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Management of Morbid Obesity: Tools for Confronting the Epidemic Washington, DC June 3, 2008 7:45 AM - 9:00 AM

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Page 1: Management of Morbid Obesity: Tools for Confronting … Images/PMU … · Management of Morbid Obesity: Tools for Confronting the Epidemic ... Duration of each study ranged from 4

Management of Morbid Obesity: Tools for Confronting the Epidemic

Washington, DC

June 3, 2008 7:45 AM - 9:00 AM

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Management of Morbid Obesity: Tools for Confronting the Epidemic Learning Objectives

• Learn at least 1 new strategy for long-term management of obesity. • List at least 2 nonpharmacologic and 2 pharmacologic treatment options for maximizing healthy weight

loss. Faculty Kelly Anne Spratt, DO Clinical Associate Professor of Medicine Cardiovascular Risk Intervention Program University of Pennsylvania School of Medicine Philadelphia, Pennsylvania Kelly Spratt, DO, is clinical associate professor of medicine at the University of Pennsylvania and an integral part of the preventive cardiology Cardiovascular Risk Intervention Program, a program designed to include outstanding prevention strategies and enrollment in clinical trials. Her practice includes noninvasive cardiology, with a strong emphasis on preventive aspects of cardiovascular disease as well as heart disease in women. She is board-certified in both internal medicine and cardiovascular disease. Dr Spratt received her medical degree from the Philadelphia College of Osteopathic Medicine, and completed her residency in internal medicine as well as a fellowship in cardiology at Hahnemann University Hospital in Philadelphia. Dr Spratt has authored journal articles and chapters in cardiology textbooks, and lectures regionally and nationally. She is involved in teaching medical students and house staff and is also actively involved in patient education in several media, including radio, television, and the Internet. She has served as consultant for “Ask the Doctor” for the Better Homes and Garden health Web site, a resource for patients with a variety of health concerns. Faculty Financial Disclosure Statement As a continuing medical education provider accredited by the ACCME, it is the policy of Pri-Med Institute to require any individual in a position to influence educational content to disclose the existence of any financial interest or other personal relationship with the manufacturer(s) of any commercial product(s). The presenting faculty reported the following: Dr Spratt has nothing to disclose. Conflict of Interest Resolution Statement When individuals in a position to control content have reported financial relationships with one or more commercial interests, as listed above, Pri-Med Institute works with them to resolve such conflicts to ensure that the content presented is free of commercial bias. The content of this presentation was vetted by the following mechanisms and modified as required to meet this standard:

• Content peer review by external topic expert • Content validation by external topic expert and internal Pri-Med Institute clinical editorial staff

Off-label/Investigational Disclosure In accordance with Pri-Med Institute policy, faculty has been asked to disclose discussion of unlabeled or unapproved use(s) of drugs or devices during the course of their presentations. Drug List Generic Trade orlistat Xenical, Alli sibutramine Meridia phentermine various

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bupropion Wellbutrin, Wellbutrin XL, Wellbutrin SR, Zyban topiramate Topamax Investigational rimonobant Acomplia (not FDA approved for obesity) axokine Regeneron Suggested Reading List Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults--The Evidence Report. National Institutes of Health. Obes Res. 1998;6(suppl 2):51S-209S. Obesity Online. http://www.obesityonline.org. Fontaine KR, Redden DT, Wang C, et al. Years of life lost due to obesity. JAMA. 2003;289(2):187-193. Knowler WC, Barrett-Connor E, Fowler SE, et al; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Eng J Med. 2002;346(6):393-403. Kaplan LM. Body weight regulation and obesity. J Gastrointest Surg. 2003;7(4):443-451. Cummings DE, Schwartz MW. Genetics and pathophysiology of human obesity. Annu Rev Med. 2003;54:453-471 Third Report of the National Cholesterol Education Program Expert Panel. Executive Summary. National Institutes of Health; 2001. NIH Publication No. 01-3670. American Society for Bariatric Surgery. http://www.asbs.org. Dzavik V, Ghali WA, Norris C, et al. Long-term survival in 11,661 patients with multivessel coronary artery disease in the era of stenting: a report from the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease (APPROACH) investigators. Am Heart J. 2001;142(1):119-126. Christou NV, Sampalis JS, Liberman M, et al. Surgery decreases long-term mortality, morbidity, and health care use in morbidly obese patients. Ann Surg. 2004;240(3):416-424.

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1

Management of Morbid Obesity:Options for Ending the Epidemic

Objectives

� Discuss the long-term health implications of obesity and be able to list at least 2 potential therapeutic options for weight loss

� Describe the benefits (including amount of weight loss expected) and risks (including perioperativemortality rate) associated with the surgical treatment of obesity

Prevalence of CVD Risk Factors in Adults:US, 1961-2001

Reproduced with permission from National Institutes of Health, National Heart, Lung, and Blood Institute. Fact Book Fiscal Year 2005. 2005:52.

50

40

30

20

10

0

Perc

ent o

f Pop

ulat

ion

Year

1960 1965 1970 1975 1980 1985 1990 1995

OverweightHypertensionSmokingHigh cholesterol

2000

60

70

2005

Morbid Obesity

• BMI of at least 30 is obese– 23.% US population (2005)

• BMI of at least 40 is morbidly• obese

– 4.8% of US population (2005)

• BMI of at least 50 is super obese

• Genetics and environment• Lifelong and progressive• Multiple serious medical complications• BMI is attempt to quantify, not a

perfect systemDeMaria EJ, NEJM 2007;356:2176-83; Ogden CL et al, JAMA 2006 Apr 5;295(13):1549-55

Obesity Trends* Among U.S. AdultsBRFSS, 1991, 1996, 2003

19961991

2003

(*BMI ≥30, or about 30 lbs overweight for 5’4” person)

Mokdad AH, et al. JAMA. 1999;282:1519-1522.; Mokdad AH, et al. JAMA. 2001;286:1195-1200.

≥25%20%–24% 15%–19% 10%–14%<10% No Data

Obesity Statistics: Projected to Double Over the Next 30 Years

50

40

30

20

10

0

BM

I ≥30

(%)

1960 1970 1980 1990 2000 2010 2020 2030

Year

U.S.

England

Australia

Brazil

Kuczmarski RJ, et al. JAMA. 1994;272:205-211.; Mokdad AH, et al. JAMA. 1999;282:1519-1522.NIH National Heart, Lung, and Blood Institute. Obes Res. 1998;6(suppl 2):51S.

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Dietary Changes

Caloric Intake—30 years with more of everything!

1497 lbs/personConsumed per year

1775 lbs/personConsumed per year

19701970 20002000

Protein 588Fat 56Sugar 139Vegetables 337Grain 136Fruit 241

Protein 621Fat 77Sugar 172Vegetables 425Grain 200Fruit 280

Harnack LJ, Am J Clin Nutr. 2000 Jun;71(6):1478-84; www.obesityonline.org

Medical Complications of Obesity

Phlebitisvenous stasislymphedema

Coronary heart disease

Pulmonary diseaseabnormal functionobstructive sleep apneahypoventilation syndrome

Gall bladder disease

Gynecologic abnormalitiesabnormal mensesinfertilitypolycystic ovarian syndrome

Gout

Stroke

Diabetes

Osteoarthritis

Cancerbreast, uterus, cervixcolon, esophagus, pancreaskidney, prostate

Nonalcoholic fatty liver diseasesteatosissteatohepatitiscirrhosis

HypertensionDyslipidemia

Cataracts

Skin

Idiopathic intracranial hypertension

Severe pancreatitis

Adipose Tissue as an Endocrine Organ

Traditional View Emerging ViewFat is an inert storage depot Fat is a secretory endocrine organ

PAI-1 = plasminogen activator inhibitor-1.; Kershaw EE, et al. J Clin Endocrinol Metab. 2004;89:2548-2556.

“SICK” FAT CELL SYNDROME= Adiposopathy

PEARAPPLE

Apples vs Pears

Effect of Obesity on Expected Lifetime Medical Care Costs* in Men

Cos

ts ($

)*

Body Mass Index (kg/m2)

0

10,000

20,000

30,000

40,000

37.5 32.5 27.5 22.535–44

45–54

55–64

Age (y

)

*Total cost of CHD, type 2 DM, hypertension, hypercholesterolemia, stroke.Thompson et al. Arch Intern Med 1999;159:2177.

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Over the past 12 months, approximately how many patients have your referred for bariatric surgery?

?

1. 0-32. 4-103. >10

Case Presentation

• A 44 year old obese woman (height 1.7 m or 65”) is seeing her PCP for management of conditions related to her obesity, including diabetes, hypertension, and gastroesophageal reflux disease. Despite efforts to lose weight, her weight has increased from 109 to 127 kg (240 to 280 lb) and her body-mass index (BMI) from 40.0 to 46.6 kg/m2.

• During a routine office visit, the patient asks her PCP whether bariatric surgery might be an option for her.

DeMaria EJ, NEJM 2007;356:2176-83

What would be your most likely recommendation for this patient at this point?

?

1. Lifestyle modification alone

2. Lifestyle modification + very low calorie diet (VLCD) under medical supervision

3. Lifestyle modification + weight loss medication

4. Lifestyle modification + referral for consideration of bariatric surgery

Which of the following therapeutic options would offer the greatest chance of significant durable weight loss?

?

1. Lifestyle modification alone

2. Lifestyle modification + very low calorie diet (VLCD) under medical supervision

3. Lifestyle modification + weight loss medication

4. Lifestyle modification + referral for consideration of bariatric surgery

Which of the following is the most important reason that you don’t refer more patients for consideration of bariatric surgery?

1. Lack of knowledge concerning indications

2. Lack of proven efficacy of the procedures

3. Lack of proven mortality benefit

4. Cost and/or inability to 3rd party payers to approve

5. Risk of perioperative complications

6. Concerns about long term side-effects and negative implications on quality of life

? Main Options for Management of Obesity:Can Be Used in Combination

• Lifestyle Modification – “Diet and Exercise”

• Medically Supervised Very Low Calorie Diets (VLCD) – 800-1000 kcal/day +/- Meal Replacements

• Weight Loss Medications– Indicated and “Off-label”

• Bariatric Surgery– Restrictive and Malabsorbtive Procedures

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Option 1:

Lifestyle Modification(“Diet and Exercise”)

Components of Lifestyle Modification for Weight Loss

� Heart Healthy Diet

� Regular Physical Exercise

� Caloric Restriction

Components of Lifestyle Modification for Weight Loss

� Heart Health Diet

� Regular Physical Exercise

� Caloric Restriction

Dietary Approaches to Stop Hypertension (DASH) Eating Plan (Isocaloric)

www.nhlbi.org

American Heart Association (AHA) Exercise Recommendations for Adults

Moderate-intensity aerobic (endurance) physical activity for a minimum of 30 min on five days each

week (IA)

OR

Vigorous-intensity aerobic physical activity for a minimum of 20 min on three days each week (IIB)

Circulation. 2007 Aug 28;116(9):1081-93.

Approximately How Many Calories are ‘Burned’ with 30 minutes of Brisk Jogging (3 miles)?

?

1. 300 kcal2. 600 kcal3. 900 kcal4. 1200 kcal

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Substituting 2 diet sodas for 2 regular

sodas

To Achieve a 300 kcal Negative Energy Balance:

Reduce intake by: Or increase activity by:

Bicycling 8 miles in 30 min

Eliminating 2 oz potato

chips

Running 3 miles in 30 min

or or

Physical Activity Alone Results in Minimal Weight Loss

*P<0.05 vs control group; Duration of each study ranged from 4 to 12 months.Wing. Med Sci Sports Exerc 1999;31(suppl):S547.

Control group

Exercise group

Stefanick 1998Stefanick 1998a Anderssen 1995Hammer 1989Verity 1989Rönnemaa 1988Wood 1988Wood 1983

-7.0 -5.0 -3.0 -1.0

Weight loss (kg)

**

**

+1.0

Interim Results of Look-Ahead Study:

ILI DSE P-value

% Change in Weight -8.6 -0.7 P<0.001

A1C at 1-year (%) 6.6 7.2 P<0.001

SBP (mmHg) 121 127 P<0.001

LDL-C (mg/dl) 107 107 ns

Triglycerides (mg/dl) 153 165 P<0.001

HDL-C (mg/dl 47 45 P<0.001

Met Syndrome (%) 79 87 P<0.001

Pi-Sunyer X, et al. Diabetes Care, 30:1374-1383.

Intensive Lifestyle Intervention (ILI) vs. Usual Diabetes Support & Education (DSE) in 5145 overweight/obese individuals with T2DM: 1- Year Results

Knowler WM, et al; Diabetes Prevention Program Research Group. N Engl J Med. 2002;346:393-403.

Effect of Lifestyle Intervention on Risk of Diabetes and Metabolic Syndrome: Diabetes Prevention Program

-8

-0.1

Wei

ght

Cha

nge,

kg

-6

-4

-2

0

PB(n = 1082)

LS(n = 1079)

MET(n = 1073)

-5.6*

-2.1*

*P <.001 vs placebo

% R

educ

tion

in

Inci

denc

e of

Dia

bete

s

-60

-40

-20

MET LS

-58*

-31

*P <.05 vs metformin

-50

-40

-30

-20

-10

0MET LS

Red

uctio

n in

Ris

k of

Met

abol

ic S

yndr

ome,

%

-17%†

-41%*

Risk of developing metabolic syndrome

n=1523

LS = lifestyle intervention; MET = metformin; PB = placebo.

Orchard TJ, et al; Diabetes Prevention Program Research Group. Ann Intern ; Med. 2005;142:611-619.

*P <.001; †P = .03

Components of Lifestyle Modification for Weight Loss

� Heart Health Diet—associated with stabilization of weight

� Regular Physical Exercise—important for weight maintenance

� Caloric Restriction

Obesity Is Caused by Long-TermPositive Energy Balance

Fatstores

Genes

Energy Intake“dietary changes”

Energy Expenditure“sedentary lifestyle”

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Caloric Intake—30 years with more of everything!

1497 lbs/personConsumed per year

1775 lbs/personConsumed per year

19701970 20002000

Protein 588Fat 56Sugar 139Vegetables 337Grain 136Fruit 241

Protein 621Fat 77Sugar 172Vegetables 425Grain 200Fruit 280

Harnack LJ, Am J Clin Nutr. 2000 Jun;71(6):1478-84; www.obesityonline.org

Effectiveness of 4 Popular Diets on Weight Loss and Cardiac Risk Factor Reduction*

*In the case of missing data, baseline values were carried forward.; †P <.01 for difference from baseline within the group.‡P <.05 for difference from baseline within the group.; Dansinger ML, et al. JAMA. 2005;293:43-53.

Diet Group, Mean Change (SD), 12-Month Data

-0.88 (2.4)‡-0.58 (1.3)†-0.58 (2.1)-0.70 (2.1)‡CRP, mg/L

-0.5 (6.5)3.4 (9.9)‡3.3 (10.3)‡3.4 (7.1)†HDL-C, mg/dL

-12.6 (19)†-9.3 (27)‡-11.8 (34)‡-7.1 (24)LDL-C, mg/dL

-2.2 (5.5)‡-3.3 (5.4)†-2.9 (5.3)†-2.5 (4.5)†Waist

circumference, cm

-3.3 (7.3)†-3.0 (4.9)†-3.2 (6.0)†-2.1 (4.8)†Weight, kg

Ornish(n = 40)

Weight Watchers(n = 40)

Zone(n = 40)

Atkins(n = 40)Variable

What Do Effective Caloric RestrictiveDiets Have in Common?

• Avoidance of Calorie Dense Foods• Consistency• Accounting and Record Keeping• Sustainability

Obese Patients Have Unrealistic Weight Loss Expectations

Outcome Weight (lbs) % Reduction

Initial 218 0

Dream 135 38

Happy 150 31

Acceptable 163 25

Disappointed 180 17

Foster et al. J Consult Clin Psychol 1997;65:79.

Assessing Readiness for More Intensive Intervention

Motivation:Stress level:

Psychiatric issues:

Time availability:

Patient seeks weight reduction

Free of major life crises

Free of severe depression, substance abuse, bulimia nervosa

Patient can devote 15-30 min/d to weight control for next 26 weeks

PATIENT READY?

Prevent weight gain and explore barriers to weight reduction

Initiate more aggressive weight loss therapy

YES NO

Option 2:

Very Low Calorie Diet (VLCD)(800-1000 Kcal +/- Meal Replacements)

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Effect of Very Low Calorie Diet (VLCD)on Weight Loss

• Weight reduction of approximately – 15-25% after 3-6 months– 9% after 1 year– 5% after 4 years

Tsai et al, Annals of Intern Med 2005; 142:56-66

Very Low Calorie Diet (800-1000 kcal/day)

• Generally not covered by insurance• Usually consists of induction and maintenance phases• Should be undertaken only under very close medical monitoring

– Usually under the care of a weight loss specialist at a specialty center—not the PCP office

• Meal replacements usually needed• Monitor carefully for metabolic and nutritional adverse effects• Important to add vitamins• Need to carefully titrate other medications• Requires multi-disciplinary staff

– Including weight loss specialist physician/medical director, dietician, behavior modification specialist or psychologist, health coach, exercise therapist

Long-term Weight Loss is Improved with Long-term Maintenance Therapy

0

2

4

6

8

10

12

14

16

18

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

Time (mo)

Wei

ght L

oss

(%)

Diet and Behavior modification therapy

Maintenance tx

No maintenance tx

P<0.05

Perri et al. J Consult Clin Psychol 1988;56:529.

Option 3:

Weight Loss Medications(Indicated and “Off-label”)

Medications are approved for use only in:Patients with a BMI of 30 or above, with no concomitant risk factors or diseases,

or patients with a BMI of 27 or above with concomitant risk factors or diseases (hypertension, dyslipidemia, CHD, type 2 diabetes, sleep apnea)

and who have not lost the recommended 1lb/week after several months on lifestyle therapy alone

Medications for obesity are only indicated for use in conjunction with lifestyle changes (diet and exercise)

General Principles of Pharmacotherapy for Obesity

Year Approved

Approved Use

DEA ScheduleGeneric Name

Most Widely Prescribed Drugs for Treating Obesity

1997Long termIVSibutramine

1973Short termIVPhentermine

1999Long termNoneOrlistat*

*Approved for OTC use in January 2007.; Yanovski SZ, Yanovski JA. N Engl J Med. 2002;346:591-602.

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Indication: Approved in 1997 for long-term use (more than 6 months) for treatment of obesityMecanism of Action: Blocks neurohormonal re-uptakeDose: Recommended dose is 5-10 mg qdContraindications: do not give with MAOIs, or other centrally acting appetite-suppressant drugs, anorexia nervosa, hypersensitivity to sibutramine, Warning: not to be used in patients with a history of CAD, arrhythmias, CHF, or stroke, uncontrolled or poorly controlled HTN, severe hepatic dysfunction, or severe renal impairment

http://www.fda.gov/cder/index.html

Sibutramine

Indication: FDA approved in 1999 for long-term treatment of obesity. Only FDA approved drug for the management of obese adolescents ages 12 to 16 years (Dec. 2003). Now available in over-the-counter [OTC] form (2007)Mechanism of Action: Binds to intestinal lipases and prevents fat absorbtionDose: 120 mg TID within 1 hr. of food intake: 60 mg for OTCContraindications: cholestasis, malabsorption syndrome. Caution should be used with patients with hyperoxaluria and Ca oxalate nephrolithiasisInteractions: decreased absorption of the fat-soluble vitamins A, D, E, and K. A multivitamin with minerals should be taken 2 hours before or after orlistat

http://www.fda.gov/cder/index.html

Orlistat

Phentermine

Indication: FDA approved in 1959 for short term use (<3 mo.) The most commonly prescribed of the anorectic agents (withdrawn in Europe)Mechanism of Action: Appetite suppressant, noradrenergic agentDosing: 15 to 30 mg before breakfastContraindications: advanced arteriosclerosis, cardiovascular disease, HTN, hyperthyroidism, glaucoma, agitation, and drug or alcohol abuseSide effects: central nervous system stimulation, impotence, arrhythmias, hypertension, psychosis

•http://www.fda.gov/cder/index.html

Sibutramine and orlistat promote a mean weight loss at 6 months of 3 to 5 kg (7-11lb.) beyond that of controls; prolonged drug courses helped sustain this loss (up to 2 years clinical trials)

Phentermine had similar short-term efficacy but are not approved for long-term use

Arterburn D,. Clin Evid. 2001;412-9; James, Lancet, 2000; Torgeson, Diabetes Care, 2004;.

Summary of Effect of Approved Medications on Weight Loss in Randomized Clinical Trials

“Off-Label” or Investigational Medications for Obesity

• Buproprion - Neurohormonal uptake inhibitor indicated in affective disorder and smoking cessation

• Topiramate - Indicated for treatment of seizure; also frequently used in treatment of migraine

• Rimonobant - endocannabinoid receptor antagonist (investigational)

• Axokine - modified ciliary neurotropic factor (investigational)

• Others

Option 4:

Bariatric Surgery(Restrictive and Malabsorptive Procedures)

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Current Bariatric Surgical Procedures

• Restrictive– Vertical Banded Gastroplasty– Laparoscopic Adjustable Gastric Banding– Sleeve procedure

• Malabsorptive– Duodenal Switch/Biliopancreatic Diversion

• Restrictive and Malabsorptive– Roux-en-Y Gastric Bypass

Roux-en-Y Gastric Bypass

• Creation of a small stomach pouch (about 30 cc initially); limb of jejunum attaches to the pouch creating bypass of the duodenum

• Can be done laparoscopically or as open procedure (3.8 hours)

• This is both a restrictive and malabsorptive procedure

• Higher incidence of mortality and adverse consequences vomiting, gallstones (36%), nutritional deficiency (40%), ulcers of pouch (1%), infection (3%)

• Best durable weight loss success rates

www.lipidsonline.com; DeMaria EJ, NEJM 2007;356:2176-83; Bult MJF, Soc of Eur J of Endocrin 158:135-145

Gastric Banding

• Adjustable saline filled band placed around the stomach creating a smaller volume for food

• Done percutaneously (2.3 hours)

• Less life threatening complications than Roux-en-Y gastric bypass

• Post-operative nausea and vomiting common

• Purely restrictive

• Tendency for less durable weight loss and less resolution of diabetes as compared to gastric bypass

www.lipidsonline.com; DeMaria EJ, NEJM 2007;356:2176-83; Bult MJF, Soc of Eur J of Endocrin 158:135-145

In a Meta-Analysis of Bariatric Surgery Cohort Trials what was that absolute weight loss seen with bariatric surgery

?

1. 10 kg2. 20 kg3. 30 kg4. 40 kg

Systematic Review of Bariatric SurgeryEfficacy Outcomes for Weight Reduction

Buchwald H, et al JAMA 2004;292:1724-1737

Weight Loss after Surgical Treatment of Obesity (Swedish Obese Subjects [SOS] Trial: Matched Controls (not randomized)

• Quality of life improved dramatically at 2 years

• Number of deaths after 10.9 years follow-up– 129 in Control– 101 Surgery– Risk Reduction of

26% (p=0.04)

Stevens, Annals of Inter Med 2001:134:1-111.; Sjostrom L, NEJM 2007;357:741-752.; Karlsson et al, Int J Obesity and Rel Metab Disorders 1998;22:113-126

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Surgical Treatment of Obesity Can Cure Type 2 Diabetes Mellitus (DM) and Impaired Glucose Tolerance (IGT)

• 608 severely obese patients treated with gastric bypass– 146 with DM; 83% became euglycemic– 152 with IGT; 99% became euglycemic

• Comparison of patients with GB with those whose insurance denied the coverage– GB: Oral hypoglycemic use decreased from 32% preop to 9%

postop– Control: Oral hypoglycemic therapy increased from 56% initially

to 88% after 6-9 years

GB=gastric bypass

MacDonald KG Jr et al, J Gastrointest Surg 1: 213-220, 1997; Pories WJ et al, World J Surg 25: 527-531, 2001

Surgical Treatment of Obesity:Resolution of Important Co-morbidities

* Refers to % resolution and/or improvement

Pories, et al. Ann Surg 1995, Sugerman, et al. Ann Surg 2003, ; Schauer, et al. Ann Surg 2003, Rasheid, et al. Obes Surg 2003, George SM, et al. World J Surg 1998, Buchwald, et al JAMA Oct 2004.

84%

68%80%

95%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Diabetes Hypertension Sleep Apnea HighCholesterol*

In a Meta-Analysis of Bariatric Surgery Cohort Trials what was the perioperative (30-day) mortality risk with gastric bypass?

?

1. 0.1%2. 0.5%3. 1%4. 5%

Systematic Review of Bariatric SurgeryPerioperative Mortality

Buchwald H, et al JAMA 2004;292:1724-1737

Gastric Bypass

Potential Complications of Gastric Bypass Surgery

Early complications

• Intestinal leakage• Acute gastric remnant

dilatation• Obstruction• Hair Loss (often recovers)• Cardiopulmonary events• Sepsis/Infection• Thromboembolism

Bult et al, Eur J Endo 2008;158:135-145

Late complications

• Anastomotic stricture (5 percent to 10 percent)

• Anemia, vitamin B12 deficiency, calcium deficiency

• Neuropathy• Cholelithiasis• Nisideroblastosis

(hyperinsulinemichypoglycemia)

• Nausea and Vomiting• Gastroesophageal Reflux

(GERD)• Dumping Syndrome• Osteopenia/Osteoporosis

Open vs. Laparoscopic Approach

• Mortality and complication rates are better with laparoscopic surgery

• Recovery time with laparoscopic surgery:– Hospitalization is shorter (two nights)– Time until back to work is shorter (2-3 weeks) – Decrease in adhesions with less risk of

bowel obstruction in the future with laparoscopic surgery

– Decrease risk of infection (12% vs 1%)– Decrease risk of ventral hernia (20% vs 1%)– Less incisional pain

www.obesityonline.org

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Who Is a Surgical Candidate?

• Meets National Institutes of Health (NIH) Criteria: BMI > 40 (or > 35 with co-morbidities)

• Age 18 to 65 years old– Adolescent and senior patients deserve special consideration.

• Failed non-surgical weight loss attempts• Understands surgery and risks• Acceptable operative risks (patient and procedure)• Stable psychological condition:

interview, psychotherapy, support groups as indicated• Patients who smoke may not be candidates without stopping for

some period of time prior to surgery.• Able to make long-term lifestyle changes (as evidenced by some

weight loss prior to procedure)• Stable, supportive family/social environment• No current alcohol or substance abuse

Bult et al, Eur J Endo 2008;158:135-145

What to Look for in a Referring Surgeon/Center:

• A Center of Excellence, the hallmark of which is the prospectivedatabase on patients which includes outcomes, safety data, and process improvement– American Society for Bariatric Surgery Criteria (ASBS)

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

• Comfortable with laparoscopic approach• Communication at every stage in the patient process with your office• The surgeon/center manages the perioperative complications and is

easy to reach regarding questions you may have about postoperative patients

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

• Fully integrated multi-disciplinary team including dietician, exercise specialist, and behavior modification coach/psychologist

Primary Care After Bariatric Surgery:Complications and Care

• Constantly discuss importance of new relationship to food, eating and exercise

• Need to monitor physiologic effects on comorbidities -though many ‘positive’ , adjustments and change in therapy may be required– BP, DM, Lipid, Heart Disease, arthritis, OSA

• For malabsorptive procedures monitor for symptoms related to dumping, gallstones (duodenum is bypassed), malabsorption(calcium, iron, B-12, folate)

• Monitor for inadequate or excessive weight loss• Monitor and treat onset of new depression

– Increased risk suicide, alcoholism, bulimia, auto accidents– Divorce or marital separations

• Other or complex etiologies– Skin excess, neuropathy, renal stones (oxalate), anemia, GERD

Primary Care after Bariatric Surgery:Vitamin Supplements

• High-Potency Multivitamin (with Folate) daily

• Calcium--1500 mg/d with Vitamin D (1000 mg/d)

• Vitamin B12--500ug po daily; 1000 ug IM each month

• Elemental Iron--65 mg/d (pre-menopausal)

• Vitamin B1 (Thiamine)--50mg daily (can stop after 6 months)

Bult, MJF, Soc of Eur J of Endocrin 158:135-145

Primary Care after Bariatric Surgery:Laboratory Studies

• Routine Care– Q 3 months x 1 year, then q 6-12 months

• CBC, Iron Studies, folate• Chemistry, LFTs, albumin, magnesium• Glucose, A1c

– Yearly• Vitamin D, Parathyroid Hormone (PTH)• Vitamin B12• Bone Density

Bult et al, Eur J Endo 2008;158:135-145

Needs to be adjusted for individual patients base on comorbidities, pace of weight loss, and type of procedure

Case Presentation

• A 44 year old obese woman (height 1.7 m or 65”) is seeing her PCP for management of conditions related to her obesity, including diabetes, hypertension, and gastroesophageal reflux disease. Despite efforts to lose weight, her weight has increased from 109 to 127 kg (240 to 280 lb) and her body-mass index (BMI) from 40.0 to 46.6 kg/m2.

• During a routine office visit, the patient asks her PCP whether bariatric surgery might be an option for her.

DeMaria EJ, NEJM 2007;356:2176-83

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What would be your most likely recommendation for this patient at this point?

?

1. Lifestyle modification alone

2. Lifestyle modification + very low calorie diet (VLCD) under medical supervision

3. Lifestyle modification + weight loss medication

4. Lifestyle modification + referral for consideration of bariatric surgery

American College of Physicians (ACP)Recommendations for Treatment of Obesity

1. Counsel all patients BMI>30 on diet/lifestyle agreeing on individual goals.

2. In patients with BMI>30 who fail to achieve weight goals consider pharmacotherapy highlighting side effects and lack of longterm data

• Agents to choose from include sibutramine, orlistat, phentermine, diethylpropion, fluoxetine and bupropion – according to side effects

3. Surgery should be considered with BMI >40 who have failed an adequate trial of diet and lifestyle. Counselling about risks vital.

• Preferably refer to high volume cneters with experienced multi-disciplinary team

Snow et al, Annal Int Med 2005;142:525-531

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