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CLINICAL DILEMMAS IN OBESITY MANAGEMENT
Robert B. Baron MD MS Professor and Associate Dean UCSF School of Medicine Declaration of full disclosure: No conflict of interest
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Case 1 50 year old woman, in good health, no history of cigarettes, in for check up. BMI 29. Should you tell her she is overweight? What further assessment and treatment should you begin?
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CLASSIFICATION OF OVERWEIGHT AND OBESITY BY BMI
Obesity Class BMI (kg/m2) Underweight <18.5 Normal – 24.9 Overweight – 29.9 Obesity I – 34.9 II – 39.9 Extreme Obesity III >40
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BMI AND MORTALITY: Overall
Combined NHANES I, II, and III data set BMI y y ≥70 y < 18.5-< 25 to < 30 to < ≥ Flegal, JAMA, 2005
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An Office-Based Approach
Make the diagnosis (and communicate it) Assess readiness for change Prescribe diet and exercise Consider medications and surgery
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HEALTH PROFESSIONAL ADVICE AND WEIGHT LOSS
12,835 adults, BMI over 30 kg/m2, check-up in last year Random-digit, population-based sample, 50 states 42% told by health professional to lose weight Those told to lose weight more likely to report trying to lose weight: OR 2.79 (95% CI )
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INTENTIONAL WEIGHT LOSS AND DEATH
Prospective CDC cohort study, 6391 adults, followed for 9 years Those reporting intentional weight loss had 24% reduction in mortality Those reporting unintentional weight loss had 31% higher mortality Those reporting attempted but unsuccessful weight loss also had 20% reduction in mortality Gregg, Ann Int Med 2003
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METABOLIC SYNDROME Fulfill 3 or more criteria:
Waist: men > 102 cm ( > 40 in); women > 88 cm ( > 35 in) HDL: men < 40; women < 50 Triglycerides: ≥150 mg/dl BP: ≥130/85 (or use of medications) Fasting glucose: ≥110 mg/dl ICD-9: 277.7 NCEP, JAMA 2001
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GOALS OF MANAGEMENT Be as fit as possible at current weight
Prevent further weight gain If successful at 1 and 2, begin weight loss
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Case 2 50 year old woman, in good health, in for check up. BMI 32 with metabolic syndrome. She says, “ I have to lose weight, and I am planning on doing that. I am about to try the South Beach diet.”
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DIET THERAPY 48 RCT’S Average weight loss 8% over 3-12 months
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VLCD’s vs LCD’s: Meta-analysis of 29 U.S. Studies
Weight loss studies with > two year f/u 13 VLCDs, 14 LCDs Mostly observational studies (few RCT’s) Weight loss (as % of initial weight): 1y 2y 3y 4y 5y LCDs VLCDs Anderson, Am J Clin Nutr, 2001
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COMPARISON OF ATKINS, ORNISH, WEIGHT WATCHERS, AND ZONE
160 patients, randomly assigned Intention to treat at 1 year Atkins Ornish WW Zone Wt Loss (kg) Completers (%) Completers at 1 year Wt Loss (kg) Dansinger, JAMA 2005
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COMPARISON OF ATKINS, ORNISH, WEIGHT WATCHERS, AND ZONE
Each group: 25% lost 5%, 10% lost 10% of initial weight Each diet reduced LDL/HDL by 10% No significant effects on BP or glucose Weight loss associated with adherence, but not diet type CRP and insulin reductions associated with weight loss, but not diet Dansinger, JAMA, 2005
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DIET APPROACHES Diets low cal (low fat, low carbohydrate), meal replacement Commercial programs Weight Watchers™, Jenny Craig™, TOPS™, Overeaters Anonymous™, Nutrisystem.com,™ Shapedown,™ The Solution™ Internet programs (by RDs) Fitday.com, Dietwatch.com, Cyberdiet.com, eDiets.com, Shapeup.org
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FITNESS AND MORTALITY Aerobics Center Longitudinal Study
25,714 men, 44 years old, 14 year observational study CV death (RR) normal overweight obese Fit Not fit Total death (RR) normal overweight obese Fit Not fit Wei, JAMA 1999
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FITNESS AND OBESITY Nurses Health Study
Total death (RR) normal overweight Active Not active 116,564 women, 24 year observational study Hu FB, NEJM 2004
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SUCCESSFUL WEIGHT LOSS MAINTENANCE
3000 subjects in National Weight Control Registry: 30-lb weight loss for 1-year Average weight loss 30kg (10 BMI units less), average weight maintenance 5.5 years 45 years old, 80% women, 97% Caucasian 46% overweight as child, 46% one parent obese, 27% both parents Wing and Hill, Ann Rev Nutr, 2001
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SUCCESSFUL WEIGHT LOSS MAINTENANCE
High levels of physical activity Women 2545 kcal/week, men 3293 kcal/week (1-hour moderate intensity per day Only 9% report no physical activity Diet low in fat, high in carbohydrate 1381 kcal day, 24% fat, 19% protein, 56% CHO 4.87 meals or snacks/day Fast food 0.74/week Regular self-monitoring of weight 44% weigh once per day; 31% once per week Wing and Hill, Ann Rev Nutr, 2001
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Case 3 46 year old woman, in good health, in for check up. BMI 42 with diabetes. In 1996 she lost 20 pounds on phen-fen. She wants a new weight loss drug and a referral for weight loss surgery.
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“LONG TERM” PHARMACOTHERAPY OF OBESITY
Review of all RCT’s more than 36 weeks published since 1960 Weight loss in excess of placebo: % of initial kg’s Phen-fen 11.0% kg Phentermine 8.1% kg Sibutramine 5.0% kg Orlistat 3.4% kg Dexfenfluramine 3.0% Kg Fluoxetine -0.4% kg Diethyproprion -1.5% kg Glazer, Arch Int Med 2001
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SIBUTRAMINE ALONE AND WITH LIFESTYLE MODIFICATION
Figure 2. Mean ({+/-}SE) Weight Loss in the Four Groups, as Determined by an Intention-to-Treat Analysis (Panel A) and a Last-Observation-Carried-Forward Analysis (Panel B). Subjects who received combined therapy lost significantly more weight at all times than subjects in the other three groups. Subjects treated with lifestyle modification alone and those treated with sibutramine plus brief therapy lost significantly more weight at week 18 than those who received sibutramine alone, with no other significant differences at any other time. Panel B shows that a last-observation-carried-forward analysis yielded the same statistical conclusions. Wadden, T. A. et al. N Engl J Med 2005;353:
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OFF-LABEL USE Sertraline – SSRI More selective 5-HT uptake inhibitor
In Phase III trials now Buproprion – NA re-uptake inhibitor RCT of 327 obese pts, 24 weeks; Wt. loss: 2% placebo vs. 5% in 300/400 mg Topiramate – CA inhibitor RCT in 385 obese pts; dose-ranging; 24 wks Wt loss: -2.6% placebo vs. -5 to -6% w/drug Topiramate: weak carbonic anhydrase inhibitor; modulates the GABA receptors – approved as an anti-epileptic drug; Unclear mechanism that contributes to weight loss effects.
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OTHER DRUGS OFF-LABEL Amantadine
Other SSRIs (fuvoxamine, venlafaxine, citalopram, others) H2 blockers (cimetidine) Metformin Wt loss: -2 kg with drug vs. -0 kg with placebo vs. -4 kg with lifestyle in DPP Exenatide (Byetta) - Wt loss: -4-5 kg in open label study at 80+ weeks Zonisamide – antiepileptic Wt loss: -5.9 kg with drug vs. 0.9 kg with placebo Topiramate: weak carbonic anhydrase inhibitor; modulates the GABA receptors – approved as an anti-epileptic drug; Unclear mechanism that contributes to weight loss effects.
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RIMONABANT (Acomplia™)
1,507 severely obese people, Europe, 2-years (2005) rimonabant 7.3 kg loss placebo 2.5 kg loss 3,040 obese people, US, 2-years (2004) rimonabant kg loss placebo 2.3 kg loss
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Change From Baseline, kg
Year 1 Body Weight Placebo 5 mg of Rimonabant 20 mg of Rimonabant Change From Baseline, kg 12 24 36 52 Weeks
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Change From Baseline, kg
Year 2 Body Weight Placebo/Placebo 20 mg rimonabant/Placebo 20 mg rimonabant/20 mg Change From Baseline, kg 52 60 68 76 84 92 104 Weeks
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RIMONABANT (Acomplia™) Side Effects
Nausea: 13.7% with drug vs. 5.5% on placebo Dizziness: double with drug Diarrhea: double with drug Depression: 2.8% vs. 1.6% Drop outs: 19% with drug vs. 13% with placebo
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PRINCIPLES OF DRUG THERAPY
NIH: BMI > 30 kg/m2 or 27 kg/m2 with co-morbidity (but in practice almost never) Motivated to begin structured exercise and low calorie diet Begin medications at completion of one month successful diet and exercise Continue medications only if additional weight loss achieved in first month with meds
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Wouldn’t It Be Easier Just To Have Surgery?
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National Trends in Annual Numbers of Bariatric Procedures, 1998-2003
Data based on nationwide inpatient sample Projection based on preliminary data from 12 states for 2003 No. of Procedures 1998 1999 2000 2001 2002 2003 Year Error bars indicate 95% confidence intervals
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Who’s Getting Surgery? Approved by most payers; cost effective
Recent review indicates more surgeries done in: women those with private insurance those living in wealthier zip codes Santry HP et al JAMA 2005;294:1909
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Types of Surgery Restrictive Malabsorptive
Horizontal Gastroplasties Vertical Banded Gastroplasty (VGB) Silastic Ring Vertical Gastroplasty (SRVG) Adjustable Gastric Banding Malabsorptive Jejunoileal Bypass (JIB) Biliopancreatic Diversion (BPD) Duodenal Switch Long Limb Gastric Bypass Restrictive with Malabsorptive Component Roux-en-Y Gastric Bypass (RYGPB)
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Restrictive Procedures Adjustable Gastric Banding
VBG Adjustable Gastric Banding Roux-en-Y GB
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BARIATRIC SURGERY META-ANALYSIS
Review of bariatric surgery (136 studies), , 22,092 patients weight loss (kgs) BMI decrease % excess weight loss Total Gastric Banding Gastric Bypass Gastroplasty Biliopancreatic diversion or duodenal switch Buchwald, JAMA, 2004
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Resolution of Comorbidities
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BARIATRIC SURGERY META-ANALYSIS
Review of bariatric surgery (136 studies), 22,092 patients Operative Mortality Gastric Banding 0.1% Gastric Bypass 0.5% Gastroplasty % Biliopancreatic diversion or duodenal switch 1.1% Buchwald, JAMA, 2004
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Mortality Rate After Bariatric Surgery
Flum, D. R. et al. JAMA 2005;294: .
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Survival After Bariatric Surgery by Age Group
Flum, D. R. et al. JAMA 2005;294:
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LACK OF METABOLIC EFFECTS OF LIPOSUCTION
15 women, before and after liposuction (8 with normal glucose tolerance, 7 with diabetes) Weight loss: 9.1 kg (NLs) and 10.5kg (DM) No change in insulin sensitivity of muscle, liver, or adipose tissue No change in C-reactive protein, IL-6, TNF alpha or adiponectin No change BP, glucose, insulin, lipids Klein, NEJM 2004
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