Weighing the Evidence on Obesity Erika Pierce, PA-C, MMS

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.

Disclosures Speaker Off-label use

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

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

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

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 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 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 18.4 22.1 2004 1,281 373,248 38.0 36.0 1,293 374,987 38.2 36.2 789 233,414 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 1,391 367,608 37.2 35.3 39.1 917 231,608 23.4 21.9 25.0 2007 2,335 361,223 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 38.8 2,396 365,696 35.0 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 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 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

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 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 2007 2,335 361,223 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

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 35.0 38.0 2009 2,924 381,129 38.3 39.8 2010 2,902 366,919 36.7 38.1

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 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

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

Screening for Obesity Use BMI Waist circumference > 35 inches for women > 40 inches for men

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 Very High Class II Obesity 35.0-39.9 Class III Obesity ≥ 40.0 Extremely High * Increased waist circumference can also be a marker for increased risk even in persons of normal weight.

Diagnosis of overweight or obese must prompt stratification of cardiovascular risk

Trends in Obesity

Obesity by State

2. Medical Risk

Overweight & Obesity Associated with Negative Health Outcomes HTN Sleep Apnea Diabetes Cancer Hyperlipidemic Pro thrombotic States Cardiovascular Diseases Musculoskeletal Disease

Obesity raises the risk of several major diseases

BMI & Mortality

3. Having the Conversation

Goals Prevent further weight gain Reduce weight Maintain a lower weight over time

First Step Screen every patient BMI Waist circumference Determine patient’s level of motivation

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 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 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.

4. Lifestyle Modification

Cornerstone of Management Counseling Lifestyle modification Diet Exercise Behavioral Changes

Do they Work? DPP Trial

Do they Work? DPP Trial

Counseling in Primary Care Works: The POWER-UP Study

Diet Focus on total calorie reduction Actual diet type does not matter Read more: p. 13-16 Evidence Document

Exercise Important in maintaining lower weight Modestly effective at achieving weight loss General health-promoting effects

Rx for a Healthier Weight

5. Weight Loss Medications

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

FDA Approved Medications Phentermine Sibutramine (Meridia) Orlistat (Xenical) (Alli) Lorcaserin (Belviq) Phentermine IR/Topiramate ER (Qsymia)

! CAUTION! Long-term safety No Demonstrated long-term benefits in reducing diabetes, HTN, or cardiovascular risk.

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)

Common Weight Loss Drugs 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) 3.6 kg greater than placebo after 1 year of therapy Nausea Headache Dizziness 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) 7.5-8.8 kg greater than placebo after 2 years of therapy 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.

Weight Loss at 1 Year for locaserin and phentermine/topiramate

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

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

! 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.

6. Weight Loss Surgery

Useful in Severe Obesity Produces substantial weight loss Reduces cardiovascular events & mortality Can improve or eliminate diabetes BUT potential for post-operative complications

Common Weight Loss Surgeries

Swedish Obese Subjects (SOS) Over 2,000 obese patients (BMI ≥ 34 Men, ≥ 38 Women) Over 20 years

SOS: Weight Loss after Surgery

SOS: Reduction in Mortality and Cardiovascular Events

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

Bariatric Surgery: Risks and 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

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.

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.

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.

Questions?