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Obesity Continuum of Care:
Behavior Modification Through
Pharmacotherapy and Surgery
Obesity Treatment Guidelines
www.nhlbi.nih.gov
www.naaso.org
Obesity Treatment Recommendations
Classification of Overweight and Obesity
by BMI, Waist Circumference and
Associated Disease Risks
Disease Risk Relative to Normal
Weight and Waist Circumference
Men (≤102 cm) ≤40 in
Women (≤88 cm) ≤35 in
Men (>102 cm) >40 in
Women (>88 cm) >35 in
< 18.5
--
--
Normal
18.5 – 24.9
--
--
Overweight
25.0 – 29.9
Increased
High
Obesity
30.0 – 34.9
I
High
Very High
35.0 – 39.9
II
Very High
Very High
> 40
III
Extremely High
Extremely High
BMI
(kg/m2)
Underweight
Extreme obesity
Obesity
Class
Additional risks:
Large waist circumference (men > 40 in; women > 35 in)
Poor aerobic fitness
Specific races and ethnic groups
Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in
Adults—The Evidence Report. Obes Res 1998;6(suppl 2).
Metabolic Syndrome:
NCEP ATP III compared to IDF
Risk Factor
ATP III *
IDF**
Central Adiposity (defined by
waist circumference)
M (waist)
> 40 in (> 102 cm)
≥ 37 in (≥ 94 cm)
F
> 35 in (> 88 cm)
≥ 31.5 in (≥ 80 cm)
≥ 150 mg/dL
(≥ 1.7 mmol/L)
≥ 150 mg/dL
(≥ 1.7 mmol/L)
< 40 mg/dL
(< 1.03 mmol/L)
< 40 mg/dL
(< 1.03 mmol/L)
< 50 mg/dL
(< 1.0 mmol/L)
< 50 mg/dL
(< 1.0 mmol/L)
Blood Pressure
≥ 130/≥ 85 mm Hg
≥ 130/≥ 85 mm Hg
Fasting Glucose
≥ 110 mg/dL
(≥ 6.1 mmol/L)
≥ 100 mg/dL
(≥ 5.6 mmol/L)
Triglycerides
HDL-C
M
F
* requires presence of 3 or more criteria
** requires central adiposity and presence of 2 more criteria
Insulin Resistance (HOMA)
Metabolic Risk Identified by
“Hypertriglyceridemic Waist”
waist
TG
waist
TG
waist
TG
waist
TG
Waist = 95 cm M
88 cm F
TG = 128 mg/dl
Men
Women
Age 18-34
•Cutpoints are lower with increased risk
Kahn and Valdez. AJCN 2003;78:928-34
Men
Women
Age 55-74
Obesity Treatment Pyramid
BMI  40
Surgery
35
Pharmacotherapy
30
Lifestyle Modification
Diet
Physical Activity
25
A Guide to Selecting Treatment
BMI Category
Treatment
25 - 26.9
27 – 29.9
30 – 34.9
35 – 39.9
≥ 40
Diet, physical
activity, and
behavior
With
co-morbidity
+
+
+
+
With
co-morbidity
+
+
+
With
co-morbidity
+
Pharmacotherapy
Surgery
The Practical Guide. 2000.
Assessing Readiness
•
•
•
•
•
Why now?
What changes will you have to make?
What will change if you lose weight?
What do others think about your weight?
What else is going on in your life?
Assessing Readiness
• We are not good at predicting outcomes.
• Patients ultimately make the decision.
• Providers assess costs/benefits in a variety of
contexts.
5 Steps to Behavior Change
1. Have patient identify specific goals
– Activity (i.e., one specific goal for exercise)
– Intake (i.e., one specific goal for diet)
2. Identify when, where, and how behaviors will be
performed
3. Have patient keep record of behavior change
(i.e., diet and activity diaries)
4. Follow-up progress at next treatment visit
5. Congratulate patient on successes; do not
criticize shortcomings
Wadden & Foster. Medical Clinics of North America, 2000.
Patient’s Dietary Intake and Trends
• 70% of American adults say they are eating “pretty much
whatever they want”1
• Caloric intake has increased by 300 calories per person
per day from 1985-20001
–
–
–
–
–
Refined grains accounted for 46% of increase
Added fats: 24% of increase
Added sugars: 23% of increase
Fruits and vegetables: 8% of increase
Meat and dairy declined
• Americans will spend 47% of their food dollar in
restaurants in 20052
1
Putnam J et al. USDA FoodReview, Vol 25 (3); 2002.
www.restaurant.org/pressroom/pressrelease.cfm?ID=979, obtained 3/14/05.
2
New Food Pyramid &
Dietary Guidelines
www.mypyramid.gov and www.healthierus.gov/dietaryguidelines
MyPyramid.gov
• Website designed for easy patient use
• MyPyramid plan provides estimates of amounts
of food by a patients entering their age, sex and
activity level
• Assessment of food intake and physical activity
levels available on MyPyramid Tracker
• Other advice and tips available at “Inside
MyPyramid”
Dietary Factors to Address
Fat
Fruits and
Vegetables
Eating Out
Portion Size
Fiber
Caloric
Beverages
One “Diet” Does Not Fit All
Comparison of Popular Diets
Mean Changes in Weight and Cardiac Risk at 12 Months
Atkins
Zone
Weight, kg
Weight Watchers
Ornish
Waist circumference, cm Total cholesterol, mg/dl
0
-2
Mean Change
-2.1
-4
-3.2 -3.0 -3.3
-2.5
-2.2
-2.9
-3.3
-3.0
-6
-8
-8.2
-10
-10.1
-12
Dansinger, et al. JAMA 2005;293:43-53.
-10.8
Meal Replacements Promote
Long and Short term Weight Loss
*1200–1500 kcal/d diet prescription
A: conventional foods
B: meal and snack replacement for 1 meal, 1 snack
Fletchner-Mors et al. Obes Res 2000;8:399.
“Do not judge the impact of physical
activity by weight loss”
Dr. Steve Blair - Cooper Institute
September 20, 2004
Why the difference in impact for
physical activity between weight
loss and weight loss maintenance?
Differences Between Weight Loss
and Weight Loss Maintenance
Weight Loss
Maintenance of Weight Loss
• Time limited
• Requires a negative energy
balance
• Reduced caloric intake is
critical
• Physical activity not required
for success
• Common
• Life-long
• Requires energy balance at
a reduced body weight
• Physical activity is critical for
success
• Rare
How Much is Enough?
Current Physical Activity
Recommendations
• Minimal public health recommendations to improve
health related outcomes
– 30 min moderate activity most days of the week (150
minutes/week)
– CDC - Centers for Disease Control
– ACSM - American College of Sports Medicine
– SG - Surgeon General
• Maximize weight loss and prevent weight regain
– 45-60 minutes/day
– IOM - Institutes of Medicine
– 60-90 minutes/day
– IASO - International Assoc for Study of Obesity
– 60 minutes/day (300 minutes/week)
– ACSM - American College Sports Medicine
• Preventing general weight gain
– Unclear
Principles of Obesity Medication Use
•
Lifestyle interventions are the foundation of medicating for obesity
–
•
The benefits of modest (5 - 10% of body weight) should be emphasized
The behavioral approach should be implemented with knowledge of the
medication’s mechanism of action
–
–
Orlistat with 30% fat diet
Sibutramine with meal plan that takes advantage of its satiety promotion
•
Obesity medications do not cure obesity, just as antihypertensives do
not cure hypertension
•
Not all patients respond to a weight loss medication.
–
•
If the drug’s use is not associated with weight loss within four weeks, it
should be stopped
Medications work as long as they are used
–
Weight gain occurs on stopping medications, although there is some
evidence in support of efficacy of intermittent medication
Antiobesity Drugs Approved for
Long-Term Use: How They Work
Sibutramine
Orlistat
• FDA approved 1997
• FDA approved 1999
• Induces feeling of satiety
• Reduces absorption of
~30% dietary fat
– Less preoccupation, feeling
satisfied with less food
– Greater control of food
intake
– Need to monitor BP early in
program
• Once daily with or without
food
– Fat in diet passes
undigested
– Facilitates weight loss
– GI side effects
• 3 times daily with meals
and a vitamin supplement
recommended
Sibutramine Key Facts
• Multiple large clinical trials demonstrating:
• Dose-related weight loss occurs for 6 months
• Amount of weight loss related to intensity of behavioral
approach
• Efficacy in weight loss maintenance demonstrated ≥ 2
years
• Weight loss produces benefits in lipids, body composition
and is associated with mean blood pressure decrease
• Trials in patients with hypertension and diabetes
• Favorable side effect profile:
• No abuse potential
• No valvuloplasty, no PPH
• Cautions
• Blood pressure should be monitored
• Should not use with MAOIs, erythromycin, ketoconazole
The Amount of Weight Loss with
Sibutramine Is Related to the Intensity
of the Behavioral Intervention*
% Weight Change at 6 months
0
Sibutramine
Sibutramine
+ Group
Sessions
Sibutramine
+ Group Sessions
+ Meal
Replacements
-2
-4
-6
-5.2
-8
-10
-12
-11.5
-14
-16
-18
-20
* Weight loss at 6 months
Wadden TA et al. Arch Intern Med 2001;161:218-227.
-17.1
STORM: 77% (ITT) Achieved > 5%
Weight Loss at Six Months
Weight Loss
230
Weight Maintenance
Body Weight (lb)
Placebo
225
220
215
210
205
200
Sibutramine
195
0
2
4
6
8
10 12 14 16 18 20 22 24
Month
*Same diet, exercise for sibutramine, placebo;
P  0.001, sibutramine vs placebo for weight maintenance
James WPT et al. Lancet. 2000;356:2119.
Waist Circumference (in.)
Weight Loss with Sibutramine Is Associated
with Improvement in Waist Circumference
(STORM
data)
44
43
Placebo
42
41
40
Sibutramine
39
38
0
2
4
6
8
10
12
14
16
18
20
22
Month
NB: Same diet and exercise for both sibutramine and placebo
James WPT et al. Lancet. 2000;356:2119.
24
Weight Loss with Sibutramine Is
Associated with Improvements in Lipids
(STORM Data)
5
Triglycerides
5
0
VLDL-Cholesterol
0
Placebo
–5
% Change
% Change
–5
–10
†

–15

*

*

–10

–15
Sibutramine
*

–20


‡
§







–20
Placebo
Sibutramine
–25
–25
0
6
12
18
Month Assessed
24
0
25
6
HDL-Cholesterol
*

20
% Change

Weight loss = months 1–6;
Weight maintenance = months 7–24;
*P < 0.001; †P = 0.002; ‡P = 0.005;
§P = 0.001 vs placebo
12
18
Month Assessed
*



15
Placebo
10
5


Adapted with permission from James WPT
et al. Lancet. 2000;356:2119.
Sibutramine
0
0
6
12
18
Month Assessed
24
24
Dose Related Effects of Sibutramine
on Systolic Blood Pressure (SBP)
Placebo
Change in SBP (mmHg)
10
n=1944
Sibutramine
Sibutramine Sibutramine
Sibutramine
n=1318
n=1924
n=128
10 mg
15 mg
20 mg
n=1126
30 mg
8
6
+3.8
4
+2.6
+1.0
2
0
-1
-0.1
-0.1
*
*
* p < 0.05 compared to placebo
**The shaded area represents doses not approved for use by the FDA.
Data on file, Abbott Laboratories.
*
Sibutramine: Effect on Blood Pressure
•
Mean BP changes in recommended dose range is ~ 1 mm Hg
increase
•
A few, < 5%, have unacceptable blood pressure increases while on
sibutramine
•
Significant weight loss, > 5%, is associated with mean BP decrease
on sibutramine
•
BP effects of sibutramine are blocked by beta blockers1
•
BP effects of sibutramine are blocked by exercise program2
•
In addition to peripheral effects, sibutramine may have central
“clonidine-like” sympatholytic effects1
•
BP changes are usually seen in the first four weeks of therapy (need
to add reference for this)
1.
2.
Birkenfeld AL et al. Circulation 2002;106: 2459-2465.
Berube-Parent S et al. IJO 2001;25: 1144-1153.
Tips for Managing Patients on
Sibutramine
• Start at 10 mg once daily
• Prescribe a sensible diet
–
–
Meal replacements for two meals and two snacks + one
sensible meal per day
Portion controlled diet with at least three meals per day
• Follow-up:
–
–
4 pounds weight loss in first 4 weeks helps predict success
Monitor blood pressure. Use clinical judgement about
continuing
• Increase dose to increase weight loss, provided BP is
well controlled. Decrease dose or discontinue for BP
concerns
• Stay within recommended dose range of 5 to 15 mg
• Encourage long term use
Orlistat: Key Facts
• Multiple large clinical trials demonstrating
• Weight loss occurs for 6 months
• Efficacy in weight loss maintenance demonstrated
≥ 4 years
• Weight loss produces benefits in glycemic control,
lipids, waist circumference, BP
• Trials in persons with diabetes and hypertension
• Independent action on LDL cholesterol
• Favorable side effect profile
• No abuse potential
• No valvulopathy, no PPH
• Cautions
• Vitamin supplement required for long term use
• May interfere with cyclosporin absorption
• Likely to be available over the counter in 2006
Effect of Long-Term Treatment With
Orlistat (The XENDOS Study)
Weight change (kg)
Completers Data
0
Placebo + lifestyle
Orlistat + lifestyle
(n=557)
(n=853)
-3
-4.1 kg
-6
-6.9 kg
-9
-12
0
52
104
156
208
Week
p < 0.001 vs placebo
Torgerson JS et al, Diabetes Care 2004; 27(1): 155-61.
Effect of Orlistat on Weight and
Body Composition in Obese
Adolescents
• 54-week multi-center, double-blind, placebo-controlled
study
• 539 obese adolescents, aged 12-16 (357 receiving
orlistat 120 mg three times daily, 182 receiving placebo)
• Baseline BMI – 2 units > than US weighted mean for the
95th percentile based on age and gender
• Patients placed on reduced-calorie diet and behavior
modification program
• 65% of patients in each treatment group completed
study
Chanoine JP, JAMA 2005 Jun 15;293(23):2873-83.
Obese Adolescents with ≥ 5% and ≥ 10%
Decrease in BMI and Body Weight after 1Year Treatment*
Intent-to-Treat Population†
≥ 5% Decrease
Orlistat
n
Placebo
≥ 10% Decrease
n
Orlistat
n
Placebo
n
BMI
26.5%
347 15.7%
178 13.3%
347 4.5%
178
Body
Weight
19.0%
348 11.7%
180 9.5%
348 3.3%
180
* Treatment designates orlistat 120 mg three times a day plus
diet or placebo plus diet.
† Last observation carried forward.
Chanoine JP, JAMA 2005 Jun 15;293(23):2873-83.
Tips for Managing Patients on
Orlistat
• Discuss potential bowel effects and mechanism with
patient
• Start at 120 mg before each meal
• Prescribe a moderate fat diet
–
•
•
•
•
Caution patients about high fat meal or snack
Metamucil has been shown to reduce bowel effects
For long term use, prescribe a multivitamin
Orlistat can interfere with cyclosporin absorption
Encourage long term use.
Obesity Pharmacotherapy Summary
• Medications approved for long-term use
–
–
sibutramine (Meridia)
orlistat (Xenical)
• Medications approved for short-term use
–
–
phentermine
others rarely used: mazindol, diethylpropion
• Medications for use in special patients
–
–
–
the depressed obese patient – bupropion (Wellbutrin) and venlafaxine
(Effexor)
type 2 diabetes – metformin , pramlintide (Symlin), exendin-4
(Exenatide)
patients with neuropsychiatric problems – topiramate (Topamax) and
zonisamide (Zonegran)
• Medications in development
–
rimonabant (Acomplia)
Bariatric Surgery: Recommendations
for Patient Selection
•
•
•
•
Between ages 18 and 50
Stable preoperative weight for 3-5 years
Smoking cessation for at least 6 weeks
Those with psychiatric history require careful
assessment
• Tests to predict success of surgery:
– Personality factors
– Eating habits
– Motivation
Grace DM. Gastroenterol Clin North Am. 1987;16:399.
Recommendations for Patient
Selection- NIH Guidelines
• Motivated subjects with acceptable surgical risks
with
– BMI ≥ 40
– OR
– BMI ≥ 35 with comorbid conditions
Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in
Adults—The Evidence Report. Obes Res 1998;6(suppl 2).
Update: Bariatric Surgery
Currently Popular Procedures
LapBandTM
Restriction
Gastric Bypass
Malabsorption
Bariatric Surgery: Mechanisms
• Operations dramatically restrict gastric size,
reducing nutritional intake
• Some types of surgery decrease the absorption
efficiency of nutrients
– Roux-en-Y gastric bypass
– Biliopancreatic diversion (BPD)
• Malabsorption procedures create a greater risk
for nutritional deficiencies
Bariatric Surgery: Side Effects &
Complications
1 in 200-300 patients in the US die from bariatric surgery
•
•
•
•
•
•
•
•
•
Iron deficiency
Vitamin B12 deficiency
Folic Acid deficiency
Dehydration
Vitamin A deficiency
Electrolyte deficiency
Protein deficiency
Hyperparathyroidism
Follow up of nutritional and
metabolic problems after
bariatric surgery
•
•
•
•
•
•
•
•
Nausea
Vomiting
Abdominal pain
Constipation
Marginal ulceration
Gallstones
Bleeding ulcer
Obstruction of the stomach outlet
Fujioka K, Diabetes Care 28:481-484,2005.
Shikora SA. Nutrition in Clinical Practice. 2000;15:13.
www.mayoclinic.com. Surgery for obesity: What is it and is it for you?. Accessed February 15, 2005.
Bariatric Surgery: Mortality
• Roux-en-Y gastric bypass surgery appears to
have a mortality rate ranging from 0.3% (95%
CI, 0.2% to 0.4%) from case series data to 1.0%
(95% CI, 0.5% to 1.9%) in controlled trials.
• Adjustable gastric banding appears to have an
early mortality rate of 0.4% (95% CI, 0.01% to
2.1%) for controlled trials and 0.02% (95% CI,
0.9% to 0.78%) for case series data.
• No statistically significant difference in mortality
seen between procedures.
Snow V. Ann Int Med 2005;142:525-531.
Surgical Volume and Mortality
• Surgical technique involved a significant learning
curve
• Centers that perform more procedures have a
lower mortality rate
• One study (Flum D, et al) found surgeons who
performed fewer than 20 procedures had patient
mortality rates of 5%, as compared with a near
0% mortality for surgeons who had performed
250 or more procedures.
Snow V. Ann Int Med 2005;142:525-531.