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Xenical® (Orlistat)
Product and disease Overview
What is Obesity?
• Obesity is a condition where a person has accumulated so
much body fat that it might have a negative effect on their
health.
• If a person's bodyweight is at least 20% higher than it should
be, he or she is considered obese. If your Body Mass Index
(BMI) is between 25 and 29.9 you are considered overweight.
If your BMI is 30 or over you are considered obese
What is Body Mass Index (BMI)?
• The body mass index (BMI) is a statistical measurement
derived from your height and weight. Although it is
considered to be a useful way to estimate healthy body
weight, it does not measure the percentage of body fat. The
BMI measurement can sometimes be misleading - a
muscleman may have a high BMI but have much less fat than
an unfit person whose BMI is lower. However, in general, the
BMI measurement can be a useful indicator for the 'average
person.
Why do people become obese?
lifestyle
calories
Not sleeping
enough
Endocrine
disruptors
Lower rates
of smoking
self-
perpetuating
obesity
Medications
Obesity
gene
Eating too many calories
• These days people are eating much more food than in
previous generations. This used to be the case just in
developed nations - however, the trend has spread
worldwide.
• Despite billions of dollars being spent on public awareness
campaigns that attempt to encourage people to eat healthily,
the majority of us continue to overeat.
Sedentary lifestyle
• With the arrival of televisions, computers, video games,
remote controls, washing machines, dish washers and other
modern convenience devices, people are commonly leading a
much more sedentary lifestyle compared to their parents and
grandparents.
• The less you move around the fewer calories you burn.
However, this is not only a question of calories. Physical
activity has an effect on how your hormones work, and
hormones have an effect on how your body deals with food.
Several studies have shown that physical activity has a
beneficial effect on your insulin levels - keeping them stable.
Unstable insulin levels are closely associated with weight gain.
• Children who have a television in their bedroom are much
more likely to be obese or overweight than kids who do not,
researchers from the Pennington Biomedical Research Center
in Baton Rouge, LA, reported in the American Journal of
Preventive Medicine (December 2012 issue).
Not sleeping enough
• Research carried out at Warwick Medical School at
the University of Warwick suggested that if you do
not sleep enough your risk of becoming obese
doubles.. Professor Francesco Cappuccio reviewed
evidence in over 28,000 children and 15,000 adults.
Their evidence clearly showed that sleep deprivation
significantly increased obesity risk in both groups.
• Professor Cappuccio explains that sleep deprivation
may lead to obesity through increased appetite as a
result of hormonal changes. If you do not sleep
enough you produce Ghrelin, a hormone that
stimulates appetite. Lack of sleep also results in your
body producing less Leptin, a hormone that
suppresses appetite
Endocrine disruptors, foods that
interfere with lipid metabolism.
• A team from the University of Barcelona (UB) led by Dr Juan
Carlos Laguna published a study in the journal Hepatology
that provides clues to the molecular mechanism through
which fructose (a type of sugar) in beverages may alter lipid
energy metabolism and cause fatty liver and metabolic
syndrome.
• Fructose is mainly metabolized in the liver, the target organ of
the metabolic alterations caused by the consumption of this
sugar.
smoking suppresses appetite
• According to the National Institutes of Health (NIH) "Not
everyone gains weight when they stop smoking. Among
people who do, the average weight gain is between 6 and 8
pounds. Roughly 10 percent of people who stop smoking gain
a large amount of weight - 30 pounds or more."
Is obesity self-perpetuating?
• The longer a person is overweight, the
harder it becomes for them to lose
weight. Many have wondered whether
obesity itself becomes a permanent state,
i.e. does obesity promote obesity?.
• Researchers from the University of Michigan
and the National Council of Science and
Technology (COINCET) in Argentina, reported
in the Journal of Clinical Investigation that in
animal experiments, obesity seems to
become a self-perpetuating state.
Obesity gene
• A faulty gene, called FTO, makes 1 in every 6 people overeat, a
team of scientists from University College London reported in
the Journal of Clinical Investigation (July 2013 issue).
Lead researcher, Racher Batterham, explained that people
who carry the FTO gene variant tend to eat too much, prefer
high-energy, fatty foods, and are usually obese. They also
appear to take much longer to reach satiety (feeling of being
full).
WHO 2013
 The latest WHO projections indicate that at least one in three
of the world's adult population is overweight and almost one
in 10 is obese. Additionally there are over 40 million children
under age five who are overweight.
 Being overweight or obese can have a serious impact on
health. Carrying extra fat leads to serious health
consequences such as cardiovascular disease (mainly heart
disease and stroke), type 2 diabetes, musculoskeletal
disorders like osteoarthritis, and some cancers (endometrial,
breast and colon). These conditions cause premature death
and substantial disability.
WHO 2013
 What is not widely known is that the risk of health problems
starts when someone is only very slightly overweight, and that
the likelihood of problems increases as someone becomes more
and more overweight. Many of these conditions cause long-
term suffering for individuals and families. In addition, the costs
for the health care system can be extremely high.
 The good news is that overweight and obesity are largely
preventable. The key to success is to achieve an energy balance
between calories consumed on one hand, and calories used on
the other hand
What is XENICAL?
• XENICAL therapeutic category: gastrointestinal lipase inhibitor
• Indicated in conjunction with a mildly hypo caloric diet for
treatment of obese patients with a BMI ≥ 30 kg/m², or
overweight patients (BMI > 28 kg/m²) with associated risk
factors.
• It is used to loose weight and maintain weight loss
Xenical Summary of Product Characteristics
Mode of Action of XENICAL
• Xenical binds to the lipase enzyme in the stomach and
intestine and inhibits its action
• Prevents the absorption of dietary fat by 30%
• Undigested fat is eliminated in the faeces.
Xenical US Prescribing Information
Acts Non Systemically
Xenical Summary of Product Characteristics
Contraindications:
- Hypersensitivity to the active substance or to
any of the excipients.
- Chronic malabsorption syndrome.
- Cholestasis
- Breast-feeding
Dosage and Administration:
• Recommended dose of XENICAL is one capsule, 3  daily
taken with water immediately before or with each main
meal or up to 1 hour after the meal
• If a meal is missed or contains no fat, the dose should be
skipped.
• In order to ensure adequate vitamins intake, patients
following a diet should be advised to have a diet rich in
fruits or vegetables and the use of multivitamin
supplement could be recommended.
• When indicated multivitamins should be taken at least 2
hours after taking Xenical or before going to bed
• Xenical capsules should be stored below 250C.
Xenical Summary of Product Characteristics
Efficacy of XENICAL:
• Xenical can reduce 5% to 10% of the body weight when
accompanied with lifestyle modification.
• Studies have also shown its efficacy among the adolescent
age group (12-16 years) with no major safety issues (except
common GI adverse events).
1. Xenical Summary of Product Characteristics
2. Chanoine JP et al. Effect of Orlistat on weight and body composition in obese adolescents. JAMA. 2005;293:2873-2883
Eat less fat
Reduce meal portion size
Increase physical activity
Xenical + lifestyle modification resulted in statistically superior
weight loss both in short and long term
-10.6
-6.2 -5.8
-3
-12
-10
-8
-6
-4
-2
0
1 year 4 years
Xenical +diet
Placebo +diet
LSMweightloss(kg)
LSM: lean squares mean
p<0.001 p<0.001
Torgerson JS, et al. Diabetes Care 2004; 27(1):155–61.
XENDOS study
Xenical plus diet produces significantly more weight loss than
diet alone in obese diabetic patients
49
23
18
9
0
10
20
30
40
50
≥ 5% Weight Loss ≥ 10% Weight Loss
Xenical 120mg
tid (n=139)
Placebo
Percentage of patients with type II diabetes mellitus who had lost ≥5%
and ≥ 10 % of initial body weight at 1 year
%ofPatients
p<0.001 p=0.017
Hollander et al. Diabetes Care 1998;21; 1288-1294
Better management of
obese type II diabetes
Xenical reduces Total Cholesterol and LDL-C
levels
-11.9
-4
-17.6
-7.6
-20
-15
-10
-5
0
Total Cholesterol LDL cholesterol
Xenical +diet
Placebo +diet
MeanChange(%)
p<0.001 p<0.001
Muls E et al .Int J Obes Relat Metab Disor 2001;25(11): 1713-21
Safety Profile:
• Because the drug is not systemically absorbed, most adverse
effects are limited to the gastrointestinal tract.
• Most commonly reported adverse events are GI symptoms :
fatty and oily stools
• Generally mild, transient side effects and decrease with time.
• GI events linked to high fat intake.
Xenical Summary of Product Characteristics
Take home message!
 Xenical can be used to loose weight in patients with risk
factors such as type 2 DM, hypertension and hyperlipidemia.
 It can be used to maintain weight loss.
 Xenical has a well characterized safety profile.
xenixal presentation done by heba to al razi team

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xenixal presentation done by heba to al razi team

  • 2. What is Obesity? • Obesity is a condition where a person has accumulated so much body fat that it might have a negative effect on their health. • If a person's bodyweight is at least 20% higher than it should be, he or she is considered obese. If your Body Mass Index (BMI) is between 25 and 29.9 you are considered overweight. If your BMI is 30 or over you are considered obese
  • 3. What is Body Mass Index (BMI)? • The body mass index (BMI) is a statistical measurement derived from your height and weight. Although it is considered to be a useful way to estimate healthy body weight, it does not measure the percentage of body fat. The BMI measurement can sometimes be misleading - a muscleman may have a high BMI but have much less fat than an unfit person whose BMI is lower. However, in general, the BMI measurement can be a useful indicator for the 'average person.
  • 4. Why do people become obese? lifestyle calories Not sleeping enough Endocrine disruptors Lower rates of smoking self- perpetuating obesity Medications Obesity gene
  • 5. Eating too many calories • These days people are eating much more food than in previous generations. This used to be the case just in developed nations - however, the trend has spread worldwide. • Despite billions of dollars being spent on public awareness campaigns that attempt to encourage people to eat healthily, the majority of us continue to overeat.
  • 6. Sedentary lifestyle • With the arrival of televisions, computers, video games, remote controls, washing machines, dish washers and other modern convenience devices, people are commonly leading a much more sedentary lifestyle compared to their parents and grandparents. • The less you move around the fewer calories you burn. However, this is not only a question of calories. Physical activity has an effect on how your hormones work, and hormones have an effect on how your body deals with food. Several studies have shown that physical activity has a beneficial effect on your insulin levels - keeping them stable. Unstable insulin levels are closely associated with weight gain.
  • 7. • Children who have a television in their bedroom are much more likely to be obese or overweight than kids who do not, researchers from the Pennington Biomedical Research Center in Baton Rouge, LA, reported in the American Journal of Preventive Medicine (December 2012 issue).
  • 8. Not sleeping enough • Research carried out at Warwick Medical School at the University of Warwick suggested that if you do not sleep enough your risk of becoming obese doubles.. Professor Francesco Cappuccio reviewed evidence in over 28,000 children and 15,000 adults. Their evidence clearly showed that sleep deprivation significantly increased obesity risk in both groups. • Professor Cappuccio explains that sleep deprivation may lead to obesity through increased appetite as a result of hormonal changes. If you do not sleep enough you produce Ghrelin, a hormone that stimulates appetite. Lack of sleep also results in your body producing less Leptin, a hormone that suppresses appetite
  • 9. Endocrine disruptors, foods that interfere with lipid metabolism. • A team from the University of Barcelona (UB) led by Dr Juan Carlos Laguna published a study in the journal Hepatology that provides clues to the molecular mechanism through which fructose (a type of sugar) in beverages may alter lipid energy metabolism and cause fatty liver and metabolic syndrome. • Fructose is mainly metabolized in the liver, the target organ of the metabolic alterations caused by the consumption of this sugar.
  • 10. smoking suppresses appetite • According to the National Institutes of Health (NIH) "Not everyone gains weight when they stop smoking. Among people who do, the average weight gain is between 6 and 8 pounds. Roughly 10 percent of people who stop smoking gain a large amount of weight - 30 pounds or more."
  • 11. Is obesity self-perpetuating? • The longer a person is overweight, the harder it becomes for them to lose weight. Many have wondered whether obesity itself becomes a permanent state, i.e. does obesity promote obesity?. • Researchers from the University of Michigan and the National Council of Science and Technology (COINCET) in Argentina, reported in the Journal of Clinical Investigation that in animal experiments, obesity seems to become a self-perpetuating state.
  • 12. Obesity gene • A faulty gene, called FTO, makes 1 in every 6 people overeat, a team of scientists from University College London reported in the Journal of Clinical Investigation (July 2013 issue). Lead researcher, Racher Batterham, explained that people who carry the FTO gene variant tend to eat too much, prefer high-energy, fatty foods, and are usually obese. They also appear to take much longer to reach satiety (feeling of being full).
  • 13. WHO 2013  The latest WHO projections indicate that at least one in three of the world's adult population is overweight and almost one in 10 is obese. Additionally there are over 40 million children under age five who are overweight.  Being overweight or obese can have a serious impact on health. Carrying extra fat leads to serious health consequences such as cardiovascular disease (mainly heart disease and stroke), type 2 diabetes, musculoskeletal disorders like osteoarthritis, and some cancers (endometrial, breast and colon). These conditions cause premature death and substantial disability.
  • 14. WHO 2013  What is not widely known is that the risk of health problems starts when someone is only very slightly overweight, and that the likelihood of problems increases as someone becomes more and more overweight. Many of these conditions cause long- term suffering for individuals and families. In addition, the costs for the health care system can be extremely high.  The good news is that overweight and obesity are largely preventable. The key to success is to achieve an energy balance between calories consumed on one hand, and calories used on the other hand
  • 15. What is XENICAL? • XENICAL therapeutic category: gastrointestinal lipase inhibitor • Indicated in conjunction with a mildly hypo caloric diet for treatment of obese patients with a BMI ≥ 30 kg/m², or overweight patients (BMI > 28 kg/m²) with associated risk factors. • It is used to loose weight and maintain weight loss Xenical Summary of Product Characteristics
  • 16. Mode of Action of XENICAL • Xenical binds to the lipase enzyme in the stomach and intestine and inhibits its action • Prevents the absorption of dietary fat by 30% • Undigested fat is eliminated in the faeces. Xenical US Prescribing Information
  • 17. Acts Non Systemically Xenical Summary of Product Characteristics
  • 18. Contraindications: - Hypersensitivity to the active substance or to any of the excipients. - Chronic malabsorption syndrome. - Cholestasis - Breast-feeding
  • 19. Dosage and Administration: • Recommended dose of XENICAL is one capsule, 3  daily taken with water immediately before or with each main meal or up to 1 hour after the meal • If a meal is missed or contains no fat, the dose should be skipped. • In order to ensure adequate vitamins intake, patients following a diet should be advised to have a diet rich in fruits or vegetables and the use of multivitamin supplement could be recommended. • When indicated multivitamins should be taken at least 2 hours after taking Xenical or before going to bed • Xenical capsules should be stored below 250C. Xenical Summary of Product Characteristics
  • 20. Efficacy of XENICAL: • Xenical can reduce 5% to 10% of the body weight when accompanied with lifestyle modification. • Studies have also shown its efficacy among the adolescent age group (12-16 years) with no major safety issues (except common GI adverse events). 1. Xenical Summary of Product Characteristics 2. Chanoine JP et al. Effect of Orlistat on weight and body composition in obese adolescents. JAMA. 2005;293:2873-2883
  • 24.
  • 25. Xenical + lifestyle modification resulted in statistically superior weight loss both in short and long term -10.6 -6.2 -5.8 -3 -12 -10 -8 -6 -4 -2 0 1 year 4 years Xenical +diet Placebo +diet LSMweightloss(kg) LSM: lean squares mean p<0.001 p<0.001 Torgerson JS, et al. Diabetes Care 2004; 27(1):155–61. XENDOS study
  • 26. Xenical plus diet produces significantly more weight loss than diet alone in obese diabetic patients 49 23 18 9 0 10 20 30 40 50 ≥ 5% Weight Loss ≥ 10% Weight Loss Xenical 120mg tid (n=139) Placebo Percentage of patients with type II diabetes mellitus who had lost ≥5% and ≥ 10 % of initial body weight at 1 year %ofPatients p<0.001 p=0.017 Hollander et al. Diabetes Care 1998;21; 1288-1294 Better management of obese type II diabetes
  • 27. Xenical reduces Total Cholesterol and LDL-C levels -11.9 -4 -17.6 -7.6 -20 -15 -10 -5 0 Total Cholesterol LDL cholesterol Xenical +diet Placebo +diet MeanChange(%) p<0.001 p<0.001 Muls E et al .Int J Obes Relat Metab Disor 2001;25(11): 1713-21
  • 28. Safety Profile: • Because the drug is not systemically absorbed, most adverse effects are limited to the gastrointestinal tract. • Most commonly reported adverse events are GI symptoms : fatty and oily stools • Generally mild, transient side effects and decrease with time. • GI events linked to high fat intake. Xenical Summary of Product Characteristics
  • 29. Take home message!  Xenical can be used to loose weight in patients with risk factors such as type 2 DM, hypertension and hyperlipidemia.  It can be used to maintain weight loss.  Xenical has a well characterized safety profile.