Transcript Document

Bariatric Surgery
Ruban Nirmalan
Medical Director, IUH Arnett Bariatrics
Disclosures
• None
7/7/2015
2
Review of Today’s Topics
• Impact of Obesity
• Weight Loss Makes a Difference
• Surgical Options for Weight Loss
• Safety and Effectiveness of Adjustable Gastric Banding
System vs. Other Surgical Options
• Adjustable gastric band Is Effective in Obese and
Moderately Obese Patients
• Gradual Weight Reduction With Gastric Band Results in
Better Quality of Weight Loss
3
Impact of Obesity
7/7/2015
4
Classification of Overweight and Obesity by Body Mass Index
(BMI), Waist Circumference and Associated Disease Risk*
NorNormal1Weigh
t1 (BMI 18.5 to 24.9)
Overweight1
Obese1
Moderate Obesity1
Morbid Obesity1
(BMI 25 to 29.9)
(BMI 30 to 34.9)
(BMI 35 to 39.9 )
(BMI 40 or more)
Class I
Obesity
Class II Obesity
Class III
Obesity
Disease Risk*
―
Increased
High
Very high
Extremely high
• Additional Risks:
– Large waist circumference (men >40 in; women >35 in)1
– Weight gain of as little as 11 pounds increases risk of developing type 2
diabetes2
– Specific races and ethnic groups1
*Disease risk for type 2 diabetes, hypertension, and cardiovascular disease (CVD), relative to normal weight and waist circumference.
1. National Institutes of Health/National Heart, Lung and Blood Institute. NIH Publication 98-4083, Rockville, MD: September 1998. 2. US Department of Health and
Human Services. The Surgeon General’s Call to Action to Prevent and Decrease Overweight and Obesity; Rockville, MD: 2001.
5
Medical Complications of Obesity1
Idiopathic intracranial hypertension
Pulmonary disease
• Abnormal function
• Obstructive sleep apnea
• Hypoventilation syndrome
Nonalcoholic fatty liver disease
• Steatosis
• Steatohepatitis
• Cirrhosis
Stroke
Cataracts
Coronary heart disease
• Diabetes
• Dyslipidemia
• Hypertension
Gall bladder disease
Severe pancreatitis
Gynecologic abnormalities
• Abnormal menses
• Infertility
• Polycystic ovarian syndrome
Osteoarthritis
Skin problems
Gout
1. Bhoyrul S, Lashock J. JMCM. 2008:11(4):10-17.
6
Cancer
• Breast, uterus, cervix, colon,
esophagus, pancreas,
kidney, prostate
Phlebitis
• Venous stasis
Widely Accepted That Obesity Is Associated With
Increased Morbidity
National Health and Nutrition Examination Survey (NHANES) 1999-2004
Prevalence of Hypertension, Type 2 Diabetes, and Dyslipidemia by BMI
Prevalence (%)
48%
39%
29%
18%
18%
10%
2%
Hypertension
Hypertension
18-24.9 kg/m2
4%
6%
Type 2 Diabetes
Type 2 Diabetes
Axis Title
≥25-29.9 kg/m2
≥30-34.9 kg/m2
21% 21%
9%
Dyslipidemia
Dyslipidemia
≥35-39.9 kg/m2
Weight gain of 11 pounds or more has been shown to increase the risk of developing Type 2
Diabetes.
Nguyen NT et al. J Am Coll Surg. 2008;207(6):928-934.
7
Obesity Trends* Among Adults
Behavioral Risk Factor Surveillance System, 1990, 1995, 2000, 2005, and 20081
1990
1995
2000
• From
Between
1990
2005
to 2000,
and 2015,
morbid
theobesity
US obese
(BMIpopulation
≥40 kg/m 2)
3
nearly
is
expected
tripled
tofrom
increase
0.8%59%
to 2.2%
to 140
MM2
2005
No Data
<10%
10%-14%
2008
15%-19%
20%-24%
25%-29%
≥30%
*BMI ≥30 or about 30 lbs overweight for 5’4” person. Includes gestational diabetes.
1. CDC US Obesity Trends. http://www.cdc.gov/obesity/data/trends.html. Accessed January 13, 2011; 2. World Health Organization, the Economist Intelligence Unit,
BCG Analysis.
8
BMI vs. Mortality
Exponential Increase in Risk
Relative Mortality Rate
per 100,000
400
350
300
250
High risk
200
Medium risk
150
Low risk
100
50
0
16
19
22
25
28
31
34
37
BMI (kg/m2)
For adults with a BMI >45, life expectancy decreases
by up to 20 years1
Data based on BMI distribution from the Third NHANES (NHANES III)—a 6-year study from 1988-1994.
Fontaine KR et al. JAMA. 2003;289(2):187-193.
9
40
45
Impact of Obesity: Social and
Economic Effects
•
Social Impact
–
–
–
•
Getting a job, making a good
impression
Dealing with judgmental behavior
Compromising health and premature
aging
Costs Associated With Obesity1
Economic Impact*1-6
–
–
–
–
–
As weight increases, so does medical
spending in the health care system
$139 billion in direct and indirect costs
annually
Annual costs for obesity are ~15×
greater than those for being overweight
Increased personal spending
on prescriptions, weight-loss products
By 2030, health care costs attributable
to overweight/obesity could account for
16% to 18% of total US health care
costs
14.5%
*Regression approach using data from 1998 Medical Expenditure Panel Survey and the 1996-97 National Health Interview Surveys. N=9867
adults. Percent of increase is significant across all payors (P<.05).
†Value of years of life lost measured by the dollar value of a quality-adjusted life year.
1. Dor A et al. September 21, 2010. www.gwumc.edu/sphhs/departments/healthpolicy/pdf/HeavyBurdenReport.pdf. Accessed February 15, 2011;
2. Finkelstein EA et al. Health Aff. 2003; doi10.1377/hthaff.w3.219; 3. Finkelstein EA et al. Obes Res. 2004;12(1):18-24; 4. Sturm R. Health Aff. 2002;21(2):245253; 5. Warner J. Web MD: November 8, 2004; 6 Wang Y et al. Obesity. 2008;16(10):2323-2330.
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†
Weight Loss Makes a
Difference
7/7/2015
11
Plasma Lipids Improve With Weight Loss:
Meta-analysis of 70 Clinical Trials1
0.02
HDL-C
Total
Cholesterol
LDL-C
HDL-C
TG
0.00
(actively losing)
*
*
*
-0.5
-1.0
-1.5
-0.04
-2.0
*
-0.06
*P ≤.05
LDL-C=low-density lipoprotein cholesterol; HDL-C=high-density lipoprotein cholesterol; TG=triglycerides.
1. Dattilo AM et al. Am J Clin Nutr. 1992;56(2):320-328.
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0.0
*
-0.02
0.5
-2.5
 mg/dL per kg of Weight Loss
 mmol/L per kg of Weight Loss
(weight stable)
Disease Resolution With Weight Loss
Weight Loss: Effect on Comorbidities
Comorbidity
∆Weight
∆Effect
>13.6 kg
>10%
A1C by 2.6
A1C by 1.6
High blood pressure2
8.8 kg
Diastolic: -7.0 mm Hg
Systolic: -5.0 mm Hg
Heart disease3
2.25 kg
-48% risk factor sum
Sleep apnea4
10%
20%
-26% AHI
-48% AHI
Type 2 diabetes1
Obesity can lead to resistance against insulin and leptin, which are two hormones that
work to regulate metabolism and appetite in the body.
AHI=apnea hypopnea index (apnea events + hypopnea events per hour of sleep)
1. Wing RR et al. Arch Intern Med. 1987;147(10):1749-1753; 2. Stevens VJ et al. Ann Intern Med. 2001;134(1):1-11; 3. Wilson PW et al. Arch Intern Med.
1999;159(10):1104-1109; 4. Peppard PE et al. JAMA. 2000;284(23):3015-3021.
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Current Obesity Treatment Guide
BMI Category (kg/m2)
Treatment
25-26.9
27-29.9
30-34.9
35-39.9
Diet, exercise,
behavior therapy
With
comorbidities
With
comorbidities
+
+
With
comorbidities
+
+
Pharmacotherapy
Surgery
National Institutes of Health. National Heart, Lung and Blood Institute. NIH Publication No. 00-4084. October 2000.
www.nhlbi.nih.gov/guidelines/obesity/prctgd_c.pdf. Accessed January 13, 2011.
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With
comorbidities
Programs Aren’t Effective Long
Term for Most Patients
Treatment
Weight Change (%)
Short Term
Long Term
Initial
Long Term
TOPS®1
Nutrition and behavior therapy, therapist
-2.3 to 0.4
at 12 weeks
-3.2 – 1.6 at 1 year
Not given
38 to 67 at 1 year
Health Management Resources®1
Very low calorie diet (VLCD) using meal
replacements with or without usual foods
-15.3 – 14.1
at 12 weeks
-8.4 at 1 year
0 – 2.5
7.5 at 1 year
-21.8 at 26 weeks
-9.0 at 1.5 years
45
57 at 1.5 years
Weight Watchers®1
Weight Watchers, group
Self-help with 2 visits and a dietician
5.3 at 26 weeks
1.5 at 26 weeks
3.2 at 2 years
0 at 2 years
18 at 1 year
18 at 1 year
27 at 2 years
27 at 2 years
Slim-Fast®2,3
Meal replacement, support pack (self-help)
-6.8 at 6 months
-11.4 at 1 year
Not given
Not given
Vtrim®4
Internet-based behavioral intervention
-7.3 at 6 months
-5.5 at 1 year
18 at 6 months
35 at 12 months
eDiets®4
Internet-based, self-help program
-3.6 at 6 months
-2.8 at 1 year
19 at 6 months
23 at 12 months
Optifast®1
Group counseling and 12-week VLCD
1. Tsai AG et al. Ann Intern Med. 2005;142(1):56-66; 2. Copeland PM. Nat Clin Pract Endocrinol Metab. 2006;2(12):658-659;
3. Truby H et al. BMJ. 2006;332(7553)1309-1314; 4. Gold BC et al. Obesity. 2007;15(1):155-164.
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Attrition Rate (%)
Why Current FDA-Approved
Weight-Loss Drugs May Not Work
• May not sustain long-term weight loss in most patients1,2,3
–
–
–
Average weight loss with medication is only 5% to 10%1,4
Obesity is a complex condition with multiple underlying causes
Medication may not be targeting all the mechanisms driving hunger and cravings
• Hunger is not the only trigger for eating
–
–
–
Other powerful forces drive eating – comfort eating, social eating
Food is not used solely for nutritional reasons
Genetics and impaired metabolism
• Side effects can interfere with compliance and increase dropout rates
–
–
–
Cause insomnia, drowsiness, irritability, or depression1
Fat absorption drugs can cause muscle cramping, diarrhea, flatulence,
and intestinal discomfort1
Consuming excess amounts of fat while taking those drugs may cause
greater intestinal discomfort
Still… benefits may outweigh risks when evaluating weight-loss
programs and pharmacotherapy
1. Abbott Laboratories. Prescribing Information. Meridia Capsules; 2006; 2. Ioannides-Demos LL et al. Pharmacotherapy for obesity. Drugs. 2005;65(10):1391-418; 3.
Li Z et al. Ann Intern Med. 2005;142(7):532-546; 4. Roche Laboratories. Prescribing Information. Xenical Capsules; 2007
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Surgical Options for
Weight Loss
7/7/2015
17
Trends in Bariatric Surgery
300,000
100
80
200,000
60
150,000
40
100,000
Procedure Share (%)
Bariatric Procedures (No.)
250,000
20
50,000
0
0
2002
2003
Total Procedures
2004
2005
Bypass Share
2006
2007
Banding Share
2008
2009
Sleeve Share
15 MM surgery candidates… only 1% (177 K) had surgery in 2009/2010.
Data on file. Allergan, Inc. Total Procedures – ASMBS 2002-2007, AGN Estimates 2008-2010; Banding 2002-2008 – LAP-BAND® Sales;
Total Banding/Bypass/Sleeve Procedures – AGN Estimates.
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Bariatric Surgical Options: How
They Work
Laparoscopic
Adjustable Gastric Banding (LAGB)1,2
Laparoscopic Roux-en-Y
Gastric Bypass (LRYGB)1
Laparoscopic
Sleeve Gastrectomy3
1. Needleman BJ. Surg Clin North Am. 2008;88(5):991-1007; 2. Dixon JB et al. Arch Intern Med. 2001;161(1):102-106; 3. Weiner RA et al. Obes Surg.
2007;17(10):1297-1305.
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Roux-en-Y Gastric Bypass
Advantages
• Rapid initial weight loss
• No implant required
Disadvantages
• Stomach stapling and intestinal
rerouting
• Non-adjustable and virtually
non-reversible
• Higher complication rates after
surgery
• Dumping syndrome possible
• Vitamin deficiencies possible
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Potential Complications
Gastric Bypass
•Blood clot to the lung
•Leakage
•Hernia
•Ulcers
•Bowel obstructions
•Vitamin/mineral deficiencies
•Dumping syndrome
•24.3% of patients had at least one complication
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Sleeve Gastrectomy
Advantages
• Rapid initial weight loss
• No implant required
Disadvantages
•
•
•
•
•
7/7/2015
Stomach stapling
Complications possible
Non-adjustable
Non-reversible
Longer hospital stay and
recovery
Potential Complications
Laparoscopic Sleeve Gastrectomy
•Leakage
•Narrowing of stomach lining
•Suture line bleeding
•Incisional hernia
•Gastroesophageal Reflux Disease
•17.7% of patients had at least one complication
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Laparoscopic Gastric Banding Surgery
Advantages
• No stapling of the stomach
• Gradual, healthy weight
loss
• Long-term weight loss
Disadvantages
• Requires adjustments by
your surgeon
• Lose one to two pounds
per week
7/7/2015
Potential Complications
Laparoscopic Adjustable Gastric
Banding
•Band slippage
•Band erosion
•Stoma blockage
•Vomiting
•6.3% of patients experienced at least one
complication
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Overall, Bariatric Surgery Has a Proven
Safety and Low Mortality Rate
Mortality Rate
2.00
Rate (%)
1.50
1.00
0.50
0.00
1. Flum DR et al. N Engl J Med. 2009;361(5):445-454; 2. DeMaria EJ et al. Ann Surg. 2007;246(4):578-582; 3. Buchwald H et al. JAMA. 2004;292(14):1724-1737; 4. US
Department of Health & Human Services. AHRQ. http://hcupnet.ahrq.gov. Accessed January 13, 2011.
26
Coronary Heart Disease (CHD) Risk Is
Significantly Reduced After Bariatric Surgery
12
20
10
8
P=.002
P<.0001
6
4
0
-20
-40
-60
-80
2
Men
Before Surgery
Vogel JA et al. Am J Cardiol. 2007;99(2):222-226.
Men
Women
After Surgery
10-year predicted CHD risk before (blue bars) and after (amber
bars) bariatric surgery for men and women.
27
Absolute mg/dL Change
10-year CHD Risk (%)
P<.0001 for all pairwise
changes from baseline
Chol
Women
LDL-C
HDL-C
TG
Change in mean lipid values for men and women. Chol = total cholesterol;
HDL-C = high-density lipoprotein cholesterol; LDL-C = low density lipoprotein
cholesterol; TG = triglycerides.
Remission or Improvement of Type 2
Diabetes Often Occurs After Bariatric Surgery
100
Improvement or Remission
of Diabetes (%)
LAGB
83%
80%
80
66%
RYGB
74%
64%
70%
60
45%
40
20
0
Pontiroli1
n=73
Spivak2
n=163
Ponce3
n=35
Dixon4
n=50
Torquati5
n=117
Skroubis 6
n=10
Pories 7
n=121
Study
1. Pontiroli AE et al. Diabetes Care. 2005;28(11):2703-2709; 2. Spivak H et al. Am J Surg. 2005;189(1):27-32; 3. Ponce J et al. Obes Surg. 2004;14(10):1335-1342; 4.
Dixon JB, O’Brien PE. Diabetes Care. 2002;25(2):358-363; 5. Torquati A et al. J Gastrointest Surg. 2005;9(8):1112-1116; 6. Skroubis G et al. Obes Surg. 2006;16(4):488495; 7. Pories WJ et al. Ann Surg. 1995;222(3):339-350.
28
Safety and
Effectiveness of
Surgical Options
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29
Low Incidence of Complications With LAGB:
Longitudinal Assessment of Bariatric Surgery (LABS)
•
Prospective, multicenter,
observational study of 30-day
outcomes in patients undergoing
bariatric surgical procedures at
10 clinical sites in the United States
from 2005 through 2007
•
Within 30 days after surgery,
0.3% of the patients died
–
•
0%, 0.2%, and 2.2% of patients died after
LAGB, laparoscopic RYGB, and open
RYGB, respectively
The composite end point of death,
deep-vein thrombosis or venous
thromboembolism, reintervention,
or failure to be discharged by
30 days after surgery occurred in
4.1% of patients
Flum DR et al. N Engl J Med. 2009;361(5):445-454.
30
14.5%
52% Mean EWL at 96 Weeks With Adjustable Gastric
Banding in Severely Obese Patients
Week
2
4
8
12
16
20
24
30
36
42
48
72
96
(n=439) (n=444) (n=429) (n=409) (n=396) (n=392) (n=396) (n=380) (n=370) (n=364) (n=371) (n=274) (n=159)
0
10
EWL (%)
20
9.5
12.7
17.6
22.5
30
27.0
30.8
40
34%
33.7
38.2
40.6
44.0 46%
46.1
50
51.0
52%
51.7
60
APEX Trial
Data based on interim analysis of ongoing LAP-BAND AP® Experience (APEX) Study.
A multicenter (44 sites), prospective, open-label, 5-year evaluation of 500 severely obese patients undergoing LAP-BAND AP® System surgery.
BMI of at least 40 or with a BMI of at least 35 with one or more severe comorbid conditions, or at least 100 lbs over estimat ed ideal body weight.
31
Average 19% Mean BMI Loss at 96 Weeks With
Adjustable Gastric Banding in Severely Obese
Patients
APEX Trial
45.0
43.0
42.5
41.8
Mean BMI
41.1
41.0
40.0
39.4
38.7
39.0
38.2
37.3
37.0
36.2
37.0
35.9
34.7
34.6
35.0
33.0
2
4
8
12
16
20
24
30
36
42
48
72
96
(n=439) (n=444) (n=429) (n=409) (n=396) (n=392) (n=396) (n=380) (n=370) (n=364) (n=371) (n=274) (n=159)
Week
Data based on interim analysis of ongoing LAP-BAND AP® Experience (APEX) Study.
.
A multicenter (44 sites), prospective, open-label, 5-year evaluation of 500 severely obese patients undergoing LAP-BAND AP® System surgery. BMI of at
least 40 or with a BMI of at least 35 with one or more severe comorbid conditions, or at least 100 lbs over estimated ideal body weight.
Data on file. Allergan, Inc.
32
Obesity-Related Comorbidities Reduced
in Severely Obese Patients at 48 Weeks
48-week data on comorbidities
with the LAP-BAND®
Improvement/Remission (%)
100
24%
80
60
55%
57%
40
20
51%
59%
18%
16%
Sleep Apnea
Osteoarthritis
(n=72)
(n=44)
26%
69%
33%
31%
24%
0
Diabetes
(n= 75)
Hypertension
(n=142)
GERD
(n=112)
Remission
Hyperlipidemia
(n=54)
Improved
Data based on interim analysis of ongoing LAP-BAND AP® Experience (APEX) Study.
A multicenter (44 sites), prospective, open-label, 5-year evaluation of 500 severely obese patients undergoing LAP-BAND AP® System surgery. BMI of at
least 40 or with a BMI of at least 35 with one or more severe comorbid conditions, or at least 100 lbs over estimated ideal body weight.
Data on file. Allergan, Inc.
33
Adjustable Gastric
Banding Is Also
Effective in Obese and
Moderately Obese
Patients
Early Intervention Data
(LBMI-001)
7/7/2015
34
% of Patients Achieving
30% EWL
More Than 82% of Patients Achieved at Least 30%
EWL at 12 Months
Primary
Endpoint
Threshold
Baseline BMI
<35 kg/m2
n=62
Error bars represent the 95% confidence interval.
Data on file. Allergan, Inc., LBMI-001.
35
Baseline BMI
≥35 kg/m2
n=81
Mean % EWL
Mean 65% EWL at 12 Months
N=143
Baseline
Month
2
Month
4
Month
6
Error bars denote 95% CI, which cannot be used to evaluate differences between time points.
Data on file. Allergan, Inc. LBMI-001.
36
Month
8
Month
10
Month
12
Weight Loss With LAGB Is Associated With Positive
Changes in Cardiovascular Laboratory Values
Treatment
N
Lab Test
Change From
Screening to Month 12
Mean
Mean
Cholesterol (mg/dL)
143
204.5
-13.7
HDL (mg/dL)
143
55.7
5.8
LDL (mg/dL)
143
121.3
-13.4
Triglycerides (mg/dL)
143
137.2
-30.7
Fasting glucose (mg/dL)
145
93.4
-3.6
HbA1c (%)
145
5.4
-0.1
SBP (mm Hg)
142
127.6
-8.1
DBP (mm Hg)
142
79.1
-3.1
DFU. Allergan, Inc. 2011.
37
Screening Lab Value
Significant Improvement in Quality of Life (QOL)
Measures (100-Point Scale)
Baseline
*
100
93
12 Months
*
*
*
97
96
89
81
79
80
Mean Score
*
76
66
61
60
44
40
20
0
Physical Function
(n=142)
Self-Esteem
(n=141)
Sexual Life
(n=139)
Public Distress
(n=143)
*P<.0001.
Weight on IWQOL-lite total score was also improved (P<.0001) at 12 months (62.8 at baseline vs 90.6 at 12 months).
DFU. Allergan, Inc. 2011.
38
Work
(n=143)
Weight Loss Sustained Into the
Second Year
Year 1
N=143*
Year 2
N=128
Primary endpoint:
% patients achieving 30% EWL
83.9
85.9
Mean % EWL
64.5
70.4
Mean % total weight loss
18.3
20.1
Year 2 data is from an interim analysis before all patients had reached
their Month 24 visit.
*Evaluable population.
Data on file. Allergan, Inc. LBMI-001.
39
Gradual Weight
Reduction With LAGB
Results in Better
Quality of Weight Loss
7/7/2015
40
Comparable Effectiveness Between Banding
and Bypass at 3 Years and Thereafter
80
70
58.2%
(N=176)
EWL (%)
60
55.2%
50
(N=640)
40
RYGB
30
LAGB
20
10
0
0
12
24
36
48
60
Time After Surgery (Months)
*LAGB using the LAP-BAND® System and another adjustable gastric band. Comparison was based on pooled data from 43 peer-reviewed reports
involving at least 100 patients at entry and providing at least 3 years of postoperative data. 1
The LAP-BAND® System was approved in the United States on the basis of a nonrandomized, single-arm study (N=299). Significant improvements
in percent of EWL vs baseline were achieved at 12 months (34.5%), 24 months (37.8%), and 36 months (36.2%).
DFU. Allergan, Inc. 2011.
O’Brien P et al. Obes Surg. 2006;16;(8)1032-1040.
41
Gastric Banding Often Enables a Healthy
Rate of Weight Loss
Gradual weight loss
with gastric banding
Rapid weight loss
with gastric bypass
• Healthy weight loss
• Excess fat lost
• Similar to diet and exercise
• Muscle, bone and necessary
fat lost
• Excess fat is lost
• Nutrients and minerals lost
• Nutrient supplementation is
necessary to prevent other
health problems
Chaston TB et al. Int J Obes (Lond). 2007;31(5):743-750.
42
Importance of Fat-Free Mass Loss
(FFML)
• Fat-free mass plays an important role in preservation and regulation
of the body.
– Preserves skeletal integrity and quality of life as the body ages, and
maintains resting metabolic rate, as well as regulates core body
temperature
• With significant weight loss, patients may lose fat-free mass such as
bone or muscle mass, nutrients or necessary fat.
• Certain bariatric surgical methods can cause malabsorption and
malnutrition, which influence fat-free mass loss.
• Nondiversionary LAGB surgery generally preserves
a favorable amount of fat-free mass.
Chaston TB et al. Int J Obes (Lond). 2007;31(5):743-750.
43
Gastric Band: Lower FFML Than
RYGB*
LAGB
RYGB
Patients (n=400)
lost a median of
Patients (n=87)
lost a median of
17.5%
31.3%
fat-free mass
fat-free mass
8%
100%
of cohort (n=400)
experienced above-average
FFML†
of cohort (n=87)
experienced
above-average FFML†
*The mean %FFML was calculated for all male subjects and all female subjects on dietary and behavioral weight loss interventions. Where
studies reported a mean of male subjects and female subjects, the cutoff was adjusted in proportion to the ratio of female subjects to male
subjects in the study.
†Average FFML was defined by the mean %FFML of subjects on dietary and behavioral weight loss interventions.
Chaston TB, Dixon JB et al. Int J Obes (Lond). 2007;31(5):743-750.
44
LAGB Is More Cost-effective Than
LRYGB
Probabilities and Cost
for 3 Years
LAGB
LRYGB
55 (38-64)
71 (59-89)
$16,200
$27,560
$150
NA
0.5 (0-1)
1 (0.5-2)
Revisions % (range)
5 (2-7)
5 (1-10)
Revision cost
$5,000
$10,000
EWL % (range)
Cost*
Adjustments
Perioperative mortality %
(range)
•The modeled cost-effectiveness analysis showed that both operative
interventions for morbid obesity, LAGB and LRYGB, were cost-effective at
$25,000 and that LAGB was more cost-effective than LRYGB for all basecase scenarios.
*2004 US dollars, adjusted for inflation, based on public data sources.
Salem L et al. Surg Obes Relat Dis. 2008;4(1):26-32.
45
LAGB Is Cost Effective in the Long-Term
Using Claims Analysis
• US health care claims data for 7000 LAGB patients
were used to quantify the costs and potential cost
savings resulting from LAGB
• Including the related medical payments in the 90
days before and after the procedure, the mean
cost of LAGB was approximately $20,000
• The net cost of coverage for LAGB was reduced to
0 by approximately 4 years after band placement in
the general population
• For those with diabetes, the net costs resulting
from LAGB were reduced to 0 in just 2 years
Finkelstein EA et al. Surg Obes Relat Dis. 2010. In Press.
Amanda’s Success Story
Before
After
“After years of yo-yo dieting, gaining back even more weight every time I quit,
I gave up. At 304 lbs, I thought I was out of weight loss options. Then I learned about
the LAP-BAND® System weight loss surgery and I knew right away it was the best
choice for me. Since my surgery in 2003, I've gone from a size 30 dress down to a
size 14. I feel so great about my decision, my positive lifestyle changes, and even
better about my results.
Best of all, I look like a new woman and I'm in control of my life!”
www.lapband.com/en/success_stories/patient_stories. Accessed January 13, 2011.
47
Duane’s Success Story
Before
After
“My moment of truth was when I hit 303 pounds. I knew right then I had to do
something or I wasn’t going to be around to see my girls grow up. Now I get to
have fun and my kids love it. The greatest feeling I ever had was when my kids
could come up to me and put their arms completely around me for the first time.
A year ago we had a class reunion and nobody knew who I was. That was cool.
I had this one girl say “Duane, you look hot.” And I said, “why didn’t you think
that 30 years ago?” Getting the LAP-BAND® System surgery was the greatest
decision I ever made in my life.”
www.lapband.com/en/success_stories/patient_stories. Accessed January 13, 2011.
48
The Role of the
Primary Care Physician
7/7/2015
49
The Physician’s Role
• Diagnose
– Recognize patients at risk
– Calculate BMI, which may be estimated to be lower than actual
value
• Educate about obesity
– Inform patients of health risks and medical hazards associated
with severe obesity
– If lifestyle recommendations are not able to be consistently
followed, then one should consider a bariatric procedure
– Describe impact of weight loss on comorbidities and mortality
– Communicate weight loss results and importance of long-term
follow-up
50
The Physician’s Role (cont’d)
• Motivate patients to address obesity
– Describe tangible options available to patients
– Share success stories
• Explain surgical options
– LAGB has a lower rate of complications compared to
other bariatric procedures1,2
– LAGB is effective for weight loss with data out to 5
years3
• Lower FFML compared with RYGB (17.5% vs 31.3%)4
7/7/2015
51
The Physician’s Role (cont’d)
– Weight loss with LAGB often improves major
cardiovascular risk factors as well as other
comorbidities5
•Hypertension
•Hyperlipidemia
•Type 2 diabetes
•Asthma
•GERD
•Obstructive sleep apnea
1. Parikh MS et al. J Am Coll Surg. 2006;202(2):252-261; 2. Weiner RA et al. Obes Surg. 2007;17(10):1297-1305;
3. O’Brien P et al. Obes Surg. 2006;16;(8)1032-1040; 4. Chaston TB, Dixon JB et al. Int J Obes (Lond). 2007;31(5):743-750;
5. Data on file. Allergan, Inc. (APEX Study)
52
The Physician’s Role (cont’d)
• Refer patient to better understand surgical options
– Important to select an experienced surgeon in a comprehensive,
weight loss center with competed support staff, able to care for
patients afflicted with obesity.
Aftercare management
– To enhance the transition to life after bariatric surgery and to
prevent weight regain and nutritional complications, all patients
should receive care from a multidisciplinary team including an
experienced primary care physician, endocrinologist or
gastroenterologist and consider enrolling postoperatively in a
comprehensive program for nutrition and lifestyle management.1
1. Heber D et al. J Clin Endocrin Metab. 2010;95(11):4823-4843.
53
Bariatric Surgery Guidelines Support Your
Referrals
• Nonsurgical treatments ineffective for most morbidly obese
patients1
• The American Academy for Clinical Endocrinologists,
the Obesity Society, and the American Society for Metabolic
& Bariatric Surgery have recommended that morbidly obese
patients (BMI >40 or BMI >35 with a obesity related
comorbidity) should be offered bariatric surgery.2
– 15 million individuals meet the criteria for morbid obesity3
• American Diabetes Association: Bariatric surgery should be
considered for adults with BMI of 35 and type 2 diabetes,
especially if the diabetes is difficult to control with lifestyle
and pharmacologic therapy.4
1. Fontaine KR et al. JAMA. 2003;289(2):187-193; 2. Mechanick JI et al. Endocr Pract. 2008;14(suppl 1):1-83; 3. ASMBS Fact Sheet.
www.asbs.org/Newsite07/media/asmbs_fs.pdf. Accessed January 13, 2011; 4. American Diabetes Association.
http://care.diabetesjournals.org/content/32/Supplement_1/S3.full.pdf+html. Accessed January 13, 2011.
54
Current Selection Criteria for Bariatric
Surgery in Adults1
Factor
Criteria
Weight (adults)
• BMI ≥40 with no comorbidities
• BMI ≥35 with one or more severe obesity-associated comorbidity
Weight loss history
• Failure of previous nonsurgical attempts at weight reduction, including
nonprofessional programs (for example, WeightWatchers®)
Commitment
•
•
•
•
Expectation that patient will adhere to postoperative care
Follow-up visits with physician(s) and team members
Recommended medical management
Instructions regarding any recommended procedures or tests
Exclusion
•
•
•
•
Reversible endocrine disorders or other disorders that cause obesity
Current drug or alcohol abuse
Uncontrolled, severe psychiatric illness
Unable to comprehend
– Risks, benefits, expected outcomes, alternatives, and required
lifestyle changes
• Not a complete list of exclusion criteria for bariatric surgery
1. Mechanick JI et al. Surg Obes Relat Dis. 2008;4(5 suppl):S109-S184.
55
Consider Early Intervention
• Early intervention with the Band System in obese and moderately
obese patients has recently been approved by the FDA.
• The gastric band has been shown to be safe and effective in individuals
with a BMI of 30 to 40 with obesity-related comorbidity.
• Majority of patients (>80%) achieved >30% EWL
– Mean 65% EWL at 1 year
• Laboratory values improved
• Quality of life measures were significantly improved
• New data supports the need for primary care physicians to refer obese
and moderately obese individuals who fail other forms of weight loss
management for bariatric surgery.
DFU. Allergan, Inc. 2011.
56
Summary
The gastric band is a safe and
effective option for your obese to
morbidly obese patients whose weight is affecting their
health
• Fewer complications compared with gastric bypass reported in 1 study1
– 9% (LAP-BAND®, n=480) vs 23% (RYGB, n=235)
• Comparable weight loss to gastric bypass after 5 years2
–
55% (LAP-BAND® , n=640) vs 58% (RYGB, n=176)
• More cost-effective than gastric bypass3
– Payers estimated to fully recover the costs of laparoscopic bariatric surgeries after
2 ¼ years in patients with diabetes and after 4 years in the entire surgical
population4
1. Parikh MS et al. J Am. College Surgeons. 2006;202(2):252-261; 2. O’Brien PE et al. Obes Surg. 2006;16(8):1032-1040;
3. Salem L et al. Surg Obes Relat Dis. 2008;4(1):26-32; 4. Finkelstein EA et al. Surg Obes Relat Dis. 2010. In Press.
57