Discussing Approaches to Treating Obesity in the Primary Care Setting

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1 Discussing Approaches to Treating Obesity in the Primary Care Setting March 12, 2015 Houston, Texas Education partner, the Institute for Medical and Nursing Education, Inc.

2 Session 3: Getting Your Patients to Weigh In: Discussing Approaches to Treating Obesity in the Primary Care Setting Learning Objectives 1. Summarize current recommendations for screening, assessment, and treatment goals in the management of adult obesity 2. Develop individualized therapeutic regimens for adults with obesity, incorporating lifestyle management and adjunct therapies as appropriate, based on current treatment recommendations and recent evidence 3. Utilize clinically validated approaches and tools to engage and support patients in the management of adult obesity as a chronic disease Faculty Donna H Ryan, MD Program Chair Professor Emerita Pennington Biomedical Research Center New Orleans, Louisiana Dr Donna Ryan is professor emerita at Pennington Biomedical Research Center, Baton Rouge, Louisiana. She served as associate executive director at Pennington Biomedical for 34 years; where she was active in research, teaching, and administration. Her research accomplishments include landmark studies of omega 3 fatty acids and membership on the team that developed the National Institutes of Health (NIH) sponsored feeding studies, Dietary Effects on Lipoproteins and Thrombogenic Activity (DELTA) and Dietary Approaches to Stop Hypertension (DASH). Dr Ryan was an investigator on NIH multicenter lifestyle intervention studies, including the Diabetes Prevention Program (DPP) study, the Preventing Overweight Using Novel Dietary Strategies (POUNDS Lost) study, and the Look AHEAD (Action for Health in Diabetes) trial. She also worked with the Louisiana office of group benefits to conduct the Louisiana Obese Subjects Study (LOSS): a pragmatic clinical trial of intensive medical therapy for severe obesity conducted in 6 Louisiana primary care clinics. This work continues in a translational phase as HEADS UP!. Dr Ryan was principal investigator for a military nutrition grant from 1988 to 2011 to develop improvements to soldier readiness, nutrition, and health. Dr Ryan served as cochair on the panel to revise the NIH supported, evidence based guidelines on the evaluation and management of overweight and obesity in adults. She is past president of The Obesity Society (TOS) and current associate editor in chief of TOS s journal, Obesity. She has authored more than 190 original publications and 45 books, chapters, and reviews; primarily in the field of obesity. Dr Ryan has served the scientific community as a reviewer and advisor in many capacities, such as the National Science Foundation medical research and development expenditures workshop (2006); the National Dairy Council review team for the Children s Hospital Oakland Research Institute (2006); chair of the Data Safety Monitoring Board (DSMB) for the NIH grant, Safety and Efficacy of Low and High Carbohydrate Diets (2002 to 2008); a member of the DSMB for EARLY Studies (2010 to the present); and as a reviewer for the European Union/European Federation of Pharmaceutical Industries and Associations innovative medicines initiative (2011 to 2012). Session 3

3 Holly Wyatt, MD Associate Professor of Medicine Division of Endocrinology, Metabolism and Diabetes Medical Director The Wellness Clinic Associate Director Anschutz Health and Wellness Center University of Colorado Denver, Anschutz Medical Campus Aurora, Colorado Dr Holly Wyatt is associate professor in the division of endocrinology, metabolism, and diabetes in the department of medicine at the University of Colorado Denver Anschutz Medical Campus. She received her undergraduate degree at The University of Texas and her medical doctorate from Baylor College of Medicine, Houston. Dr Wyatt completed her internal medicine and endocrinology training at the University of Colorado. She is a practicing physician and clinical researcher at the Anschutz Health and Wellness Center and is the medical director of the Wellness Clinic, which specializes in long-term strategies for weight management. Dr Wyatt has more than 18 years of clinical experience in weight reduction using behavioral treatment, dietary therapy, physical activity interventions, weight loss medications, and surgery. Recently, she became the medical expert for Season 4 of ABC s Extreme Weight Loss. Dr Wyatt has spent much of her research time investigating what makes people successful during their weight loss journey by following more than 10,000 successful losers in the National Weight Control Registry. She also has investigated the reasons why Colorado is the leanest state in the nation. Dr Wyatt s passion for and expertise in helping obese individuals successfully transform their bodies, minds, and lifestyles has made her a popular clinician, speaker, and obesity educator. She shares much of what she has learned in a new book she coauthored titled State of Slim: Fix Your Metabolism and Drop 20 Pounds in 8 Weeks on the Colorado Diet. Video Interaction Victoria A Catenacci, MD Assistant Professor of Medicine Department of Medicine Division of Endocrinology, Metabolism and Diabetes University of Colorado School of Medicine Aurora, Colorado Dr Victoria Catenacci earned her medical degree at Yale University School of Medicine and completed her residency in internal medicine at Yale-New Haven Hospital, where she served as chief resident. She completed her fellowship in endocrinology, metabolism, and diabetes at the University of Colorado School of Medicine; where she was appointed to a faculty position in She is currently assistant professor of medicine in the department of medicine, division of endocrinology, metabolism, and diabetes. Her areas of clinical focus are in general endocrinology and weight management. Dr Catenacci sees patients half a day per week in a general endocrine clinic at the University of Colorado Anschutz Outpatient Pavilion, where she treats a range of endocrine conditions, including diabetes, thyroid disease, metabolic bone disease, and lipid disorders. She also spends half a day per week seeing patients in a weight management clinic at the University of Colorado Anschutz Health and Wellness Center, where she focuses on individualized behavioral strategies for weight management along with the use of weight loss medications for appropriately selected patients. Dr Catenacci s primary research interest is in the role of physical activity in long-term weight loss maintenance. She has conducted several studies for the National Weight Control Registry that have provided information on the physical activity and dietary habits of successful weight loss maintainers. She has authored a comprehensive review on the role of physical activity in weight loss and maintenance, published in Nature Clinical Practice Endocrinology & Metabolism. Dr Catenacci has received a National Institutes of Health (NIH) F32 national research service award and an NIH K23 career Session 3

4 development award. She is currently the principal investigator for a 5 year NIH funded interventional trial designed to evaluate whether an exercise intervention timed after diet-induced weight loss (rather than initiated at the same time) improves exercise adherence and long term weight loss. She has also served as a subinvestigator on several industrysponsored weight loss medication trials. Faculty Financial Disclosure Statements The presenting faculty reported the following: Victoria A Catenacci, MD, receives research grant support from GI Dynamics and Novo Nordisk Inc. Donna H Ryan, MD, is part of a speakers bureau for Eisai Co, Ltd, Novo Nordisk Inc, Takeda Pharmaceuticals, and Vivus, Inc, and is part of a medical advisory board for Eisai Co, Ltd, Novo Nordisk Inc, Real Appeal Inc, Takeda Pharmaceuticals, and Vivus, Inc. Additionally, Dr Ryan is a consultant for Novo Nordisk Inc, Takeda Pharmaceuticals, and Vivus, Inc, and has equity interest in Scientific Intake. Holly Wyatt, MD, is part of a medical advisory board for Atkins Nutritionals, Inc; Eisai Co, Ltd; Retrofit, Inc; and Vivus, Inc. She also serves as a research consultant for Takeda Pharmaceuticals USA, Inc; receives research support from the American Beverage Association, GI Dynamics, and Novo Nordisk Inc; and is a stockholder in Active Planet. Additionally, she receives royalties from UptoDate, Inc, and owns a patent in Energy Gap. Education Partner Financial Disclosure Statement The content collaborators at the Institute for Medical and Nursing Education, Inc., reported the following: Kimberly McFarland, PhD, holds stock interests in Incyte and Procter & Gamble. Acronym List Acronym Definition A1C glycated hemoglobin AACE American Association of Clinical Endocrinologists ACC American College of Cardiology ACEI angiotensin-converting enzyme inhibitor AD antidepressant AE adverse effect AGI alpha glucosidase inhibitor AHA American Heart Association ASBP American Society of Bariatric Physicians B benzphetamine BMI body mass index BP blood pressure BW body weight CCB calcium channel blocker CDC Centers for Disease Control and Prevention CHD coronary heart disease CI contraindication CV cardiovascular CVD cardiovascular disease D diethylpropion DB double-blind DPP-4i dipeptidyl peptidase 4 inhibitor DVT deep vein thrombosis ER extended release F FBG FDA GERD GI GLP-1 RA HDL-C HMR HR hscrp HTN ITT LABS LAGB LDLC LIRA Look AHEAD MEN2 MOAI MTC follow-up fasting blood glucose US Food and Drug Administration gastroesophageal reflux disease gastrointestinal glucagon-like peptide-1 receptor agonist high-density lipoprotein cholesterol Health Management Resources heart rate high-sensitivity C reactive protein hypertension intent-to treat Longitudinal Assessment of Bariatric Surgery laparoscopic adjustable gastric banding low density lipoprotein cholesterol liraglutide Action for Health in Diabetes trial multiple endocrine neoplasia syndrome type 2 monoamine oxidase inhibitor medullary thyroid carcinoma Session 3

5 NAFLD NMS NSAID ORL OSN P PAI1 PBO PCOS P/T pt Pz RI RYGB S SB SBP nonalcoholic fatty liver disease neuroleptic malignant syndrome nonsteroidal antiinflammatory drug orlistat online social network phentermine plasminogen activator inhibitor 1 placebo polycystic ovary syndrome phentermine/topiramate patient phendimetrazine renal insufficiency/impairment Roux en Y gastric bypass screening single blind systolic blood pressure SG SGLT2i SSRI T2DM TC TG TOPS TOS UAC US VLDLC VTE WC YMCA sleeve gastrectomy sodium glucose cotransporter 2 inhibitor selective serotonin reuptake inhibitor type 2 diabetes mellitus total cholesterol triglyceride Take Off Pounds Sensibly The Obesity Society urinary albumin to creatinine ratio United States very low density lipoprotein cholesterol venous thromboembolism waist circumference Young Men s Christian Association Suggested Reading List Apovian CM, Aronne LJ, Bessesen DH, et al. Pharmacological management of obesity: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015;100(2): Courcoulas AP, Christian NJ, Belle SH, et al. Weight change and health outcomes at 3 years after bariatric surgery among individuals with severe obesity. JAMA. 2013;310(22): Knowler WC, Fowler SE, Hamman RF, et al; for the Diabetes Prevention Program Research Group. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009;374(9702): Garber AJ, Abrahamson MJ, Barzilay JI, et al. American Association of Clinical Endocrinologists comprehensive diabetes management algorithm 2013 consensus statement executive summary. Endocr Pract. 2013;19(3): Jensen MD, Ryan DH, Donato KA, et al. Guidelines (2013) for managing overweight and obesity in adults. Obesity. 2014;22(Suppl 2):S1-S410. Look AHEAD Research Group. Eight-year weight losses with intensive lifestyle intervention: the look AHEAD study. Obesity. 2014;22(1):5-13. Moyer VA; for the U.S. Preventive Services Task Force. Screening for and management of obesity in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012;157(5): Seger JC, Horn DB, Westman EC, et al. Obesity algorithm, presented by the American Society of Bariatric Physicians; Accessed January 28, Wadden TA, Neiberg RH, Wing RR, et al. Four-year weight losses in the Look AHEAD study: factors associated with longterm success. Obesity. 2011;19(10): Yanovski SZ, Yanovski JA. Long-term drug treatment for obesity: a systematic and clinical review. JAMA. 2014;311(1): Session 3

6 SESSION 3 10:30 11:45am Getting Your Patients to Weigh In Discussing Approaches to Treating Obesity in the Primary Care Setting SPEAKERS Donna Ryan, MD Holly Wyatt, MD Presenter Disclosure Information The following relationships exist related to this presentation: Donna H Ryan, MD, is part of a speakers bureau for Eisai Co, Ltd, Novo Nordisk Inc, Takeda Pharmaceuticals, and Vivus, Inc, and is part of a medical advisory board for Eisai Co, Ltd, Novo Nordisk Inc, Real Appeal Inc, Takeda Pharmaceuticals, and Vivus, Inc. Additionally, Dr Ryan is a consultant for Novo Nordisk Inc, Takeda Pharmaceuticals, and Vivus, Inc, and has equity interest in Scientific Intake. Holly Wyatt, MD, is part of a medical advisory board for Atkins Nutritionals, Inc; Eisai Co, Ltd; Retrofit, Inc; and Vivus, Inc. She also serves as a research consultant for Takeda Pharmaceuticals USA, Inc; receives research support from the American Beverage Association, GI Dynamics, and Novo Nordisk Inc; and is a stockholder in Active Planet. Additionally, she receives royalties from UptoDate, Inc, and owns a patent in Energy Gap. Presenter Disclosure Information Off-Label/Investigational Discussion In accordance with pmicme policy, faculty have been asked to disclose discussion of unlabeled or unapproved use(s) of drugs or devices during the course of their presentations. Education partner, the Institute for Medical and Nursing Education, Inc. Learning Objectives Summarize current recommendations for screening, assessment, and treatment goals in the management of adult obesity Develop individualized therapeutic regimens for adults with obesity, incorporating lifestyle management and adjunct therapies as appropriate, based on current treatment recommendations and recent evidence Utilize clinically validated approaches and tools to engage and support patients in the management of adult obesity as a chronic disease Cornerstones of Obesity Management: Disease Recognition, Patient Engagement, and Lifestyle Management Holly Wyatt, MD Associate Professor of Medicine Division of Endocrinology, Metabolism, and Diabetes University of Colorado School of Medicine Aurora, Colorado

7 Talk Outline Treating obesity as a chronic disease current recommendations Recognition/screening Therapeutic goals Assessing disease severity to determine treatment options Patient engagement Addressing obesity treatment with the individual patient Discussing disease history and severity Establishing individual goals Comprehensive lifestyle management core intervention for obesity management Components (reduced caloric intake, increased activity, behavior) Current recommendations Resources, tools, and tips to help your patients TREATING OBESITY AS A CHRONIC DISEASE Reputable Sources of Treatment Recommendations for Adult Obesity Determining the Need to Treat Obesity AHA/ACC/TOS (Obesity 2) 1 : focus on lifestyle intervention with guidance on referral for surgery AACE 2 : algorithm based on assessment of disease severity ASBP 3 : comprehensive and holistic approach Endocrine Society 4 : detailed description of pharmacological intervention Screen 1-3 BMI is appropriate to identify individuals at elevated risk of obesityrelated complications Assess 1-3 Risk Presence and severity of complications to guide decisions regarding treatment modality and intensity 1. Jensen MD, et al. Obesity. 2014;22(suppl 2):S1-S Garber AJ, et al. Endocr Pract. 2013;19 (suppl 2): Seger JC, et al. Obesity algorithm, presented by the ASBP. 4. Apovian CM, et al. J Clin Endocrinol Metab Jan 15. [Epub ahead of print]. 1. Jensen MD, et al. Obesity. 2014;22(suppl 2):S1-S Garber AJ, et al. Endocr Pract. 2013;19: Seger JC, et al. Obesity Algorithm, presented by the ASBP. Hazard Ratio 3.5 BMI and Health Risk: Rationale for Weight Categories According to BMI BMI and All-Cause Mortality 1,a Women Men BMI Range, kg/m 2 Category 2 BMI Range, kg/m 2 US Adults, % 3 Elevated Risk 2 Normal Overweight CVD Obese, class I CVD, all-cause mortality Obese, class II CVD, all-cause mortality Obese, class III 40 6 CVD, all-cause mortality a 19 studies including 1.46 million white adults (median age, 58 years; 58% women) who never smoked and had no history of cancer or heart disease at baseline; median follow-up of 10 years. 1. Berrington de Gonzalez A, et al. N Engl J Med. 2010;363: ; 2. Jensen MD, et al. Obesity. 2014;22(suppl 2):S1-S410; 3. Ogden C, et al. JAMA. 2014;311: Health Consequences of Overweight and Obesity Impact on Multiple Systems Depression/ psychological disorders, social stigmatization Gallbladder disease/nafld, GERD, pancreatitis Cancer (eg, breast, uterus, colon, esophagus, pancreas, kidney, prostate) Osteoarthritis, disability/immobility Stroke Sleep apnea/respiratory CHD/CVD, HTN, dyslipidemia T2DM and prediabetes PCOS, reproductive disorders Urinary stress incontinence CDC. Overweight and obesity. Causes and consequences. Garvey WT, et al. Endocr Pract. 2014;20: ; Seger JC, et al. Obesity algorithm, presented by the ASBP. Chen SM, et al. J Dig Dis. 2012;13:

8 General Goals of Obesity Management Assessing Disease Severity to Determine Treatment Options: Multiple Considerations Objective 1-3 Medical rather than cosmetic benefit Meaningful health improvements Greater losses = greater benefits 1-3 3%-5% meaningful improvement in some CV risk factors 10% substantial benefits in managing comorbidities (cardiometabolic, mechanical) Recommendations 1-3 5%-10% as initial goal (within 6 months) Once initial goal is met, reassess health goals and adjust therapy as necessary Anthropometric assessment 1-3 Example: BMI Only part of evaluation Limitations (eg, individual variability) Health status 1-3 Presence of complications Severity of complications Consider both to determine 1-3 Treatment need Treatment type Treatment intensity Approaches for staging obesity severity have been published 4,5 1. Jensen MD, et al. Obesity. 2014;22(suppl 2):S1-S Garber AJ, et al. Endocr Pract. 2013;19 (suppl 2): Seger JC, et al. Obesity algorithm, presented by the ASBP. 1. Jensen MD, et al. Obesity. 2014;22(suppl 2):S1-S410; 2. Garber AJ, et al. Endocr Pract. 2013;19 (suppl 2):1-48; 3. Seger JC, et al. Obesity algorithm, presented by the ASBP. 4. Sharma AM, Kushner RF. Int J Obes (Lond). 2009;33: ; 5. Garvey WT, et al. Endocr Pract. 2014;20: You Can Make a Difference Please Discuss Weight Management With Your Patients PATIENT ENGAGEMENT If patients hear from a physician or other healthcare professional that they are overweight, they are 6 more likely to perceive themselves as overweight 2.5 more likely to attempt weight loss In this study 45.2% of individuals with BMI 25 had been told they were overweight 66.4% of individuals with BMI 30 had been told they were overweight Post RE, et al. Arch Intern Med. 2011;171: Modified 5 A s: One Approach to Obesity Counseling in Primary Care 1,3 ASK for permission to discuss body weight create a dialogue that is: Nonjudgmental Safe Open ASSESS health status, obesity indicators, root causes of weight gain ADVISE patient of benefits and risks of weight loss, long-term strategy AGREE on goals and treatment expectations ARRANGE/ASSIST (or REFER) to identify barriers, resources, and providers identify, educate, recommend, support The clinician and patient should agree whether weight loss is appropriate in the context of competing priorities 2 1. Vallis M, et al. Can Fam Physician. 2013;59: Jensen MD, et al. Obesity. 2014;22(suppl 2):S1-S Seger JC, et al. Obesity algorithm, presented by the ASBP. Best Good OK Not good Bad Discussing Weight With Patients: Patients Preferred Terms Weight Weight problem, BMI, excess weight, unhealthy body weight Unhealthy BMI Excess fat, large size, obesity, heaviness Fatness Volger S, et al. Obesity. 2012;20:

9 Assess Weight and Lifestyle Histories to Identify Factors Contributing to Weight Gain and Barriers to Weight Loss Questions to ask History of weight gain and loss over time? Previous weight loss attempts? Dietary habits? Physical activity? Family history of obesity? Other medical conditions or medications that may affect weight? Answers may guide approach to adjusting weight-loss regimen Address/readdress contributing factors and barriers Intensify lifestyle/behavioral intervention Add adjunct therapies Optimize current regimens Jensen MD, et al. Obesity. 2014;22(suppl 2):S1-S410. Optimize Current Regimens Medications for Coexisting Conditions May Promote Weight Gain Category Drugs That Cause Weight Gain Possible Alternatives Neuroleptics Tricyclics (ADs) Thioridazine, haloperidol, olanzapine, quetiapine, risperidone, clozapine Amitriptyline, nortriptyline, imipramine, doxepin Phenelzine Ziprasidone, aripiprazole Protriptyline, bupropion, nefazodone MAOIs (ADs) SSRIs (ADs) Paroxetine Fluoxetine, sertraline Other (ADs) Mirtazapine, duloxetine Bupropion Anticonvulsants Valproate, carbamazepine, gabapentin, Topiramate, lamotrigine, pregabalin, vigabatrin zonisamide, felbamate Antidiabetic agents Insulin, sulfonylureas, thiazolidinediones AGIs, DPP-4i s, SGLT2i s, GLP-1 RAs, metformin Antihistamines Cyproheptadine Inhalers, decongestants β- and α-adrenergic blockers Propranolol, doxazosin ACEIs, CCBs Steroid hormones Contraceptives, glucocorticoids, progestational steroids Barrier methods, NSAIDs Kushner RF, Ryan DH. JAMA. 2014;312: ; Apovian CM, et al. J Clin Endocrinol Metab Jan 15. [Epub ahead of print]. Addressing Patient Expectations and Negotiating Reasonable Goals Are Important First Steps Patients Expectations for Obesity Treatment Outcomes 1,a If I achieved this weight loss 38% 33% 31% 25% 17% I would feel... that I achieved my dream weight..that I met my current goal happy that it was acceptable disappointed Patients may have ambitious goals and feel disappointed with modest loss 1 Patients and providers should agree on goals 2-4 COMPREHENSIVE LIFESTYLE MANAGEMENT CORE INTERVENTION FOR OBESITY MANAGEMENT a N = 60 women; mean starting weight = lb. 1. Foster GD, et al. J Consult Clin Psychol. 1997;65:79-85; 2. Jensen MD, et al. Obesity. 2014;22(suppl 2):S1-S410; 3. Garber AJ, et al. Endocr Pract. 2013;19 (suppl 2):1-48; 4. Seger JC, et al. Obesity algorithm, presented by the ASBP. Prescribe a Nutritional Plan to Reduce Caloric Intake Methods to Reduce Caloric Intake 1,2 Limit calories 1 Women: kcal/d Men: kcal/d Energy deficit (500 or 750 kcal/d) 1 Evidence-based diet that restricts certain food types (eg, high carbohydrate, high fat) 1,2 Very low calorie diet (< 800 kcal/d) ONLY 1 In limited circumstances With medical monitoring and high-intensity lifestyle intervention Consider Patient Preferences and Health Status 1 Preferably refer to a nutrition professional for counseling A variety of diets will promote weight loss 1. Jensen MD, et al. Obesity. 2014;22(suppl 2):S1-S Seger JC, et al. Obesity algorithm, presented by the ASBP. U.S. News & World Report Best Weight-Loss Diets: Patients Have Many Options Diet Weight Watchers Description Point system based on food characteristics encourages healthy choices; group support available Meal replacements, fruits, vegetables; quick start and transition HMR Diet phases; lifestyle training; weekly coaching; home or clinic Biggest Loser Diet Books providing guidance on calorie restriction and exercise Jenny Craig Personalized prepackaged meal/exercise plan with support a Raw Food Diet Volumetrics Atkins Flexitarian Diet Slim-Fast Vegan Diet 75% to 80% of daily foods are plant based and not heated above 115 F; substantial preparation time Focus on low-density, high-volume foods Low carb; frozen food line is available Mostly vegetarian; outlined 5-week meal plan Meal replacement program Excludes all animal products HMR, Health Management Resources. a Consultants with access to expertise of registered dietitians. U.S. News and World Report. Best diets

10 Consider Commercial Programs That Have Features Consistent With Recommendations 1-3 Self-monitoring weight and diaries Portion control meal replacements Regular, moderate physical activity Social support individual and group sessions Incremental steps to behavior change Option for long-term participation or weight maintenance support Examples: Weight Watchers, Jenny Craig, TOPS, NutriSystem, YMCA Diabetes Prevention Program 1. Moyer V, et al. Ann Intern Med. 2012;157: Jensen MD, et al. Obesity. 2014;22(suppl 2):S1-S Wadden T, et al. Circulation. 2012;125: Prescribe Increased Physical Activity Prescription 1,2 Include frequency, intensity, time spent, type, enjoyment level, and default and back-up plans min/week moderate or 75 min/week vigorous aerobic activity 1,2 Resistance training to preserve lean mass 2 > min/week moderate or > 150 min/week vigorous aerobic activity for more robust weight loss and to prevent weight regain 1,2 Accounting records eg, written or electric activity logs, pedometer/accelerometer logs, metrics (miles, laps, reps) 2 1. Jensen MD, et al. Obesity. 2014;22(suppl 2):S1-S Seger JC, et al. Obesity algorithm, presented by the ASBP. Encourage Patients to Also Increase Non-training Activity Priority is to increase energy expenditure and decrease sedentary time Leisure time Competitive sports Noncompetitive sports (eg, hiking, cycling) Nonsport alternatives (dancing) Daily activities Walk instead of using motorized transportation Use stairs instead of elevators or escalators Carry overnight travel bags instead of using rollers Avoid prolonged inactivity What Does the State-of-the-Art Effective Lifestyle Intervention Look Like? Look AHEAD Study Academic setting Trained TEAM of interventionists Personal weight loss goal 10% a Weight-loss induction (months 1-6) 1 individual and 3 group sessions/month Lots of contact! Weight-loss maintenance (months 7-12) 1 individual and 2 group sessions/month Participants expected to attend at least 1 group session Weight-loss maintenance (years 2-4) Monthly individual counseling (face-to-face, phone call, or ) Refresher courses 2 to 3 times/year (6-8 weeks each) Seger JC, et al. Obesity algorithm, presented by the ASBP. a Study weight loss goal 7%. Look AHEAD Research Group. Obesity. 2006;14: Look AHEAD clinical trial protocol. https://www.lookaheadtrial.org/public/lookaheadprotocol.pdf. Prescribe a Program That Offers Behavioral Intervention Ideal Initiation High contact frequency 1,2 14 group or individual sessions in 6 months 1 On-site, highintensity program with behavioral strategies 1,2,b a Includes goal setting, self-monitoring; b Health professionals (eg, registered dietitians, psychologists, exercise specialists, health counselors), and lay persons who were trained in and used formal weight-management protocols. Alternatives 1,2 Telephone or electronic counseling (with personalized feedback) Commercial programs with evidence of safety and efficacy Maintenance 1,2 Continued contact ( 1 /month) a Counseling/sessions/contact should be with trained interventionist(s) 1,b Face-to-face is recommended 1 May pose barriers (time, expense, loss of anonymity) 3 Electronic delivery may result in less weight loss than face-to-face 1 1. Jensen MD, et al. Obesity. 2014;22(suppl 2):S1-S410; 2. Seger JC, et al. Obesity algorithm, presented by the ASBP. 3. Sullivan DK, et al. J Nutr Educ Behav. 2013;45: Additional Resources and Tools to Facilitate Self-Monitoring and Planning Pedometers and sports watches 1 Personal-activity monitors (eg, BodyMedia FIT, DirectLife, Fitbit One, Fitbit Zip, ActiGraph, Jawbone Up, Basis B1) 2 Phone applications (eg, Calorie King, 3 GoMeals, 3 Fitter Fitness Calculator, 3 SparkPeople, 3 Strava Cycling, 3 South Beach Diet, 3 Charity Miles, 4 LiveStrong, 5 MyFitnessPal 6 ) Internet (eg, ChooseMyPlate, SparkPeople, 1. Meyer J, Hein A. Medicine ;2.e7. 2. Lee JM, et al. Med Sci Sports Exerc. 2014;46(9): Diabetes Forecast. 4. Neithercott C. Diabetes apps. 5. LiveSTrong mobile apps. MyPlate calorie tracker. 6. MyFitnessPal. Apps.

11 Summary Obesity management recommendations include Screening criteria to identify individuals who may benefit from treatment (eg, BMI 25) Assessment of disease severity to inform individualized management Patient-focused, unbiased communication approaches (eg, 5 A s, appropriate word choice) promote Productive patient and clinician collaboration Efforts to identify and address contributing factors and management barriers Identification of appropriate treatment options Comprehensive lifestyle management is the cornerstone for the management of overweight and obesity Behavioral intervention Reduced calorie intake Increased physical activity Clinicians and patients can leverage many evidence-supported resources, approaches, and tools for individualized lifestyle management CASE PRESENTATION Patient Description: Tamara Female 38 years old Married, 2 children (12 and 8) High school teacher Follow-up for prediabetes and weight 1 year after starting intensive lifestyle intervention program Lost 8% (19 lb/9 kg) in 6-month intensive phase Regained 13 lb (7 kg) since transitioning to 1-year maintenance phase 6 months ago Current medications Paroxetine 30 mg/d initiated by psychiatrist 3 months ago Atorvastatin 10 mg/d for past 2 years Indicator Height, in (cm) Weight, lb (kg) 1 Year Ago 71 (180) 242 (110) 6 Mo Ago 71 (180) 223 (101) Today 71 (180) 236 (108) BMI, kg/m BP, mm Hg 144/88 136/78 140/85 FBG, mg/dl A1C, % Cholesterol, mg/dl Total LDL-C HDL-C TG Adjunct Therapeutic Approaches for Management of Adult Obesity Donna H Ryan, MD Professor Emerita Pennington Biomedical Research Center Baton Rouge, Louisiana Talk Outline Adjunct therapies for long-term weight management When are they appropriate? What is their role in weight management? Who are good candidates? Pharmacotherapy for long-term weight management Talking to your patient about pharmacotherapy Therapeutic expectations Efficacy Safety and tolerability Agent-specific considerations Impact on complications Bariatric surgery for long-term weight management Talking to your patient about bariatric surgery Therapeutic expectations Efficacy Safety and tolerability Impact on complications General Recommendations Regarding Therapeutic Options for Adult Obesity 1-3 Comprehensive lifestyle management - First intervention appropriate for all levels of disease severity - Patient candidates - BMI 30 - BMI 25 to 29.9 with risk factors a - Other approaches are adjunct to this core approach Pharmacotherapy - Patient candidates - BMI BMI 27 with obesity complication/manifestation a AACE lifestyle modification is also appropriate for individuals with BMI of 25 to 29.9 with no complications, with less emphasis on weight loss, more on preventing weight gain. b AACE severe comorbidity; ASBP BMI 30 with complication. Adjunct Therapies Bariatric surgery - Reserved for more severe disease - Patient candidates - BMI BMI 35 with obesity complication/manifestation b 1. Jensen MD, et al. Obesity. 2014;22(suppl 2):S1-S Garber A, et al. Endocr Pract. 2013;19(suppl 2): Seger JC, et al. Obesity algorithm, presented by the ASBP.

12 Principles to Guide Choice of Therapies Use lower-risk approaches for individuals at lower risk Reserve higher-risk approaches for those at highest risk Harms are small 1 Lifestyle 5 Contraindications, precautions, warnings, AEs 2 Medication + lifestyle 6 Gastric band 7,8 Reserved for severe disease Extensive care Invasive possible complications 3,4 Gastric bypass 7,8 0% 5% 10% 15% 20% 25% 30% 35% Approximate Mean Weight Loss 1. Moyer V, et al. Ann Intern Med. 2012;157: ; 2. US FDA. 3. Fried M, et al. Obes Facts. 2013;6: ; 4. Mechanick JI, et al. Obesity. 2013;21(suppl 1):S1-S27; 5. Jensen MD, et al. Obesity. 2014;22(suppl 2):S1-S410; 6. Colman E, et al. N Engl J Med. 2012;367: ;7. LABS Consortium. N Engl J Med. 2009;361: ; 8. Courcoulas AP, et al. JAMA. 2013;310: Expert Pearls Regarding Adjunct Therapies for Obesity Management Lifestyle management is the core therapy for obesity management everything else is added to this 1-4 Adjunct therapies are an option for those who struggle to lose weight and/or maintain weight loss 1-4 Lifestyle management may need to be adjusted when adjunct therapy is added for example Low-fat diet should be used with orlistat 5 Smaller food portions are required with bariatric surgery 6 Medications employed for weight management should be approved for the indication 1-4 Use according to product label 1-4 Use lowest recommended dose that provides effective weight loss 4 1. Jensen MD, et al. Obesity. 2014;22(suppl 2):S1-S410; 2. Garber AJ, et al. Endocr Pract. 2013;19 (suppl 2):1-48; 3. Seger JC, et al. Obesity algorithm, presented by the ASBP. 4. Apovian CM, et al. J Clin Endocrinol Metab Jan 15. [Epub ahead of print]; 5. US FDA. 6. Mechanick JI, et al. Obesity. 2013;21(suppl 1):S1-S27. Discussing Long-Term Weight Management With Patients: Pharmacological Agents Practice shared decision making with patient engage in discussion of potential risks/benefits and whether a medication is right for them PHARMACOTHERAPY Because obesity is a chronic disease, long-term management is required Pharmacological agents are used as an adjunct to lifestyle modification 1 Agents approved for short-term use 1,2 Modest weight loss ( 3-4 kg over 1 year) Should be discontinued after 12 weeks not approved for long-term use Agents approved for long-term use 1,2 Modest but clinically significant weight loss (5%-10%) Important to take as prescribed and monitor for efficacy and adverse effects Increase to maximum dose or discontinue if an agent is not effective a May consider an alternative agent if one is not effective Cost may not be covered by insurance a For all but orlistat, discontinue if 5% weight loss (4% with liraglutide 3.0 mg) is not achieved after 12 weeks on maximum/maintenance dose US FDA. 2. Yanovski SZ, Yanovski JA. JAMA. 2014;311: Mechanisms of Action of Medications Approved in the United States for Long-Term Weight Management Therapeutic Efficacy of Medications Approved in the United States for Long-Term Weight Management Agent Orlistat 1,2 Lorcaserin 1,2 Schedule IV Phentermine/topiramate ER 1,2 Schedule IV Naltrexone ER/bupropion ER 2 Liraglutide 3.0 mg 2 Mechanism of Action Lipase inhibitor Fat excretion in stool Serotonin receptor agonist Appetite suppression Sympathomimetic/antiepileptic Appetite suppression Opioid antagonist/antidepressant Appetite regulation, reward system GLP-1 RA Appetite suppression Agent Dosage (oral, except sc for liraglutide 3.0 mg) 1 1-Year Efficacy, Difference vs PBO 1 Weight, % Pts Losing Pts Losing 5% of Initial 10% of Initial Weight, % Weight, % Orlistat 120 mg, 3 daily a b 12 b Lorcaserin 10 mg, 2 daily Phentermine/ topiramate ER c Naltrexone ER/ bupropion ER d 7.5 mg/46 mg 1 daily 16 mg/180 mg 2 daily Liraglutide 3.0 mg, 1 daily All differences significant vs PBO (P <.05) 1. Yanovski SZ, Yanovski JA. JAMA. 2014;311: US FDA. a Prescription dose; 60 mg over-the-counter version has been recalled 2 ; b Estimate calculated as difference between averages across 5 trials for each treatment group; c 15 mg/92 mg dose, only for use if 7.5 mg/46 mg is not effective, yielded 9% weight loss vs PBO; d Efficacy data from COR-I trial. 1. US FDA. 2. US FDA. Safety alerts for human medical products. yalertsforhumanmedicalproducts/ucm htm.

13 Medications for Long-Term Use: Categorical Results (10%) In Trials Longer Than 1 Year Patients in Category, % 100 PBO 16 ORL 26 10% Loss (4 years) 1,b Patients in Category, % LIRA, liraglutide; ORL, orlistat; P/T, phentermine/topiramate; PBO, placebo. a With P/T(15/92), which is only for use if 7.5 mg/46 mg is not effective, 54% had 10% weight loss 4 ; b Completer population; c Intent-to-treat population, last observation carried forward. a PBO P/T (7.5/46) % Loss (108 weeks) 2,b Patients in Category, % 100 P <.05 for all comparisons of active agents vs comparator ORL LIRA 2.4/ > 10% Loss (2 years) 3,c 1. Torgerson JS, et al. Diabetes Care. 2004;27: Garvey WT, et al. Am J Clin Nutr. 2012;95: Astrup A, et al. Int J Obes (Lond). 2011;36: US FDA. BW Change, % Orlistat 1,a 0 Placebo Orlistat (120 mg) -4-8 Weight Regain After Crossover to Placebo Week SB DB DB Slightly hypocaloric diet Weight maintenance (eucaloric) diet Mean BW, kg 100 BW, body weight; DB, double-blind; PBO, placebo; SB, single-blind lead-in. a ITT population (N = 683 for year 1; N = 519 for year 2; 83% female); mean baseline characteristics: BMI, 36 kg/m 2 ; age, years; b Participants continuing past year 1, rerandomized at year 2 (N = 1523; 83%-84% female at year 1 baseline); mean baseline characteristics (start of year 1): BMI, 36 kg/m 2 ; age, 44 years. 96 Lorcaserin 2,b Year 1 Year Week PBO in years 1 and 2 Lorcaserin (10 mg) in year 1, PBO in year 2 Lorcaserin in years 1 and 2 1. Sjöström L, et al. Lancet. 1998;352: Smith SR, et al. N Engl J Med. 2010;363: Weight-Loss Maintenance and Loss With Medication After Low-Energy Diet a LIRA 3.0 mg: PBO: Change in Body Weight, % n = 207 n = 206 n = 156 n = 144 S Run-in Treatment period F n = 153 n = ± 21.0 kg % -2 PBO % c -6 LIRA 3.0 mg Time, weeks LIRA 3.0 mg vs PBO Maintained run-in loss ( 5%): 81% vs 49% c Lost 5% during treatment period: 51% vs 22% c Lost 10% during treatment period: 26% vs 6% c S, screening; F, follow-up. a LIRA 3.0 mg vs PBO after 4 to 12 weeks of low-energy diet ( kcal/d); N = 422; mean run-in weight (week 12) = kg; mean randomization weight (week 0) = 99.6 kg; c P <.0001 vs PBO. Wadden T, et al. Int J Obes (Lond). 2013;37: Agent Orlistat Medications for Long-Term Weight Management: Common Adverse Effects Lorcaserin Phentermine/ topiramate ER Naltrexone ER/ bupropion ER Liraglutide 3.0 mg a More common than with PBO and in > 5% of patients. Common Adverse Effects a Oily spotting, flatus with discharge, fecal urgency, fatty oily stool, increased defecation, fecal incontinence Headache, fatigue, dizziness, nausea, dry mouth, constipation Paresthesia, dizziness, distorted taste, insomnia, constipation, dry mouth Nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, diarrhea Nausea, hypoglycemia (in T2DM), diarrhea, constipation, vomiting, headache, decreased appetite, dyspepsia, fatigue, dizziness, abdominal pain, increased lipase levels US FDA. Medications for Long-Term Weight Management: Contraindications a Medications for Long-Term Weight Management: Warnings and Precautions Orlistat Pregnancy Chronic malabsorption syndrome Cholestasis Lorcaserin Pregnancy Phentermine/topiramate ER Pregnancy Glaucoma Hyperthyroidism During or within 14 days of taking MAOIs a Known hypersensitivity to agent or any component of this product included for all agents. Naltrexone ER/bupropion ER Pregnancy Uncontrolled hypertension Seizure disorders; anorexia nervosa or bulimia; abrupt discontinuation of alcohol, benzodiazepines, barbiturates, antiepileptic drugs Use of other bupropioncontaining products Chronic opioid use During or within 14 days of taking MAOIs Liraglutide 3.0 mg Pregnancy Personal or family history of MTC or MEN 2 US FDA. Orlistat Cyclosporine exposure Supplement (fat-soluble vitamins) Liver injury (rare) Urinary oxalate monitor if risk of renal insufficiency Substantial weight loss can increase the risk of cholelithiasis GI effects with high-fat diet NMS, neuroleptic malignant syndrome. a When used with antidiabetic medications. Lorcaserin Serotonin syndrome or NMS-like reactions Valvular heart disease Cognitive impairment Psychiatric disorders Depression/suicidal thoughts Hypoglycemia a Priapism Phentermine/topiramate ER Fetal toxicity Heart rate Suicidal behavior/ideation Acute myopia and secondary angle-closure glaucoma Mood and sleep disorders Cognitive impairment Metabolic acidosis Elevated creatinine levels Hypoglycemia a US FDA.

14 Medications for Long-Term Weight Management: Warnings and Precautions (cont) Naltrexone ER/bupropion ER Suicidal thoughts and behaviors Neuropsychiatric reactions Seizure risk adhere to dosing schedule and avoid administration with a high-fat meal to limit risk Increased BP and HR monitor Hepatotoxicity (naltrexone) Angle-closure glaucoma (antidepressant) Hypoglycemia a a When used with antidiabetic medications. Liraglutide 3.0 mg Risk of thyroid C-cell tumors Acute pancreatitis Acute gallbladder disease Increased HR monitor Renal impairment Hypersensitivity Suicidal behavior and ideation Hypoglycemia a Boxes indicate boxed warnings in prescribing information US FDA. Medications for Long-Term Weight Management: Impact on A1C and CV Risk Factors Over 1 Year in T2DM Agent A1C, % A1C < 7%, % of patients CV Risk Factors With Significantly Greater Improvement vs PBO Agent PBO Agent PBO Orlistat a,b 0.6 LDL-C, TC, LDL/HDL, SBP Lorcaserin a a,c 26.3 c WC d Phentermine/ topiramate ER 3,e 1.6 a a,c 40 c SBP Naltrexone ER/ bupropion ER a a 26.3 HDL-C, TG, WC Liraglutide 3.0 mg 5,6,f 1.3 a a 22.9 WC, SBP, TC, VLDL-C, HDL-C, hscrp, PAI-1, UAC f HR, heart rate; hscrp, high-sensitivity C-reactive protein; PAI-1, plasminogen 1. Miles JM, et al. Diabetes Care. 2002;25: ; activator inhibitor-1; SBP, systolic blood pressure; TC, total cholesterol; TG, 2. O Neil PM, et al. Obesity. 2012;20: ; triglycerides; UAC, urinary albumin-to-creatinine ratio; VLDL-C, very lowdensity lipoprotein cholesterol; WC, waist circumference. 4. Hollander P, et al. Diabetes Care. 2013;36: ; 3. Garvey WT, et al. Diabetes Care. 2014;37: ; a P <.05 vs PBO; b Adjusted for changes in diabetes medications; c 7%; 5. Davies M, et al. ADA 74th Scientific Sessions d Significant decrease in HR reported vs PBO; e Maximum dose (15 mg/92 [abstract 97-OR]; 6. Bode B, et al EASD Annual mg); f Significant increases in HR and fibrinogen reported vs PBO. Meeting [abstract 181]. Discussing Long-Term Weight Management With Patients: Bariatric Surgery For appropriate candidates, bariatric surgery may be a good option for improving health 1 BARIATRIC SURGERY Offer appropriate candidates referral to an experienced bariatric surgeon 1 BMI 40 or 35 with complications/manifestations of obesity who are motivated to lose weight Insufficient response to comprehensive lifestyle management with or without medication Ensure that patients are fully informed regarding risks, benefits, options (procedure, surgeon, institution), and longterm follow-up 2 1. Jensen MD, et al. Obesity. 2014;22(suppl 2):S1-S Mechanick JI, et al. Obesity. 2013;21(suppl 1):S1-S27. Longitudinal Assessment of Bariatric Surgery-2 (LABS-2): Major Clinical Outcomes at 3 Years 1,a LABS-2: Mortality and Subsequent Bariatric Surgery at 3 Years 1 Weight Change, % LAGB Median, observed Modeled RYGB Median, observed Modeled Follow-Up Time, y a Prospective, observational study initiated in 2006 at multiple US centers to assess longer-term outcomes. Observed Remission Rates, % Comorbidity RYGB LAGB Diabetes Dyslipidemia Hypertension Weight loss with sleeve gastrectomy (SG) procedure, based on recent meta-analysis 2 Greater than LAGB Similar to RYGB 1. Courcoulas AP, et al. JAMA. 2013;310: Chang S, et al. JAMA Surg. 2014;149: RYGB (n = 1738) LAGB (n = 610) Event Events/ Events/ N 300 P-Y a N 300 P-Y a Mortality, within 30 days 3 b Mortality, after 30 days Subsequent bariatric surgery 4 c d 17.5 Longer-term and detailed complication data are being collected 1 Patient characteristics (eg, history of DVT/VTE) have been associated with 30-day major adverse outcomes, including mortality 2 Recent meta-analysis suggests that mortality and complication rates with SG are between those with LAGB and RYGB 3 a Events per 300 person-years: estimated number of events if 100 patients were followed for 3 years. b Sepsis (1), CVD (1), pulmonary embolism (1). c Revision (2), reversal (2). d Band replacement (7), port revision (19), other revision (10), band removal (21), revision to another bariatric procedure (20). 1. Courcoulas AP, et al. JAMA. 2013;310: Flum DR, et al. N Engl J Med. 2009;361: Chang S, et al. JAMA Surg. 2014;149:

15 Summary Adjunct therapies (pharmacotherapy, bariatric surgery) are generally reserved for individuals with greater health risk due to complications/manifestations of obesity 5 medications are currently approved for long-term obesity management in the United States Different mechanisms of action and clinical profiles, particularly related to contraindications, safety, and tolerability More options in case of contraindications, tolerability issues, lack of efficacy CASE PRESENTATION Bariatric surgery may be an appropriate option for some individuals with obesity Patient Update: Tamara Follow-up for weight management and prediabetes 12 weeks since last appointment Based on plan developed at previous visit Switched antidepressants Began attending Weight Watchers Lost 6 lbs in first 4 weeks; weight has been stable since Current medications Bupropion 150 mg twice daily for past 3 months Atorvastatin 10 mg/d for past 2 years Indicator 12 Weeks Ago This Visit Height, in (cm) 71 (180) 71 (180) Weight, lb (kg) 236 (108) 230 (108) BMI, kg/m BP, mm Hg 140/85 142/83 FBG, mg/dl A1C, % Cholesterol, mg/dl Total LDL-C HDL-C TG

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