Sanofi-aventis’ SITE Uncovers India’s Silent Killers

As India’s place in the world economy grows, raising the standard of living of its citizens and astounding economists, political leaders, and the public around the globe, its people have as rapidly moved into the crosshairs of two of the most lethal diseases of affluence:  diabetes and hypertension.

International Diabetes Federation's estimates are that there are 50.8 million diabetics in India in 2010, rising to 87 million by the year 2030.The epidemic of type 2 diabetes in urban adults has been especially virulent, as the rate has in- creased from less than 3% in 1970 to 12.0% in 2000. But even rural areas are not immune. "Diabetes has risen rapidly in rural areas, with a threefold increase (from 2.4 per- cent to 6.4 percent) in rural southern India over a fourteen-year period," Health Affairs reported.

Hypertension too is on the rise.  Indians with hypertension are projected to number 214 million in 2025, up nearly 100 million since 2000. Thus, its scourge is even greater than diabetes. With India's fast-growing population projected to overcome China's in the next thirty years, India could achieve another global distinction: "At the current rate of hypertension we will have the largest number of people with hypertension in the world," reported the Journal of Association of Physicians of India.

There was a serious concern that awareness of diabetes and hypertension including their risk factors, symptoms and treatment options, among healthcare providers and patients alike was dangerously low.

About 18 months ago, researchers at Sanofi-Aventis [or Aventis Pharma Limited] began asking questions: Just how serious is hypertension in India?  Is India facing a twin epidemic of diabetes and hypertension? How well are these diseases being diagnosed and treated? There was a serious concern that awareness of both diseases, including their risk factors, symptoms, and treatment options, among health care providers and patients alike was dangerously low.

The outcome of these internal discussions, as well as discussions with potential partners (namely, doctors, hospitals, and institutes), was the decision to launch one of India's largest studies of diabetes and hypertension prevalence. On 8th January 2009 sanofi-aventis formally announced the creation of SITE (Screening India's Twin Epidemic), a cross-sectional study to estimate the prevalence of diagnosed and undiagnosed cases of diabetes and hypertension in outpatient settings in major cities across India. Its goals? Increase disease awareness, provide healthy literacy, and that would enable better screening and treatment strategies.

"Diabetes was already posing an enormous health as well as economic problem for the country, as was hypertension," said Dr. Muruga Vadivale, Senior Director - Medical and Regulatory Affairs, sanofi-aventis India. "A large cross-sectional study could provide doctors and public health officials with valuable insights on both diseases and create awareness among medical professionals and the public about early screening for these diseases."

Today, SITE has enrolled approximately 16,000 patients from 800 centers across 8 states in India. It has partnered with 800 general practitioners and consulting physicians, to conduct the screenings and record and report the results. It is being con- ducted in waves over two years, one state at a time, with 2,000 patients screened from each state over two days per wave. On each of the two days, centers screen 10 patients, who must be over age 18 and not pregnant and have signed data-release consent form. The eight states included in the study are Maharashtra, Delhi, West Bengal, Tamil Nadu, Andhra Pradesh, Karnataka, Gujarat, and Madhya Pradesh.

"Through SITE we hope to identify gaps in treatment needs at the first point of contact for a patient," said Dr. Shashank Joshi, Consultant Endocrinologist, Lilavati Hospital and National Coordinator of SITE study. "SITE will give us important insights on how we screen patients for risk factors and how well we manage them versus current guidelines."

Patients visit centers on two separate days to be screened for the following parameters:

As of October 2010, the results from two states, Maharashtra (November 2009) and Delhi (May 2010), have been released. The results from all the states are ready, and an internal process of validation is currently underway. Declaration of these results are expected shortly.

Maharashtra and New Delhi

In May 2010 the results of the New Delhi screenings were announced, allowing medical researchers, public health officials and physicians to compare the prevalence of diabetes and hypertension in Maharashtra and New Delhi. The findings were both alarming and revealing.

The twin epidemics of diabetes and hypertensions do exist in both states, although it's more serious in Maharashtra where 29% of the patients were both diabetic and hypertensive, as compared to 21% in New Delhi. As expected, hypertension is more prevalent than diabetes in both states. Less expected, though, were the regional differences: both diabetes and hyper- tension are more prevalent in Maharashtra (40% and 56%, respectively) than in New Delhi (33% and 48%, respectively).

As troubling were the rates of patients who had been diagnosed and treated, but whose conditions were still uncontrolled. In Maharashtra, three-quarters of known diabetics had uncontrolled Hba1c% levels, as compared to two- thirds in New Delhi. Uncontrolled hypertension also is a serious problem in both states and occurs at about the same rate: 79% in Maharashtra and 77% in New Delhi.

Why the Twin Epidemics Now?

The "main determinants," according to K. Sranath Reddy of the Public Health Foundation of India and others, are urbanization, industrialization, and globalization -more precisely, much larger forces that are working to dramatically improve standards of living, but also are prompting dramatic and unhealthy changes in diet and behaviors. Writing in The Lancet in 2005, Reddy, Bela Shah of the Indian Council of Medical Research, Cherian Varghese of the WHO, and former health minister Anbumani Ramadoss explained:

The Indian economy is growing at 7% per year. With in- creasing life expectancy, the proportion of the population older than 35 years is expected to rise from 28% in 1981 to 42% in 2021. The proportion of people in urban residence, presently around 30%, is expected to rise to about 43% in 2021. ¼Urbanization and industrialization are changing the patterns of living in ways that increase behavioral and biological risk factor levels in the population.

A 2008 Health Affairs article put a finer point on causation, explaining further both the interaction between these larger forces and the practical implications of urban migration and dietary changes for the man and woman on the street:

Globalization, urbanization, and the nutrition transition act in synergy to change the way people live and eat, leading to increased rates of obesity and diabetes.  Globalization facilitates the pervasiveness of diabetes risk factors, while cities create environments in which many people are exposed to these risk factors: access to prepackaged, processed foods; efficient transportation methods that discourage physical activity; and technology-oriented jobs that strengthen economies but require less expenditure of energy.

The impact of this dietary shift - "from consumption of simple, traditional foods to heavily marketed foods high in calories, sugar, and animal fat but low in vitamins and minerals" derived from fruits and vegetables on public health overall and incidence o f chronic diseases can hardly be overstated, especially considering that the change has been so dramatic, as Health Affairs explained:

Traditional Indian diets consist of a high percentage of complex carbohydrates and a low percentage of fat; modern dietary patterns show high consumption refined carbohydrates, fat, dairy products, and sugar; decreased consumption of fiber; and large increases in overall caloric intake in both urban and rural settings. During 1979-2001, energy and fat intake greatly increased, and consumption of meat products, milk, sugar and other sweeteners, and vegetable oils increased by 50 percent, 60 percent, 25 per- cent, and 100 percent, respectively.

What is Diabetes?

Diabetes is a chronic condition in which the body does not produce or properly use insulin, the hormone needed to transport glucose (sugar) from the blood into the cells of the body for energy. Elevated blood glucose levels “can lead to serious damage to many of the body's systems, especially the nerves and blood vessels."

In Type 1 diabetes, which is typically diagnosed in children, the body produces little or no insulin. Often called juvenile diabetes because it's typically diagnosed in children, it is not caused by obesity. Type 2 diabetes is the most common, accounting for about 90% of all diabetes. With Type 2 diabetes, the body produces sufficient levels of insulin, but cannot effectively use it. Historically, an adult disease, it is increasingly occurring in obese children and is associated with unhealthy diet, excessive weight and physical inactivity, according to the WHO.

What is hypertension?

Hypertension is high blood pressure. Blood pressure is the force of blood pushing against the walls of arteries as it flows through them. According to the WHO and the American Heart Association, hypertension is usually defined in adults as a diastolic blood pressure of 90 mm Hg or greater, or a systolic blood pressure of 140 mm Hg or greater. High blood pressure directly increases the risk of coronary heart disease (which leads to heart attack) and stroke, especially along with other risk factors.

SITE Shines a Light

On the eve of the release of the third and fourth states’ results, sanofi-aventis is already witnessing SITE’s benefits.  Through partnerships with doctors, hospitals and other organizations in these eight states, SITE has raised disease awareness – of the risk factors, symptoms and treatment of diabetes, hypertension and other related conditions, such as cardiovascular diseases.  Moreover, greater awareness and literacy are not limited to the patients being screened.  Rather, their family members and friends no doubt benefit as well.  Moreover, these doctors’ enhanced awareness and capacity benefits all of their patients, not just SITE volunteers.

“Because health matters” is much more than sanofi-aventis’ motto.  It’s the inspiration behind our research – for the next compound and medicine that relieve suffering and save lives – as well as our public health activities.  Because health matters, SITE was launched.  And because SITE matters, lives are being saved, suffering relieved.

Sanofi-aventis in India

Sanofi-aventis is one of the world's leading pharmaceutical companies.In India, sanofi-aventis operates through two entities, Aventis Pharma Limited and Sanofi-Synthelabo (India) Limited, a wholly owned subsidiary of sanofi-aventis. Aventis Pharma Limited has 1,840 employees in India. It has state-of-the-art manufacturing facilities in Ankleshwar and Goa, where active pharmaceutical ingredients and formulations are manufactured. Sanofi-Synthelabo (India) Limited has around 275 employees. The two companies have offices in Mumbai, Chennai, Kolkata, and New Delhi.

References:

• International Diabetes Foundation, www.diabetesatlas.org/content/south-east-asia retrieved Oct. 5, 2010.
• K. Srinath Reddy et al., "Responding to the threat of chronic diseases in India," The Lancet,
• K. Srinath Reddy, "India Wakes Up to the Threat of Cardiovascular Diseases," Journal of the American College of Cardiology, 2007; 50: p. 1370.
• "Responding to the Threat," p. 2.
• "Responding to the threat," p. 2. 
• Karen Siegel et al., "Finding a Policy Solution to India's Diabetes Epidemic," Health Affairs, 2008; 27; 4: p. 1078.
• Ibid. p. 1080.