokedas bidis. Use of smokeless tobacco (either chewed or applied to the gums) is slightly

more than one quarter of total tobacco consumption.

50

One third of Indian men smoke, but only 2% of women do so. Smokeless tobacco use isfound in almost 40% of men and 10% of women. The prevalence of tobacco consumptionand the type of product consumed varies between urban and rural populations and bywealth status.57Rural populations have a higher prevalence of tobacco use (63%) thanurban dwellers (40%). Rural residents also have a higher prevalence of bidi smoking(37%) than urbanites (20%).50

Tobacco Consumption Increasing

Tobacco consumption is growing by 2%-3% per year.57According to several studies bidi

smoking, cigarette smoking and tobacco chewing appear to be increasing among youthand occurring at a greater rate in the younger age groups (sixth grade versus eighthgrade).58According to the Global Youth Tobacco Survey (GYTS) conducted in Indiaduring 2000-2004, current smoking of any tobacco product was 8.3% among those ages13-15. Smoking ranged from a low of 2.2% in Himachal Pradesh to a high of 34.5% inMizoram. Cigarette smoking was almost twice as high as bidi smoking.59

It is interesting to note that in the late 1990s bidi smoking became popular with U.S.adolescents (ages 11-18). Bidis are perceived as a natural herbal product andtherefore safer than cigarettes. Flavored with strawberry, vanilla, grape also improved thetaste over cigarettes.60, 61

Health Consequences

Whatever the form of tobacco consumption, the health consequences of tobacco use aresignificant including higher risks for developing cardiovascular disease, peripheralarterial disease and TAO in addition to various types of cancers and pulmonarydisorders.62-67It also appears that bidi smoking increases the risk for developing TAOwhen compared with smoking regular cigarettes.68

THROMBOANGIITIS OBLITERANS (TAO)

Thromboangiitis obliterans (TAO) also known as Buergers Disease is a non-atherosclerotic, occlusive inflammatory disease that most commonly affects the small andmedium sized arteries, veins and nerves in the upper and lower extremities. Othervascular beds can also be affected. Cases have been reported in the cerebral, coronary,aortic and intestinal vessels.69, 70

TAO is characterized by exacerbations and remissions; increasingly severe episodes ofocclusive inflammatory thrombus formation followed by partial recanalization.69, 70


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Related to Smoking

The cause is unknown. However, almost all patients are smokers and most are heavysmokers. Symptoms of the disease typically occur before age 40 in males. While still amale disease in India and other parts of Asia, the percentage of women suffering from

TAO has been increasing in the U.S. most likely due to the increase in femalesmoking.69, 71

Certain ethnic groups, such as Ashkenazi Jews, may have a genetic predisposition.71InIndian and Bangladeshi populations smoking bidis, which contain higher nicotine and tarcontent as well as other toxic substances, may act as a trigger for the development ofthromboangiitis obliterans.68

Symptoms

Foot claudication and burning pain in the hands and feet are the most commonsymptoms.72However, in the majority of cases (70%-80%) a diagnosis is not made until

critical ischemia occurs.71Superficial thrombophlebitis (an inflammatory venousresponse caused by a blood clot near the skin surface) and Raynauds phenomenon occurin 40% of patients.73Raynauds is a condition in which the blood vessels of the fingersand toes constrict in response to cold or strong emotions. The restricted blood supplycauses skin discoloration and pain.

At the Cleveland Clinic 81% of the patients presented with rest pain, 63% withclaudication and 76% with ischemic ulcer.69At Chiang Mai University Hospital inThailand 75% of TAO patients presented with burning pain in the hands and feet, 74%digital gangrene and 44% digital ulcer.72

**


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16THE SAGE GROUP

Table 11 displays the number of cases of TAO and estimates the market based on threealternative percentages of patients presenting to the hospital for treatment.

Table 11

India 2008-2013

Thromboangiitis Obliterans Patient Market(Numbers in Thousands)

Year Number of Cases Number of TAO Patients Treated

12% 25% 50%

20082009201020112012

201320142015

Source: THE SAGE GROUP.

Assuming that 12% to 50% of TAO patients are diagnosed and treated, there were 60,000and 240,000 TAO patients in 2008.

Since the only effective treatment is cessation of tobacco usage,69, 74 Almost all of thesepatients would be available for new therapies, especially therapies that cost less thanamputation ($906 in a private hospital). In higher income patients the cost target would

be less than $4,000 or that of a lower limb bypass.

It is important to note that the above figures represent both new and old patients sufferingfrom recurring exacerbations. Over the course of the patients lifetime, exacerbationsincrease in severity especially in those who continue to smoke or use tobacco in anyform.69, 71

CRITICAL LIMB ISCHEMIA CAUSED BY THROMBOANGIITIS

Prevalence

Between 60% and 80% of TAO patients present with critical limb ischemia defined asrest pain, non-healing ulcers or gangrene. To estimate the number of TAO patientssuffering from CLI we used a single point estimate of 70%.69, 71, 74, 85, 86

In 2008 THE SAGE GROUP estimates that 340,000 TAO patients suffered from criticalischemia. By 2015 over 400,000 patients could have Buergers Disease. Refer to Table12 on the following page.**


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INDIATHE DIABETIC CAPITAL OF THE WORLD

41 Million Diabetics and 36 Million with Prediabetes

According to the International Diabetes Federation (IDF) in 2007 there were 41 milliondiabetics in India; another 36 million had impaired glucose tolerance (IGT).155By 2025the number of Indian diabetics is expected to increase to 70 million.155

Table 16

2007

Top Ten Diabetic Countries

Prevalence of Diabetes and Impaired Glucose Tolerance in the Adult Population Ages 20-79

Country DM*

%

Number DM

(Thousands)

IGT*

%

Number IGT

(Thousands)

India 6.7 40,851 5.6 35,906China 4.1 39,810 6.9 64,324United States 7.8 19,157 5.0 12,375Russia 7.6 9,632 15.2 17,840Germany 7.9 7,379 4.0 4,035Japan 4.9 6,978 10.9 12,892Pakistan 9.6 6,930 8.7 6,442Brazil 6.2 6,913 7.3 8,360Mexico 10.6 6,116 8.0 4,781Egypt 11.0 4,357 5.1 1,977

*Comparative prevalence adjusted for the world populationDM = Diabetes Mellitus, IGT = Impaired Glucose Tolerance.

Source: Diabetes Atlas155and THE SAGE GROUP.

India has the unfortunate distinction of leading the world in the number of diabetics. Incomparison China the second most diabetic country has 39.8 million; the U.S. is inthird place with 20 million diabetics. (IDF) The other countries in the top 10 are shown inTable 16 above.

**


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PERIPHERAL ARTERIAL DISEASE IN INDIAN DIABETICS

Few prevalence studies have been published on atherosclerotic lower limb disease inIndians, especially in subjects living on the subcontinent. With the exception of theChennai Urban Population Study (CUPS) most of the recent research involves the

prevalence of PAD in those attending diabetic clinics or hospitals.

166-171

The majority ofthese studies were conducted in diabetic clinics in one state in southern India, Chennaiformerly known as Madras.

Chennai Urban Population Study (CUPS)

The Chennai Urban Population Study is the only population-based study of PADconducted in India that we could locate.166CUPS examined the prevalence and riskfactors for peripheral arterial disease in 1,262 subjects age 20 and older in 2 residentialareas of Chennai in South India.

PAD was found in 3.2% of the population of Chennai. As would be expected theprevalence of PAD was highest in diabetics (6.3%) and lowest in those with normalglucose (2.7%). Those with impaired glucose tolerance had a PAD prevalence of 2.9%.Known diabetics had a higher prevalence of lower limb atherosclerosis (7.8%) thannewly diagnosed diabetics (3.5%).166

The percentage prevalence of PAD by age and glucose status from CUPS is shown inTable 17 below.

Table 17Peripheral Arterial Disease

Age Specific Prevalence Rates by Glucose Status

Chennai Urban Population Study (CUPS) 2000

Age Group PAD Prevalence by Glucose Status

Normal

%

DM and IGT

%

< 30 0 031-50 1.5 2.151-70 3.4 6.3>70 12.5 17.6

Source: Premalatha166

Although PAD was relatively uncommon in middle-aged subjects, the prevalence rateincreased dramatically in those older than 50. Multivariate analysis identified age as themost significant risk factor for lower limb occlusive disease.166

CUPS Peripheral Arterial Disease Prevalence Compared with U.S. and European

Populations


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The CUPS authors concluded that the prevalence of PAD in Asian Indians is lower thanin Western and Caucasian populations. However, recent research conducted in similarage groups in the U.S. and Europe indicates that this may not be the case.

Data from the U.S. 1999-2000 NHANES Survey found PAD in 4.5% of the overall

population ages 40 and older and in 9.5% of those with diabetes.

172

Since PAD wasdefined as ABI less than 0.90 the definition is relatively comparable with that employedin Chennai.89

Several studies have been conducted in Spanish, Italian and French populations ages 15or 20 and older. Defined as ABI less than 0.90, lower limb disease is present inapproximately 2%-5% of those with normal glucose.173-177The 3% CUPS prevalence innormal glucose individuals is within this range.

In the general population little if any PAD is found in those younger that ages 40.89 PADprevalence is modest in those ages 40-55.89Approximately 1%-5% of Europeans and

U.S. citizens with normal glucose and no cardiovascular risk factors have ABI less than0.90.172-174, 176, 178-181 The CUPS prevalence of 1.5% in those 31 to 50 is also reasonablyconsistent with this range.

The prevalence of PAD in European nondiabetic populations ages 50-60 and older isbetween 18%-19%.137, 182-184 In those 65 and older the prevalence is between 11% and20% with the range depending on the definition of PAD.136, 185

In diabetic populations the percentage of those with peripheral occlusive disease tends tobe low in those 45 and younger and increases with age and duration of diabetes. Researchconducted in European populations that include a broad range of ages (15-20 years andolder) found that 8%-21% of the diabetics had PAD.140,176, 186, 187The lower prevalence isin French diabetics and the higher in Italian diabetics.

Based on U.S. and European studies between 24% to 45% of elderly diabetics suffer fromPAD.136, 137, 140, 142, 143, 187, 188-193The range reflects somewhat different age groups andvarying definitions of PAD.

Prevalence of PAD Likely Understated

Although CUPS is a very significant study, we believe that it understates the prevalenceof PAD for several reasons.

For logistical reasons, ABI was measured in only half of the participants. Unfortunately,this resulted in a very small sample. Of the 631 with ABI measurements only 80 subjectshad diabetes and 34 IGT and of these only 5 and 1 respectively had PAD.166Finally, thetwo residential areas were middle and lower income, which to the extent that upper**


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THE DIABETES METHOD

The Diabetes Method was previously employed to estimate PAD and CLI in the U.S. and15 Western European countries.89, 199

Briefly, this method involves segmenting the population by age and glucose status,calculating the prevalence of PAD in each glucose category and finally the prevalence ofcritical ischemia by PAD and glucose status.

NUMBER OF INDIANS WITH PERIPHERAL ARTERIAL DISEASE

As displayed in Table 19, in 2008 an estimated 15 to 22 million Indian citizens hadatherosclerotic lower limb disease. By 2015 these numbers are projected to increase to 19to 28 million.

Table 19

India 2008-2015

Prevalence of Peripheral Arterial Disease(Numbers in Thousands)

Year Peripheral Arterial Disease

CUPS

(Age 30+)

Bikaner

(Age 30+)

2008200920102011

2012201320142015


Using the International Diabetes Federation (IDF) prevalences for diabetes and IGT, wesegmented the population ages 20 and older by age group and glucose status. Since welacked age-specific PAD prevalences for impaired glucose tolerance (IGT) we used onlytwo glucose groups. PAD prevalences by age group and glucose status were calculatedbased on the two studies, CUPS and Bikaner.166, 167

Population numbers and projections by age and sex were derived from queries of the U.S.Census Bureaus International Data Base.14

PAD Estimates Based on CUPS Prevalence

**


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NUMBER OF INDIANS WITH CRITICAL LIMB ISCHEMIA CAUSED BY

PERIPHERAL ARTERIAL DISEASE

In 2008 between -- and -- million Indians suffered from critical limb ischemia due toperipheral arterial disease. By 2015 these numbers could increase to between -- and --

million. (See Table 20.)

The difference between the two forecasts reflects the two different PAD estimates shownpreviously in Table 19. Critical limb ischemia was calculated based on the samepercentage prevalence for both PAD projections.

Table 20India 2008-2015

Population Ages 40 and Older

Prevalence of Critical Limb Ischemia Caused by PAD(Numbers in Thousands)

YearCLI

CUPSCLI

Bikaner

20082009201020112012201320142015


**

CRITICAL LIMB ISCHEMIA/PERIPHERAL ARTERIAL DISEASE MARKET

Patients

On the following page Table 22 displays the market estimates based on 6% or 12% of

critical limb ischemia patients diagnosed and treated. The number of CLI/PAD cases inthe first column is that based on the Bikaner estimates shown previously in Table 20.Market estimates based on the CUPS prevalence of peripheral arterial disease areavailable on request.

In 2008 the CLI market would be -- to -- patients. By 2015 the market is projected to be -- to -- patients.


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Table 22

India 2008-2015

Atherosclerotic Critical Limb Ischemia Patient Market(Numbers in Thousands)

Year Number of CLI/PAD Cases Number of CLI/PAD Patients Treated

6% 12%

2008

2009201020112012201320142015


Limbs

Table 23 displays the atherosclerotic critical limb market in numbers of limbs. Assumingthat 50% of the CLI/PAD patients shown in Table 22 suffer from 2-limb disease, the2008 CLI/PAD market would be -- to -- limbs.89

Table 23

India 2008-2015

Atherosclerotic Critical Limb Ischemia Limb Market

(Numbers in Thousands)

Year Number of CLI/PAD Limbs Treated

6% 12%

20082009201020112012201320142015


**


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REFERENCES (FIRST AND LAST PAGES)

1. CIA. [Internet]. The world fact book. India. [Accessed 2009, June]. Available at:https://www.cia.gov/library/.../the-world-factbook/.../IN.html.

2. India at a Glance. [Internet.] India Brand Equity Foundation. [Accessed 2009, Aug.]

Available at: http://www.ibef.org.

3. Population projections for India and states. [Internet.] Report of the technical group onpopulation projections constituted by the national Commission on Population 2006. Censusof India 2001. Office of the Registrar General and Census Commissioner, India 2A,Mansingh Road, New Delhi. [Accessed 2009, Jun.] Available at:gujhealth.gov.in/basicstatastics/pdf/Projection_Report.pdf.

4. Gupta R. Burden of coronary heart disease in India. Indian Heart J 2005; 57: 632-8.

5. Gupta R. Recent trends in coronary heart disease epidemiology in India. Indian Heart J.2008 Mar-Apr; 60(2 Suppl B):B4-18. Review.

6. Joshi R, Chow CK, Raju PK, et al. Fatal and nonfatal cardiovascular disease and the use oftherapies for secondary prevention in a rural region of India. Circulation 2009; 119:1950-55.

7. Chaturvedi V, Bhargava B. Health care delivery for coronary heart disease in Indiawhereare we headed? Am Heart Hosp J. 2007; 5(1):32-7.

8. World health statistics 2009. [Internet.] World Health Organization. [Accessed 2009, Aug.]Available at: www.who.int/whosis/whostat/EN_WHS09_Full.pdf.

8. Singh RB, Sharma JP, Rastogi V, et al. Prevalence of coronary artery disease and coronary

risk factors in rural and urban populations of north India. Eur Heart J 1997; 18: 1728-35.

9. Josi SR, Das AK, Vijay VJ, Mohan V. Challenges of diabetes care in India: sheer numberslack of awareness and inadequate control. J Assoc Physicians India. 2008 Jun; 56:443-50.

10. Gupta R. Type 2 diabetes in India: regional disparities. Br J Diabetes Vasc Dis 2007;7: 12-16.

11. Indrayan A. Forecasting vascular disease cases and associated mortality in India. [Internet].In: Burden of Disease India. National Commission on Macroeconomics and Health.Ministry of Health & Family Welfare. Government of India 2005 Sept. New Delhi, India. P.197-215. [Accessed 2009, Jun.] Available at:

www.who.int/macrohealth/action/national.../en/index.html.

12. Kinsella K, He W. An ageing world: 2008. U.S. Census Bureau. International populationreports, P95/09-1. US Government Printing Office Washington DC. 2009. Available at:www.census.gov/prod/2009pubs/p95-09-1.pdf.


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206. Gaur DS, Varma A, Gupta P. [Internet]. Diabetic foot in Uttaranchal. JK Science 2007;9(1): 18-20. [Accessed 2009, Sept.] Available at:www.jkscience.org/archive/volume91/Diabetic%20foot.pdf.

207. Abbott CA, Morris JA, Garrow AP, et al. Foot ulcer risk is lower in South-Asian and

African-Caribbean compared with European diabetic patients in the U.K. Diabetes Care2005; 28: 1869-75.

208. Viswanathan V. The diabetic foot: perspectives from Chennai, South India. Int J LowerExtrem Wounds 2007; 6(1): 34-6.

209. Prompers L, Schaper N, Apelqvist J. Prediction of outcome in individuals with diabeticfoot ulcers: focus on the differences between individuals with and without peripheralarterial disease. The EURODIALE Study. Diabetologia 2008; 51: 747-55.

210. Mills JL. Buergers Disease in the 21stcentury: diagnosis, clinical features, and therapy.Semin Vasc Surgery 2003; 16(3): 179-89.

211. Jindal RM, Patel SM. Buergers Disease in Western India. Postgrad Med J 1993; 69:326-7.

212. Bedi VS. Secretary, Vascular Society of India. Personal Communication. 2009, July 20.


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CONTACT INFORMATION

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Mary L. YostPresident(404) [email protected]

Marketing

Harrington WitherspoonSenior Vice President(404) [email protected]

India Sample Pgs

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