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Page 1: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss
Page 2: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Weighing the Evidence on Obesity

Erika Pierce, PA-C, MMS

Page 3: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Learning Objectives Upon completion of this activity, participants will be able to:

Describe the definition, causes, prevalence and risks associated with obesity;

Discuss counseling on lifestyle modification for diet, exercise and behavioral changes as first line approaches;

Assess the relative risks and benefits of drug therapy including phentermine, orlistat, phentermine/topiramte and lorcaserin;

Analyze clinical trials (Look Ahead and POWER-UP) on multi-component primary care-based interventions;

Consider the relative risks and benefits of weight loss surgery for selected patients.

Page 4: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Disclosures

Speaker

Off-label use

Page 5: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Where Are We Going? The Map

Obesity as a Disease Epidemic

Medical Risk

Having the Conversation

Lifestyle Modifications

Medications for Weight Loss

– Phentermine

– Orlistat

– Phentermine/topiramate

– Lorcaserin

Weight Loss Surgery

Page 6: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Obesity as a Disease

⅓ adults in U.S. are obese (78 million)

⅓ adults in U.S. are overweight

Current trends has 45% obese by 2030

Annual estimated cost: $150 billion

40% of this cost borne by Medicare & Medicaid

Page 7: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Maine Data

Adults report 5% less leisure time activity 2000-2010

2011: K-3rd grade students:

– 18.4% obese

– 17% overweight

– M > F

2011: High school students:

– 15.9% overweight

– 12.9% obese

– M > F

Page 8: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Weight Status According to Body Mass Index, Adults Ages 18 years and Older, by Year, Maine, 2000-2010

Year Healthy Weight Overweight Obese

n N % LCL UCL n N % LCL UCL n N % LCL UCL

2000 1,804 382,095 42.8 40.2 45.3 1,607 329,970 36.9 34.5 39.4 911 181,317 20.3 18.3 22.3

2001 898 362,372 40.2 37.9 42.5 888 359,865 40.0 37.7 42.2 467 178,460 19.8 18.0 21.6

2002 920 370,461 40.1 37.8 42.4 838 357,622 38.7 36.5 41.0 499 195,039 21.1 19.2 23.0

2003 912 384,772 40.8 38.5 43.1 848 366,897 38.9 36.6 41.2 464 191,191 20.3 18.4 22.1

2004 1,281 373,248 38.0 36.0 40.0 1,293 374,987 38.2 36.2 40.2 789 233,414 23.8 22.0 25.6

2005 1,430 381,717 39.3 37.4 41.3 1,368 365,245 37.6 35.7 39.5 895 224,150 23.1 21.5 24.7

2006 1,456 388,665 39.3 37.4 41.3 1,391 367,608 37.2 35.3 39.1 917 231,608 23.4 21.9 25.0

2007 2,335 361,223 36.0 34.4 37.5 2,482 385,297 38.4 36.8 39.9 1,670 257,674 25.7 24.3 27.0

2008 2,333 373,584 37.3 35.7 38.8 2,396 365,696 36.5 35.0 38.0 1,711 262,922 26.2 24.9 27.6

2009 2,629 347,791 34.9 33.5 36.4 2,924 381,129 38.3 36.8 39.8 2,120 266,307 26.8 25.5 28.1

2010 2,623 355,609 35.6 34.1 37.1 2,902 366,919 36.7 35.3 38.1 2,212 276,987 27.7 26.4 29.0

Source: Behavioral Risk Factor Surveillance System

Healthy weight is a BMI between 18.5 and 25, Overweight is a BMI between 25.1 and 30, Obese is a BMI over 30; based on self-reported height

and weight.

n = unweighted number of adults (numerator); N = weighted number of adults (weighted numerator)

LCL = Lower 95% confidence limit of the weighted percentage; UCL = Upper 95% confidence limit of the weighted percentage. All percentages

are weighted to be more representative of the population of Maine and to adjust

NA = Not available

Page 9: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Maine Data: Healthy Weight

Year Healthy Weight

n N % LCL UCL

2000 1,804 382,095 42.8 40.2 45.3

2001 898 362,372 40.2 37.9 42.5

2002 920 370,461 40.1 37.8 42.4

2003 912 384,772 40.8 38.5 43.1

2004 1,281 373,248 38.0 36.0 40.0

2005 1,430 381,717 39.3 37.4 41.3

2006 1,456 388,665 39.3 37.4 41.3

2007 2,335 361,223 36.0 34.4 37.5

2008 2,333 373,584 37.3 35.7 38.8

2009 2,629 347,791 34.9 33.5 36.4

2010 2,623 355,609 35.6 34.1 37.1

Page 10: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Maine Data: Overweight Year Overweight

n N % LCL UCL

2000 1,607 329,970 36.9 34.5 39.4

2001 888 359,865 40.0 37.7 42.2

2002 838 357,622 38.7 36.5 41.0

2003 848 366,897 38.9 36.6 41.2

2004 1,293 374,987 38.2 36.2 40.2

2005 1,368 365,245 37.6 35.7 39.5

2006 1,391 367,608 37.2 35.3 39.1

2007 2,482 385,297 38.4 36.8 39.9

2008 2,396 365,696 36.5 35.0 38.0

2009 2,924 381,129 38.3 36.8 39.8

2010 2,902 366,919 36.7 35.3 38.1

Page 11: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Maine Data: Obese

Year Obese

n N % LCL UCL

2000 911 181,317 20.3 18.3 22.3

2001 467 178,460 19.8 18.0 21.6

2002 499 195,039 21.1 19.2 23.0

2003 464 191,191 20.3 18.4 22.1

2004 789 233,414 23.8 22.0 25.6

2005 895 224,150 23.1 21.5 24.7

2006 917 231,608 23.4 21.9 25.0

2007 1,670 257,674 25.7 24.3 27.0

2008 1,711 262,922 26.2 24.9 27.6

2009 2,120 266,307 26.8 25.5 28.1

2010 2,212 276,987 27.7 26.4 29.0

Page 12: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Causes of Obesity

We live in a food swamp.

Social patterns of physical activity

Food consumption

↑ portion sizes

Added sugars, fats, calorie dense foods escalated

Consuming more calories

Sedentary lifestyles

Page 13: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Screening for Obesity

Use BMI

Waist circumference

> 35 inches for women

> 40 inches for men

Page 14: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Risk for type 2 diabetes, hypertension, or CVD relative to normal weight and waist circumference

BMI (kg/m2) Men ≤ 102 cm (≤ 40 in) Women ≤ 88 cm (≤ 35 in)

Men > 102 cm (> 40 in) Women > 88 cm (> 35 in)

Underweight < 18.5 - -

Normal* 18.5-24.9 - -

Overweight 25.0-29.9 Increased High

Class I Obesity 30.0-34.9 High Very High

Class II Obesity 35.0-39.9 Very High Very High

Class III Obesity ≥ 40.0 Extremely High Extremely High

* Increased waist circumference can also be a marker for increased risk even in persons

of normal weight.

Page 15: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Diagnosis of overweight or obese must prompt stratification of

cardiovascular risk

Page 16: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Trends in Obesity

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Obesity by State

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2. Medical Risk

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Overweight & Obesity Associated with Negative Health Outcomes

HTN

Diabetes

Hyperlipidemic

Cardiovascular Diseases

Sleep Apnea

Cancer

Pro thrombotic States

Musculoskeletal Disease

Page 20: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Obesity raises the risk of several major diseases

Page 21: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

BMI & Mortality

Page 22: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

3. Having the Conversation

Page 23: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Goals

1. Prevent further weight gain

2. Reduce weight

3. Maintain a lower weight over time

Page 24: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

First Step

Screen every patient

– BMI

– Waist circumference

– Determine patient’s level of motivation

Page 25: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Determine patient’s level of motivation

Stage of Readiness Key Questions

Not Ready • Raise Awareness • Elicit Change Talk* • Advise and Encourage

Would you be interested in knowing more about reaching a healthy weight? How can I help? What might need to be different for you to consider a change in the future?

Unsure • Evaluate Ambivalence • Elicit Change Talk* • Build Readiness

Where does that leave you now? What do you see as your next steps? What are you thinking or feeling at this point? How does being overweight affect you?

Ready • Strengthen Commitment • Elicit Change Talk* • Facilitate Action Planning

Why is this important to you now? What are your ideas for making this work? What is hard about managing your weight? What might get in the way? How might you work around the barriers? How might you reward yourself along the way?

* Elicit Change Talk: Encourage patients to present their own arguments for changing behavior.

Page 26: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

4. Lifestyle Modification

Page 27: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Cornerstone of Management

Counseling

– Lifestyle modification

• Diet

• Exercise

• Behavioral Changes

Page 28: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Do they Work? DPP Trial

Page 29: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Do they Work? DPP Trial

Page 30: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Counseling in Primary Care Works: The POWER-UP Study

Page 31: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Diet

Focus on total calorie reduction

Actual diet type does not matter

Read more:

– p. 13-16 Evidence Document

Page 32: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Exercise

Important in maintaining lower weight

Modestly effective at achieving weight loss

General health-promoting effects

Page 33: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Rx for a Healthier Weight

Page 34: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

5. Weight Loss Medications

Page 35: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Weight Loss Medications

Can result in weight loss

Use as adjunct to calorie reduced diet

Increase physical activity

Selected patients

– BMI > 30

– BMI > 27 with comorbid condition

Page 36: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

FDA Approved Medications

Phentermine

Sibutramine (Meridia)

Orlistat (Xenical) (Alli)

Lorcaserin (Belviq)

Phentermine IR/Topiramate ER (Qsymia)

Page 37: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

CAUTION! Long-term safety

No Demonstrated long-term benefits in reducing diabetes, HTN, or cardiovascular risk.

Page 38: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Prior Medication Troubles Removed from the Market

Nearly all previous prescription diet medications were removed from the market because of dangerous side effects after one or more years of routine use:

amphetamines (cardiovascular toxicity, addiction

fenfluramine (Pondimin: pulmonary hypertension

dexfenfluramine (Redux: pulmonary hypertension and cardiac valvulopathy)

sibutramine (Meridia: cardiovascular toxicity)

Page 39: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Common Weight Loss Drugs Drug Efficacy Common potential side

effects Safety

orlistat (Xenical, Alli)

Weight loss: 2 kg greater than placebo after 4 years of therapy Clinical outcomes: not documented

• Flatus, greasy/loose stools or diarrhea, fecal incontinence, and abdominal cramps

• Worsened by increased dietary fat intake

• Contraindicated during pregnancy. • Malabsorption of fat-soluble vitamins; concurrent use

of multivitamin recommended • Patients on warfarin may need to decrease their

warfarin dose.

lorcaserin (Belviq)

Weight loss: 3.6 kg greater than placebo after 1 year of therapy Clinical outcomes: not documented

• Nausea • Headache • Dizziness

• Contraindicated during pregnancy. • Avoid use with other serotonergic agents (including

most antidepressants, and some muscle relaxants). • Concern over increased rate of cardiac valve disease

and a possible increase in the risk of breast tumors.

phentermine IR/ topiramate ER (Qsymia)

Weight loss: 7.5-8.8 kg greater than placebo after 2 years of therapy Clinical outcomes: not documented

• Anticholinergic symptoms (such as dry mouth and constipation)

• Irritability, anxiety, insomnia, and depression

• Increased heart rate

• Contraindicated in hyperthyroidism, glaucoma, patients taking MAO inhibitors, pregnancy.

• Prescribe with a Risk Management Program for women of childbearing age, including monthly pregnancy test.

• Adjust dose in renal and hepatic impairment. • Abuse potential. • Discontinuation requires tapering to avoid seizures.

Page 40: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Weight Loss at 1 Year for locaserin and phentermine/topiramate

Page 41: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Average Retail Costs for Monthly Supplies of Equivalent Doses of Agents*

Page 42: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Looking Ahead

5,145 U.S. Adults

Overweight or Obese with Diabetes

Stopped early

Intensive lifestyle modification aim

– 3.9% greater weight loss

– 5.3% greater partial or complete remission of Diabetes

Enroll higher risk patients

Page 43: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

No over-the-counter weight loss supplement is effective for weight loss.

Some products contain illegal stimulants or prescription medications.

Ask patients about their use of these supplements and counsel them

about their risks.

Page 44: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

6. Weight Loss Surgery

Page 45: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Useful in Severe Obesity

Produces substantial weight loss

Reduces cardiovascular events & mortality

Can improve or eliminate diabetes

BUT potential for post-operative complications

Page 46: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Common Weight Loss Surgeries

Page 47: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Swedish Obese Subjects (SOS)

Over 2,000 obese patients (BMI ≥ 34 Men, ≥ 38 Women)

Over 20 years

Page 48: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

SOS: Weight Loss after Surgery

Page 49: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

SOS: Reduction in Mortality and Cardiovascular Events

Page 50: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Bariatric Surgery: Patient Selection

BMI ≥40 or BMI ≥35 with weight-related comorbidity

Prior attempts at lifestyle modification were unsuccessful

No contraindications such as binge-eating disorder, substance abuse, depression, psychosis, or anxiety disorder

Acceptable surgery risk

Page 51: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Bariatric Surgery: Risks and Benefits

Benefits Uncertainties Risks

• Weight loss: rapid and sustained

• Reduction in HbA1c: elimination of diabetes in some patients

• Reduction in incidence of diabetes

• Improvement in other cardiovascular risk factors; hypertension, lipid profile

• Improved quality of life

• Reduction in CV events

• Reduction in all-cause mortality

• Long-term clinical outcomes in less obese diabetic patients with BMI < 35

• Prevalence of weight regain over time in routine use

• Post-surgical complications including increased morbidity and mortality in the short term

• Nutritional and electrolyte deficiencies

• GI symptoms

Page 52: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Tips for Management

Calculate BMI for all patients. If BMI ≥ 25, discuss the health risks of being overweight or obese.

Assess patient’s readiness to modify lifestyle and define success in terms of realistic goals.

Page 53: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Tips for Management

There is solid evidence that lifestyle interventions can reduce weight:

– Food intake is the key to weight loss.

– Exercise can help with weight management and improves health.

– Counseling in primary care actually works.

Page 54: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Tips for Management

Prescription drugs have some efficacy data but safety concerns limit their use.

Weight loss surgery is selected patients can lead to long-term weight loss and decreased risk of diabetes and mortality.

Page 55: Weighing the Evidence MICIS Pierce.pdf · obesity; Discuss counseling on lifestyle modification for diet, exercise and ... Consider the relative risks and benefits of weight loss

Questions?