Lectura 5 Parte 3

AACE/ACE Obesity CPG, Endocr Pract.
2016;22(Suppl 3) 1
2 AACE/ACE Obesity CPG, Endocr Pract. 2016;22(Suppl 3)
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ramate as a potential aid to smoking cessation. Addiction. monitoring of food craving post-bariatric surgery: com-
2008;103(4):687-694. [EL 1; RCT] parison with overweight and normal weight women. Clin
1771. Ma JZ, Johnson BA, Yu E, et al. Fine-grain analysis of Obes. 2014;4(3):136-142. [EL 3; CSS]
the treatment effect of topiramate on methamphetamine 1786. Rosenbaum M, Goldsmith R, Bloomfield D, et al. Low-
addiction with latent variable analysis. Drug Alcohol dose leptin reverses skeletal muscle, autonomic, and
Depend. 2013;130(1-3):45-51. [EL 1; RCT, secondary neuroendocrine adaptations to maintenance of reduced
analysis] weight. J Clin Invest. 2005;115(12):3579-3586. [EL 2;
1772. Elkashef A, Kahn R, Yu E, et al. Topiramate for the PCS, small cohort N = 10]
treatment of methamphetamine addiction: a multi-center 1787. Rosenbaum M, Sy M, Pavlovich K, Leibel RL, Hirsch
placebo-controlled trial. Addiction. 2012;107(7):1297- J. Leptin reverses weight loss-induced changes in
1306. [EL 1; RCT] regional neural activity responses to visual food stimuli. J
1773. Johnson BA, Ait-Daoud N, Wang XQ, et al. Topiramate Clin Invest. 2008;118(7):2583-2591. [EL 2; PCS, small
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AACE/ACE ALGORITHM FOR THE MEDICAL CARE

OF PATIENTS WITH OBESITY
Patient Screen positive for overweight or obesity Presence of weight-related disease or complication
Presentation BMI ≥25 kg/m2 (≥23 kg/m2 in some ethnicities) that could be improved by weight-loss therapy
• Medical history • Physical examination • Clinical laboratory

Evaluation • Review of systems, emphasizing weight-related complications
• Obesity history: graph weight vs age, lifestyle patterns/preferences, previous interventions
•Confirm that elevated BMI represents excess adiposity

Anthro- •Measure waist circumference to evaluate cardiometabolic disease risk
Diagnosi
pometric BMI kg/m2

s
Diagnosis
<25 25–29.9 OVERWEIGHT | ≥30 OBESITY
NORMAL WEIGHT
Checklist of Obesity-Related Complications
<23
Clinical in certain ethnicities
(staging and risk stratification based on complication-specific criteria)
Diagnosis Waist circumference below

regional/ethnic cutoffs
None Mild to Moderate Severe
STAGE 0 STAGE 1 STAGE 2
One or more mild- At least one severe

to-moderate complica- complication or
Diagnostic NORMAL WEIGHT No complications tions or may be treated requires significant
effectively with weight loss for
Categories (no obesity) moderate weight loss effective treatment
OVERWEIGHT BMI 25–29.9

BMI ≥25 BMI ≥25
OBESITY BMI ≥30
PRIMARY SECONDARY
Phases of TERTI ARY
Prevent Prevent progressive
Chronic Disease overweight/obesity weight gain or achieve Achieve weight loss sufficient to
Prevention and weight loss to prevent ameliorate the com plications and
complications prevent further deterioration
Treatment Goals
• Healthy meal plan • Lifestyle/behavioral • Lifestyle/behavioral • Lifestyle/behavioral

therapy therapy therapy
Treatment Based • Physical activity
• Consider pharmaco- • Consider pharmaco- • Add pharmaco-
on Clinical • Health education
therapy if lifestyle therapy (BMI ≥27) therapy (BMI ≥27)
Judgment • Built environment alone not effective • Consider bariatric
surgery (BMI ≥35)
• Once the plateau for weight loss has been achieved, re-evaluate the weight-related complications. If the
complications have not been ameliorated, weight-loss therapy should be intensified or
Follow-Up complication-specific interventions need to be employed.
• Obesity is a chronic disease and the diagnostic categories for obesity may not be static. Therefore, patients
require ongoing follow-up, re-evaluation and long-term treatment.
Abbreviation: BMI = body mass index

ANTHROPOMETRIC COMPONENT OF THE MEDICAL DIAGNOSIS OF OBESITY

Evidence-based screening and diagnosis for excess adiposity in clinical settings
Screening Annual BMI
• BMI ≥25 kg/m2 • BMI <25 kg/m2

Diagnosis
• BMI ≥23 kg/m² • BMI <23 kg/m²
(Anthropometric Component)
for some for some
ethnicities ethnicities
1. Clinical interpretation of BMI: Ensure elevated BMI is indicative of excess

adiposity by assessing: age, gender, muscularity, hydration status, edema,
third space fluid collection, large tumors, sarcopenia
2. Waist circumference if BMI <35: Adds information pertaining to Clinical Component
cardiometabolic disease risk; use gender- and ethnicity-specific cut-off values of Diagnosis
3. Can consider body composition technologies: e.g., bioelectrical
impedance, air/water displacement plethysmography, or dual-energy X-ray
absorptiometry scan
Abbreviation: BMI = body mass index.
CLINICAL COMPONENT OF THE MEDICAL DIAGNOSIS OF OBESITY

Evaluation of a checklist of weight-related complications. Candidates for weight-loss therapy can present with either
excess adiposity (i.e., the anthropometric component) or weight-related complications (i.e., the clinical component)
Patients Present with Patients Present with

Candidates for Weight
Overweight or Obesity Weight-Related Disease or Complication
Loss Therapy
(Anthropometric Component) (Clinical Component)
Prediabetes
Metabolic Syndrome
Evaluate for weight-related Type 2 Diabetes
complications Dyslipidemia
Hypertension
Patients present Cardiovascular Disease
with BMI ≥25 kg/m2, Nonalcoholic Fatty Liver Disease
or ≥23 kg/m2 in Evaluate for overweight Polycystic Ovary Syndrome
certain ethnicities, or obesity Female Infertility
and excess adiposity Male Hypogonadism
Obstructive Sleep Apnea
Asthma/Reactive Airway Disease
Osteoarthritis
Urinary Stress Incontinence
Gastroesophageal Reflux Disease
Depression
CHECKLIST OF WEIGHT-RELATED COMPLICATIONS:

SCREENING AND DIAGNOSES IN PATIENTS WITH OVERWEIGHT/OBESITY
Weight-Related Basis for Screening and/or Suggested Secondary Testing When Needed To Confirm
Complication Diagnosis Diagnosis, Stage Severity, or Guide Therapy
Prediabetes Fasting glucose; A1C; If fasting glucose is 100-125 mg/dL, a repeat elevated fasting glucose completes
2-hour OGTT glucose diagnosis of IFG; however, 2-hour OGTT should also be performed to exclude
diabetes and IGT. Fasting and 2-hour OGTT should be performed if initial fasting
glucose is normal and A1C is elevated, or in high-risk patients based on family
history or metabolic syndrome.
Metabolic Syndrome Waist circumference, blood Initial evaluation completes diagnosis; use OGTT to test for IGT or diabetes.
pressure, fasting glucose,
triglycerides, HDL-c
Type 2 Diabetes Fasting glucose; A1C; Overtly elevated (i.e., ≥200 mg/dL) or a repeat fasting glucose ≥126 mg/dL
2-hour OGTT glucose; completes diagnosis. If fasting glucose and/or A1C is consistent with prediabetes,
symptoms of hyperglycemia 2-hour OGTT should be performed to test for diabetes. A1C should be performed
to help guide therapy.
Dyslipidemia Lipid panel (total cholesterol, Lipid panel completes diagnosis; lipoprotein subclasses, apoB100 may further
HDL-c, triglycerides, LDL-c, define risk.
non-HDL-c)
Hypertension Sitting blood pressure Repeat elevated blood pressure measurements to complete diagnosis; home
blood pressure or ambulatory blood pressure monitoring may help complete
testing.
Cardiovascular Disease Physical exam; ROS; history and Additional testing based on findings and risk status (e.g., ankle-brachial index,
medical records stress testing, coronary artery calcium score and the MESA risk score calculator,
arteriography, carotid ultrasound).
NAFLD / NASH Physical exam; LFTs Imaging (e.g., ultrasound, MRI, elastography) and/or liver biopsy needed to
complete diagnosis.
PCOS and Female Physical exam; ROS; menstrual Hormonal testing (e.g., androgen levels, SHBG, LH/FSH, estradiol), ovulation
Infertility and reproductive history testing, imaging of ovaries, may be needed to complete diagnosis.
Male Hypogonadism Physical exam; ROS Hormonal testing (total and free testosterone, SHBG, LH/FSH, prolactin) as needed
to complete diagnosis.
Obstructive Sleep Apnea Physical exam; neck circumference; Polysomnography needed to complete diagnosis.
ROS
Asthma / Respiratory Physical exam; ROS Chest X-ray and spirometry may be needed to complete diagnosis.
Disease
Osteoarthritis Physical exam; ROS Radiographic imaging may be needed to complete diagnosis.
Urinary Stress Physical exam; ROS Urine culture, urodynamic testing may be needed to complete diagnosis.
Incontinence
GERD Physical exam; ROS Endoscopy, esophageal motility study may be needed to complete diagnosis.
Depression, Anxiety, History; ROS Screening/diagnostic evaluation or questionnaires based on criteria in
Binge Eating Disorder, Diagnostic and Statistical Manual of Mental Disorders; referral to clinical
Stigmatization psychologist
or psychiatrist.
Disability Physical exam; ROS Functional testing may be helpful.
Additional Evaluation Relevant to the Differential Diagnosis of Obesity

Interpretation of BMI Physical exam to ensure that Assess muscularity, edema, volume status, pregnancy, third space fluid
BMI value is indicative of excess accumulation, sarcopenia, large tumors, lipodystrophy, etc. Bioelectric impedance,
adiposity air/water displacement plethysmography, or dual-energy absorptiometry scan
may be considered.
Obesity Secondary to Physical exam; ROS TSH for suspected hypothyroidism; salivary/serum/urine cortisol for
Hormonal Disorder hypercortisolism if clinical findings or symptoms present.
Iatrogenic Obesity Review current medications and Withdraw offending medication and/or substitute with weight-neutral alternative.
(e.g., secondary to medication history Follow-up assessment may be needed to complete diagnosis.
medications)
Genetic Syndrome Physical exam; ROS; family history If clinical findings are suggestive, genetic testing of patient and perhaps family
members may be needed to complete diagnosis.
Abbreviations: A1C = glycated hemoglobin; BMI = body mass index; FSH = follicle-stimulating hormone; GERD = gastroesophageal reflux disease; HDL-c = high-density lipoprotein
cholesterol; IFG = impaired fasting glucose; IGT = impaired glucose tolerance; LFTs = liver function tests; LDL-c = low-density lipoprotein cholesterol; LH = luteinizing hormone; MRI =
magnetic resonance imaging; NAFLD = non-alcoholic fatty liver disease; NASH = non-alcoholic steatohepatitis; OGTT = oral glucose tolerance test; PCOS = polycystic ovarian syndrome;
ROS = review of symptoms; SHBG = sex hormone-binding globulin; TSH = thyroid-stimulating hormone.
LIFESTYLE THERAPY
Evidence-based lifestyle therapy for treatment of obesity should include three components
MEAL PLAN PHYSICAL ACTIVITY BEHAVIOR
• Reduced-calorie healthy meal plan • Voluntary aerobic physical activity An interventional package that
• ~500–750 kcal daily deficit progressing to >150 minutes/week includes any number of the following:
performed on 3–5 separate days
• Individualize based on personal • Self-monitoring
per week
and cultural preferences (food intake, exercise, weight)
• Resistance exercise: single-set
• Meal plans can include: • Goal setting
repetitions involving major muscle
Mediterranean, DASH, low-carb, • Education (face-to-face meetings,
groups, 2–3 times per week
low-fat, volumetric, high protein, group sessions, remote technologies)
vegetarian • Reduce sedentary behavior
• Problem-solving strategies
• Meal replacements • Individualize program based on
preferences and take into • Stimulus control
• Very low-calorie diet is an option
account physical limitations • Behavioral contracting
for selected patients and
requires medical supervision Team member or expertise: • Stress reduction
exercise trainer, physical activity coach, • Psychologic evaluation, counseling,
Team member or expertise:
physical/occupational therapist and treatment when needed
dietitian, health educator
• Cognitive restructuring
• Motivational interviewing
• Mobilization of social support
structures
Team member or expertise:
health educator, behaviorist, clinical
psychologist, psychiatrist
WHEN TO INITIATE WEIGHT-LOSS MEDICATIONS IN PATIENTS WITH OVERWEIGHT/OBESITY
INITIATE WEIGHT LOSS MEDICATION AS AN

INITIATE LIFESTYLE THERAPY
ADJUNCT TO LIFESTYLE THERAPY
1. No Complications. 1. Failure to lose weight.

Patients with overweight or obesity who Add medication for patients who have
have no clinically significant weight-related progressive weight gain or who have not
complications (secondary prevention) achieved clinical improvement in weight-related
complications on lifestyle therapy alone.
2. Mild to Moderate Complications. 2. Weight Regain on Lifestyle Therapy.

• Patient with mild to moderate weight- Add medication for patients with overweight
related complications when lifestyle therapy (BMI 25 to 29.9 kg/m2) or obesity who are
is anticipated to achieve sufficient weight experiencing weight regain following initial
loss to ameliorate the complication success on lifestyle therapy alone.
(tertiary prevention)
• Note: weight-loss medications may also be
indicated based on clinical judgment 3. Presence of Weight-Related
Complications.
Initiate medication concurrent with lifestyle
therapy for patients with overweight (BMI to
29.9 kg/m2) or obesity who have weight-related
complications, particularly if severe, in order to
achieve sufficient weight loss to ameliorate the
complication (tertiary prevention).
TREATMENT GOALS BASED ON DIAGNOSIS IN THE MEDICAL MANAGEMENT

OF PATIENTS WITH OBESITY
DIAGNOSIS TREATMENT GOALS

Anthropometric Clinical Intervention/ Clinical Goals
Component Component Weight-Loss Goal
PRIMARY PREVENTION
Primordial BMI ≤25 (≤23 in certain Obesogenic environment • Public education Decreased incidence of overweight/obesity
Prevention ethnicities) • Built environment in populations
• Access to healthy foods
Primary BMI ≤25 (≤23 in High-risk individuals or subgroups based • Annual BMI screening Decreased incidence of overweight/obesity
Prevention certain ethnicities) on individual or cultural behaviors, • Healthy meal plan in high-risk individuals or identifiable
ethnicity, family history, biomarkers, • Increased physical activity subgroups
or genetics
SECONDARY PREVENTION
Overweight BMI 25–29.9 (BMI 23–24.9 No clinically significant or detectable • Prevent progressive • Prevent progression to obesity
in certain ethnicities) weight-related complications weight gain or • Prevent the development of weight-
• Weight loss related complications
Obesity BMI ≥30 (≥25 in certain No clinically significant or detectable • Weight loss or Prevent the development of weight-related
ethnicities) weight-related complications • Prevent progressive complications
weight gain
TERTIARY PREVENTION
Overweight BMI ≥25 Metabolic syndrome 10% Prevention of T2DM
or Obesity (≥23 in certain
ethnicities) Prediabetes 10% Prevention of T2DM
T2DM 5-15% or more • Reduction in A1C

• Reduction in number and/or doses of
glucose-lowering medications
• Diabetes remission especially when
diabetes duration is short
Dyslipidemia 5-15% or more • Lower triglycerides

• Raise HDL-c
• Lower non-HDL-c
Hypertension 5-15% or more • Lower systolic and diastolic BP

• Reductions in number and/or doses of
antihypertensive medications
Nonalcoholic Steatosis 5% or more Reduction in intrahepatocellular lipid

fatty liver
disease Steatohepatitis 10-40% Reduction in inflammation and fibrosis
Polycystic ovary syndrome 5-15% or more • Ovulation

• Regularization of menses
• Reduction in hirsutism
• Enhanced insulin sensitivity
• Reduced serum androgen levels
Female infertility 10% or more • Ovulation

• Pregnancy and live birth
Male hypogonadism 5-10% or more Increase in serum testosterone
Obstructive sleep apnea 7-11% or more • Improved symptomatology

• Decreased apnea-hypopnea index
Asthma/reactive airway disease 7-8% or more • Improvement in forced expiratory

volume at 1 second
• Improved symptomatology
Osteoarthritis • ≥10% • Improved symptomatology

• 5-10% or more when • Increased function
coupled with exercise
Urinary stress incontinence 5-10% or more Reduced frequency of incontinence
Gastroesophageal reflux disease 10% or more Improved symptomatology
Depression Uncertain • Improved symptomatology

• Improvement in depression scores
Abbreviations: A1C = hemoglobin A1c; BMI = body mass index; BP = blood pressure; HDL-c = high-density lipoprotein cholesterol; T2DM = type 2 diabetes mellitus.
PREFERRED WEIGHT-LOSS MEDICATIONS: INDIVIDUALIZATION OF THERAPY

KEY: PREFERRED DRUG USE WITH CAUTION AVOID
MEDICATIONS FOR CHRONIC WEIGHT MANAGEMENT

CLINICAL CHARACTERISTICS
OR CO-EXISTING DISEASES Orlistat Lorcaserin Phentermine/ Naltrexone ER/ Liraglutide 3 mg
topiramate ER bupropion ER
Diabetes Prevention Insufficient data for Insufficient data for

(metabolic syndrome, T2DM prevention T2DM prevention
prediabetes)
Type 2 Diabetes
Mellitus
Hypertension Monitor heart rate Monitor BP and heart Monitor heart rate
rate
Contraindicated in
uncontrolled HTN
Cardiovascular CAD Monitor heart rate Monitor heart rate, BP Monitor heart rate
Disease Arrhythmia Monitor for bradycardia Monitor heart rate, Monitor heart rate, Monitor heart rate,
rhythm rhythm, BP rhythm
CHF Insufficient data Insufficient data Insufficient data Insufficient data Insufficient data
Chronic Kidney Mild
Disease (50–79 mL/min)
Moderate (30– Do not exceed Do not exceed
49 mL/min) 7.5 mg/46 mg per day 8 mg/90 mg bid
Severe Watch for oxalate Urinary clearance of Urinary clearance of Urinary clearance of Avoid vomiting and
(<30 mL/min) nephropathy drug metabolites drug drug volume depletion
Nephrolithiasis Calcium oxalate stones Calcium phosphate
stones
Hepatic Impairment Mild-Moderate Watch for cholelithiasis Hepatic metabolism Do not exceed Do not exceed Watch for
(Child-Pugh 5–9) of drug 7.5 mg/46 mg per day 8 mg/90 mg in AM cholelithiasis
Severe Not recommended Not recommended Not recommended Not recommended Not recommended
(Child-Pugh >9)
Depression Insufficient safety data Avoid maximum dose: Insufficient safety data
15 mg/92 mg per day
Avoid combinations of Avoid in adolescents
serotonergic drugs and young adults
Anxiety Avoid max dose:
15 mg/92 mg per day
Psychoses Insufficient data Insufficient data Insufficient data Insufficient data Insufficient data
Binge Eating Insufficient data; Insufficient data; Insufficient data, though Insufficient data
Disorder however, possible however, possible possible benefit based
benefit based on benefit based on on studies with
reduction in food studies with topiramate bupropion
cravings Avoid in patients with
purging or bulimia
nervosa
Glaucoma Contraindicated, may May trigger angle
trigger angle closure closure
Seizure Disorder If discontinuing from Bupropion lowers
max dose, taper seizure threshold
slowly
Pancreatitis Monitor for symptoms Monitor for symptoms
Avoid if prior or
current disease
Opioid Use Will antagonize opioids
and opiates
Women of Pregnancy Use contraception and Use contraception and Use contraception Use contraception and Use contraception and
Reproductive discontinue orlistat discontinue lorcaserin and discontinue discontinue naltrexone discontinue liraglutide
Potential should pregnancy occur should pregnancy occur phentermine/topiramate ER/bupropion ER should 3 mg should pregnancy
should pregnancy pregnancy occur occur
occur (perform monthly
pregnacy checks to
identify early pregnancy)
Breast-feeding Not recommended Not recommended Not recommended Not recommended Not recommended
Age ≥65 years * Limited data available Insufficient data Limited data available Insufficient data Limited data available
Alcoholism/ Might have abuse Insufficient data, though Avoid due to seizure
Addiction potential due to topiramate might exert risk and lower seizure
euphoria at high doses therapeutic benefits threshold on bupropion
Post-Bariatric Insufficient data Insufficient data Limited data available Insufficient data Data available at
Surgery 1.8 – 3.0 mg/day
* Use medications only with clear health-related goals in mind; assess patient for osteoporosis and sarcopenia.
Abbreviations: BP = blood pressure; CAD = coronary artery disease; CHF = congestive heart failure; HTN = hypertension; T2DM = Type 2 Diabetes Mellitus.
DIAGNOSIS AND MEDICAL MANAGEMENT OF OBESITY
DIAGNOSIS COMPLICATION-SPECIFIC STAGING AND TREATMENT

Anthropometric Clinical Component Disease Stage Chronic Suggested Therapy
Component Disease Phase (based on clinical judgment)
(BMI kg/m2) of Prevention
<25
<23 in certain ethnicties Normal • Healthy lifestyle:
waist circumference weight Primary healthy meal plan/
below regional/ (no obesity) physical activity
ethnic cutoffs
25–29.9 Evaluate for presence or Overweight Secondary • Lifestyle therapy:

absence of adiposity- stage 0 Reduced-calorie healthy meal
23–24.9 in certain
related complications plan/physical activity/
ethnicities (no complications)
and severity of behavioral interventions
complications
≥30 • Metabolic syndrome Obesity Secondary • Lifestyle therapy:
stage 0 Reduced-calorie healthy meal
≥25 in certain • Prediabetes
plan/physical activity/
ethnicities • Type 2 diabetes (no complications) behavioral interventions
• Dyslipidemia • Weight-loss medications:
• Hypertension Consider if lifestyle therapy fails
• Cardiovascular to prevent progressive weight
disease gain (BMI ≥27)
• Nonalcoholic fatty
≥25 liver disease Obesity Tertiary • Lifestyle therapy:
≥23 in certain • Polycystic ovary plan/physical activity/
ethnicties syndrome (1 or more behavioral interventions
• Female infertility mild to moderate
complications) • Weight-loss medications:
• Male hypogonadism Consider if lifestyle therapy fails
• Obstructive sleep to achieve therapeutic
apnea target or initiate concurrently
with lifestyle therapy (BMI ≥27)
• Asthma/reactive
airway disease
≥25 • Osteoarthritis Obesity Tertiary • Lifestyle therapy:
≥23 in certain • Urinary stress plan/physical activity/
ethnicties incontinence (at least 1 severe behavioral interventions
• Gastroesophageal complication)
• Add weight-loss medication:
reflux disease Initiate concurrently with
• Depression lifestyle therapy (BMI ≥27)
• Consider bariatric surgery:
(BMI ≥35)
a. All patients with BMI ≥25 have either overweight or obesity stage 0 or higher, depending on the initial clinical evaluation for presence and
severity of complications. These patients should be followed over time and evaluated for changes in both anthropometric and clinical diagnostic
components. The diagnoses of overweight/obesity stage 0, obesity stage 1, and obesity stage 2 are not static, and disease progression may warrant
more aggressive weight-loss therapy in the future. BMI values ≥25 have been clinically confirmed
to represent excess adiposity after evaluation for muscularity, edema, sarcopenia, etc.
b. Stages are determined using criteria specific to each obesity-related complication; stage 0 = no complication; stage 1 = mild to moderate;
stage 2 = severe.
c. Treatment plans should be individualized; suggested interventions are appropriate for obtaining the sufficient degree of weight loss generally
required to treat the obesity-related complication(s) at the specified stage of severity.
d. BMI ≥27 is consistent with the recommendations established by the US Food and Drug Administration for weight-loss medications.
Abbreviation: BMI = body mass index.

AACE OBESITY CARE MODEL
• Obesity care legislation

• Public health policy
HEALTHY BUILT ENVIRONMENT • Health messaging
• Promotes healthy lifestyle
• Payment reform
• Preventive care paradigm
REFORMED HEALTH
• Optimize drug pipeline
CARE SYSTEM • Education/research
• Patient access to therapy
• Decision support
• Self-management • Delivery system design
• Empanelment PREPARED • Informatics/registries
ACTIVATED
• Patient-team partner OBESITY • Leadership/behaviors
PATIENT
• Activated community PRACTICE • Continuity of care
• Access to information • Enhanced access to care
• Coordinated care
• Clinical research design

• Relevant metrics
IMPROVED POPULATION-BASED • Improved overall health
OUTCOMES • Economic outcomes
• Feedback to revise
Clinical Care Model
• Technology-driven
FUTURE INNOVATIONS • Outcome-driven

WEIGHT-LOSS MEDICATIONS APPROVED BY THE FDA FOR LONG-TERM TREATMENT OF OBESITY
Anti-obesity Mechanism of Action, Dose Common Side Effects Contraindications, Cautions, Monitoring and Comments
Medication Study Name, and Safety Concerns
(Trade Name) Study Duration: % TBWL  Contraindication
Year of FDA Approval Greater Than Placebo • Warning, Safety Concern
Orlistat Lipase inhibitor 120 mg PO TID (before • Steatorrhea  Pregnancy and breastfeeding Monitor for:
meals) • Fecal urgency  Chronic malabsorption syndrome • Cholelithiasis
XENDOS • Incontinence  Cholestasis • Nephrolithiasis
(XenicalTM)
OTC: 60 mg PO TID • Flatulence  Oxalate nephrolithiasis
(AlliTM) – OTC 1 yr: 4.0% (before meals) - Recommend standard multivitamin (to include vitamins A, D, E,
• Oily spotting • Rare severe liver injury
4 yr: 2.6% • Frequent bowel and K) at bedtime or 2 hours after orlistat dose
1999 • Cholelithiasis - Eating >30% kcal from fat results in greater GI side effects
movements • Malabsorption of fat-soluble vitamins
• Abdominal pain - FDA-approved for children ≥12 years old
• Effects on other medications: - Administer levothyroxine and orlistat 4 hours apart
• Headache • Warfarin (enhance)
• Anti-epileptics (decrease)
• Levothyroxine (decrease)
• Cyclosporine (decrease)
Lorcaserin Serotonin 10 mg PO BID • Headache  Pregnancy and breastfeeding Monitor for:

(5HT2c) receptor agonist • Nausea  Serotonin syndrome or • Symptoms of cardiac valve disease
(Belviq®) • Dizziness neuroleptic malignant syndrome • Bradycardia
BLOSSOM • Fatigue • Safety data lacking in patients who • Serotonin syndrome
BLOOM • Xerostomia have depression • Neuroleptic malignant syndrome
2012
• Dry eye • Concomitant use of SSRI, SNRI, MAOI, • Depression
1 yr: 3.0%-3.6% • Constipation bupropion, St. John’s wort as may • Severe mood alteration, euphoria, dissociative state
2 yr: 3.1% • Diarrhea increase risk of developing serotonin • Confusion/somnolence
• Back pain syndrome • Priapism
• Nasopharyngitis • Uncontrolled mood disorder • Leukopenia
• Hyperprolactinemia • Cognitive impairment • Euphoria at high doses could predispose to abuse
• Avoid in patients with severe liver • Hypoglycemia in patients having T2DM treated
injury or renal insufficiency with insulin and/or sulfonylureas
• Caution for patients with
bradycardia, heart block, or heart
failure
• Unproven concern for potential
cardiac valvulopathy
• Leukopenia
Phentermine/ NE-releasing agent Starting dose: • Headache  Pregnancy and breastfeeding Monitor for:
(phentermine) 3.75/23 mg PO QD • Paresthesia (topiramate teratogenicity) • Increased heart rate
Topiramate ER for 2 weeks • Insomnia  Hyperthyroidism • Depressive symptomatology or worsening
GABA receptor • Decreased bicarbonate  Acute angle-closure glaucoma depression especially on maximum dose
(Qsymia®) modulation (topiramate) Recommended dose: • Xerostomia  Concomitant MAOI use (within 14 days) • Hypokalemia (especially with HCTZ or furosemide)
7.5/46 mg PO QD • Constipation • Tachyarrhythmia • Acute myopia and/or ocular pain
2012 EQUIP • Nasopharyngitis • Decreased cognition • Acute kidney stone formation
CONQUER Escalation dose: • Anxiety • Seizure disorder • Hypoglycemia in patients having T2DM treated
SEQUEL 11.25/69 mg PO QD • Depression • Anxiety and panic attacks with insulin and/or sulfonylureas
• Cognitive impairment • Nephrolithiasis
1 yr: 8.6%-9.3% on Maximum dose: (concentration and - Potential for lactic acidosis (hyperchloremic non-anion gap) in
• Hyperchloremic metabolic acidosis combination with metformin
high dose; 6.6% on 15/92 mg PO QD memory) • Dose adjustment with hepatic or - MAOI (allow ≥14 days between discontinuation)
treatment dose • Dizziness renal impairment
• Nausea - 15 mg/92 mg dose should not be discontinued
• Concern for abuse potential abruptly (increased risk of seizure); taper over at least
2 yr: 8.7% on high dose; • Dysgeusia • Combined use with alcohol or
7.5% on treatment dose 1 week
depressant drugs can worsen cognitive - Health care professional should check ßHCG before
impairment initiating, followed by monthly self-testing at home
- Monitor electrolytes and creatinine before and during treatment
- Can cause menstrual spotting in women taking birth control
pills due to altered metabolism of estrogen and progestins
Anti-obesity Mechanism of Action, Dose Common Side Effects Contraindications, Cautions, Monitoring and Comments
Medication Study Name, and Safety Concerns
(Trade Name) Study Duration: % TBWL  Contraindication
Year of FDA Approval Greater Than Placebo • Warning, Safety Concern
Naltrexone ER/ Opiate antagonist Titrate dose: • Nausea  Pregnancy and breastfeeding Monitor for:
(naltrexone) • Headache  Uncontrolled hypertension • Increased heart rate and blood pressure
Bupropion ER Week 1: • Insomnia  Seizure disorder • Worsening depression or suicidal ideation
Reuptake inhibitor of DA 1 tab (8/90 mg) • Vomiting  Anorexia nervosa • Worsening of migraines
(Contrave®) and NE (bupropion) PO QAM • Constipation  Bulimia nervosa • Liver injury (naltrexone)
• Diarrhea  Severe depression • Hypoglycemia in patients having T2DM treated with
2014 COR-I Week 2: • Dizziness  Drug or alcohol withdrawal insulin and/or sulfonylureas
COR-II 1 tab (8/90 mg) • Anxiety  Concomitant MAOI (within 14 days) • Seizures (bupropion lowers seizure threshold)
COR-BMOD PO BID • Xerostomia  Chronic opioid use
- MAOI (allow ≥14 days between discontinuation)
• Cardiac arrhythmia - Dose adjustment for patients with renal and hepatic
1 yr: 4.2%-5.2% Week 3: • Dose adjustment for liver or
2 tabs (total 16/180 impairment
kidney impairment - Avoid taking medication with a high-fat meal
mg) PO QAM and 1 tab • Narrow-angle glaucoma
(8/90 mg) PO QHS - Can cause false positive urine test for amphetamine
• Uncontrolled migraine disorder - Bupropion inhibits CYP2D6
• Generalized anxiety disorder
Week 4: • Bipolar disorder
2 tabs (total 16/180 • Safety data lacking in patients who
mg) PO QHS have depression
• Seizures (bupropion lowers
seizure threshold)
Liraglutide 3 mg GLP-1 analog Titrate dose weekly • Nausea  Pregnancy and breastfeeding Monitor for:
by 0.6 mg as

• Vomiting  Personal or family history of medullary • Pancreatitis
SCALE Obesity & tolerated by patient • Diarrhea thyroid cancer or MEN2 • Cholelithiasis and cholecystitis
(Saxenda®)
Prediabetes (side effects): • Constipation  Pancreatitis • Hypoglycemia in patients having T2DM treated with
• Headache  Acute gallbladder disease insulin and/or sulfonylureas
2014
1 yr: 5.6% 0.6 mg SC QD🠚 • Dyspepsia • Gastroparesis • Increased heart rate
1.2 mg SC QD🠚 • Increased heart rate • Severe renal impairment can result • Dehydration from nausea/vomiting
1.8 mg SC QD🠚 from vomiting and dehydration • Injection site reactions
2.4 mg SC QD🠚 • Use caution in patients with
3.0 mg SC QD - Titrate dose based on tolerability (nausea and GI side effects)
history of pancreatitis
• Use caution in patients with cholelithiasis
• Suicidal ideation and behavior
• Injection site reactions
Abbreviations: BID = twice daily; CYP2D6 = cytochrome P450 2D6; DA = dopamine; FDA = US Food and Drug be discontinued.
Administration; GI = gastrointestinal; GLP-1 = glucagon-like peptide 1; HCTZ = hydrochlorothiazide; • For liraglutide 3 mg:
MAOI = monoxidase inhibitor; MEN2 = multiple endocrine neoplasia type 2; NE = norepinephrine; If the patient has not lost at least 4% of body weight 16 weeks after initiation, the medication
should OTC = over-the-counter medication; % TBWL = percent total body weight loss from baseline over that observed in be discontinued.
the placebo group; PO = oral; QAM = every morning; QD = daily; QHS = every bedtime; SC = subcutaneous;
SNRI = serotonin–norepinephrine reuptake inhibitor; SSRI = selective serotonin reuptake inhibitor; References:
TID = 3 times a day; T2DM = type 2 diabetes mellitus. 1–4 and package inserts for each medication
FDA indication for all medications: BMI >30 kg/m2 or BMI ≥27kg/m2 with significant comorbidity. 1. Wyatt HR. Update on treatment strategies for obesity. J Clin Endocrinol Metab. 2013;98(4):1299-1306.
2. Garvey WT, Garber AJ, Mechanick JI, Bray GA, Dagogo-Jack S, Einhorn D, et al. American Association of Clinical
After 3 to 4 months of treatment with anti-obesity medication: Endocrinologists and American College of Endocrinology position statement on the 2014 advanced framework
• For naltrexone ER/bupropion ER and lorcaserin: for a new diagnosis of obesity as a chronic disease. Endocr Pract. 2014;20(9):977-989.
If the patient has not lost at least 5% of their baseline body weight at 12 weeks on the maintenance dose, the 3. Yanovski SZ, Yanovski JA. Long-term drug treatment for obesity: a systematic and clinical review.
medication should be discontinued. JAMA. 2014;311(1):74-86.
• For phentermine/topiramate ER: 4. Fujioka K. Current and emerging medications for overweight and obesity in people with comorbidities.
Continue medication if the patient has lost >5% body weight after 12 weeks on recommended dose (7.5 mg/42 Diabetes Obes Metab. 2015;17(11):1021-1032.
mg); if the patient has not lost at least 3% of body weight after being on the recommended dose for 12 weeks
then the medication should be discontinued, or the patient can be transitioned to maximum dose (15 mg/92
mg); if patient has not lost at least 5% after 12 additional weeks on the maximum dose, the medication should
Appendix 3
AMERICAN ASSOCIATION OF CLINICAL
ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF
ENDOCRINOLOGY
OBESITY CHRONIC CARE MODEL
Obesity is a chronic disease that has become increasingly responsible for patient suffering and social costs worldwide.
The conceptualization of obesity as a lifestyle choice and primarily a cosmetic concern is not only debunked by scientific
evidence, but has failed our patients and our societies. With improved efficacy and an increased range of treatment
options, it is incumbent that the full force of our medical chronic care model (CCM) be brought to focus on obesity
prevention and treatment. This shift can only be achieved through activated health care systems, as well as regulatory and
legislative measures that ensure patient access to therapies of proven benefit. The American Association of Clinical
Endocrinologists (AACE) and the American College of Endocrinology (ACE) Comprehensive Clinical Practice Guidelines
for Medical Care of Patients with Obesity represent an evidence-based CCM that emphasizes weight-loss therapy directed
at the prevention and treatment of obesity-related complications. This clinical practice guideline (CPG) approaches obesity
as a chronic medical illness that is a source of morbidity, mortality, and compromised quality of life. The guidelines target
more aggressive treatment for patients with weight-related complications who benefit most from weight loss and as such,
optimize benefit/ risk ratios and cost-effectiveness (i.e., the “complications-centric” approach). The medical CCM
promulgated by these guidelines is not isolated but exists within the context of our larger health care system, communities,
governments, and societies. Therefore, a CCM for obesity must become an operational, integral component of the health
care system and be embraced by the larger society to optimally benefit patients in particular and public health in general.
Introduced in the 1990s, the general concept of the CCM for disease management was designed for primary care
practice settings and credited with improving clinical outcomes (1,2). The core aspiration is that patients become activated
and empowered, while health care systems become prepared and proactive. In general, there are 3 interrelated settings for
the CCM: community, health care system, and provider organization (private practice, health center, integrated system,
etc) (3). The 6 integrated components of the AACE/ACE Obesity CCM are as follows:
 Component 1: Built Environment (contextualization; community resources, laws, and policies; safe public
spaces for physical activity, lifestyle education, self-help, and socialization; and minimization of adverse
obesogenic drivers; includes home and workplace)
 Component 2: Healthcare System (recognition and prioritization of health promotion and obesity prevention,
with a favorable economic model [payment reform] that engages health care professionals [primary care and
specialists] and patients, while making comprehensive, evidence-based obesity care affordable and accessible)
 Component 3: Decision Support (creation and electronic implementation of evidence-based CPGs for
comprehensive, complications-centric obesity care)
 Component 4: Delivery System Design (creation and coordination of an obesity care team that is available for
routine patient encounters and oriented toward management of both acute and chronic issues; includes lifestyle,
pharmacotherapy, and bariatric procedures)
 Component 5: Clinical Information Systems (routine patient care, CPGs, interactive/feedback, and registries)
 Component 6: Self-Management Support (education, behavioral medicine, follow-up, and feedback regarding
obesity care; recognition by the patient of need for obesity prevention and care)
Effective integration of the components of this CCM is central to successful implementation and realization of
superior clinical outcomes in comprehensive, complications-centric obesity care. The specific processes for a
CCM have been described as building blocks (4) and are described here in the context of the AACE and ACE
Obesity CCM:
 Block 1: Engaged Leadership (commitment to transformative care and focus on health promotion, obesity
prevention, and comprehensive, complications-centric obesity management to improve patient health)
 Block 2: Data-Driven Improvement (evidence-based interventions and metrics; use of registries; properly
designed clinical trials)
 Block 3: Empanelment (linking patients with an obesity care team and primary care clinician; basis for
performance metrics)
 Block 4: Team-Based Care (team leaders [primary care physician, endocrinologist, or other obesity specialist
AND advanced practice professional] and support [nurse, registered dietitian, behaviorist, psychologist,
pharmacist, physical activity trainer, social worker, etc])
 Block 5: Patient-Team Partnership (empowered, activated patient with a prepared, proactive practice that is
empathetic and supportive; physician that promotes personal health behaviors; motivational interviewing, shared
decision-making, and trustworthy relationships)
 Block 6: Population-Based Care (routine health promotion and coaching with preventive services; use of
specialized teams for patients with specific weight-related complications; family-oriented care that addresses
childhood obesity; identification of relevant metrics [e.g., weight, body mass index, waist circumference, target
blood pressure, target lipids, target renal and liver function, symptom relief, performance, and reduction of
major adverse cardiac events])
 Block 7: Continuity of Care (linked to all blocks and necessary for effective CCM; requires payment reform)
 Block 8: Enhanced Access to Care (includes nights and weekends and adds capacity to meet demand; uses e-
visits, phone visits, group visits, telemedicine visits, efficient use of obesity team members, and payment
reform)
 Block 9: Comprehensive Coordinated Care (primary care, weight loss, weight-related complications, other
specialized care; accountability by primary care; includes outpatient, inpatient, and long-term care; infrastructure
for appointment logistics, transportation, interpretation, comfort and safety, electronic connectivity, and
information-sharing)
 Block 10: Alternative Encounters (payment reforms to drive and facilitate novel modalities for each of the
above blocks to optimize obesity care)
In conclusion, a contemporary AACE/ACE Obesity CCM focuses on an upstream approach (3) that promotes general
health and prevents obesity as a disease state while providing downstream comprehensive, complications-centric, disease
management. The CCM uses evidence-based treatment guidelines for obesity to define a concerted approach, which is
required to stem the increasing suffering and social costs of this disease. The above text, recommendations in the
Executive Summary, explanations and evidence base in Appendix 1, and the pictorial algorithm in Appendix 2 contribute
detail to the AACE/ACE Obesity CCM provided in Figure 1.
REFERENCES
1. Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness, parts 1 and 2. JAMA.
2002;288:1775-1779, 1909-1914.
2. Barr VJ, Robinson S, Marin-Link B, et al. The expanded chronic care model: an integration of concepts and strategies from
population health promotion and the chronic care model. Hosp Q. 2003;7:73-82.
3. Bodenheimer T, Willard-Grace R. The chronic care model and the transformation of primary care. In: Mechanick JI, Kushner
RF, eds. Lifestyle Medicine: A Manual for Clinical Practice. New York, NY: Springer International; 2016: 89-96.
4. Bodenheimer T, Ghorob A, Willard-Grace R, Grumbach K. The 10 building blocks of high-performing primary care. Ann
Fam Med. 2014;12:166-171.
Fig. 1. The AACE/ACE Obesity Chronic Care Model*
*See text for details.

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AACE/ACE Obesity CPG, Endocr Pract.

AACE/ACE ALGORITHM FOR THE MEDICAL CARE

• Medical history • Physical examination • Clinical laboratory

•Confirm that elevated BMI represents excess adiposity

pometric BMI kg/m2

Diagnosis Waist circumference below

STAGE 0 STAGE 1 STAGE 2

One or more mild- At least one severe

OVERWEIGHT BMI 25–29.9

• Healthy meal plan • Lifestyle/behavioral • Lifestyle/behavioral • Lifestyle/behavioral

Abbreviation: BMI = body mass index

ANTHROPOMETRIC COMPONENT OF THE MEDICAL DIAGNOSIS OF OBESITY

Screening Annual BMI

• BMI ≥25 kg/m2 • BMI <25 kg/m2

1. Clinical interpretation of BMI: Ensure elevated BMI is indicative of excess

Abbreviation: BMI = body mass index.

CLINICAL COMPONENT OF THE MEDICAL DIAGNOSIS OF OBESITY

Patients Present with Patients Present with

CHECKLIST OF WEIGHT-RELATED COMPLICATIONS:

Additional Evaluation Relevant to the Differential Diagnosis of Obesity

MEAL PLAN PHYSICAL ACTIVITY BEHAVIOR

WHEN TO INITIATE WEIGHT-LOSS MEDICATIONS IN PATIENTS WITH OVERWEIGHT/OBESITY

INITIATE WEIGHT LOSS MEDICATION AS AN

1. No Complications. 1. Failure to lose weight.

2. Mild to Moderate Complications. 2. Weight Regain on Lifestyle Therapy.

TREATMENT GOALS BASED ON DIAGNOSIS IN THE MEDICAL MANAGEMENT

DIAGNOSIS TREATMENT GOALS

T2DM 5-15% or more • Reduction in A1C

Dyslipidemia 5-15% or more • Lower triglycerides

Hypertension 5-15% or more • Lower systolic and diastolic BP

Nonalcoholic Steatosis 5% or more Reduction in intrahepatocellular lipid

Polycystic ovary syndrome 5-15% or more • Ovulation

Female infertility 10% or more • Ovulation

Male hypogonadism 5-10% or more Increase in serum testosterone

Obstructive sleep apnea 7-11% or more • Improved symptomatology

Asthma/reactive airway disease 7-8% or more • Improvement in forced expiratory

Osteoarthritis • ≥10% • Improved symptomatology

Urinary stress incontinence 5-10% or more Reduced frequency of incontinence

Gastroesophageal reflux disease 10% or more Improved symptomatology

Depression Uncertain • Improved symptomatology

PREFERRED WEIGHT-LOSS MEDICATIONS: INDIVIDUALIZATION OF THERAPY

MEDICATIONS FOR CHRONIC WEIGHT MANAGEMENT

Diabetes Prevention Insufficient data for Insufficient data for

DIAGNOSIS AND MEDICAL MANAGEMENT OF OBESITY

DIAGNOSIS COMPLICATION-SPECIFIC STAGING AND TREATMENT

25–29.9 Evaluate for presence or Overweight Secondary • Lifestyle therapy:

Abbreviation: BMI = body mass index.

AACE OBESITY CARE MODEL

• Obesity care legislation

• Clinical research design

200 AACE/ACE Obesity CPG, Endocr Pract. 2016;22(Suppl 3)

Lorcaserin Serotonin 10 mg PO BID • Headache  Pregnancy and breastfeeding Monitor for:

AACE/ACE Obesity CPG, Endocr Pract. 2016;22(Suppl 3) 201

Fig. 1. The AACE/ACE Obesity Chronic Care Model*

*See text for details.

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