Weight Loss Benefits

Weight And Risk Factors
Before you decide to pursue a weight-loss program, you should understand the causes and health risks associated with being overweight. Here is some important information that may help motivate you to tackle this complex and serious health condition.

Why Are People Overweight?
Many people find it difficult to eat a low-calorie diet with so much high-calorie, high-fat food available -- just think of those enormous serving sizes of fast food and junk food. The consumption of excess fatty food and calories plays a significant role in the development of excess weight. While fat is an important component of a balanced diet, excess dietary fat contributes to excess body weight since fat provides twice the number of calories per gram of weight as carbohydrates and protein.

Evidence suggests that the "satiation signal" may not work well in people who are considerably overweight. In other words, during a meal, they don't develop the feeling "I've had enough to eat" early enough. This can lead to overeating and weight gain.

Low levels of physical activity can also lead to weight gain. If you don't burn off the calories you consume through your normal daily activities, they will be stored in your body as fat. The good news is that even moderate amounts of non-strenuous activity can reduce the risk of developing many serious diseases.

In addition to overeating and lack of physical activity, genetics, heredity, environment and socio-economics can all increase a person's risk of becoming considerably overweight.

Who Suffers from This Condition?
Excess weight is a problem facing an estimated 97 million adults in the U.S. Currently, about one-fifth of all U.S. adults are believed to be considerably overweight. Although people of all ages, races and ethnicity can become overweight, there are some people who are at greater risk than others. For example, women are more likely to become considerably overweight than are men, particularly in certain ethnic groups such as African-Americans and Mexican-Americans.

Does This Condition Lead to Other Serious Health Problems?
Excess weight has been proven to contribute to an increased risk of developing many medical problems, including high blood pressure, high cholesterol, heart disease, type 2 diabetes, breathing problems, sleep disorders, common arthritis and some forms of cancer. Research shows that 70% of people who are considerably overweight develop at least one other related health problem.

Obesity has also been linked to psychological problems such as poor self-esteem, loneliness, depression and excessive overeating or binge eating.

The good news is that losing weight can lower your risks of developing these and other health conditions. In fact, obesity is one of the most preventable causes of death - second only to smoking.

Health Risk of Obesity

The increasing prevalence of overweight and obesity in the United States and the corresponding incidence of obesity-related comorbidities underscore the need for preventing and treating the condition of obesity rather than focusing solely on its associated health risks.

As we know from the literature, obesity is closely associated with the increasing risk of a number of complications that can occur alone or concomitantly. These include hypertension, dyslipidemia, cardiovascular disease, stroke, type 2 diabetes, gallbladder disease, respiratory dysfunction, gout and osteoarthritis. And there are still others - certain cancers, for example.41

Chronic diseases, such as type 2 diabetes, hypertension and hypercholesterolemia, are frequent consequences of obesity. Data from the National Center for Health Statistics' Third National Health and Nutrition Examination Survey (NHANES III, 1988-1994) show that 65% of overweight and obese adults (BMI > 27) have at least one of these chronic diseases, and 27% have two or more.16

Further, the impact of these obesity-related comorbidities grows as patients gain weight; the risk of occurrence, prevalence and severity of these comorbidities are, in general, positively correlated with BMI.39,54,70 Epidemiological studies have found a curvilinear relationship between body weight and increasing risk of both mortality and morbidity. In fact, comorbid chronic disease is the major risk.



Multiple Risk Factors and Obesity

Chronic diseases, such as type 2 diabetes, hypertension and hypercholesterolemia, are frequent consequences of obesity. Data from the National Center for Health Statistics' Third National Health and Nutrition Examination Survey (NHANES III, 1988-1994) show that 65% of overweight and obese adults (BMI >27) have at least one of these chronic diseases, and 27% have two or more.

Further, the impact of these obesity-related comorbidities grows as patients gain weight; the risk of occurrence, prevalence and severity of these comorbidities are, in general, positively correlated with BMI. Epidemiological studies have found a curvilinear relationship between body weight and increasing risk of both mortality and morbidity. In fact, comorbid chronic disease is the major risk.

Type 2 Diabetes and Obesity

NHANES III found that approximately 12% of persons with a BMI of 27 or greater have type 2 diabetes. Of the medical conditions commonly termed "diabetes," type 2 is by far the most prevalent; it accounts for 85% to 90% of the diabetic population.

Obesity is a major risk factor for type 2 diabetes. In fact, this condition is largely a disease of the overweight; as many as 80% of these patients are obese.

Relative risk also increases with BMI in adults of both sexes. For example, in one study of a large cohort of women aged 30 to 55 (see figure below), the age-adjusted relative risk for type 2 diabetes - when compared with risk in those with a BMI of 22 or greater - was 15.8 for those with BMI 27.0 to 28.9 and 40.3 for those with BMI 31.0 to 32.9. Women with a BMI of 35.0 or greater were actually over 93 times more at risk for developing the disease.14 Moreover, African Americans, particularly those who are older and have a higher BMI, are at increased risk.

Weight loss improves health in patients with type 2 diabetes

It has been shown to “ameliorate insulin resistance, to improve carbohydrate tolerance and to reduce hyperglycemia and hyperinsulinemia.”

Published studies have shown that serum glucose levels began to improve within days after starting a weight-loss program – even on a moderately hypocaloric (1200 to 1500 calories/day) diet.48 Weight reduction in patients with type 2 diabetes also lead to increases in HDL cholesterol levels.

XENICAL is indicated for obesity management in patients with an initial body mass index (BMI) of 30 or more and in patients with a BMI of 27 or more in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia). After 6 months, 72% of patients lost 5% or more of their initial body weight, with a mean loss of 23 lbs. Weight loss has been shown to reduce or eliminate the need for diabetic drug therapy.It has also been demonstrated in a modest number of studies to improve abnormally low insulin sensitivity and coronary risk – promoting plasma lipoprotein levels found in obese subjects with the prediabetic condition known as syndrome X.

Specific Health Benefits:

Population with Abnormal (Untreated) Risk Factors at Randomization

Weight Loss with XENICAL Plus Diet: Improved Fasting Insulin
In patients with abnormal baseline values of fasting insulin(>120 pmol/L), weight loss with XENICAL plus diet resulted in a greater decrease in fasting insulin than placebo (-39 pmol/L vs. –16 pmol/L, respectively) from randomization to 1 year.

Population as a Whole

XENICAL Plus Diet: Successful Weight Loss

In clinical trials involving 1064 patients, 69% on XENICAL plus diet lost 3% or more of initial body weight within 3 months, with a mean loss of 13 lbs.

The mean change in fasting insulin was –6.7 pmol/L for patients on XENICAL plus diet and +0.58 for patients on placebo plus diet.

In clinical trials, the overall mean weight loss from randomization to the end of 1 year in the intent-to-treat population was 13.4 lbs in patients treated with XENICAL plus diet versus 5.8 lbs in placebo-treated patients.

Hypertension and Obesity

"Obesity is the major modifiable correlate of blood pressure"27 and a major factor in the development of hypertension. There is a 5 to 6 times greater risk of developing hypertension among those who are obese.

The Framingham study found that a 15% gain in weight was associated with an 18% increase in systolic blood pressure. Compared with those of normal weight, people who were 20% overweight had an eightfold greater incidence of hypertension.

Weight loss improves health in hypertensive patients

In a review of long-term studies of clinical effects of weight loss, the author observes, "Patients with [mild] hypertension can attain a clinically significant decrease in blood pressure or even achieve normal blood pressure long before achieving their ideal body weight." 47 In a comprehensive review, another author notes, "A loss of only 10% of initial body weight has been shown to reduce blood pressure significantly in overweight adults, and weight loss has been shown to prevent blood pressure elevation in individuals at risk for developing hypertension."

XENICAL is indicated for obesity management in patients with an initial body mass index (BMI) of 30 or more and in patients with a BMI of 27 or more in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia). After 6 months, 72% of patients lost 5% or more of their initial body weight, with a mean loss of 23 lbs. Weight loss may also reduce or eliminate the need for antihypertensive drug therapy in patients with mild hypertension. A major review found that "long-term studies have confirmed the effectiveness of weight reduction in reducing blood pressure and enabling some patients to become normotensive without the use of antihypertensive drugs and others to reduce the dosage of required drugs or the number of drugs taken."

Specific Health Benefits:

Population with Abnormal (Untreated) Risk Factors at Randomization

Weight Loss with XENICAL Plus Diet: Improved Blood Pressure
In the population with abnormal blood pressure at baseline (systolic BP >140 mm Hg), the change in systolic blood pressure from randomization to 1 year was greater for patients on XENICAL plus diet (-10.89 mm Hg) than for patients on placebo plus diet (-5.07 mm Hg). Patients with diastolic blood pressure >90 mm Hg on XENICAL plus diet also had greater results in diastolic blood pressure (-7.9 mm Hg) than those on placebo plus diet did (-5.5 mm Hg).

Population as a Whole

XENICAL Plus Diet: Successful Weight Loss

In clinical trials involving 1064 patients, 69% on XENICAL plus diet lost 3% or more of initial body weight within 3 months, with a mean loss of 13 lbs.

The mean change in systolic blood pressure was -1.01 mm Hg for patients on XENICAL plus diet and +0.58 mm Hg for patients on placebo plus diet. The mean change in diastolic blood pressure was -1.19 mm Hg for patients on XENICAL plus diet and +0.46 mm Hg for patients on placebo plus diet.

In clinical trials, the overall mean weight loss from randomization to the end of 1 year in the intent-to-treat population was 13.4 lbs in patients treated with XENICAL plus diet versus 5.8 lbs in placebo-treated patients.

Hypercholesterolemia and Obesity

Abnormal levels of blood lipids are associated with obesity.Approximately 38% of patients with a BMI of 27 or greater are hypercholesterolemic. In addition, high-density lipoprotein (HDL) levels and HDL/LDL (low-density lipoprotein) ratios are typically decreased in obesity (whereas triglyceride levels are generally increased), leading to greater risk of atherogenesis.

The Framingham study found that for every 10% increase in relative weight, plasma cholesterol increased by 12 mg/dL.

Weight loss with XENICAL plus diet improved lipid levels

Even a relatively small weight loss of 5% to 10% of initial body weight lowers levels of triglycerides, decreases total cholesterol and increases levels of HDL cholesterol - thereby improving the ratio of LDL cholesterol to HDL cholesterol and reducing the risk of atherosclerosis.

In one study, three times as many patients (25% on XENICAL plus diet versus 8% on placebo plus diet,P<0.001) lost 10% or more of their body weight from randomization (mean: 31 lbs; range: 18 to 67 lbs).

XENICAL is indicated for obesity management in patients with an initial body mass index (BMI) of 30 or more and in patients with a BMI of 27 or more in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia). After 6 months, 72% of patients lost 5% or more of their initial body weight, with a mean loss of 23 lbs. Weight loss with XENICAL plus diet has been shown to significantly reduce total and LDL cholesterol levels, increase HDL cholesterol and improve the LDL/HDL ratio.

Specific Health Benefits:

Population with Abnormal (Untreated) Risk Factors at Randomization

Weight Loss with XENICAL Plus Diet: Improved Lipid Levels
The changes from randomization following 1-year treatment in the population with abnormal lipid levels (LDL >130 mg/dL, LDL/HDL >3.5, HDL <35 mg/dL) were greater for patients on XENICAL plus diet compared to patients on placebo plus diet with respect to LDL cholesterol (-7.83% vs. +1.14%) and the LDL/HDL ratio (-0.64 vs. 0.46). HDL cholesterol increased in the placebo group by 20.1% and in the XENICAL group by 18.8%.< /P> < P > Population As A Whole

XENICAL Plus Diet: Successful Weight Loss

In clinical trials involving 1064 patients, 69% on XENICAL plus diet lost 3% or more of initial body weight within 3 months, with a mean loss of 13 lbs.

The mean change in total cholesterol was -2.0% for patients on XENICAL plus diet and +5.0% for patients on placebo plus diet. The mean change in LDL cholesterol was -4.0% for patients on XENICAL plus diet and +5.0% for patients on placebo plus diet. The mean change in HDL cholesterol was +9.3% for patients on XENICAL plus diet and +12.8% for patients on placebo plus diet.

In clinical trials, the overall mean weight loss from randomization to the end of 1 year in the intent-to-treat population was 13.4 lbs in patients treated with XENICAL plus diet versus 5.8 lbs in placebo-treated patients.