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Bariatric Surgery

Ruban Nirmalan Medical Director, IUH Arnett Bariatrics

• None

Disclosures

4/24/2020 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

4/24/2020

Impact of Obesity

Classification of Overweight and Obesity by Body Mass Index (BMI), Waist Circumference and Associated Disease Risk*

Nor Normal

Weigh t

(BMI 18.5 to 24.9) Overweight

(BMI 25 to 29.9) Obese

(BMI 30 to 34.9) Moderate Obesity

(BMI 35 to 39.9 ) Morbid Obesity

(BMI 40 or more)

Class I Obesity Class II Obesity Class III Obesity ― Increased Disease Risk* 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 diabetes 2 – Specific races and ethnic groups 1 5 *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.

Medical Complications of Obesity

1 Pulmonary disease • Abnormal function • Obstructive sleep apnea • Hypoventilation syndrome Nonalcoholic fatty liver disease • Steatosis • • Steatohepatitis Cirrhosis Gall bladder disease Idiopathic intracranial hypertension Stroke Cataracts Coronary heart disease • Diabetes • Dyslipidemia • Hypertension Gynecologic abnormalities • Abnormal menses • Infertility • Polycystic ovarian syndrome Severe pancreatitis Cancer • Breast, uterus, cervix, colon, esophagus, pancreas, kidney, prostate 6 Osteoarthritis Skin problems Gout 1. Bhoyrul S, Lashock J.

JMCM.

2008:11(4):10-17.

Phlebitis • Venous stasis

Widely Accepted That Obesity Is Associated With Increased Morbidity

18% National Health and Nutrition Examination Survey (NHANES) 1999-2004 Prevalence of Hypertension, Type 2 Diabetes, and Dyslipidemia by BMI 48% 39% 29% 18% 21% 21% 2% 4% 6% 10% 9% 18-24.9 kg/m 2 Axis Title ≥25-29.9 kg/m 2 ≥30-34.9 kg/m 2 ≥35-39.9 kg/m 2

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.

Obesity Trends* Among Adults

Behavioral Risk Factor Surveillance System, 1990, 1995, 2000, 2005, and 2008 1 1990 1995 2000 • • From 1990 to 2000, morbid obesity (BMI ≥40 kg/m nearly tripled from 0.8% to 2.2% 3 2 2 ) 2005 2008 No Data <10% 10%-14% 15%-19% 20%-24% 25%-29% ≥30% 8 *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.

BMI vs. Mortality

Exponential Increase in Risk 400 350 300 250 200 150 100 50 0 16 19 22 25 28

BMI (kg/m 2 )

31 34 37 For adults with a BMI >45, life expectancy decreases by up to 20 years 1 40 45

High risk Medium risk Low risk

9 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.

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 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 Costs Associated With Obesity 1 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 (

<.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):245 253; 5. Warner J. Web MD: November 8, 2004 ; 6 Wang Y et al.

Obesity

. 2008;16(10):2323-2330.

10 †

4/24/2020

Weight Loss Makes a Difference

Plasma Lipids Improve With Weight Loss: Meta-analysis of 70 Clinical Trials

0.02

0.00

Total Cholesterol LDL-C

-0.02

-0.04

-0.06

* *

HDL-C (weight stable) HDL-C (actively losing) 0.5

0.0

* *

-0.5

-1.0

-1.5

-2.0

-2.5

≤.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.

Disease Resolution With Weight Loss

Comorbidity Type 2 diabetes 1 High blood pressure 2 Weight Loss: Effect on Comorbidities ∆Weight >13.6 kg >10% 8.8 kg ∆Effect A1C by 2.6

A1C by 1.6

Diastolic: -7.0 mm Hg Systolic: -5.0 mm Hg Heart disease 3 2.25 kg -48% risk factor sum Sleep apnea 4 10% 20% -26% AHI -48% AHI 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. 13

Current Obesity Treatment Guide

Treatment 25-26.9

Diet, exercise, behavior therapy With comorbidities BMI Category (kg/m 2 ) 27-29.9

With comorbidities 30-34.9

+ Pharmacotherapy With comorbidities + Surgery 35-39.9

+ + With comorbidities 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.

Major US Commercial Weight Loss Programs Aren’t Effective Long Term for Most Patients

Treatment

TOPS

®1

Nutrition and behavior therapy, therapist

Health Management Resources

®1

Very low calorie diet (VLCD) using meal replacements with or without usual foods

Optifast

®1

Group counseling and 12-week VLCD

Weight Watchers

®1

Weight Watchers, group Self-help with 2 visits and a dietician

Slim-Fast

®2,3

Meal replacement, support pack (self-help)

Vtrim

®4

Internet-based behavioral intervention

eDiets

®4

Internet-based, self-help program

Weight Change (%) Short Term

-2.3 to 0.4 at 12 weeks -15.3 – 14.1 at 12 weeks -21.8 at 26 weeks 5.3 at 26 weeks 1.5 at 26 weeks -6.8 at 6 months -7.3 at 6 months

Long Term

-3.2 – 1.6 at 1 year -8.4 at 1 year -9.0 at 1.5 years 3.2 at 2 years 0 at 2 years -11.4 at 1 year -5.5 at 1 year

Attrition Rate (%) Initial

Not given 0 – 2.5

45 18 at 1 year 18 at 1 year Not given 18 at 6 months -3.6 at 6 months -2.8 at 1 year 1. Tsai AG et al.

Ann Intern Med.

2005;142(1):56-66; 2. Copeland PM.

Nat Clin Pract Endocrinol Metab.

3. Truby H et al.

BMJ

. 2006;332(7553)1309-1314; 4. Gold BC et al.

Obesity.

2007;15(1):155-164.

2006;2(12):658-659; 15 19 at 6 months

Long Term

38 to 67 at 1 year 7.5 at 1 year 57 at 1.5 years 27 at 2 years 27 at 2 years Not given 35 at 12 months 23 at 12 months

Why Current FDA-Approved Weight-Loss Drugs May Not Work

• • • May not sustain long-term weight loss in most patients 1,2,3 – 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 depression 1 – Fat absorption drugs can cause muscle cramping, diarrhea, flatulence, and intestinal discomfort 1 – 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 16

4/24/2020

Surgical Options for Weight Loss

Trends in Bariatric Surgery

300,000 250,000 200,000 150,000 100,000 50,000 100 80 60 40 20 0 2002 2003 Total Procedures 2004 2005 Bypass Share 2006 2007 Banding Share 2008 2009 Sleeve Share 0 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 ® Total Banding/Bypass/Sleeve Procedures – AGN Estimates.

Sales; 18

Bariatric Surgical Options: How They Work

Laparoscopic Adjustable Gastric Banding (LAGB) 1,2

Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) 1

Laparoscopic Sleeve Gastrectomy 3 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.

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 4/24/2020

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 4/24/2020

Sleeve Gastrectomy

• • Advantages Rapid initial weight loss No implant required • • • • • Disadvantages Stomach stapling Complications possible Non-adjustable Non-reversible Longer hospital stay and recovery 4/24/2020

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 4/24/2020

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 4/24/2020

Potential Complications Laparoscopic Adjustable Gastric Banding

• Band slippage • Band erosion • Stoma blockage • Vomiting • 6.3% of patients experienced at least one complication 4/24/2020

Overall, Bariatric Surgery Has a Proven Safety and Low Mortality Rate

Mortality Rate 2.00

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.

Coronary Heart Disease (CHD) Risk Is Significantly Reduced After Bariatric Surgery

12 10

=.002

8 6 4

<.0001

Men

Before Surgery

Women

After Surgery 10-year predicted CHD risk before (blue bars) and after (amber bars) bariatric surgery for men and women.

Vogel JA et al.

Am J Cardiol.

2007;99(2):222-226.

27 20 0 -20

<.0001 for all pairwise changes from baseline -40 -60 -80 Chol

Men

LDL-C

Women

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 80 60

45%

40 20 0 Pontiroli 1 n=73

66%

Spivak 2 n=163

80% 64% LAGB RYGB 74% 70% 83%

Ponce 3 n=35 Dixon 4 n=50

Study

Torquati 5 n=117 Skroubis 6 n=10 Pories 7 n=121 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):488 495; 7. Pories WJ et al.

Ann Surg

. 1995;222(3):339-350.

4/24/2020

Safety and Effectiveness of Surgical Options

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 14.5% Flum DR et al.

N Engl J Med

. 2009;361(5):445-454.

52% Mean EWL at 96 Weeks With Adjustable Gastric Banding in Severely Obese Patients

Week

2 (n=439) 4 (n=444) 8 (n=429) 12 (n=409) 16 (n=396) 20 (n=392) 24 (n=396) 30 (n=380) 36 (n=370) 42 (n=364) 48 (n=371) 72 (n=274) 96 (n=159) 10 20 30

9.5

12.7

17.6

22.5

27.0

30.8

38.2

40.6

44.0

50 60

51.0

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.

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

41.1

41.0

39.0

40.0

39.4

38.7

38.2

37.3

37.0

37.0

36.2

35.9

34.7

34.6

35.0

33.0

2 (n=439) 4 (n=444) 8 (n=429) 12 (n=409) 16 (n=396) 20 (n=392) 24 (n=396) 30 (n=380) 36 (n=370) 42 (n=364) 48 (n=371) 72 (n=274) 96 (n=159)

Week

Data based on interim analysis of ongoing LAP-BAND AP ® Experience (APEX) Study.

Data on file. Allergan, Inc.

Obesity-Related Comorbidities Reduced in Severely Obese Patients at 48 Weeks

48-week data on comorbidities with the LAP-BAND ® 100 80 60 40 20 0 24% 55% 57% 51% 59% 26% 69% 33% Diabetes

(n= 75)

24% 18% 16% 31% Hypertension

(n=142)

GERD

(n=112)

Remission Sleep Apnea

(n=72)

Improved Osteoarthritis

(n=44)

Hyperlipidemia

(n=54) Data based on interim analysis of ongoing LAP-BAND AP ® Experience (APEX) Study.

Data on file. Allergan, Inc.

4/24/2020

Adjustable Gastric Banding Is Also Effective in Obese and Moderately Obese Patients

Early Intervention Data (LBMI-001) 34

More Than 82% of Patients Achieved at Least 30% EWL at 12 Months

Error bars represent the 95% confidence interval.

Data on file. Allergan, Inc., LBMI-001.

35 Baseline BMI <35 kg/m 2 n=62 Primary Endpoint Threshold Baseline BMI ≥35 kg/m 2 n=81

Mean 65% EWL at 12 Months

N=143 Baseline Month 2 Month 4 Month 6 Month 8 Month 10 Month 12 Error bars denote 95% CI, which cannot be used to evaluate differences between time points.

Data on file. Allergan, Inc. LBMI-001.

Weight Loss With LAGB Is Associated With Positive Changes in Cardiovascular Laboratory Values

Treatment Lab Test

Cholesterol (mg/dL) HDL (mg/dL) LDL (mg/dL) Triglycerides (mg/dL) Fasting glucose (mg/dL) HbA1c (%) SBP (mm Hg) DBP (mm Hg) N 143 143 143 143 145 145 142 142 Screening Lab Value Mean 204.5

55.7

121.3

137.2

93.4

5.4

127.6

79.1

Change From Screening to Month 12 Mean -13.7

5.8

-13.4

-30.7

-3.6

-0.1

-8.1

-3.1

DFU. Allergan, Inc. 2011.

Significant Improvement in Quality of Life (QOL) Measures (100-Point Scale)

100 80 60 40

93 44

20 0 Physical Function (n=142) Self-Esteem (n=141)

Baseline 12 Months

89 66

Sexual Life (n=139)

Public Distress (n=143)

Work (n=143) *

<.0001.

Weight on IWQOL-lite total score was also improved (

<.0001) at 12 months (62.8 at baseline vs 90.6 at 12 months).

DFU. Allergan, Inc. 2011.

Weight Loss Sustained Into the Second Year

Primary endpoint: % patients achieving 30% EWL Mean % EWL Mean % total weight loss Year 1 N=143* 83.9

64.5

18.3

Year 2 N=128 85.9

70.4

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.

4/24/2020

Gradual Weight Reduction With LAGB Results in Better Quality of Weight Loss

Comparable Effectiveness Between Banding and Bypass at 3 Years and Thereafter

80 30 20 10 0 70 60 50 40

RYGB LAGB 58.2%

(N=176)

55.2%

(N=640)

0 12 24 36 Time After Surgery (Months) 48 60

*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.

Gastric Banding Often Enables a Healthy Rate of Weight Loss

Gradual weight loss with gastric banding

• Healthy weight loss • Similar to diet and exercise • Excess fat is lost

Rapid weight loss with gastric bypass

• Excess fat lost • Muscle, bone and necessary fat 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.

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.

Gastric Band: Lower FFML Than RYGB

* LAGB Patients (n=400) lost a median of 17.5% fat-free mass 8% of cohort (n=400) experienced above-average FFML † RYGB Patients (n=87) lost a median of 31.3% fat-free mass 100% 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.

LAGB Is More Cost-effective Than LRYGB

Probabilities and Cost for 3 Years EWL % (range) Cost* Adjustments Perioperative mortality % (range) Revisions % (range) Revision cost LAGB 55 (38-64) $16,200 $150 0.5 (0-1) 5 (2-7) $5,000 LRYGB 71 (59-89) $27,560 NA 1 (0.5-2) 5 (1-10) $10,000 • 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 base case 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.

LAGB Is Cost Effective in the Long-Term Using Claims Analysi s •

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.

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.

4/24/2020

The Role of the Primary Care Physician

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

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 procedures 1,2 – LAGB is effective for weight loss with data out to 5 years 3 • Lower FFML compared with RYGB (17.5% vs 31.3%) 4 4/24/2020 51

The Physician’s Role

(cont’d) – Weight loss with LAGB often improves major cardiovascular risk factors as well as other comorbidities 5 •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.

Bariatric Surgery Guidelines Support Your Referrals

• Nonsurgical treatments ineffective for most morbidly obese patients 1 • 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 obesity 3 • 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.

Current Selection Criteria for Bariatric Surgery in Adults

Factor

Weight (adults) Weight loss history Commitment Exclusion

Criteria

• • BMI ≥40 with no comorbidities BMI ≥35 with one or more severe obesity-associated comorbidity • Failure of previous nonsurgical attempts at weight reduction, including nonprofessional programs (for example,

WeightWatchers

® ) • • • • 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 • • • • • 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.

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.

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 study 1 • – 9% ( LAP-BAND ® , n=480) vs 23% (RYGB, n=235) Comparable weight loss to gastric bypass after 5 years 2 • – 55% ( LAP-BAND ® , n=640) vs 58% (RYGB, n=176) More cost-effective than gastric bypass 3 – 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 population 4 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.