1. 3 Steps to Successful Obesity Management

2. Learning objectives
Review recent findings about the biologic regulation of eating and weight control
Discuss the clinical recommendations and benefits of sustained weight loss in overweight and obese patients
Apply principles of motivational interviewing and shared decision-making to improve the clinical management of obesity and promote behavioral changes
Understand current guidelines for managing obesity, including the role of pharmacological therapy as an adjunct to lifestyle changes in reducing weight gain and promoting weight loss
Review reimbursement options for intensive behavioral therapy (IBT) in obesity management

3. Disclosures
Brought to you by a medical education collaboration between the Mississippi Osteopathic Medical Association and the Endocrine Society.
Developed by Knighten Health. Supported by an unrestricted education grant from Novo Nordisk Inc.
Janet Ricks, DO: No relevant financial relationships with any commercial interests

4. The case for putting weight first

5. How much body weight does a patient with obesity need to lose to lower his or her risk of health problems and death?
10%
25% 3% 8%

6. Obesity is a complex and multifactorial disease1-6
Gut microbiota
Fat cells
Expenditure
Intake
Genetics/ epigenetics
Energy balance
Medications
Environment
1. Woods SC et al. Int J Obes Relat Metab Disord. 2002;26(suppl 4):S8-S Ludwig DS. JAMA. 2014;311: Speliotes EK et al. Nat Genet. 210;42:
4. Garvey WT et al. Endocr Pract. 2014;20: Bray GA, Ryan DH. Ann NY Acad Sci. 2014;1311: The Obesity Society Infographic Task Force, November Accessed December 10, 2015.

7. Obesity is “getting worse in this country,” rapidly
BMI
<18.5
>40
underweight
normal
overweight
obesity I
obesity II
obesity III
U.S. adult population
31%
34%
20.6%
8.1%
6.4%
35.1% obese
69% overweight and obese
More than two-thirds of U.S. adults
Ogden CL, Carroll MD, Flegal KM. JAMA Jul;312(2);

8. Overweight and Obesity Increase Risk of Disease
BMI
<18.5
>40
underweight
normal
overweight
obesity I
obesity II
obesity III
Waist Circumference: Men > 40 in, Women > 35 in
Disease risk relative to normal weight and waist circumference
High
Very High
Extremely High
Ogden CL, Carroll MD, Flegal KM. JAMA Jul;312(2);
Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity Obes Res. 1998;6(suppl 2).

9. As little as 3% - 5% weight loss reduces the risk of disease
BMI
<18.5
>40
underweight
normal
overweight
obesity I
obesity II
obesity III
Waist Circumference: Men > 40 in, Women > 35 in
Disease risk relative to normal weight and waist circumference
High
Very High
Extremely High
Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity Obes Res. 1998;6(suppl 2).

10. Why is losing weight and keeping it off so difficult?

11. Obesity as an endocrine-related disease
Under normal conditions, food intake and energy expenditure are balanced by a homeostatic system that maintains stability of body fat content over time.
Obesity results through a perturbation in CNS regulation of energy homeostasis.
American Medical Association (AMA) recognizes obesity as a disease:
It is a multi-metabolic and hormonal disease state
It has characteristic signs and symptoms
Increase in fat mass associated with obesity is directly related to comorbidities such as type 2 diabetes mellitus, cardiovascular disease, and some types of cancer
Disease results through a perturbation in the central nervous system (CNS) regulation of energy homeostasis
Morton GJ, Meek TH, Schwartz MW. Nat Rev Neurosci. 2014 Jun;15(6):

12. Pancreas Insulin, Amylin
Multiple hormonal signals influence hypothalamic neurons and appetite1-3
Stomach Ghrelin
Increases appetite
Suppresses appetite
Appetite
Fat cells Leptin
Gut GLP-1, CCK, PYY
Pancreas Insulin, Amylin
1. Woods SC et al. Int J Obes Relat Metab Disord. 2002;26(suppl 4):S8-S Suzuki K et al. Exp Diabetes Res. 2012;2012: Valassi E et al. Nutr Metab Cardiovasc. 2008;18:

13. Physiology of reduced obese state
Metabolic and hormonal changes drive weight regain
The metabolic handicap: reduction in energy expenditure disproportionate to weight reduction.
Mr. Smith
220 pounds
needs 2200 kcal/day
Mr. Jones
200 pounds
needs 2000 kcal/day
Loses weight to 200 pounds
Needs 1830 kcal/day
↑ hunger, ↓satiety ≠
Smith Jones

14. Long-term persistence of hormonal adaptations to weight loss
Changes in Weight from Baseline to Week 62
11 lb GAIN
30 lb LOSS
10 week weight-loss program
Sumithran P et al. N Engl J Med. 2011;365:

15. 14% weight loss produced changes in 8 hormones that encourage weight regain
Mean fasting and postprandial levels of some peripheral signals at baseline and 62 weeks
10-week, lifestyle-based weight loss intervention in healthy overweight and obese adults (n=34) led to
sustained elevations in appetite stimulating hormone(s) and
decreases in appetite suppressing hormones
Net result of these hormonal changes is WEIGHT GAIN!
14% weight loss
reduced:
increased:
Leptin – 65%
Peptide YY
Cholecystokinin
Insulin
Amylin
Ghrelin
Pancreatic polypeptide
Gastric inhibitory polypeptide
Measures of appetite
Sumithran P et al. N Engl J Med. 2011;365:

16. What are the risks of overweight
What are the risks of overweight? How much weight loss is needed for health benefit?

17. Obesity and comorbidities
Idiopathic intracranial hypertension
Stroke
Pulmonary disease
Abnormal function
Obstructive sleep apnea
Hypoventilation syndrome
Cataracts
Coronary heart disease
Diabetes
Dyslipidemia
Hypertension
Nonalcoholic fatty liver disease
Steatosis
Steatohepatitis
Cirrhosis
Gall bladder disease
Severe pancreatitis
Gynecologic abnormalities
Abnormal menses
Infertility
Polycystic ovarian syndrome
Cancer
Breast, uterus, cervix, colon, esophagus, pancreas, kidney, prostate
Osteoarthritis
Phlebitis
Venous stasis
Skin
Gout

18. Modest weight loss has benefits, with greater weight loss associated with greater benefit
Measures of glycemia1
-3%
Triglycerides1
HDL cholesterol1
-5%
Systolic and diastolic blood pressure
Hepatic steatosis measured by MRS2
Measures of feeling and function: Symptoms of urinary stress incontinence3 Measures of sexual function4,5 Quality of life measures(IWQOL)6
NASH Activity Score measured on biopsy7
-10%
Apnea-hypopnea index8
Reduction in CV events, mortality, remission of T2DM
-15%
1. Wing et al. Diabetes Care 2011;34: Lazo et al. Diabetes Care 2010;33:2156– 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 Promrat et al. Hepatology 2010;51:121– Foster et al. Arch Intern Med 2009;169:1619–1626

19. Why is modest weight loss beneficial?
SCAT =
Subcutaneous Adipose Tissue
VAT =
Visceral Adipose Tissue
10% weight loss = 30% VAT Loss
Deterioration
Lipid profile
Improvement
Impaired
Insulin sensitivity
Improved 
Blood insulin 
Blood glucose
Risk markers for thrombosis
Inflammatory markers
Endothelial function
VAT
VAT
SCAT
SCAT
Abdominal obesity, increased waist circumference
After weight loss, reduced waist circumference
Increased risk
Lowered risk
Adapted from: Després J, et al. BMJ. 2001;322:

20. Summary (Risks of overweight & obesity, Benefits of weight modest weight loss)
Obesity is associated with an increased risk for coronary heart disease, type 2 diabetes, various types of cancer, gallstones, and disability.
Obesity is associated with an increased risk for death, particularly in adults younger than 65 years.
The risk of disease increases with BMI and waist circumference.
Weight loss as little as 3% - 5% in obese individuals is associated with a lower incidence of health problems and death.

21. Obesity is a disease, but are we talking about it?
USPSTF recommends screening all adults for obesity yet:
A third of patients with a BMI ≥ 30 were never told by their doctors that they have obesity
Rates of physician counseling appear to be decreasing, by as much as 25 percent. Those rates are worse for patients with obesity co-morbidities
Family practitioner–patient conversations about nutrition last an average of 55 seconds
Intensive behavioral counseling can induce clinically meaningful weight loss, but there is little research on primary care practitioners providing such care
1. Post RE et al. Arch Intern Med. 2011;171(4): ; 2. Kraschnewski JL et al. Med Care. 2013;51:186–92; 3. Eaton CB, Am J Prev Med Oct;23(3):174-9;
4. Wadden TA et al. JAMA Nov 5;312(17):

22. How much body weight does a patient with obesity need to lose to lower his or her risk of health problems and death?
10%
25% 3% 8%

23. STEP 1: Talk to patients about obesity
Motivational interviewing and shared decision-making with patients

24. What is the first thing you should do when discussing weight with patients?
Recommend a diet.
Ask permission to discuss weight.
Ask about their exercise routines.
Explain a high BMI's health risks.

25. Meet Rosalia: Working mom with a family history of type 2 diabetes
CC: in for annual visit.
SH: 49-year-old office manager for Blue Cross, recently promoted, divorced, 2 children
Does not smoke or drink
Took paroxetine around time of divorce for depression – continues on it.
Her father has T2DM and is on dialysis; She says “I know this runs in families and I don’t want it to happen to me.
Meds: Has been on paroxetine since her divorce 4 years ago, asymptomatic.
Workup
Height: 5’8”; weight: 223 lbs; BMI: 34 kg/m2 (comments: “I need to lose at least 80 pounds”)
BP: 130/80 mm; pulse: 70 bpm, Resp: WNL
Mammogram report: normal
Lab Chem Survey: glucose 107, A1c 5.8%, otherwise normal. Cholesterol 238, HDL 64, TG 124, LDL CBC & UA normal. TSH Pap smear normal.

26. How do you think about your patients’ weight struggles?
What you might think:
She needs to lose at least 80 pounds.
I need to start her on metformin, advise her to lose weight and see her back in a year.
She can lose weight by just eating a bit less and exercising a bit more. I will tell her about healthy lifestyle.
If she struggles, she just needs more resolve. She doesn’t need medications. She can do this on her own.
The reality:
She can greatly reduce her risk for diabetes with loss of just pounds.
She can improve risk for diabetes, BP, and lipids with weight loss. This needs to be the first and central approach.
Weight loss requires skills training. The more intensive the coaching, the greater the chance of meaningful weight loss.
Some of her medications caused her to gain weight. She may need help with medications both to lose weight and to address biologic adaptations to weight loss.

27. The 5As of Obesity Management
Ask
Ask for permission to discuss weight
Explore readiness for change
Assess
Assess obesity class and stage
Assess for drivers (root cause), complications, and barriers
Advise
Advise on obesity risks (related more to obesity stage than BMI)
Explain benefits of modest weight loss focusing on improving health & wellbeing
Explain need for long-term strategy
Discuss treatment options
Agree
Agree on realistic weight-loss expectations
Agree on treatment plan
Assist
Address drivers and barriers
Provide education and resources
Refer to appropriate provider
Arrange follow-up
Vallis M, et al. Can Fam Physician. 2013;59:27-31;​
Meriwether RA, et al. Am Fam Physician. 2008;77(8):

28. Talk to Rosalia using the 5 As of obesity management
Ask: “Let’s talk about your exam. Your mammogram is normal and your exam, and most of your tests are fine. But your blood sugar and A1c are higher than we like to see. This is pre- diabetes. The single best thing you could do for your health would be to make some lifestyle changes that produce some weight loss. Is today a good time to talk about your weight?”
Rosalia: “Yes, we can talk about it. I know I need to lose weight – at least 80 pounds. I don’t want to end up like my father.”
You: I’m glad to hear you are taking this seriously. We can talk about a goal later, but the good news is that you can improve your diabetes risk with pounds loss. Let me ask you a few questions to get started.”
What if she says, “No”?
Assess:
Comorbidities (sleep apnea symptoms, depression symptoms)
Drivers of weight gain (medications including OTC; sleep deprivation, stress)
Complications and Barriers to weight loss success.
Current lifestyle.
What has worked in the past.
What hasn’t worked in the past.

29. Motivational interviewing (OARS Strategy)
Open-ended questions
Ask open-ended questions that encourage thought- provoking response
Engage in a 2-way dialogue
Goal is to understand a patient’s barriers and expectations A
Affirmative statements
Recognize and support the patient’s personal strengths, successes, and efforts to change
Goal is to promote a collaborative relationship R
Reflections
Use reflective listening
Respond thoughtfully by paraphrasing
Confirm that the patient has been heard
Validate the patient’s point of view S
Summary statements
Use statements that recount and clarify the patient’s statements
Identify specific points to act upon

30. Talk with Rosalia using OARS motivational interviewing strategy
Clinician (you):
You mentioned 80 pounds, but losing pounds and even as little as 8 pounds can reduce your risk.
How do you feel about that statement?
Or, “What are some of your thoughts on losing weight?"
Health is the right reason to make lifestyle changes. You CAN decrease your diabetes risk.
Regaining weight is the result of our bodies’ natural defenses. It’s not your fault. It sounds like you are saying you need some help with maintaining lost weight. What do you think about that?
That’s one option we can discuss for our long term strategy. I’m hearing that you’ve struggled with weight and recognize how it is affecting your health and quality of life. Ok. Now, let’s discuss some strategies to develop a long-term plan to help you address your concerns
Rosalia:
I know I can do it because I have done it before. With Weight Watchers online once. I lost 10 pounds in 3 months. I also did Jenny Craig with even more weight loss. I know I will never be skinny, but I want to be healthy and be around for my kids.
Yes, but I can’t keep it off, so I wasn’t successful.
Yes. I don’t think I can do it without help. I might need something. What about medication?
OK! O A
Open-ended
Affirmative
Reflections
Summary R S

31. Talking to patients about weight: Patient-centered communication
Keys to Successful Conversations
Choose words carefully:
“Healthy eating habits” not “diet”
“Physical activity routine” not “exercise”
“Weight” or “healthy weight” not “fat” or “fatness”
Other terms to avoid: “excess fat,” “heaviness,” “large size,” “weight problem”
Listen actively, with empathy and encouragement
Be non-judgmental
Preventing Weight Bias. Module 2: Helping Without Harming in Clinical Practice. The Rudd Center for Food Policy and Obesity. Yale University.

32. Summary Ask Assess Advise Agree Assist
Ask for permission to discuss weight
Explore readiness for change
Assess
Assess obesity class and stage
Assess for drivers (root cause), complications, and barriers
Advise
Advise on obesity risks (related more to obesity stage than BMI)
Explain benefits of modest weight loss focusing on improving health & wellbeing
Explain need for long-term strategy
Discuss treatment options
Agree
Agree on realistic weight-loss expectations
Agree on treatment plan
Assist
Address drivers and barriers
Provide education and resources
Refer to appropriate provider
Arrange follow-up
Vallis M, et al. Can Fam Physician. 2013;59:27-31;​
Meriwether RA, et al. Am Fam Physician. 2008;77(8): ​

33. What is the first thing you should do when discussing weight with patients?
Recommend a diet.
Ask permission to discuss weight.
Ask about their exercise routines.
Explain a high BMI's health risks.

34. STEP 2: Manage obesity with a toolbox of options
Guidelines on Pharmacologic Management of Obesity

35. When should you consider an obesity medication for patients?
To help a patient better adhere to a healthy-eating plan
To help a patient who has lost weight with healthy eating habits and physical activity keep the lost weight off
To help a patient lose more weight than they might lose on their own
All of these

36. Weight management intensification options
Patients with low risk should have lower intensity, lower risk approaches. Higher risk approaches are justified when patients have more complicated obesity.
Mean Weight Loss 0% 3% 8%
12%
16%
32%
Diet and Lifestyle1
Gastric Band2
Gastric Bypass or Sleeve2
Lifestyle plus Obesity Medications
From LABS3: Perioperative DVT, thromboembolism or death 1% for gastric band 5% for bypass
1. Jensen et al. Circulation 2014;129(25 Suppl 2):S102-38;
2. Courcoulas et al. JAMA 2013;310: ;
3. LABS consortium. N Engl J Med 2009;361:

37. Pharmacological Management Of Obesity:
An Endocrine Society Clinical Practice Guideline January 15, 2015
Apovian C, Aronne LJ, et al. J Clin Endocrinol Metab.  Feb;100(2):

38. Common Medications for Chronic Diseases Associated with Weight
Weight Gain Associated With Use
Alternatives (Weight Reducing in Parentheses)
Diabetes
Insulin, sulfonylureas, TZDs, mitiglinide, sitagliptin?
(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;100:342-62

39. Who Qualifies for Obesity Medications?
We need obesity medications to:
help patients better adhere to their dietary plan
help more patients achieve meaningful weight loss
produce more weight loss so that health benefits will be greater
help patients sustain lost weight
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 recommendation based on High quality evidence
Apovian CM et al. J Clin Endocrinol Metab, February 2015, 100(2):34

40. Where obesity treatments work: Gut hormone and neuroendocrine targets
LAGB surgery
Stomach
Fat Metabolism Drugs (Beloranib)
Adipose Tissue
Appetite Suppressing Drugs Hypothalamus
Lipase Inhibitors (Orlistat) Intestines
Vagal Blocking Device Vagus nerve
Gastric Bypass, BPD Gastric Sleeve surgeries
Intestines
FDA approved drugs
Naltrexone/Bupropion
Liraglutide 3 Mg
Phentermine/ Topiramate
Lorcaserin
Orlistat
Mendieta-Zero´n H, Lo´pez M , Die´guez C. Gen Comp Endocrinol Feb 1;155(3): doi: /j.ygcen Epub 2007 Nov 21.

41. FDA-approved medications and how they work
Agent
Action
Approval
Scheduled drug
Phentermine
Sympathomimetic agent
Approved, short term use, 1956
Yes
Orlistat
Xenical®, Alli®
Pancreatic lipase inhibitor
Approved, 1997 No
Lorcaserin
Belviq®
5-HT2C serotonin agonist
Little affinity for other serotonergic receptors
Approved 2012
Phentermine/Topiramate ER Qsymia™
Sympathomimetic
Anticonvulsant (GABA receptor modulator carbonic anhydrase inhibitor, glutamate antagonist)
Naltrexone SR/Bupropion SR
Contrave®
Opioid receptor antagonist
Dopamine/noradrenaline reuptake inhibitor
Approved 2014
Liraglutide 3.0 mg
Saxenda®
GLP-1 receptor agonist

42. Medications approved for chronic weight management – safety and tolerability
 Agent
Safety
Contraindications
Tolerability
Orlistat
Warning: ↑cyclosporine exposure; rare liver failure; multivit advised
Chronic malabsorption; gall bladder disease
All the symptoms of steatorrhea (fatty discharge, etc.)
Lorcaserin
Warnings: serotonin syndrome; valvular heart disease; cognitive impairment; depression; hypoglycemia; priapism
Do not use with MAOIs.
Use with “extreme caution” with serotonergic drugs (SSRIs, SNRIs); Pregnancy
Headache, dizziness, fatigue
Phentermine/ Topiramate ER
Warning: fetal toxicity; acute myopia; cognitive dysfunction; metabolic acidosis; hypoglycemia
Glaucoma; hyperthyroidism; MAOIs; Pregnancy
Paresthesias, dysgeusia; dizziness, dry mouth
Naltrexone SR/ Bupropion SR
Boxed warning: suicidality; Warning: BP, HR; ↑ seizure risk; glaucoma; hepatotoxicity
Seizure disorder; uncontrolled HTN; chronic opioid use; MAOIs; Pregnancy
Nausea, vomiting, headache, dizziness, insomnia
Liraglutide 3 mg
Boxed warning: rodent thyroid c-cell tumors. Warnings: acute pancreatitis, acute gallbladder disease, hypoglycemia, heart rate increase; renal impairment; suicidal behavior
Patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia.; Pregnancy
Nausea, vomiting, diarrhea, constipation, dyspepsia, abdominal pain.
All data from product label

43. Orlistat Two forms Alli 60mg (OTC) and Xenical 120mg (Rx)
Should be taken three times daily prior to meals in conjunction with reduced calorie diet
Meals should contain <30% fat to decrease risk of GI side effects
Side effects are mostly GI: abdominal pain, nausea, oily stools. Fecal urgency, flatus with discharge
Has been used out to 4 years
Drug interactions: cyclosporine, fat-soluble vitamin, levothyroxine, warfarin, amiodarone, antiepileptic drugs (mostly due to decreased absorption)
Reversible inhibitor of gastric lipase – unable to hydrolyze dietary fats and triglycerides into absorbable free fatty acids and monoglycerides
Mean percentage weight loss (treated vs placebo) at one year was 3% (13.4 lbs vs 5.8 lbs)

44. Lorcaserin (Belviq®)
Serotonin 2C receptor agonist acting in the hypothalamus to promote satiety and decrease food consumption
Dose is 1mg twice daily – discontinue use if 5% weight loss not achieved by week 12
Safety with other serotonergic or antidopaminergic drugs has not been established – concern for Serotonin Syndrome or Neuroleptic Malignant Syndrome
Side effects: headache, dizziness, fatigue, nausea, dry mouth, constipation
Potential drug interactions: Serotonergic drugs (selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), triptans, bupropion, dextromethorphan, St. John’s Wort): use with extreme caution due to the risk of serotonin syndrome
Used in conjunction with reduced calorie diet
Weight loss at 52 weeks vs placebo: 5.8 kg vs 2.5 kg.
% of patients losing >5% of body weight: 47.1% vs 22.6%.
% of patient losing >10% body weight: 22.4% vs 8.7%

45. Phentermine/Topiramate (Qsymia®)
Phentermine – sympathetic amine – release of catecholamines in the hypothalamus resulting in reduced appetite
Topiramate – MOA for weight loss unknown, but augments the activity of gamma-aminobutyrate, modulates voltage-gated ion channels, inhibits glutamate receptors, inhibits carbonic anhydrase
Adverse effects and contraindications are specific to the components of the drugs:
CI: pregnancy, glaucoma, hyperthyroidism, during or within 14 days of using MAOI, known hypersensitivity
Adverse effects: fetal toxicity, elevation in heart rate, suicidal behavior and ideation, mood and sleep disorders, cognitive impairment, metabolic acidosis
Others: paresthesias, dysgeusia
Four dosing options: 3.75mg/23mg, 7.5mg/46mg, 11.5mg/69mg, 15mg/92mg – the 3.75/23mg and 11.5/69mg doses are used for titration only
Start 3.75/23mg daily for 14 days, then titrate to 7.5/46mg – if weight loss <3% at 12 week, then titrate again. 11.5/69 for 14 days then increase to 15/92mg. If not achieved at least 5% weight loss at 12 weeks, discontinue medication.
Used in conjunction with reduce calorie intake and increased physical activity
Weight reduction (% change from baseline) vs placebo
Patients losing >5% body weight: 62-70% vs 17-21%
Patients losing > 10% body weight: 37-48% vs 7%

46. Naltrexone 8mg/Buproprion 90mg Extended Release (Contrave®)
MOA: effects on two separate areas of the brain involved in the regulation of food intake: the hypothalamus (appetite regulatory center) and the mesolimbic dopamine circuit (reward system).
Adverse effects and contraindications are specific to the components of the drugs
Contraindications: Uncontrolled hypertension, Seizure disorders, anorexia nervosa or bulimia, or undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs; Chronic opioid use; During or within 14 days of taking monoamine oxidase inhibitors (MAOI), pregnancy
Adverse effects: Most common adverse reactions (greater than or equal to 5%): nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth and diarrhea
Dose must be titrated up over 4 weeks: once daily x 1 week, twice daily x 1 week, 2 pills in the am, one in the pm x 1 week, 2 twice daily
Used in conjunction with reduce calorie intake and increased physical activity
Weight reduction vs placebo (% change from baseline): vs
% Patients losing >5% body weight vs placebo: vs 17-43
% Patients losing >10% body weight vs placebo: vs 5-21

47. Liraglutide (Saxenda®)
Liraglutide approved for adjunctive treatment of diabetes, however, when used for weight management, the dose is higher – goal dose is 3mg daily
Same adverse effects and contraindications when used for diabetes:
Contraindications: Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2, Pregnancy
Adverse effects: nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, decreased appetite, dyspepsia, fatigue, dizziness, abdominal pain, and increased lipase
Dosing is once again higher – initiate dose at 0.6mg daily and titrate up by 0.6mg weekly
GLP-1 is a physiological regulator of appetite and calorie intake, and the GLP-1 receptor is present in several areas of the brain involved in appetite regulation
Weight changes vs placebo (% change from baseline): vs 0.3-3
% Patients losing >5% body weight vs placebo: vs 16-34
% Patients losing >10% body weight vs placebo: vs 5-15

48. Weight loss effects and effects independent of weight loss
 Agent
Weight loss-related
Weight loss independent – positive
Weight loss independent – negative
Orlistat
Expected
Independent effect on ↓ LDL cholesterol
Reduction in fat soluble vitamin levels
Lorcaserin
? Independent effect on glycemia -
Phentermine/ Topiramate ER
Naltrexone SR/ Bupropion SR
Expected; Except less than expected reduction in pulse, BP
Less than expected decrease in BP and pulse
Liraglutide 3 mg
Expected; Except increased pulse
Independent effect on glycemia
Increase in lipase, uncertain significance
Data from prescribing information
SNRI, serotonin–norepinephrine reuptake inhibitor; SSRI, selective serotonin reuptake inhibitor; MAOI monoamine reuptake inhibitor; BP blood pressure
HR heart rate;

49. Placebo-subtracted weight loss in patients with and without T2DM
NOTE: These are not head-to-head comparisons; populations differ across studies and lifestyle intervention differs across studies.
Orlistat1, mg TID 52 weeks
Lorcaserin5,6 10 mg BID 52 weeks
Liraglutide7,8 3.0 mg QD
56 weeks
Naltrexone/bupropion3,4
32/360 mg ER QD
56 weeks
PHEN/TPM9,10 7.5/46 mg ER QD
56 weeks
Percent weight loss at one year
Values are placebo-subtracted and approximated from kg weight reductions where applicable
1. Torgerson et al. Diabetes Care 2004;27:155–61; 2. Berne et al. Diabet Med 2005;22:612–8; 3. Smith et al. N Engl J Med 2010;363:245–56; 4. O’Neil et al. Obesity 2012;20:1426–36; 5. Apovian et al. Obesity (Silver Spring) 2013;21:935–43; 6. Hollander et al. Diabetes Care 2013;36:4022–9; 7. Pi-Sunyer et al. Diabetologia 2014;57:73- OR; 8. Davies et al. Diabetologia 2014;57:39-OR; 9. Gadde et al. Lancet 2011;377:1341–52; 10. Garvey et al. Diabetes Care online September, 2014

50. Weight loss: Individual variation
McCullough PA, et al. Poster AANP 2013.

51. Proportion (%) achieving 5% weight loss after 52 weeks at top dose
NOTE: These are not head-to-head comparisons; patient populations differ across studies and lifestyle interventions differ across studies.
Percentage (%)
Orlistat mg TID
Lorcaserin2 10 mg BID
Liraglutide3 3.0 mg QD
Naltrexone/bupropion4
32/360 mg QD
Naltrexone/bupropion5
32/360 mg - BMOD
PHEN/TPM6 7.5/46 mg ER QD
1. Torgerson et al. Diabetes Care 2004;27:155–61; 2. Smith et al. N Engl J Med 2010;363:245–56; 3. Astrup, et al. Lancet 2009; Greenway, et al. Lancet 2010; Wadden , et al. Obesity (2011) 19, 110– Gadde et al. Lancet 2011;377:1341–52

52. Proportion (%) achieving 10% weight loss after 52 weeks at top dose
NOTE: These are not head-to-head comparisons; patient populations differ across studies and lifestyle interventions differ across studies.
Percentage (%)
Orlistat mg TID
Lorcaserin2 10 mg BID
Liraglutide3 3.0 mg QD
Naltrexone/bupropion4
32/360 mg QD
Naltrexone/bupropion5
32/360 mg - BMOD
PHEN/TPM6 7.5/46 mg ER QD
1. Torgerson et al. Diabetes Care 2004;27:155–61; 2. Smith et al. N Engl J Med 2010;363:245–56; 3. Astrup, et al. Lancet 2009; Greenway, et al. Lancet 2010; Wadden , et al. Obesity (2011) 19, 110– Gadde et al. Lancet 2011;377:1341–52

53. Developing a treatment plan for Rosalia
Advising on treatment options
You advised Rosalia that losing at least 5% of weight loss in the next 12 weeks is, for now, a good goal.
You reviewed medications and other drivers of weight gain (acetominophen PM, paroxetine).
Rosalia asked about weight-loss medication and you discussed the available options.
Agreeing on weight goals and treatment plan*
Rosalia will attend weekly Weight Watchers meetings because her office wellness program offers it.
Instead of eating at her desk, Rosalia will join co-workers on lunchtime walks. She sets a goal of 150 minutes per week of brisk walking.
Rosalia will adopt a low-glycemic index diet in the Weight Watchers program after a visit with a dietitian.
Together, you make a decision to taper and discontinue paroxetine and to discontinue acetaminophen PM.
Rosalia will monitor sleep duration on her Fitbit and has engaged in meditation through a smartphone app.
Rosalia begins liraglutide 0.6 mg with a dose escalation planned to 3.0 mg.
Follow-up plan
Refer her to a local dietician you’ve worked with in the past.
Schedule follow-up visits weekly for the next 3 weeks, then monthly for the next 3 months.
Check in at 12 weeks to confirm if she’s lost at least 5% of her weight.
Follow at least every three months thereafter.
After 6 months, renew emphasis on physical activity, trying to push to 250 minutes of moderate activity per week. Continue liraglutide.

54. Rosalia’s treatment strategy
Ask
Ask for permission to discuss weight
Explore readiness for change
Assess
Assess obesity class and stage
Assess for drivers (root cause), complications, and barriers
Advise
Advise on obesity risks (related more to obesity stage than BMI)
Explain benefits of modest weight loss focusing on improving health & wellbeing
Explain need for long-term strategy
Discuss treatment options
Agree
Agree on realistic weight-loss expectations
Agree on treatment plan
Assist
Address drivers and barriers
Provide education and resources
Refer to appropriate provider
Arrange follow-up
Vallis M, et al. Can Fam Physician. 2013;59:27-31;​
Meriwether RA, et al. Am Fam Physician. 2008;77(8):

55. Weight management intensification options
Patients with low risk should have lower intensity, less risk approaches. Higher risk approaches are justified when patients have more complicated obesity.
Mean Weight Loss 0% 3% 8%
12%
16%
32%
Diet and Lifestyle1
Gastric Band2
Gastric Bypass or Sleeve2
Lifestyle plus Obesity Medications
From LABS3: Perioperative DVT, thromboembolism or death 1% for gastric band 5% for bypass
1. Jensen et al. Circulation 2014;129(25 Suppl 2):S102-38; 2. Courcoulas et al. JAMA 2013;310: ; 3. LABS consortium. N Engl J Med 2009;361:

56. Bariatric surgery criteria
BMI
<18.5
>40
underweight
normal
overweight
obesity I
obesity II
obesity III
With ≥1 severe obesity-associated comorbidity
(e.g., diabetes or OSA)
With no comorbidities

57. Effectiveness and risks of bariatric surgery and devices: RESULTS
An Updated Systematic Review and Meta-analysis,
Bariatric surgery1:
Provides substantial and sustained effects on weight loss
Ameliorates obesity-attributable comorbidities in most patients
Risks of complication, reoperation, and death exist
Gastric Bypass
More effective weight loss
More complications
Adjustable Gastric Banding
Lower mortality
Lower complication rates
Higher reoperation rate
Less weight loss than gastric bypass
Sleeve Gastrectomy
More effective weight loss than adjustable gastric banding; comparable with gastric bypass
ReShape™ Integrated Dual Balloon System2
Two attached balloons placed into stomach through mouth and inflated
25.44% EWL and 11.27% TBWL at 12 months
ORBERA™ Intragastric Balloon System3
Balloon placed into stomach through mouth and filled with saline
10.2% WL at 6 months
1. Change S-H, et al. JAMA Surg. 2014;149(3): ; 2. ASGE Bariatric Endoscopy Task Force, et al. Gastrointest Endosc Sep;82(3): e5 3.

58. Resolution of comorbidities
Idiopathic intracranial hypertension
Stroke
Pulmonary disease
Abnormal function
Obstructive sleep apnea
Hypoventilation syndrome
74-98% resolved
Cataracts
Coronary heart disease
Diabetes
Dyslipidemia
Hypertension 69% resolved
90% reduced
Nonalcoholic fatty liver disease
Steatosis
Steatohepatitis
Cirrhosis
Gall bladder disease
Severe pancreatitis
Gynecologic abnormalities
Abnormal menses
Infertility
Polycystic ovarian syndrome
Cancer
Breast, uterus, cervix, colon, esophagus, pancreas, kidney, prostate
41% resolved
Osteoarthritis
Phlebitis 95% resolved
Venous stasis
Skin
Gout 72% resolved

59. Bariatric surgery – low mortality
When performed at a Bariatric Surgery Center of Excellence 59

60. Putting it all together:
Obesity is a complex, chronic disease
Risk for obesity is driven by environmental and biologic factors in genetically susceptible individuals
Moderate weight loss can improve health, but response to treatment is highly variable and weight regain is common
When patients struggle, intensification of approach is appropriate
Combinations of approaches (diet, exercise, drugs, devices and surgery) produce more weight loss and health benefit

61. When should you consider an obesity medication for patients?
To help a patient better adhere to a healthy-eating plan
To help a patient who has lost weight with healthy eating habits and physical activity keep the lost weight off
To help a patient lose more weight than they might lose on their own
All of these

62. STEP 3: Get reimbursed
Reimbursement for Obesity Management

63. What must be documented as part of intensive behavioral therapy for obesity?
That the patient lost at least 6.6 pounds after six months.
That treatment was consistent with the 5A approach.
Up to 22 IBT sessions over 12 months.
All of these

64. Reimbursement of IBT for obesity
Key Considerations
Obesity is a disease and should be treated like one.
If you can’t treat it like a disease, treat comorbid conditions, billed using E&M codes.
Medicare Part B allows reimbursement for IBT for obesity w/some restrictions for:
screening for obesity in adults using BMI;
dietary (nutritional) assessment; and,
intensive behavioral counseling and therapy to promote sustained weight loss through high-intensity interventions on diet and exercise.
Medicare coinsurance and Part B deductible are waived.
Private insurance coverage of IBT for obesity remains highly variable However, because Medicare policy exerts a major influence on the commercial health care system, which often adopts its reimbursement and coverage policies..
Centers for Medicare and Medicaid Services

65. Requirements for Medicare coverage
Eligible beneficiaries
Qualified primary care providers
Allowable visits
Allowable primary care settings
BMI>30kg/m2
Competent and alert when counseling is provided
Must lose 3kg (6.6lbs) during the first 6 months for continuing coverage
A physician who has a primary specialty designation of family practice, general practice, geriatric medicine, internal medicine, OB/GYN, or pediatric medicine
A qualified non-physician practitioner who is a certified clinical nurse specialist, nurse practitioner, or physician assistant
Auxiliary personnel such as registered dieticians working for one of the provider specialty types listed above
22 IBT sessions for obesity is maximum in a 12-month period
1 face-to-face visit every week for first month
1 face-to-face visit every other week for months 2-6
1 face-to-face visit every month for months 7-12 if beneficiary loses at least 3kg (6.6lbs) during first 6 months
Independent clinics
Outpatient clinics
Physician’s offices
State or local public health clinics
U.S. Department of Health and Human Services. Intensive Behavioral Therapy (IBT) for Obesity. Centers for Medicare & Medicaid Services, August 2012

66. Documentation for IBT for obesity
Medical records must document all coverage requirements, including the determination of weight loss at the 6- month visit
Must document treatment consistent with the 5A’s approach
Stand Alone Benefit: The IBT for obesity covered by Medicare is a stand alone billable service separate from the initial preventive physical exam (IPPE) or the Annual Wellness Visit (AMV).
Medicare beneficiaries may obtain IBT for obesity services at any time following Medicare Part B enrollment, including during IPPE or AMV encounter.
Note: Obesity counseling is not separately payable with another visit on the same day with the exception initial physical exams, diabetes self-management and medical nutrition therapy services (code 77X), and distinct procedural services claims (modifier 59)
CMS. MLN Matters MM

67. Billing and coding requirements for IBT
Coding and Diagnosis Information
Use the Healthcare Common Procedure Coding System (HCPCS code) G0447 (face-to-face behavioral counseling for obesity) and relevant ICD- 9-DM Diagnosis Code for BMI 30.0 and over (V85.30-V85.39, V85.41 ·V
Do not use or
No need to add comorbid diagnoses
Use preventative codes mandated by ACA for follow-up and management
Covered IBT can be provided “incident to” i.e., by auxiliary staff member such as NP or PA under direct supervision of physician.
Can be an efficient and cost-effective way to provide IBT for obesity in a busy practice setting
Physicians of other specialties may be compensated for IBT if they have multiple credentials and bill under approved taxonomy codes – e.g., NP or PA.
Centers for Medicare and Medicaid Services

68. Summary: Learning Objectives
Review recent findings about the biologic regulation of eating and weight control
Discuss the clinical recommendations and benefits of sustained weight loss in overweight and obese patients
Apply principles of motivational interviewing and shared decision-making to improve the clinical management of obesity and promote behavioral changes
Understand current guidelines for managing obesity, including the role of pharmacological therapy as an adjunct to lifestyle changes in reducing weight gain and promoting weight loss
Review reimbursement options for intensive behavioral therapy (IBT) in obesity management

69. What must be documented as part of intensive behavioral therapy for obesity?
That the patient lost at least 6.6 pounds after six months.
That treatment was consistent with the 5A approach.
Up to 22 IBT sessions over 12 months.
All of these

70. Resources On the official Weight First website, you can find:
On the official Weight First website, you can find:
Links to guidelines, papers, and studies referenced in the presentation
Access to presentation slides
Opportunity for AMA PRA Category 1 CME credit
More information about obesity medical management