Obesity Clinical Practice Guidelines Where we are and where we re going! Donna H. Ryan, MD

Transcription

1 Obesity Clinical Practice Guidelines Where we are and where we re going! Donna H. Ryan, MD

2 Disclosure Dr. Ryan has received financial remuneration for services rendered to Amgen, Eisai, Jansen, Novo Nordisk, Pfizer, Takeda, Vivus and Real Appeal and has ownership interest in Scientific Intake and Tulip Medical.

3 Guidelines, Guidelines, Guidelines > 44 countries have published guidelines targeting obesity In US, obesity guidelines from AHA/ACC/TOS 2013, AACE 2014, ENDO 2015, ASBP (OMA) 2015 US obesity guidelines overlap with Lifestyle Guidelines overlap in dietary and physical activity recommendations ACC/AHA Lifestyle Guidelines (2014) Dietary Guidelines for Americans (2015) Physical Activity Guidelines for Americans (2008)

4 US Guidelines for Obesity Clarity or Confusion?

5 Objectives Using 4 recent Guidelines as a basis, Describe the different approaches to clinical evaluations needed to identify patients who need medical intervention for weight loss; and Translate the recommendations for different treatment approaches into actionable steps for primary care offices in Lifestyle intervention Lifestyle intervention and pharmacotherapy Lifestyle intervention and bariatric surgery Discuss unmet needs and future directions

6 Where to find them Jensen MD, Ryan DH, Donato KA, et al. Guidelines (2013) for managing overweight and obesity in adults. Obesity 2014;22(S2):S1-S410. AACE Advanced framework for a new diagnosis of obesity as a chronic disease. Available at Seger JC, Horn DB, Westman EC, Primack C, et al. Obesity Algorithm, presented by the American Society of Bariatric Physicians, Apovian CM, Aronne LJ, Bessesen DH et al. Pharmacologic Management of obesity: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2015;100(2): All may be downloaded free of charge.

7 Primary Sources (Guidelines) in this talk. Obesity 2 ACC/AHA/TOS 2014 AACE Advanced Framework 2014 ASBP (OMA) annual ENDO Pharma Management 2015

8 Where to find them (for free) Jensen MD, Ryan DH, Donato KA, et al. Guidelines (2013) for managing overweight and obesity in adults. Obesity 2014;22(S2):S1-S410. AACE Advanced framework for a new diagnosis of obesity as a chronic disease. Available at Apovian CM, Aronne LJ, Bessesen DH et al. Pharmacologic Management of obesity: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2015;100(2): All may be downloaded free of charge from TOS, AACE and Endocrine Society websites.

9 The Good News These Guidelines target different audiences, are additive Obesity 2 Targets PCPs AACE Targets specialists ASBP Obesity Algorithm ENDO Pharmacotherapy Systematic Evidence Review Consensus of expert opinion Consensus of expert opinion Systematic Evidence Review Trustworthy authoritative with focus on 5 questions Focus on specialty approach to obesity as disease Detailed approach to weight management. Annual updates. 2 critical questions: meds that promote weight gain or weight loss

10 Let s look at some office scenarios; let s use the 4 sources to illustrate patient evaluation and treatment selection

11 How Do You Decide Who Needs Medical Intervention to Lose Weight?

12 Major Message from 2013 AHA/ACCC/TOS Guidelines It is imperative that PCPs engage in weight management as a pathway to better health for their patients. Screen with BMI at every visit. But BMI is only a screening tool. Waist circumference is a risk factor. Use the conventional cutpoints >35 inches for women and > 40 inches for men to identify patients that are high risk. Patients that are overweight and obese should be screened for CVD risk factors and comorbidities. Who needs to lose weight? BMI >30 kg/m 2 or BMI >25 kg/m 2 with a risk factor, like elevated waist circumference.

13 Staging the patient - the first step in the AACE Advanced Framework 1. Stage 0; BMI >25 or BMI >30, but no complications 2. Stage 1; BMI >25 or BMI >30 and mild/moderate complications 3. Stage 3; BMI > 25 or BMI >30 and at least one severe complication AACE Advanced framework. diagnosis-of-obesity-as-a-chronic-disease.pdf.

14 Major Message from AACE Framework Stage 0 obesity healthy diet, exercise pattern via lifestyle modification Stage 1 or 2 obesity* weight loss is important but 5-10% for stage 1 and >10% for stage 2. More intensity of weight loss effort is needed for more severe disease. * Designates BMI >25 kg/m 2

15

16 How do busy practitioners make this operational? BMI part of ehr WC only for BMI kg/m 2 BP part of vital signs Lipid profile, fasting glucose, A1c Symptom checklist You are already doing these things!

17 Another thing to note on the History form: Medications Diabetes Depression Neuropsychiatric problems HRT You are already doing these things!

18 How Much Weight Does the 1. 5% is enough 2. 10% is enough Patient Need to Lose? 3. The goal is the patient s decision. I say, Go for it. 4. It does not matter, because it will all be regained. 5. They must reach BMI <25.

19 Second Major Message from 2013 Obesity Guidelines You do not need to get all your patients to an ideal weight. Modest weight loss has major health benefits. Patients may do very well with lifestyle changes (diet and exercise). But if they struggle, we need to intensify approaches.

20 Obesity Guidelines: Recommendation 2 Grade A (Strong) Counsel patients about the benefits of weight loss: Lifestyle changes that produce modest (3% to 5%) sustained weight loss result in clinically meaningful health benefits - improvements in TG, glucose, HbA1c, and diabetes risk. Greater amounts of weight loss improve blood pressure, LDL-C, HDL-C, and reduce the need for medications to control blood glucose, blood pressure, and lipids, as well as further reduce TG and glucose. Note: most studies recommended a goal of 5% to 10% weight loss After 10-kg weight loss (85 kg, BMI 29)

21 Look AHEAD 1-year Data: Modest Weight Loss (5% to 10%) Improved CVD Markers Change in blood pressure (mm Hg) Diastolic Systolic Change in triglycerides (mg/dl) (mmol/l) Change in HDL and LDL (mg/dl) HDL LDL (mmol/l) LDL, P= Weight loss category Weight loss category Weight loss category Data presented as adjusted least square means and 95% CIs. Stable weight defined as ±2% of baseline weight. P< vs baseline for all weight categories,unless specified otherwise. Wing RR, et al. Diabetes Care. 2011;34(7):

22 Does this mean that we only need to target modest weight loss? No! AACE: Obesity with a serious complication warrants aggressive initial therapy: lifestyle + meds and consider bariatric surgery. ASBP: Goals are multiple improve health, improve quality of life, improve body weight and body composition The principle: the goal is improving targeted health goals through weight reduction

23 Modest Weight Loss Has Benefits, with Greater Weight Loss Associated with Greater Benefit Measures of glycemia 1 Triglycerides 1 and HDL cholesterol 1 Systolic and diastolic blood pressure Hepatic steatosis measured by MRS 2 Measures of feeling and function: Symptoms of urinary stress incontinence 5 Measures of sexual function 6,7 Quality of life measures (IWQOL) 8 NASH Activity Score measured on biopsy 3 Apnea-hypopnea index 4 Reduction in CV events, mortality, remission of T2DM 1. Wing et al. Diabetes Care 2011;34: Lazo et al. Diabetes Care 2010;33: Promrat et al. Hepatology 2010;51: Foster et al. Arch Intern Med 2009;169: % -5.0% -10.0% -15.0% 5. Phelan et al. Urol. 2012;187: Wing et al. Diab Care 2013;36: Wing et al. Journal of Sexual Medicine 2010 ; 7: Crosby, Manual for the IWQOL-LITE Measure 9. Sjostrom,et al

24 Your patient asks, My husband lost 20 pounds on the Wheat Belly Diet. Will this work for me? Your response is: 1. Yes, you should try it. 2. Yes, it will work as long as you follow it. 3. No. You must count calories. 4. Let s schedule some time to talk about weight loss? 5. I do not know. I have not read the book.

25 Third Major Message from 2013 Obesity Guidelines There is no magic diet for weight loss. Choose the diet composition based on the patient s health status and personal preference.

26 Obesity Guidelines: Recommendation 3 Grade A (Strong) Prescribe a diet to achieve reduced calorie intake, as part of a comprehensive lifestyle intervention. Use any one of the following methods: A to 1500 kcal/day for women and 1500 to 1800 kcal/day for men; B. Calculate energy requirements & subtract 500 to 750 kcal/day; or C. Prescribe one of the evidence-based diets that restricts certain food types (such as, high-carbohydrate foods, low-fiber foods, or high-fat foods)

27 Adherence Predicts Loss of Body Fat During Dieting Change in % Body Fat r=-0.74; p< Adherence to Diet Lyon XH, et al. Int J Obes Relat Metab Disord. 1995;19(4):

28 Does this mean that ANY diet is ok for weight loss, as long as its calorie reduced?

29 Diet Pattern Recommendations for LDL-C and BP Lowering Advise adults who would benefit from LDL-C or BP lowering to: Adapt this dietary pattern to appropriate calorie requirements, personal and cultural food preferences, and nutrition therapy for other medical conditions (including DM) Achieve this pattern by following plans such as the DASH dietary pattern, the US Department of Agriculture Food Pattern, or the AHA Diet Strength of evidence: Strong IA Eckel RH, et al. J Am Coll Cardiol. 2014;63:

30 Heart Healthy Nutrition and Physical Activity Behaviors for All Consume a dietary pattern that emphasizes intake of vegetables, fruits, and whole grains; includes low-fat dairy products, poultry, fish, legumes, nontropical vegetable oils, and nuts; and limits intake of sodium, sweets, sugarsweetened beverages, and red meats Adapt this dietary pattern to appropriate calorie requirements, personal and cultural food preferences, and nutrition therapy for other medical conditions, eg, DM Eckel RH, et al. J Am Coll Cardiol. 2014;63:

31 Fourth Major Message From 2013 Obesity Guidelines Losing weight requires honing a skill set of behaviors around diet and physical activity Everyone who needs to lose weight should have access to a comprehensive lifestyle intervention program with at least 14 sessions in 6 months and follow-up for 1 year If your patient does not have access to a comprehensive program in a medical or community setting, a commercial program with an evidence base to recommend it is acceptable Jensen MD, et al. Obesity. 2014;22:S Apovian CM, et al. J Clin Endocrinol Metab. 2015;100:

32 If I give my patient a diet sheet and exercise prescription, what are the odds that the patient will achieve 5% weight loss? 1) 1 in 5 2) 2 in 5 3) 3 in 5 4) 4 in 5 5) 100%, because my patients always take my advice

33 Obesity Guidelines: Recommendation 4 Grade A (Strong) Patients who need to lose weight should receive a comprehensive program (diet, physical activity, and behavior modification) of 6 months or longer The gold standard is on-site, high-intensity ( 14 sessions in 6 months) comprehensive intervention delivered in group or individual sessions by a trained interventionist and persisting for 1 year Other approaches (ie, Web-based, telephonic) may be used when patients cannot access the gold standard, although the amount of weight loss on average may be less (evidence grade B, moderate) Jensen MD, et al. Obesity. 2014;22:S Apovian CM, et al. J Clin Endocrinol Metab. 2015;100:

34 Major Messages About Lifestyle Intervention from 2013 Obesity Guidelines Losing weight requires honing a skill set of behaviors around diet and physical activity. Everyone who needs to lose weight should have access to a comprehensive lifestyle intervention program with 14 sessions in 6 months and follow-up for a year. If your patient does not have access to a comprehensive program in a medical or community setting, a commercial program with an evidence base to recommend it is acceptable. Jensen MD, et al. Obesity. 2014;22(S2):S1-S410.

35 Obesity Guidelines: Recommendation 4 Grade A (Strong) Patients who need to lose weight should receive a comprehensive program (diet, physical activity, and behavior modification) of 6 months or longer. The gold standard is on-site, high intensity (>14 sessions in 6 months) comprehensive intervention delivered in group or individual sessions by a trained interventionist and persisting for a year or more. Other approaches (ie, web-based, telephonic) may be used when patients cannot access the gold standard; albeit though, the amount of weight loss on average may be less. Jensen MD, et al. Obesity. 2014;22(S2):S1-S410.

36 What do the Guidelines say about patients who struggle? When do we add meds?

37 Apovian CM, Aronne LJ, Bessesen DH et al. Pharmacologic Management of obesity: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2015 doi: /jc Bariatric Surgery Pharmacotherapy Behavioral Modification to Change Diet, Physical Activity Guidance on medications which produce weight loss or are weight neutral But within the context of foundational treatment with diet, physical activity and behavior modification And recognizing that some patients benefit from bariatric surgery.

38 Prescribing Medications with a Weight Loss Indication from the ENDO Guidelines

39 Who Qualifies for Obesity Medications? Recommendation: Prescribe as an adjunct to diet, exercise and behavior modification for individuals with BMI 30+; or 27+ with comorbidity; who are unable to lose and successfully maintain weight; and who meet label indications. 1 (strong rec, high quality evidence) Apovian CM, Aronne LJ, Bessesen DH et al. Pharmacologic Management of obesity: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2015 doi: /jc

40 When do you monitor and judge safety and efficacy? Suggestion: Assess efficacy and safety monthly for the first 3 months, then every 3 months thereafter. 2 (weak rec, low quality evidence) Recommendation: At 3 months, if loss is 5% or more, continue. If not, discontinue and seek alternative approaches. 1 (strong rec, high quality evidence) Apovian CM, Aronne LJ, Bessesen DH et al. Pharmacologic Management of obesity: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2015 doi: /jc

41 How long should medications be used? Suggestion: For eligible patients, use mediations To promote long-term weight loss maintenance. 2 (weak rec, low quality evidence) Apovian CM, Aronne LJ, Bessesen DH et al. Pharmacologic Management of obesity: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2015 doi: /jc

42 What dose should be used? Suggestion: Initiate and escalate dose (based on efficacy and tolerability) to the recommended dose and do not exceed upper approved dose boundaries. 2 (weak rec, low quality evidence) Apovian CM, Aronne LJ, Bessesen DH et al. Pharmacologic Management of obesity: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2015 doi: /jc

43 Are there cautions with hypertension and cvd? Recommendation: In patients with uncontrolled hypertension and/or history of cvd, do not use sympathomimetic agents (phentermine and diethylpropion). 1 (strong rec, moderately high quality evidence) Suggestion: In patients with cardiovascular disease, use agents with no sympathomimetic action, such as lorcaserin and orlistat. 2 (weak rec, very low quality evidence) Apovian CM, Aronne LJ, Bessesen DH et al. Pharmacologic Management of obesity: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2015 doi: /jc

44 Are there special issues with patients with type 2 diabetes? Suggestion: In patients with type 2 diabetes use antidiabetic medications that have additional actions to promote weight loss (GLP-1 analogs, SGLT-2 inhibitors in addition to the first line agent, metformin) 2 (weak rec, moderately high quality evidence) Apovian CM, Aronne LJ, Bessesen DH et al. Pharmacologic Management of obesity: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2015 doi: /jc

45 Drugs that Cause Weight Gain and Alternative Approaches for Overweight and Obese Patients

46 Common Medications for Chronic Diseases and Weight Diabetes Weight Gain Associated With Use Insulin, sulfonylureas, TZDs, mitiglinide, sitagliptin? Alternatives (Weight Reducing in Parentheses) (Metformin), (acarbose), (miglitol), (pramlintide), (exenatide), (liraglutide), (SGLT-2 inhibitors) Hypertension medications α-blocker?, β-blocker? ACE inhibitors?, calcium channel blockers?, angiotensin-2 RAs Antidepressants and mood stabilizers Amytriptyline, doxepin, imipramine, nortriptyline, trimipramine, mirtazapine, fluoxetine?, sertraline?, paroxetine, fluvoxamine (Bupropion), nefazodone, fluoxetine (short term, sertraline, < 1 year) Oral contraceptives Progestational steroids Barrier methods, intrauterine devices? represents uncertain/under investigation. Apovian CM, et al. J Clin Endocrinol Metab. 2015;100:

47 Overweight and Obese Patients with Hypertension Recommendation: Use ACE inhibitors, ARBs and Ca channel blockers as first-line therapy, rather than beta blockers. 1 (strong rec, high quality evidence) Apovian CM, Aronne LJ, Bessesen DH et al. Pharmacologic Management of obesity: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2015 doi: /jc

48 Patients with Overweight and Obesity Requiring Antidepressant, Antipsychotic or Antiepileptic Therapy Recommendation: Use a shared decision making process in selecting medication, providing patients with estimates of weight effects of medications. 1 (strong rec, moderately high quality evidence) Apovian CM, Aronne LJ, Bessesen DH et al. Pharmacologic Management of obesity: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2015 doi: /jc

49 Antipsychotic and Anticonvulsant Medications and Weight Antipsychotics Anticonvulsants WEIGHT GAIN ASSOCIATED WITH USE Clozapine Risperidone Olanzapine Quetiapine Haloperidol Perphenazine Quetiapine Carbamazepine Gabapentin Valproate ALTERNATIVES (WEIGHT REDUCTING IN PARENTHESES)* Ziprasidone Aripiprizole Lamotrigine? (Topiramate) (Zonisamide) * Only phentermine/topiramate ER is FDA-approved for chronic weight management in patients with BMI 30+ kg/m 2 or BMI 27 <30 kg/m 2 with one or more comorbidities Apovian CM, Aronne LJ, Bessesen DH et al. Pharmacologic Management of obesity: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2015 doi: /jc

50 Ungraded Best Practice Recommendation We suggest against the off-label use of medications approved for other disease states for the sole purpose of producing weight loss. Apovian CM, Aronne LJ, Bessesen DH et al. Pharmacologic Management of obesity: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2015 doi: /jc

51 What does the Advanced Framework Say? Treatment based on clinical judgment Overweight / Obesity Stage 0 Obesity Stage 1 Obesity Stage 2 Healthy meal pattern Calorie restriction Physical activity Intensive Lifestyle / Behavioral Therapy? Medications Intensive Lifestyle / Behavioral Therapy + Medications Consider Bariatric Surgery AACE Advanced framework. diagnosis-of-obesity-as-a-chronic-disease.pdf.

52 How long should medications be used? From the ENDO Guidelines Suggestion: For eligible patients, use mediations To promote long-term weight loss maintenance. 2 Apovian CM, Aronne LJ, Bessesen DH et al. Pharmacologic Management of obesity: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2015 doi: /jc

53 What do the 3 Guidelines say about bariatric surgery? They all agree!

54 ACC/AHA/TOS Obesity Guidelines: Recommendation 5 Grade A (Strong) Advise your patients with a BMI >35 kg/m 2 and a co-morbidity or >40 kg/m 2 that bariatric surgery may be an appropriate option to improve health and offer referral to an experienced bariatric surgeon for consultation and evaluation.

55 Are there gaps in Guidelines? Better advice on the healthy obese state BMI >30 and no risk factors based on systematic evidence review. Update the BMI limits for bariatric surgery, based on systematic evidence review. Recommendations on treatments that are ineffective or potentially harmful, baed on systematic evidence review.

56 That s your brief tour of the Guidelines. Just remember

57 Remember Your office is already doing many aspects of evaluation and staging. Treatment strategy is determined by severity/acuity of risk. You are already gathering info on medication use. A good start is prescribing wisely. Your job is to match the patient profile to the lifestyle and medication plan. Your job is also to be a proactive resource for patients who would benefit from bariatric surgery.

58 Thank you!