Proven approaches to treating obesity and its associated co-morbidities

The Treatment of Obesity

DSL#12-1303

This promotional education activity is brought to you by Ethicon and is not certified for continuing medical education. XXX is a paid consultant of Ethicon.

Presentation Topics

• What is obesity?

• Obesity treatment options

• Recent clinical evidence

• Obesity patient management

What is obesity?

Genetic

Environmental

Behavioral

Psychological

Physiological

Metabolic

American Obesity Association. Fact Sheet: Obesity in the U.S. May 2, 2005. http://www.obesity.org

Obesity is a complex, multi-factorial, chronic metabolic disease

Obesity involves the following factors:

Sumithran P, Prendergast, LA, Delbridge E, et al. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011; 365:1597-1604.

A contributing factor to obesity is the body’s metabolic “set point”

Dieting Triggers Hormonal & Neuro Signals

Appetite (Ghrelin)

Satiety (PYY, CCK)

Metabolism (Leptin, Melanocortin)

Cummings DE, Weigle DS, Frayo RS et al. Plasma ghrelin levels after diet-induced weight loss or gastric bypass surgery.

N Engl J Med. 2002; 346(21): 1623-30. Cummings DE, Schwartz M. Genetics and pathyphysiology of human obesity. Annu Rev Med 2003; 54:453-71.

Hormones play a significant role in controlling weight

NIH Body Mass Index classifications

Between 25 and 29.9 BMI Overweight

30 or higher BMI Obese

40 or higher BMI Morbidly obese

Vorvick LJ. Body Mass Index. MedlinePlus. Accessed October 9, 2012 from http://www.nlm.nih.gov/medlineplus/ency/article/007196.htm

The National Institute of Health uses BMI to define obesity

• Body mass index (BMI) is:– a measure of body fat based on height and weight.

• Morbid obesity is:– a multi-factorial disease of excess fat storage (40+ BMI) and associated

diseases of other systems

– lifelong and progressive.

According to NIH guidelines, here is what obesity looks like*

Normal Weight (BMI 19 to 24.9)

130 poundsBMI 22

Overweight(BMI 25 to 29.9)

152 poundsBMI 26

Obese (Class I)(BMI 30 to 34.9)

175 poundsBMI 30

Obese (Class II)(BMI 35 to 39.9 )

205 poundsBMI 35

Morbidly Obese(BMI 40 or more)

234 poundsBMI 40

*For a 5’4” femaleVorvick LJ. Body Mass Index. MedlinePlus. Accessed October 9, 2012 from

http://www.nlm.nih.gov/medlineplus/ency/article/007196.htm and National Heart Lung Blood Institute. Classification of Overweight and Obesity by BMI, Waist Circumference, and Associated Disease Risks. Accessed October 9, 2012 from

http://www.nhlbi.nih.gov/health/public/heart/obesity/lose_wt/bmi_dis.htm

No Data < 10% 10%-14% 15%-19% 20%-24% 25%-29% ≥ 30%

1990 2010

% of the population that is obese by state

75 million adult Americans are considered obese

Ogden CL, Carroll MD, Kit BK et al. Prevalence of obesity in the United States, 2009-2010. NCHS Data Brief 2012; 82 and Centers for Disease Control and Prevention. US Obesity Trends, trends by state 1985-2010

One third of the U.S. adult population is considered obese and the number is growing

• $168 billion is the estimated US annual medical cost of obesity1

• There is 50% higher per capita medical spending on obese patients than for normal weight individuals1

• There is an 80% higher prescription drug spending for the obese patient than for normal weight individuals2

• 16.5% of national health expenditures are spent treating obesity-related illness1

Obesity is an expensive disease.

1. Cawley, J, Meyerhoefer, C. The Medical Care Costs of Obesity: An Instrumental Variables Approach. National Bureau of Economic Research. October 2010. 2. Finkelstein EA, Trogdon JG, Cohen JW et al. Annual medical spending attributable to obesity: Payer-

and service-specific estimates. Health Affairs 2009; 28(5):w822-w831.

There is a significant economic impact of obesity

Pulmonary diseaseabnormal PFTsobstructive sleep apneahypoventilation syndrome

Nonalcoholic fatty liver diseasesteatosissteatohepatitiscirrhosis

Cardio/Metabolic Syndromediabetesdyslipidemiahypertensionmetabolic syndrome

Gynecologic abnormalitiesabnormal mensesinfertilitypolycystic ovarian syndromestress incontinence

Osteoarthritis

Skin

Gallbladder disease

Cancerbreast, uterus, cervix, colon, esophagus, pancreaskidney, prostate

Phlebitisvenous stasis

Gout

Depression

Stroke

GERD

Severe pancreatitis

Premature DeathReferences at end of presentation

There are significant co-morbidities associated with obesity

Prevalence of Significant Morbidities per Weight

Stommel M, Schoenborn CA. Variations in BMI and prevalence of health risks in diverse racial and ethnic populations. Obesity 2010; 18(9):1821-1826.

As a patient’s BMI rises, so does the prevalence of co-morbid conditions

Obesity has serious consequences

• Life expectancy decreases as BMI increases – For people with obesity, there is a 33% to 179% higher risk of mortality

Graph represents years of life lost for white men.Allison DB, Fontaine KR, Manson JE et al. Annual deaths attributable to obesity in the United States. 1999; 282(16):1530-1538.

Fontaine KR, Redden DT, Wang C et al. Years of life lost due to obesity. JAMA 2003;289:187.

Obesity Treatment Options

National Institutes of Health. The practical guide: Identification, evaluation, and treatment of overweight and obesity in adults. NIH Publication Number 00-4084; 2000.

The recommended treatment for obesity depends on the severity of the disease

Lifestyle Modifications

• Caloric intake should be reduced by 500 to 1,000 calories per day (kcal/day) from the current level.

• Daily food logs for 4-6 weeks

• Weekly weigh-in

• Increased physical activity

• Water intake

• Behavior modification

Lifestyle Modifications

• Comparison of weight loss/behavior programs: Atkins®, Zone, Weight Watchers®, and Ornish Diets

Dansinger ML, Gleason JI, Griffith JL, et al. Comparison of the Atkins, Ornish, Weight Watchers, and Zone diets for weight loss and heart disease reduction. JAMA 2005;293(1)43-53. Sjostrom L, Peltonen M, Jacobson P et al. Bariatric surgery and long-term cardiovascular events.

NEJM 2012; 307(1):56-65.Atkins is a registered trademark of Atkins Nutritionals, Inc.

Weight Watchers is a registered trademark of Weight Watchers International, Inc.

Type of Diet Completing One Year Weight Loss at One Year

Atkins® 21/40 (53%) 2.1 kg (4 lbs.)

Zone 26/40 (65%) 3.2 kg (7 lbs.)

Weight Watchers® 26/40 (65%) 3.0 kg (6 lbs.)

Ornish 20/40 (50%) 3.3 kg (7 lbs.)

According to the Swedish Obesity Study 20 year data published in JAMA, patients lost 1% with diet and lifestyle changes.

Trademarks are the property of their respective owners.

Pharmacotherapy: Medications for Weight Loss

• For patients with:– BMI ≥ 27 with co-morbidities or

– BMI ≥ 30 without co-morbidities

• There are 5 drugs currently available for patients.   – Alli®

– Xenical®

– Adipex®

– Qsymia™

– Belviq®

Pharmacotherapy

Xenical (orlistat)1

Alli (orlistat)2

Adipex (phentermine)3

Qsymia (phentermine/topirama

te extended release)

Belviq (lorcaserin

hydrocholride)

Mechanism of action

Blocks fat absorption

Blocks fat absorption

Induces satietyReduced appetite &

possible satiety enhancement

Reduced appetite & feel fuller sooner

Dosage 120 mg TID 60 mg TID15 – 37.5 mg

QD

3.75 mg/23 mg QD for 14 days, then increase to 7.5 mg/46 mg QD. Dose may be titrated

higher if WL not achieved after 12 weeks

10 mg BID

Average weight Loss

5.7 lbs at 1 year

5 – 10 lbs at 6 months

7.92 lbs at 1 year

5.1%-10.9% of body weight at 1 year

5.8% of body weight at 1 year

ConcernsGI symptoms,

risk of liver damage

GI symptoms risk of liver

damage

Monitor blood pressure

Monitor heart ratePossible risk of cardiac event

1. Xenical Prescribing Information. 2. Alli product label. 3. ePocrates–Adipex-P monograph; Li Z, MaglioneM, TuW et al. Meta-analysis: Pharmacologic Treatment of Obesity. Ann Intern Med. 2005;142:532-546.

2. 4. Qsymia Pirescribing Information 5. Belviq Prescribing Information.

• For patients with:– BMI ≥ 35 with co-morbidities or

– BMI ≥ 40 without co-morbidities

• Provides medically significant sustained weight loss

• Involves alteration of the GI tract that affects cellular and molecular signaling and leads to a physiologic improvement in energy balance, nutrient utilization, and metabolic disorders.

• Examined in many clinical studies for effects on weight and co-morbidities

Bariatric & Metabolic Surgery:

Average Weight Loss from baseline; meta-analysis of various studies up to 4 years in length.1. Phillips E, Ponce J, Cunneen SA, et al. Safety and effectiveness of REALIZE® adjustable gastric band: 3-year prospective study in the

United States. Surg Obes Rel Dis. 2009; 5:588-597. P<0.0012. Fischer L, Hildebrandt C, Bruckner T, Kenngott H, Linke GR, Gehrig T, Büchler MW, Müller-Stich BP. Excessive weight loss after

sleeve gastrectomy: a systematic review. Obes Surg. 2012 May;22(5):721-31.3. O’Brien PE, McPhail T, Chaston TB, et al. Systematic review of medium-term weight loss after bariatric operations. Obes Surg. 2006;

16(8):1032-1040.

TreatmentExcess

Weight Loss

Laparoscopic Adjustable Gastric Banding1 41%

Sleeve Gastrectomy2 66%

Gastric Bypass Surgery3 62%

Comparison of surgical treatment options

Surgery is Currently the Most Effective Treatment for Morbid Obesity

“It is clear that obesity surgery today offers the only effective long-term treatment option for the severely obese patient.”

- American Heart Association (AHA), 2011

“Bariatric surgery should be considered for adults with BMI ≥ 35 kg/m2 and type 2 diabetes, especially if the diabetes is difficult to control with lifestyle and pharmacologic therapy.”

- ADA “The Standards of Medical Care in Diabetes,” 2009

“Weight-loss surgery is the most effective treatment for morbid obesity producing durable weight loss, improvement or remission of co-morbid conditions, and longer life.”

- Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), 2009

1 Poirer.P, Cornier M-A, Mazzone T. Bariatric surgery and cardiovascular risk factors: A scientific statement from the American Heart Association.Circulation 2011;123:1683-1701.l

2 American Diabetes Association.  Standards of medical care in diabetes – 2009.  Diabetes Care 2009; 32 (S1): S13-S613 SAGES Guidelines Committee. SAGES guideline for clinical application of laparoscopic bariatric surgery.

Surg Endosc 2008 Oct;22(10):2281-300

Major medical societies are advocating for bariatric surgery

Avidor Y, Still CD, Brunner M, et al. Primary care and subspecialty management of morbid obesity: referral patterns for bariatric surgery. Surg Obes Relat Dis. 2007;3(3):392-407

Treatments Prescribed for Morbid Obesity

Continuum of care for the obese patient

.* From Janssen

There are many healthcare professionals that must work together to identify the right time for the right treatment.

Surgical Options for Obesity Treatment

Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2008. Obes Surg 2009; 19:1605-1611.

Bariatric Surgery Procedure Types

A laparoscopic approach for bariatric surgery is performed ~90% of the time.

Adjustable Gastric Banding

Place implantable device around upper most part of stomach

Re-sect approximately three-fourths of

the stomach

Sleeve Gastrectomy

Bypass a portion of the small intestine and create a

15-30cc stomach pouch

Roux-en-Y Gastric Bypass

Bariatric surgery – most common procedures

~245,000 procedures annually (US)

Comparing the benefits and risks of bariatric surgery

Obstructive sleep apnea45% to 76% resolved

Asthma39% improved

Diabetes 25% to 66% controlled Hypertension 42% to 66% resolved

Urinary stress incontinence*50% resolved

Osteoarthritis* /Degenerative joint disease

41% resolved

Depression*47% reduced

Nonalcoholic fatty liver disease37% resolution of steatosis

Migraines*46% improved

References at end of presentation. * Study population predominantly female.

There are significant co-morbidity improvements associated with bariatric surgery

90-Day Adverse Event Rates by Procedure*

Serious events include death, anastomotic leakage, cardiac arrest, deep vein thrombosis, evisceration, heart failure, liver failure, multi-system organ failure, myocardial infarction, pneumothorax, pulmonary embolism, renal failure, respiratory failure, sepsis, stroke, systemic inflammatory response syndrome, and bleeding requiring blood transfusion. Does not include non-serious events such as nausea/vomiting, dehydration, and atelectasis .

*When performed at a Bariatric Surgery Center of Excellence

SRC BOLD Report: Summary of Key Statistics Prepared for SRC’s Strategic Alliance Partners. March 2010. Data is reported on 80,157 research-consented patients who have had a surgery entered in BOLD from June 2007 through Sept 22, 2009. All patients with data in BOLD

have had their bariatric surgery performed by a surgeon participating in SRC’s Bariatric Surgery Center of Excellence (BSCOE) program.

Source: Direct Research, LLC, Center for Medicare and Medicaid Services, FY 2010 MedPAR, Medicare Fee-for-Service Inpatient Discharges with Selected Procedures

CMS: Inpatient Discharge Data (2010)Morbidity & mortality rates of gastric bypass are similar to other common procedures

• Benefits:– Highest level of excess weight loss

– Co-morbidity resolution or reduction

– Reduction in mortality

• Risks:– General risks of surgery

– Band erosion / slippage / leak / malfunction

– Esophageal spasm/reflux or esophageal/stomach inflammation

– Gastric perforation

– Outlet obstruction

Note: Lists are not exhaustive. Risks are in addition to the general risks of surgery. Patient weight, age and medical history play a significant role in determining specific risks.

Bariatric Surgery: Benefits vs. Risks

Recent Clinical EvidenceBariatric Surgery and Medication Usage

Surgical treatment and medications achieved glycemic control in more patients than medical therapy alone.

STAMPEDE

Schauer PR, Kashyap SR, Wolski K, et al. Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes. N Engl J Med. 2012; 366:1567-1576.

Study supported by a grant from Ethicon.

STAMPEDE results

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

12%

42%

37%

Patients at Glycemic Control, 12 months

Medical Therapy Medical Therapy + Gastric Bypass

*p=0.002

Medical Therapy + Sleeve Gastrectomy

**p=0.008

*

**

Glycemic control: HbA1c < 6.0% with or without diabetes medications, 12 mo after randomization. Figures adapted from study data.

Surgical treatment and medications achieved glycemic control of HbA1c < 6.0% in more patients than medical therapy alone

Significantly more diabetic patients achieved glycemic control following bariatric surgery

0%

10%

20%

30%

40%

50%

60%

70%

80%

0%

68%

45%

Patients at Glycemic Control, 12 months

STAMPEDE results

Surgical treatment and medications achieved glycemic control of HbA1c < 7.0% in more patients than medical therapy alone

Significantly more diabetic patients achieved glycemic control following bariatric surgery Medical Therapy Medical Therapy +

Gastric Bypass*p<0.001

Medical Therapy + Sleeve Gastrectomy

**p<0.001

*

*

**

Glycemic control: HbA1c < 7.0% without diabetes medications, 12 mo after randomization. Figures adapted from study data.

Mingrone

Bariatric surgery resulted in better glucose control than did medical therapy

Mingrone, G, et. al. Bariatric Surgery versus Conventional Medical Therapy for Type 2 Diabetes, N Engl J Med 2012, March 26, [Epub ahead of print]

Mingrone – ResultsGlycated Hemoglobin Levels during 2 Years of Follow-up

Mingrone, G, et. al. Bariatric Surgery versus Conventional Medical Therapy for Type 2 Diabetes, N Engl J Med 2012, March 26, [Epub ahead of print]

T2DM resolved or improved in 87% of patients following bariatric surgery

Buchwald(systematic review)

Total

Gas

tric

Bandin

g

Gas

tropla

sty

Gas

tric

Bypas

s

BPD/DS

0%

20%

40%

60%

80%

100%

Resolved Resolved or Improved

Buchwald: Systematic Review & Meta-Analysis (2009)T2DM resolved or improved in 87% of patients following bariatric surgery

• Systematic review & meta-analysis reviewing 621 studies including 135,246 patients

• Overall, T2DM 87% resolved or improved (78% resolved) for patients after bariatric surgery

Buchwald H, Estok R, Farbach K, et al. Weight and Type 2 Diabetes after Bariatric Surgery: Systematic Review and Meta-analysis. Am J Med. 2009;122(3):248-256. Figure adapted from source data. Data included includes 621 studies with 888 treatment arms & 135,246 patients; 103 treatment arms with 3188 patients reported on resolution of diabetes. Resolution

based on clinical and laboratory manifestations of diabetes resolved (off diabetes medications with normal fasting blood glucose [<100 mg/dL] or HbA1c [≤6%]),

81%87% 87% 85%

99%

Total

46% fewer T2DM related claims for patients with bariatric surgery

Klein(3 year matched cohort analysis)

Klein: 3-Year Matched Cohort Analysis (2011) 46% fewer T2DM-related claims for patients following bariatric surgery

• 56% fewer diabetes prescriptions were filled for bariatric surgery patients.

• There was a significantly lower supply cost in diabetes medication for surgery patients.

Source: Klein S, Ghosh A, Cremieux PY, Eapen S, McGavock TJ. Economic impact of the clinical benefits of bariatric surgery in diabetes patients with BMI ≥35 kg/m2. Obesity. 2011;19:581-587.

76% decline in diabetes medication use at 12 months post-surgery

Segal(AHRQ 1 – year cohort study)

Segal: AHRQ 1-Year Cohort Study (2010)76% decline in diabetes medication use at 12 months post-surgery (p≤0.0001)

■ nonsurgical group

◊ surgical group

Source: Segal JB, Clark JM, Shore AD, et al. Prompt reduction in use of medications for comorbid conditions after bariatric surgery. Effective Healthcare Research Report No. 28. Rockville, MD: Agency for Healthcare Research and Quality; 2010. (Fig 1, page 14)

Lower proportion - and likelihood - of having T2DM at 5 years post bariatric surgery

Bolen(5 year matched cohort analysis)

Bolen: 5-Year Matched Cohort Analysis (2012)Lower proportion – and likelihood - having T2DM at 5yr following bariatric surgery

Source: Bolen, Shari and others. Clinical Outcomes after Bariatric Surgery: A Five-Year Matched Cohort Analysis in Seven US States. Obesity Surgery (2012) 22: 749-763, Figure adapted from source data. Non-concurrent, matched cohort study following

22,693 persons who underwent bariatric surgery using logistic regression between groups for up to 5 years.

Swedish Obese Subjects (SOS)

Bariatric surgery appears to be markedly more efficient than usual care in the prevention of Type 2 diabetes in obese persons.

Carlsson LMS, Peltonen M, Ahlin S et al, Bariatric Surgery and Prevention of Type 2 Diabetes in Swedish Obese Subjects. N Engl J Med 2012; 367:695-704.

Carlsson et al.Significantly lower incidence of Type 2 Diabetes in Bariatric / Metabolic Surgery group at 15 years

50

Carlsson LMS, Peltonen M, Ahlin S et al, Bariatric Surgery and Prevention of Type 2 Diabetes in Swedish Obese Subjects. N Engl J Med 2012; 367:695-704.

Who to refer and how to refer to bariatric surgery

Who is a Surgical Candidate?

• Meets National Institutes of Health Criteria: BMI ≥ 40 (or ≥ 35 with obesity-related co-morbidities)

• Common insurance requirements:– 18 years or older

– Failed medically supervised weight loss attempts

– Understands surgery and risks

– Acceptable operative risks (patient and procedure)

– Stable psychological condition: interview, psychotherapy, support groups as indicated

Having the Conversation with your Patients

• Open the discussion for them – delicately and in a sensitive manner

• Tools can help open the discussion (e.g. BMI)

• Address your patient’s chief complaints first

• Empathy and respect are important

• Discuss the options for significant weight loss

• If interested, suggest that they attend a seminar

What to provide for the surgical consultation

A Bariatric referral for consultation is similar to any other specialist referral. They will examine the patient

to determine if surgery is the best option.

• Healthcare Provider documentation on weight loss attempts

• Letter from Healthcare Provider describing history of weight loss attempts– Insurance company requirement

• Medical records

• Pre-surgery H&P evaluation (if needed)

What to Look for in a Bariatric Surgeon / Surgical Center

• A Center of Excellence, the hallmark of which is the prospective database on patients including outcomes, safety data, and process improvement

• A surgeon who works primarily as a bariatric surgeon and performs at least 50 cases per year

• A surgeon/center that communicates at every stage in the patient process with your office and is available to answer questions

• A program that features support groups for patient participation and a strong commitment to the psychological aspects of the program

Requirements for approval depend on insurance policy. Most require:

• BMI >40 or >35 with significant co-morbidities

• Documented history of medical weight loss attempts (3-6 months)

• 5 year weight history

• Psychological evaluation

• Nutrition counseling

Insurance Coverage

1. In patient visits, determine which patients are appropriate for a bariatric surgery consult.

2. Identify bariatric surgeons in your area who meet your standards for referral.

3. Recommend bariatric surgery to selected obese patients

4. Rethink surgery as a therapeutic intervention, not just for severely obese patients*

page 57

* Schauer PR, Kashyap SR, Wolski K, et al. Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes. N Engl J Med. 2012; 366:1567-1576 and Cohen RV, Pinheiro JC, Schiavon CA et al. Effects of gastric bypass

surgery in patients with type 2 diabetes and only mild obesity. Diabetes Care 2012; 35:1420-1428.

Next Steps

How to treat the post operative bariatric surgery patient

Post-Op expectations

• Recovery takes time and patience.

• Weight loss amount and timing of weight loss vary

• The diet will be strict

• Patients may experience discomfort and pain as body heals

• Length of time to return to normal activities varies

• For band patients, they should expect ongoing band fill appointments

Post-Op Management

• Post-operative pneumonia / atelectasis

• Deep venous thrombosis / pulmonary embolism

• Incisional infections

• Nausea / vomiting / dehydration

• Anastomotic & staple line leak

• Thiamin deficiency

• Diarrhea

• Nutritional Screening / Supplements

• Medication Adjustments

Summary

A growing consensus favors bariatric surgery

“Bariatric surgery should be considered for adults with BMI ≥ 35 kg/m2 and type 2 diabetes, especially if the diabetes is difficult to control with lifestyle and pharmacologic therapy.”

– American Diabetes Association (2009)

“When indicated, surgical intervention leads to significant improvements in decreasing excess weight and co-morbidities that can be maintained over time.”

– American Heart Association (2011)

“Bariatric surgery is an appropriate treatment for people with type 2 diabetes and obesity not achieving recommended treatment targets with medical therapies”

– International Diabetes Federation (2011)

“The beneficial effect of surgery on reversal of existing DM and prevention of its development has been confirmed in a number of studies”

– American Association of Clinical Endocrinologists (2011)

Sources: American Diabetes Association. Standards of medical care in diabetes – 2009. Diabetes Care 2009; 32(S1):S13-S61,Poirier P, Cornier M-A, Mazzone T et al. Bariatric surgery and cardiovascular risk factors: A scientific statement from the American Heart Association. Circulation 2011; 123:00-00.

International Diabetes Federation. Bariatric surgical and procedural interventions in the treatment of obese patients with type 2 diabetes. 2011.Handelsman Y, Mechanick JI, Blone L et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for developing a diabetes mellitus comprehensive plan. Endocr Prac 2011; 17(Suppl 2).

A growing consensus favors bariatric surgery

Source: The Endocrine Society, Evaluating the Benefits of Treating Type 2 Diabetes with Bariatric Surgery, March 30, 2012.

“The Endocrine Society recommends that practitioners consider several factors in recommending surgery for their obese patients with type 2 diabetes, including patient’s BMI and age, the number of years of diabetes and the assessment of the (patient’s) ability to comply with the long-term lifestyle changes that are required to maximize success of surgery and minimize complications.”

“… remission of diabetes, even if temporary, will still lead to a reduction in the progression to secondary complications of diabetes (such as retinopathy, neuropathy and nephropathy), which would be an important outcome of … surgery.”

– The Endocrine Society (March 2012)

Bariatric Surgery Conclusions

• Most effective treatment for morbid obesity (SAGES)

• Helps Type 2 diabetic patients achieve glycemic control more effectively than intensive medical therapy within 1 year (STAMPEDE & Mingrone)

• Resolves or improves Type 2 diabetes and other obesity-related CV comorbidities for up to 5 years (STAMPEDE , Buchwald, Klein and Bolen)

• Reduces medication use for Type 2 diabetes and other CV comorbidities for up to 3 years (STAMPEDE, AHRQ/Segal and Klein)

• Results in morbidity & mortality rates that are similar to well-established general surgery procedures (DeMaria)

• Reduces the risk of cardiovascular death (myocardial infarction or stroke) compared to customary intervention (Sjostrom)

• Is an acceptable treatment option for obese patients with T2DM by professional medical societies including the ADA, AHA, IDF, AACE & the Endocrine Society.

Summary

• Obesity is a disease that is growing in prevalence and should be treated as a medical condition

• Bariatric surgery is the most effective therapy available for morbid obesity*

• Surgical weight loss impacts a number of co-morbidities associated with obesity

• You can confidently make a bariatric surgery referral using clear and accepted clinical guidelines and assessment tools

• The bariatric surgeon is a specialist available to you for the treatment of obese patients

* Poirer.P, Cornier M-A, Mazzone T. Bariatric surgery and cardiovascular risk factors: A scientific statement from the American Heart Association.Circulation 2011;123:1683-1701. and SAGES Guidelines Committee. SAGES guideline for

clinical application of laparoscopic bariatric surgery. Surg Endosc 2008 Oct;22(10):2281-300

References for “There are significant co-morbidities associated with obesity”1. Calle EE, Rodriguez C, Walker-Thurmond K. Overweight, obesity, and mortality from cancer

in a prospectively studied cohort of adults. NEJM 2003; 348(17):1625-38.

2. Koenig SM. Pulmonary complications of obesity. Am J Med Sci2001; 321(4):249-279.

3. Mattar SG, Velcu LM, Rabinovitz M, et al. Surgically-induced weight loss significantly improves nonalcoholic fatty liver disease and the metabolic syndrome. Annals of Surgery 2005; 242(4):610-620

4. National Institutes of Health. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults. 1998; NIH Publication No. 98-4083.

5. The Obesity Society. What is Obesity. Accessed May 19, 2010 from http://www.obesity.org/information/what_is_obesity.asp

6. Sugerman HJ, Sugerman EL, Wolfe L, et al. Risks and benefits of gastric bypass in morbidly obese patients with severe venous stasis disease. Annals of Surgery 234(1):41-46.

7. Yosipovitch G, DeVore A, Dawn A. Obesity and the skin: Skin physiology and skin manifestations of obesity. J Am AcadDermatol2007; 56:901-916.

• OSA: Tice JA, Karliner L, Walsh J, et al. Gastric banding or bypass? A systematic review comparing the two most popular bariatric procedures. Am J Med. 2008 Oct;121(10):885-93.

• Asthma: Reddy RC, Baptist AP, Fan Z, et al. The effects of bariatric surgery on asthma severity. Obes Surg. 2011 Feb;21(2):200-6.

• Urinary stress incontinence: Kuruba R, Almahmeed T, Martinez F, et al. Bariatric surgery improves urinary incontinence in morbidly obese individuals. Surg Obes Relat Dis. 2007 Nov-Dec;3(6):586-90.

• Osteoarthritis & Depression: Schauer PR, Ikramuddin S, Gourash W, et al. Outcomes after laparoscopic Roux-en-Y gastric bypass for morbid obesity. Ann Surg. 2000 Oct;232(4):515-29.

• Migranes: Bond DS, Vithiananthan S, Nash JM, et al. Improvement of migraine headaches in severely obese patients after bariatric surgery. Neurology. 2011 Mar 29;76(13):1135-8.

• Hypertension: Tice JA, Karliner L, Walsh J, et al. Gastric banding or bypass? A systematic review comparing the two most popular bariatric procedures. Am J Med. 2008 Oct;121(10):885-93 and Ethicon analysis of data from US Clinical Trial PMA 070009.

• NAFLD: Mattar SG, Velcu LM, Rabinovitz M, et al. Surgically-induced weight loss significantly improves nonalcoholic fatty liver disease and the metabolic syndrome. Ann Surg. 2005 Oct;242(4):610-7.

References for “There are significant co-morbidity improvements associated with bariatric surgery”

• Type 2 Diabetes: Schauer PR, Sangeeta KR, Wolski K et al. Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes. The New England Journal of Medicine 2012; 366(17):1567‐76.;

• Adams TD, Davidson LE, Litwen SE et al.Health Benefits of Gastric Bypass Surgery After 6 Years. JAMA 2012; 308(11): 1122‐1131.;

• Mingrone G, Panunzi S, De Gaetano A et al. Bariatric Surgery versus Conventional Medical Therapy for Type 2 Diabetes. The New England Journal of Medicine 2012; 366(17): 1577‐85.;

• Dorman RB, Serrot FJ, Miller CJ et al. Case‐Matched Outcomes in Bariatric Surgery Treatment of Type 2 Diabetes in Morbidly Obese Patient. Ann Surg 2012; 255: 287‐293;

References for “There are significant co-morbidity improvements associated with bariatric surgery”

• Tice JA, Karliner L, Walsh J et al. Gastric Banding or Bypass? A Systematic Review Comparing the Two Most Popular Bariatric Procedures. The American Journal of Medicine 2008: 121(10): 885‐93.;

• Buchwald H, Avidor Y, Braunwald E et al. Bariatric Surgery: A Systematic Review and Meta‐ Analysis. JAMA 2004; 292:1724‐1737.

• Wong SKH, Kong APS, So WY et al. Use of laparoscopic sleeve gastrectomy and adjustable gastric banding for suboptimally controlled diabetes in Hong Kong. Diabetes, Obesity and Metabolism 2011; 14(4): 372‐374;

• Brethauer SA, Hammel JP Schauer PR et al. Review of sleeve gastrectomy as staging and primary bariatric procedure. Surgery for Obesity and Related Disease 2009; 5: 469‐475.

References for “There are significant co-morbidity improvements associated with bariatric surgery”