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Presenter Disclosure Gary D. Foster, PhD Obesity, Weight Loss and OSA Scientific Advisory Board/Advisory Panel: Nutrisystem, ConAgra Foods, Tate and Lyle, United Health Group Gary D. Foster, Ph.D. Consultant: Chief Scientific Officer,


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SLIDE 1

Obesity, Weight Loss and OSA

Gary D. Foster, Ph.D.

Chief Scientific Officer, Weight Watchers International Adjunct Professor of Medicine, Public Health & Psychology Founder and Emeritus Director, Center for Obesity Research and Education Temple University School of Medicine

Gary D. Foster, PhD

Scientific Advisory Board/Advisory Panel:

  • Nutrisystem, ConAgra Foods, Tate and Lyle, United Health Group

Consultant:

  • Eisai, Medtronic, GSK, Food Service Corporation

Research Support:

  • NIH, USDA, CDC, Robert Wood Johnson Foundation, Coca-Cola

Company, Nutrisystem, American Beverage Association, Novo Nordisk Employee/Shareholder: Weight Watchers International

Presenter Disclosure Overview

  • Obesity and OSA
  • Weight Loss and OSA
  • Treatment of Obesity

– Behavioral Treatment – Dietary Treatment – Pharmacological Treatment – Patient Expectations Prevalence of Overweight and Obesity Among US Adults

Flegal, K et al. JAMA, 2002; Hedley, AA et al. JAMA, 2004;Ogden et al JAMA,2006, Flegal et al. JAMA, 2010

Overweight (BMI ≥25) Obesity (BMI ≥ 30)

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SLIDE 2

Pulmonary disease abnormal function

  • bstructive sleep apnea

hypoventilation syndrome Nonalcoholic fatty liver disease steatosis steatohepatitis cirrhosis Coronary heart disease Diabetes Dyslipidemia Hypertension Gynecologic abnormalities abnormal menses infertility polycystic ovarian syndrome Osteoarthritis Skin Gall bladder disease Cancer breast, uterus, cervix colon, esophagus, pancreas kidney, prostate Phlebitis venous stasis Gout

Medical Complications of Obesity

Idiopathic intracranial hypertension Stroke Cataracts Severe pancreatitis

Obesity and OSA

  • Two-thirds of OSA participants are obese1
  • One SD increase in BMI is associated with

a 4-fold increase in AHI2

  • 40% of weight-loss patients have RDI>53,4

1 Guilleminault C. et al, Chest, 1998 2 Young T. et al, NEJM, 1993 3 Richman R. et al, IJO, 1994 4 Vgontzas A. et al, Arch Intern Med, 1994

Romero-Corral A. et al., Chest, 2010

Interactions between OSA, obesity, sleep deprivation & metabolic abnormalities

Weight Loss and OSA

  • Weight losses of 9% to 20% have been

associated with reductions in AHI of 30% to 74%1

  • A 1% change in weight is associated with a

3% change in AHI2

– 10% ↓ in weight is associated with a 26% ↓ in AHI – 10% ↑ in weight is associated with a 32% ↑ in AHI1

1 Strobel RJ & Rosen RC., Sleep, 1996 2 Peppard et al., JAMA, 2000

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SLIDE 3

Relationship between change in AHI and change in BMI during a mean period of 5 years

n=160, at Baseline Mean BMI 29.3 ± 4.7 kg/m2, Mean AHI 23.0 ± 22.6 events/h

Berger G et al., Eur Respir J, 2009

r2= 0.258 p<0.001

Weight Loss and AHI

  • Until 2009, no RCT had assessed the effects of

weight loss on OSA

  • Among weight-loss treated (n=15) and control

(n=8) patients, a 9% weight loss was associated with 47% reduction in AHI

  • Across uncontrolled studies, there was no

significant relationship between weight loss and the change in AHI

Effect of a very low energy diet on moderate and severe OSA in

  • bese men: a randomized controlled trial
  • Sample description

– 63 obese men – Age = 49 ± 7.3 y – Weight = 112.5 ± 14.2 kg – AHI = 37 ± 15 events/h – BMI ≈ 34.6 kg/m2

  • Randomly assigned to 1 of 2 conditions

– A liquid very low energy diet (2.3 MJ/day, 549.3 kcal/day) for 7 weeks to promote weight loss, followed by 2 weeks of gradual introduction of normal foods. – The control group adhered to their usual diet. – 9 week study

Johansson et al., BMJ, 2009

Changes in Weight and AHI at 9 weeks

  • 50
  • 40
  • 30
  • 20
  • 10

10 20 Weight (kg) AHI (events/h) Change Control Intervention

Johansson et al., BMJ, 2009

[Data represent mean changes with standard deviation (SD)]

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SLIDE 4

Improvement in OSA at week 9

Johansson et al., BMJ, 2009

  • Proportions of patients

defined as having no (cured), mild, moderate, or severe

  • bstructive sleep apnea at

week 9

  • Proportions of patients who

improved, maintained, or worsened their obstructive sleep apnea status after 9 weeks

  • Error bars are 95% CIs.

Changes in Weight and AHI at 1 yr

Johansson et al., BMJ, 2011

P< 0.001 for both

  • 50
  • 40
  • 30
  • 20
  • 10

10 20

Weight (kg) AHI (events/hr)

9 weeks 1 year

Change

Lifestyle intervention with weight reduction: First-line treatment in mild OSA

  • Sample Description

– 72 (53 males, 19 females) patients with mild OSA – Age = 51.3 ± 8.8 y – Weight = 96.8 ± 11.6 kg – AHI= 9.65 ± 3.0 events/h – BMI= 32.4 ± 2.7

  • Randomly assigned to 1 of 2 conditions

– A 12 week VLCD (600-800 kcal/day) program with supervised lifestyle modification – Routine lifestyle counseling – Duration was 1 year

Tuomilehto HP et al., Am J Respir Crit Care Med 2009

The odds ratio for having mild OSA at 1 y was 27% lower in the intervention group

  • 20.0
  • 15.0
  • 10.0
  • 5.0

0.0 5.0 10.0 Weight (kg) AHI (total) Change Control Intervention

Changes in Weight and AHI at 1 yr

(n=72)

Tuomilehto HP et al., Am J Respir Crit Care Med 2009

[Data represent mean changes with standard deviation (SD)]

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SLIDE 5

Change in Weight and AHI at 1 yr

Tuomilehto HP et al., Am J Respir Crit Care Med 2009

  • 5kg
  • 2.0

events/h

10 20 30 40 50 60 70 80 90 100 > 15kg 15 to 5 kg 5 to 0 kg > 0 kg Weight change from baseline to 12 month follow-up Remission of mild OSA (%)

  • Remission of mild OSA at 1 yr

Tuomilehto HP et al., Am J Respir Crit Care Med 2009

  • Sustained improvements of OSA by

lifestyle changes at 2 yr follow-up (n=71, 99%)

Tuomilehto HP et al., Am J Clin Nutr, 2010 Vertical bars indicate 95% CIs.

Sleep AHEAD:

Sleep Apnea in Look AHEAD Participants

Sleep

AHEAD

Action for Health in Diabetes

Sleep AHEAD supported by NIH NHLBI grant HL070301 Look AHEAD supported by NIH NIDDK grants DK57135, DK57002, DK56992, and DK57178

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SLIDE 6

Sleep AHEAD Inclusion/Exclusion Criteria

Inclusion Criteria

  • Score on a questionnaire designed to

identify individuals at increased risk of OSA

Exclusion Criteria

  • Patients currently being treated for OSA

(e.g., CPAP, oral appliance)

  • Participants who had prior surgical

treatment for OSA

Columbia

PSGRL

Providence Pittsburgh New York City Philadelphia

Overnight polysomnograms were performed in the participants’ homes The following signals are recorded on a data acquisition system (Compumedics PS2):

– Electroencephalogram (C3A2, C4A1) – Bilateral electrooculograms (A2 & A1, respectively) – Bipolar submental electromyogram – Movements of the rib cage and abdomen – Nasal pressure as an index of airflow – Body position – Pulse oximetry – Electrocardiogram – Presence or absence of snoring

Polysomnogram Scoring Criteria

  • Apnea

– cessation of airflow for ≥ 10 sec

  • Hypopnea

– At least a 30% reduction in chest wall movement or airflow lasting at least 10 seconds with ≥ 4% oxygen desaturation

  • Apnea-Hypopnea Index (AHI)

– the mean number of apneas and hypopneas per hour of sleep

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SLIDE 7

Sleep AHEAD Measures

Baseline, 1, 2, and 4 years:

  • Apnea-hypopnea index
  • Body weight
  • Waist circumference
  • Neck circumference

No difference between DSE and ILI groups

Sleep Ahead Participants (N=305)

Foster et al., Diabetes Care, 2009

Variable Mean ± SD Race/ethnicity (%) White 73.0 African American 19.1 Other 7.9 Postmenopause (%) 90.1 Age (years) 61.3 ± 6.5 BMI (kg/m2) 36.5 ± 5.8 Weight (kg) 101.7 ± 18.0 Height (cm) 167.0 ± 9.7

No difference between DSE and ILI groups

Sleep Ahead Participants (N=305)

Foster et al., Diabetes Care, 2009

Variable Mean ± SD Waist Circumference (cm) 115.0 ± 13.0 Neck Circumference (cm) 41.1 ± 4.4 Obstructive apnea index 11.1 ± 12.8 Central apnea index 0.4 ± 1.0

Hypopneas w/ ≥ 4% oxygen desaturation

Apnea-hypopnea index 20.5 ± 16.8 Hypopnea index 9.0 ± 8.1 Oxygen desaturation index (≥4%) 17.6 ± 14.7 Epworth Sleepiness Score 7.9 ± 4.6

Baseline Prevalence

  • f OSA
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SLIDE 8

Sleep Disordered Breathing in Obese Patients with Type 2 Diabetes (N=305)

AHI < 5 AHI 5-14.9 AHI 15-29.9 AHI > 30

13.4% No OSA 30.5% Moderate 22.6% Severe

Foster et al., Diabetes Care, 2009

33.5 % Mild Undiagnosed, Unscreened Sleep Disordered Breathing in Obese Patients with Type 2 Diabetes (N=202)

AHI < 5 AHI 5-14.9 AHI 15-29.9 AHI > 30

12.4% No OSA 32.2 % Mild 33.1% Moderate 22.3% Severe

Foster et al., Diabetes Care, 2009

Risk Factors for Presence of OSA

  • Waist circumference (OR=1.1;95% CI:

1.0-1.1; p<.05)

– A 1 cm increase in waist circumference was associated with an increase of 10% in the predicted odds of the presence of OSA (AHI>5)

  • No other measured variables, including

symptoms, predicted the presence of OSA

Foster et al., Diabetes Care, 2009

One-Year Results

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SLIDE 9

Year 1 Date range of FU assessments 2002 – 2004 Number of subjects completing FU 219 (83%) Number (%) receiving treatment 14 (6.4%)

Subjects with OSA on treatment at follow-up visits

The between-group differences were significant for changes in weight (p <.0001) and AHI (p < .0001). Error bars represent 95% CIs.

  • 15
  • 10
  • 5

5 10

1 2

Adjusted Change

DSE ILI

Weight (kg) AHI (events/hr)

Changes in Weight and AHI at 1 y

Foster et al., Arch Intern Med, 2009

Changes in OSA category at 1 y

Foster et al., Arch Intern Med, 2009

  • 20
  • 15
  • 10
  • 5

5 10 15 Gain (≥ 5 kg) N=10 Stable (± 5kg) N=122 Loss (5-9.9kg) N=36 Loss (≥ 10 kg) N=51 Change in Weight Change in AHI

After controlling for multiple comparisons, participants who lost ≥ 10 kg had significantly greater reductions in AHI than all other groups (p < .01 for all).

Error bars represent 95% CIs.

Changes in AHI by change in weight 1y

Foster et al., Arch Intern Med, 2009

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SLIDE 10

Predictors of Change in AHI at 1 y

  • Baseline Variable

– The only statistically significant multivariable predictor of change in AHI was baseline AHI (b=-.28, CI: -.40 to -.16; p<.0001).

  • Change Variable

– Change in weight was the only statistically significant predictor of change in AHI (b=.55, CI: .20 to .90; p=.003).

Foster et al., Arch Intern Med, 2009

Four-Year Results

Year 1 Year 2 Year 4 Date range of FU assessments 2002 – 2004 2004 – 2006 2006 – 2008 Number of subjects completing FU 219 (83%) 210 (80%) 165 (63%) Number (%) receiving treatment 14 (6.4%) 19 (9.0%) 19 (11.5%)

Kuna et al, Sleep 2013

Sleep AHEAD subjects with OSA

  • n treatment at follow-up visits

Sustained improvements of OSA by lifestyle changes

  • 12
  • 8
  • 4

4 8 Change in Weight (kg)

  • 12
  • 8
  • 4

4 8 Change in AHI (events/hr)

  • - DSE -- ILI

Weight AHI

Kuna et al, Sleep 2013 Data represents mean changes with standard error (SE)

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SLIDE 11

10 20 30 40 50 60 70 1 2 3 OSA Category % of Participants ILI DSE Worse Improved Same

Changes in OSA category at 4 y

Kuna et al, Sleep 2013

Remission of OSA by Treatment Group

Kuna et al, Sleep 2013

5 10 15 20 25

ILI DSE

% Remission

Remission of OSA, AHI < 5 events/h

Predictors of Change in AHI at 4 y

  • Baseline Variables

– The change in AHI over time was strongly related to baseline AHI (p < 0.0001) with greater changes in AHI

  • ver time occurring in individuals with higher AHI at

baseline

  • Change Variables

– The change in AHI over time was dependent on the change in weight (p < 0.0001) – When change in weight was added to the model, intervention arm still remained significant (p = 0.001) indicating an effect of ILI on change in AHI over time independent of weight change

Kuna et al, Sleep 2013

A Randomized, Double-Blind, Placebo-Controlled Study of an Oral, Extended-Release Formulation of Phentermine/Topiramate for the Treatment

  • f Obstructive Sleep Apnea in Obese Adults
  • Sample description

– N = 55 (26 Males, 24 Females) – Age = ~52 – Weight = ~105 kg – AHI = ~44 events/h – BMI = ~36 kg/m2

  • Randomly assigned to 1 of 2 conditions

– Phentermine 15mg plus extended-release Topiramate 92mg – The placebo group – 28 week study

Winslow et al., Sleep, 2012

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SLIDE 12

P/T vs. Placebo for Weight Loss Treatment of OSA at week 28

Winslow et al., Sleep 2012

*

Surgical VS Conventional Therapy for Weight Loss Treatment of Obstructive Sleep Apnea

  • Sample description

– N = 60 (35 Males, 25 Females) – Age = ~47 y – Weight = ~130 kg – AHI = ~61 events/h – BMI = ~45 kg/m2

  • Randomly assigned to 1 of 2 conditions

– Lap Band surgery – Conventional lifestyle counseling – 2 year study

Dixon et al., JAMA, 2012

Surgical vs. Conventional Therapy for Weight Loss Treatment of OSA

Dixon et al., JAMA 2012

*

Obstructive Sleep Apnea after Weight Loss: A Clinical Trial Comparing Gastric Bypass and Intensive Lifestyle Intervention

  • Sample description

– N = 84 (34 Males, 50 Females) – Age = ~49 y – Weight = ~134 kg – AHI = ~25 events/h – BMI = ~46 kg/m2

  • 2 conditions (not randomized)

– RYGB surgery – Intensive lifestyle intervention – 1 year study

Fredheim et al., JCSM, 2013

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SLIDE 13
  • 45
  • 40
  • 35
  • 30
  • 25
  • 20
  • 15
  • 10
  • 5

Change Weight (Kg)

Surgery Lifestyle

AHI (events/hour)

* * Surgery vs. Lifestyle Intervention for Weight Loss Treatment of OSA

Fredheim et al., JCSM, 2013

Conclusions

  • Obesity is a potent, modifiable risk factor for OSA
  • OSA is present in a high proportion of obese adults

with type 2 diabetes

  • Weight loss produces clinically significant

improvements in AHI among various patient types and OSA severity levels

  • Change in AHI is related to initial AHI and weight loss,

although other lifestyle factors likely play a role

Rationale For Treating Obesity

  • Many OSA patients are obese
  • Reductions in weight are associated

with improvements in SDB

  • Reductions in weight improve many

comorbidty conditions that obesity and OSA share

Barriers

  • Fatigue
  • “One more thing to do”
  • Multiple behavior changes
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SLIDE 14

The guidelines can be found at The Obesity Society http://onlinelibrary.wiley.com/doi/1 0.1002/oby.20660/pdf

12 Nov. 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults

Obesity Treatment Guidelines

The Practical Guide can be found at: NHLBI web site: www.nhlbi.nih.gov The Obesity Society web site: www.obesity.org

Guide for Selecting Obesity Treatment

The Practical Guide: Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. October 2000, NIH Pub. No.00- 4084

Treatment 25-26.9 27-29.9 30-34.9 35-39.9 >40 Diet, Exercise, Behavior Tx

+ + + + +

Pharmaco- therapy With co- morbidities

+ + +

Surgery With co- morbidities

+

BMI Category (kg/m2)

Antecedent → Behavior → Consequence

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SLIDE 15

A Sample Behavior Chain

Brownell KD. The LEARN Program for Weight Control. 7th ed. American Health Publishing Co; 2003.

Buy Cookies Leave Cookies on Counter Home on Saturday Afternoon Tired and Bored Eat While Watching TV Take Cookies to TV Room Go to Kitchen Urge to Eat Eat Rapidly Until Full Feel Guilty/ Like a Failure Restraint Weakens Further More Eating

Self-Monitoring Food Intake

  • Types of foods
  • Portion sizes
  • Calories (reduce by 500 kcal/d)
  • Times, places, and activities
  • Thoughts and moods

Brownell: Learn Program for Weight Control, 1998

The Dieter’s Dilemma

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SLIDE 16

Comparison of Low-Carbohydrate and Low-Fat Diets for Obesity: A Two-Year, Multi-Center Randomized Trial

317 Participants (208 women, 99 men) 45.5 ± 9.7 years old 36.1 ± 3.5kg/m2 BMI 74.9% European American

Participants were randomly assigned to either: Low-carbohydrate diet: Limited carbohydrate intake with unrestricted consumption of fat and protein. Low-fat diet: Limiting energy intake to 1200 to 1500 kcal/d for women and 1500 to 1800 kcal/d for men, with approximately 55 percent of calories from carbohydrate, 30 percent from fat, and 15 percent from protein. All participants received group behavior treatment for 2 years.

Foster et al. Ann Intern Med, 2010

Weight Loss

  • 14
  • 12
  • 10
  • 8
  • 6
  • 4
  • 2

Month Change in Weight (kg) 3 6 12 24 Low-fat Low-carbohydrate

Foster et al. Ann Intern Med, 2010

Lipid Changes

* * * * *

Foster et al. Ann Intern Med, 2010

Comparison of Weight-Loss Diets with Different Compositions of Fat, Protein, and Carbohydrates

  • Sample description (N=811)

515 female, 296 male Age 51.9 ± 9 years old BMI 33 ± 4.0kg/m2 Weight 93 ±16 kg

  • All participants were offered group and individual

instructional sessions for 2 years.

Sacks et al. NEJM, 2008

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SLIDE 17

POUNDS LOST: Diets

Diet Protein Fat Carbohydrate

Orange 25% 40% 35% Green 15% 40% 45% Pink 25% 20% 55% Blue 15% 20% 65%

Sacks et al. NEJM, 2008

POUNDS LOST: Body weight Over 2 Yrs, ITT

  • 7
  • 6
  • 5
  • 4
  • 3
  • 2
  • 1

6 12 18 24 65/15/20 55/25/20 45/15/40 35/25/40

Months

Carbohydrate/Protein/Fa t (% energy)

Diet Composition

Sacks et al. NEJM, 2008

  • Provide fixed-portion and calorie amounts
  • Reduce choices and contact with

problem foods

  • Are convenient to use
  • Satisfy appetite (monotony and sensory

specific satiety)

  • Facilitate dietary adherence

Portion-Controlled Meals

  • 4
  • 6.5
  • 4.4
  • 7
  • 10
  • 8
  • 6
  • 4
  • 2

2 4 3 months 12 months

Mean Weight Losses for Completers

RCD PMR

*p<.001 *p<.001 Weight Loss (in kg)

Meta-Analysis of Partial Meal Replacements (PMR) vs. Reduced Calorie Diets (RCD)

Heymsfeld et al. IJO, 2003

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SLIDE 18

Drugs Approved by FDA for Treating Obesity

Status Generic Name Trade Name Rx Phentermine Rx Orlistat Xenical OTC (Approved 2/07) Orlistat60mg alli Rx (Approved 2012) phentermine and topiramate Qsymia Rx (Approved 2013) locaserin Belviq

Generic Drug (Proprietary Name[s] Dose Frequency/d) Mechanism Of Action Wholesale Price/mo, $ 1-y Weight Change Relative to Placebo, Mean (95% CI), kg Common Adverse Effects

Phentermine 15-37.5 mg (Adipex-P, Fastin, Oby-Cap, Ionamin, Others; 1×) Noradrenergic causing appetite suppression 6-45 Not included Insomnia, elevation in heart rate, dry mouth, taste alterations, dizziness, tremors, headache, diarrhea, constipation, vomiting, gastrointestinal distress, anxiety, and restlessness Diethylpropion 25 mg or 75 mg, SR (Tenuate, Tenuate Dospan, Tepanil; low dose, 3×; SR dose, 1×) Noradrenergic causing appetite suppression 47-120 Not included Same as phentermine Phendimetrazine 17.5-70 mg or 105 mg, SR (Bontril; lower doses, 2-3×; SR dose, 1×) Noradrenergic causing appetite suppression 6-20 Not included Same as phentermine Benzphetamine 25-50 mg (Didrex; 1-3×) Noradrenergic causing appetite suppression 20-50 Not included Same as phentermine

Drugs With US Food and Drug Administration Short Term Approval

Yanovski and Yanovski et al., JAMA, 2014

Drugs With US Food and Drug Administration Long Term Approval

Generic Drug (Proprietary Name[s] Dose Frequency/d) Mechanism Of Action Wholesale Price/mo, $ 1-y Weight Change Relative to Placebo , Mean (95% CI), kg Common Adverse Effects

Orlistat 60 mg (Alli) or 120 mg (Xenical; 3× within 1 h of a fat containing meal) Lipase inhibitor causing excretion of approximately 30% of ingested triglycerides in stool 60 mg, 45 120 mg, 207 60 mg, −2.5 kg (−1.5 to −3.5) 120 mg, −3.4 kg (−3.2 to −3.6) Oily spotting, flatus with discharge, fecal urgency, fatty oily stool, increased defecation, fecal incontinence Lorcaserin 10 mg (Belviq; 2×) Highly selective serotonergic 5-HT2C receptor agonist causing appetite suppression 240 −3.2 kg (−2.7 to −3.8) Headache, dizziness, fatigue, nausea, dry mouth, cough, and constipation; and in patients with type 2 diabetes, back pain, cough, and hypoglycemia Phentermine plus topiramate- ER (Qsymia; 3.75 mg/23 mg for 2 weeks, increased to 7.5 mg/46 mg, escalating to a max

  • f 15 mg/92 mg; 1×)

Noradrenergic + GABA-receptor activator, kainite /AMPA glutamate receptor inhibitor causing appetite suppression 140-195 7.5 mg/46 mg, −6.7 kg (−5.9 to −7.5) 15 mg/92 mg, −8.9 kg (−8.3 to −9.4) Paresthesias dizziness, taste alterations, insomnia, constipation, dry mouth, elevation in heart rate, memory or cognitive changes

Yanovski and Yanovski, JAMA 2014

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SLIDE 19

Phentermine and Topiramate Extended Release

MOA:

  • Phentermine – stimulates release of norepinephrine,

epinephrine, and adrenaline

  • Topiramate – antiepileptic

Indication: chronic weight management in adults Dosage:

  • 3.75mg/23mg PHEN/TPM QD for 14 days, followed

by 7.5mg/46mg QD

  • Increase dose if 3% weight loss is not achieved within

12 weeks on 7.5mg/46mg

  • Discontinue if 5% weight loss is not achieved after 12

weeks on max dose (15mg/92mg)

Lorcaserin

MOA: Selective serotonin 2C (5-HT2C) receptor agonist Indication: chronic weight management in adults Dosage:

  • 10 mg BID
  • If >5% weight loss is not achieved within 12

weeks, therapy should be discontinued

Drug development timelines

Lorcaserin Phen/ Topiramate

Bupropion + Naltrexone

OTC Orlistat Rimonabant

Taranabant Obipinabant Bupropion + Zonisamide Leptin + Pramlintide GLP-1 analogs

1997 sibutramine 1999 orlistat

How Can Efficacy be Scaled?

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SLIDE 20

USPSTF recommendation for the screening for and management of obesity in adult: B rating (2012)

Intensive, multi-component behavioral counseling for

  • besity includes:

– 12 to 26 sessions in the first year – Group and/or individual sessions – Help people make healthy eating choices – Physical activity – Address issues that make it difficult to change behaviors – Help people monitor their own behaviors – Help people develop strategies to maintain healthy eating and physical activity behaviors

What About Apps?

To determine the degree to which commercial weight loss mobile apps include the behavioral strategies included in evidence-based weight-loss interventions, and to identify features that enhance behavioral strategies via technology. 30 weight mobile apps were evaluated for these platforms

  • IPhone
  • Android

20 behavioral strategies (similar to DPP) Data were analyzed in June 2012

Pagoto et al, AJPM, 2013

Outcomes

The vast majority of apps included goal setting for weight loss (93.3%) and diet (90%). The next most common strategy was calorie balance; 86.7% of the apps allowed users to view their net calories Technology-Enhanced Features:

  • The food item barcode scanner was the most

common of these strategies, appearing in 56.7% of mobile apps

Outcomes

Behavioral strategies was observed in 18.8%

  • f mobile apps

The two mobile apps that had the highest percentage of behavioral strategies:

  • MyNetDiary (free) 65%
  • MyNetDiary Pro (paid) 65%
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SLIDE 21

Tech Features

Almost half (46.7%) included a social media component, involving the capability to either connect to other app users or post to an online social network, such as Facebook, Twitter, or one created by the company itself. E-mail reminders

  • 20% included reminders when tracking lapsed
  • 10% included the capability of setting reminders

for meal time.

Paid vs. Free Mobile Apps

Paid mobile apps, which ranged in price from $0.99 to $4.99, were no more likely than free apps to include behavioral strategies In terms of technology-assisted features:

  • 40% of paid mobile apps included barcode

scanners, compared to 73% of free apps, p=0.06

  • 27% of paid apps included social networks,

compared to 60% of free apps, p=0.06.

Primary care referral to a commercial provider for weight loss treatment versus standard care: a randomised controlled trial

  • Sample description

– N = 772 (104 Males, 668 Females) – Age = ~47 y – Weight = ~86 kg – BMI = ~31 kg/m2

  • Randomly Assigned to 1 of 2 conditions

– Commercial weight loss program – Standard care – 1 year study

Jebb et al., Lancet, 2011

Mean Weight Loss

Commercial Program Standard Care

Jebb et al., Lancet, 2011

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SLIDE 22

Combining Behavioral Weight Loss Treatment and a Commercial Program: A Randomized Clinical Trial

  • Sample description

– N = 141 (14 Males, 127 Females) – Age = ~49 y – Weight = ~ 96 kg – BMI = ~ 36 kg/m2

  • Randomly Assigned to 1 of 3 conditions

– Behavioral weight loss treatment – Commercial weight loss program – Combined treatment – 12, 24, 48 week assessments

Pinto et al., Obesity, 2013

Mean Weight Loss

Pinto et al., Obesity, 2013

An NIH-sponsored, 48-week randomized clinical trial

  • The study compared a

behavioral weight loss program (BWL) lead by a healthcare professional, Weight Watchers (WW), and a combination (CT) of 12 weeks of BWL followed by 36 weeks of WW, more than half of the WW group lost ≥ 5%.

  • This was significantly

more than BWL or CT. It also cost less.

Pinto et al, Obesity, 2013 * WW > BWL, CT

BWL WW CT

Lost ≥ 5% of BL weight % of participants

*

60 50 40 30 20 10

Dream Weight

A weight you would choose if you could weigh whatever you wanted.

Happy Weight

This weight is not as ideal as the first one. It is a weight, however, that you would be happy to achieve.

Acceptable Weight

A weight that you would not be particularly happy with, but

  • ne that you could accept, since it is less than your current

weight.

Disappointed Weight

A weight that is less than your current weight, but one that you could not view as successful in any way. You would be disappointed if this were your final weight after the program.

Foster et al, J Consult Clin Psychol, 1997

Defined Weights

slide-23
SLIDE 23

Defined Weights

% Reduction1 % Reduction2 Dream 38% 38.4% Happy 31% 30.9% Acceptable 25% 24.9% Disappointed 17% 15.7%

1Foster et al. JCCP 65(1) 79-85 1997 2Foster et al Arch Int Med. 161 2133-2139 2001

% Achieving Defined Weights at Week 48

(N=45, Weight loss: 16.3 + 7.2 kg)

Acceptable Happy

Dream = 0%

Disappointed

Did not reach Disappointed Weight

9% 47% 20% 24%

Foster et al, J Consult Clin Psychol, 1997

slide-24
SLIDE 24

Helping Patients Accept More Modest Weight Losses

  • Be clear about what treatment can do

and what it cannot do

  • Discuss biological limits
  • Focus on nonweight outcomes
  • Be empathic about dissatisfaction with

weight/shape