Best Practices in Obesity Management: The Role of …...Best Practices in Obesity Management: The...

BestPracticesinObesityManagement: TheRoleofNewandEmergingTherapies

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Angela Golden DNP, FNP-C,

FAANP

Angela GoldenNovo Nordisk: Speaker and Advisory BureauHealth-Script (Orexigen): Speaker’s Bureau

Identify key recommendations and strategies from current clinical guidelines for the management of obesity

Compare the safety, efficacy, and pharmacokinetic profiles of anti-obesity medications

Identify best practices for selecting, initiating, and advancing appropriate pharmacological therapies for patient-specific management of obesity


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Obesity and its Consequences

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Adult Obesity: 2016

1. Ogd e n C e t a l . JAMA 2014;311:806-14. 2. F le ga l KM, e t a l . JAMA. 2016;315(21): 284-2291

Overweight or obesity affects 69% of adults ≥20 years1

Obesity affects ~35% adults ≥20 years1

Significant increase in Stage 3 obesity for women2

35

40

34

41

38

48

43

37

18

Male

Female

20-39

40-59

≥60

African American

Latino

Non-Hispanic White

Asian American

GENDERAGEETHNICITY

Percentage

F le ga l KM, e t a l . JAMA. 2016;315(21): 284-2291

Obesogenic Medications

PhysiologicEnvironmental

Genetic

Go ld e n A . Ob e si ty. In A . Ho l l ie r (Ed .) 2016:281-285

Lo ck e A , e t a l . Na ture . 2015; 518(7538):197-206

§ Heritable traits§ Chromosomal abnormalit ies

§ Endocrine disrupting chemicals§ Low macronutrient /high calorie

foods

§ Medications causing weight gain

§ Altered microbiome§ GI/CNS regulat ion of hunger +

satiety hormones

?GI, ga stro in te stina l ; CNS, ce n tra l ne rvo us syste m

The Complexity of Appetite Regulation

Die trich MO, e t al . Na t Re v Drug Disc. 2012;11(9):675-691Suzuk i K, et a l. Exp Dia b etes Re s. 2012;2012:824Murra y S, e t a l . Nat Rev Endo crino l. 2014;10:540-552

GLP-1 = glucagon-like peptide 1CCK = cholecystokininYY = peptide YYFFA = free fatty acidsAA = amino acids

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GABA = γ-aminobutyric acid, AgRP = agouti-related protein, NPY = neuropeptide, α-MSH = alpha-melanocyte-st imulat ing hormone, POMC = pro-opiomelanocortin, CART = cocaine and amphetamine-regulated transcript, MC4 = melanocort in 4 receptor

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The Complexity of Appetite Regulation

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Adaptive responses to weigh loss promotes

weight regain.

§ Fall in energy expenditure

§ Increase in appetite

§ Dysfunctional hormonal system

Physiology of Weight Regain

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A p o via n CM, et al . J Cl in Endo crino l Me tab 2015;100:342-62 Sumithra n P, et al . Ne w Eng l J Me d. 2011;365:1597-1604.

Body Mass Index (BMI) in kg/m2

Overweight Class 1 Obesity Class 2 Obesity Class 3 Obesity25-29.9 30-34.9 35-39.9 ≥40

≥35 w/comorbidit ies

Waist CircumferenceMen Abdominal Obesity Women Abdominal Obesity

>/ = 40 inches (>102 cm) >/ = 35 inches (>88cm)Waist circumference cut-points differ by ethnicity

Endocrine Society Pre-obesity: 26 kg/m2

Ga rve y WT, e t a l . End o cr Pra ct 2016;22 Sup p l 3:1-20

A p o via n CM, e t a l . J Cl in End o crino l Me ta b 2015;100:342-62.

Nonalcoholic fatty liver diseasePolycystic ovary syndromeFemale infertilityMale hypogonadismObstructive sleep apneaAsthmaOsteoarthritisDepression

Diabetes risk, metabolic syndrome, and prediabetesType 2 diabetesDyslipidemiaHypertensionCardiovascular disease and cardiovascular disease mortalityUrinary stress incontinence

Ga rve y WT, e t a l . End o cr Pra ct 2016;22 Sup p l 3:1-203; Ba ys HE , Se ge r JC, Prima ck C, McCa rth y W, Lo ng J, Sch mid t SL, Da n ie l S, We nd t J, Ho rn

DB, We stma n EC: Ob e si ty A lgo ri th m, p re se n te d b y th e Ob e si ty Me d icine A sso cia tio n . www.o b e si tya lgo ri th m.o rg. 2016-2017.

The adverse health consequences of increased body fat (especially visceral fat) are not just ‘comorbidities’ or ‘associated risk factors’.

Obesity is a

complex, multifactorial,

chronic disease

Obesity is defined as a chronic, relapsing, multi-factorial, neurobehavioral

disease, wherein an increase in body fat promotes adipose

tissues dysfunction and abnormal fat mass physical forces, resulting in adverse

metabolic, biomechanical, and psychosocial health

consequences.

Ba ys HE , Se ge r JC, Prima ck C, McCa rth y W, Lo ng J, Sch mid t SL, Da n ie l S, We nd t J, Ho rn DB, We stma n EC: Ob e si ty A lgo ri th m,

p re se n te d b y th e Ob e si ty Me d icine A sso cia tio n . www.o b e si tya lgo ri th m.o rg. 2016-2017.Je nse n MD, e t a l . Ci rcu la tio n 2014;129:S102-S138

Obesity is associated with a significant increase in mortality and many health

risks

The higher the BMI, the greater the risk of morbidity and mortality


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42 years oldWorks part-time as a bankerLives with her husband and 2 daughtersHas tried multiple times to lose weightTried phentermine in past for weight loss but did not tolerate the side effects (“felt jittery”)Has not reached her weight goal

How would you approach evaluation?

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g©ObesityActionCoalition

Ask Permission to discuss weight

Explore readiness for

change

Assess BMI, waist circumference, obesity stage

Explore drivers + complications

of excess weight

AdviseHealth risks of

obesity + benefits of weight loss

Long-term strategy + treatment options

Agree Expectations + targets

Behavioral changes

Assist Identify barriers to optimal

health

Create follow-up plan

V a l l is M, e t a l . Ca n F a m Physicia n 2013 59:27-31.

History: weight, activity, nutrition, family

• Complete blood count (CBC), fasting lipid panel, fasting glucose, HbA1c, liver function tests, vitamin D, thyroid stimulating hormone (TSH)

Laboratory studies

• Examples: sleep apnea, depressionAssess + treat obesity-related comorbidities

• Measure weight + height to calculate BMI • Waist circumference for patients w/ BMI >25kg/m2

• Blood pressure

Physical exam

Je nse n MD, e t a l . Circu la tio n 2014;129:S102-S138; Ga rve y WT, e t a l . End o cr Pra ct 2016;22 Sup p l 3:1-203

Sleep Apnea: intermittent use of CPAP

GERD: treated with protonix

Osteoarthritis both knees: takes intermittent ibuprofen

Reproductive barrier: IUD

Mild depression and anxiety: treated successfully with citalopram

ETOH: drinks socially—1 glass of wine/week. No illicit drugs.

No history of seizures, hypertension, heart disease, or pancreatitis

BMI 29 kg/m2

CMP, CBC,TSH noncontributory

TC= 245

LDL = 134

TG = 173

HgbA1C = 5.8

PHQ9 = 4

BMI, b o d y ma ss ind e x; CMP, co mp re h e nsive me ta b o l ic p a ne l ; CBC, co mp le te b lo o d co unt; TSH, th yro id stimu la ting h o rmo ne ; TC, to ta l ch o le ste ro l ;

LDL, lo w-d e nsi ty l ip o p ro te in ; TG, triglyce rid e s; Hb A 1c, glyca te d h e mo glo b in ; PHQ9, Pa tie n t He a l th Que stio nna ire

I ’ve tried to lose weight many, many times—at least 6 or 7. Sometimes I do lose weight, but I always gain it back again. I’m getting real

frustrated.

I’ve been overweight since I was 17. I’m always thinking about food, especially sweets and snacks. I find it hard to curb my cravings—instead of eating only a few chips, I usually end up eating the

whole bag.

© Obesi ty Action Coal i tio n


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What would you recommend as next steps in management?

Weight gain Regain

CravingsPrediabetes

DepressionGERD

Osteoarthritis

Best Practice Strategies

Similarities1-3

§ Individualized eating plans § Counseling patients to

increase physical activity§ Behavioral interventions § Medication may be

appropriate for some patients

§ Referral to an obesity specialist or surgery may be appropriate

New Focus

Differences1

Endocrine Society paradigm shift toward pharmacologictherapy over no therapy at all for patients:

§ With a history of unsuccessful weight lost and maintenance

§ Who meet label indications

1. A p o via n CM, e t a l . J Cl in End o crino l Me ta b 2015;100:342-62.

2. Ga rve y WT, e t a l . End o cr Pra ct 2016;22 Sup p l 3:1-203.3. Je nse n MD, e t a l . Circu la tio n 2014;129:S102-S138

Weight loss of 5%-10% of body

weight

Reduce obesity-associated

complications within 6 months

Improve patient health and quality

of life

Je nse n MD, e t a l . Circu la tio n 2014;129:S102-S138; Ga rve y WT, e t a l . End o cr Pra ct 2016;22 Sup p l 3:1-203.;Y a no vsk i SZ , e t a l . JAMA 2014;311:74-86; A p ovia n CM, e t a l. J Cl in End o crino lMe ta b 2015;100:342-62

Reduces sleep apnea, depression

Improves physical function

Reduces CVD risk factorsPrevents/delays T2DMImproves osteoarthrit is

Meal Plan Physical Activity BehaviorEnergy deficit ≥500kcal/day

Low-carbLow-fat

VolumetricHigh proteinVegetarian

MediterraneanDASH

Self-monitoringGoal settingEducation

Problem-solving strategies

Stimulus controlStress reduction

Counseling

Individualized

Increase leisure time physical

activity

Decrease sedentary time

↑ >150 mins/week on 3-5 separate

days

Je nse n MD, e t al . Ci rcu la tion 2014;129:S102-S138.Ga rve y WT, e t a l . End ocr Pract 2016;22 Supp l3:1-203.Mo za ffa ria n D. Circu la tion . 2016 Ja n ;133(2):187-225. *Alone or with adjunctive therapies

Track progress:Daily activity logsPedometer logs

Training metrics


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Applications to log nutrition and physical activity

Body-weight scales w/feedback

Wearable technology

Websites

Social media

Do b k in BH. Curr Op in Ne uro l 2013 26:602-608. Ch o u WY , e t a l . Tra nsl Be ha v Me d 2014 4:314-323. Ja k icic J, e t a l . JAMA 2016;316:1161-1171 © Obesi ty Action Coal i tio n

Explore readiness to change

Continue lifestyle therapy

Agree on weight loss goal of 5-7% of Pamela’s

current weight

Consensus to discuss medication options

Think:Motivational Interviewing & Shared Decision Making

A. Orlistat (Alli, Xenica)B. Phentermine/topiramate (Qsymia)C. Naltrexone/bupropion (Contrave)D. Phentermine (Adipex)E. Liraglutide (Saxenda)F. Lorcaserin (Belviq, Belviq XR)

Therapy Options, Factors to Consider When Selecting Therapy, and Efficacy/Safety Evidence

h ttp s://d a i lyme d .n lm.n ih .go v/d a i lyme d /ind e x.cf m; Bra y GA , e t a l . Circu la tio n 2012;125:1695-703

A p o via n CM, e t a l . J Cl in End o crino l Me ta b 2015;100:342-62

Generic Drug* Dose Contraindications Side Effects

Phentermine 8mg-37.5mg Anxiety disorder, CVD, hypertension, MAO inhibitors, glaucoma, hyperthyroidism, seizures,pregnancy/breastfeeding,drug abuse history

Insomnia, palpitat ions, tachycardia, dry mouth, taste alterat ions, dizziness, tremors, headache, diarrhea, constipation, vomit ing, gastrointest inal distress, anxiety, rest lessness, increased blood pressure

Diethylpropion 25 mg or 75 mg, SR

Phendimetrazine 17.5-70 mg or 105 mg, SR

Benzphetamine 25-50 mg

*Me ch a n ism o f a ctio n = Symp a th o mime tic—

no ra d re ne rgic ca using a p p e ti te sup p re ssio n

US Drug Enforcement Agency scheduled drugRisk for addiction

Not indicated for long term use 13 weeks by label

Endocrine Society allows for possible long term use:

§ No CVD § No psychiatric/substance abuse history§ Has been informed about therapies that are approved for long-term use § Document off-label use in patient’s medical record§ No clinical significant increase in pulse/BP when taking phentermine§ Demonstrates significant weight loss with phentermine§ Start at 7.5 or 15 mg/d—dose escalate if not achieving significant weight

loss§ Monitor monthly during dose escalat ion

A p o via n CM, e t a l . J Cl in End o crino l Me ta b 2015;100:342-62


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h ttp s://d a i lyme d .n lm.n ih .go v/d a i lyme d /ind e x.cf m

Generic Drug Mechanism of ActionOrlistat (oral) Pancreatic lipase inhibitor—impairs

gastrointestinal energy absorption, causing excretion of approximately 30% of ingested triglycerides in stool

Lorcaserin(oral)

Highly selective serotonergic 5-HT2C receptor agonist causing appetite suppression

Phentermine/ topiramate-ER (oral)

Noradrenergic + GABA-receptoractivator, kainite/AMPA glutamate receptor inhibitor causing appetite suppression

Liraglutide✝(subcuta neo us injection)

GLP-1 receptor agonist

Naltrexone SR/bupropion Opioid receptor antagonist; dopamine and noradrenaline reuptake inhibitor

Therapy Length of Trial Total WeightLoss

Mean Weight Loss

Orlistat ≥1 year -5.3 kg -6.1%

Lorcaserin 1 year -5.8 kg -5.8%

Phentermine/topiramate ≥1 year -10.2 kg - 9.8%

Bupropion/naltrexone ≥1 year -6.1 kg -5.4%

Liraglutide* ≥1 year -8.4kg -8.0%

Le Bla nc E , e t a l . Ann In te rn Me d 2011;155:434; V i lsb ø l l T, e t a l . BMJ 2012;344:d 7771 ; Bra y GA , e t a l . L a nce t 2016;387:1947-56

*Pi -Sunye r X , e t a l . Ne w Eng l J Me d 2015; 373: 11-22


Pharmacologic interventions may be helpful as adjuvant therapy with lifestyle interventions for patients with BMI ≥30

kg/m2 or ≥27 kg/m2 with comorbidities.

§ Different patients respond to different medications- I f one option does not work, consider others

§ Discontinue medication in patients who do not respond with weight loss of at least 5% at 12 weeks

§ Avoid in pregnancy - Pregnancy tests at baseline- Consider a disclosure signature

Safety

Co-morbidit ies

Patienthistory

Cost + insurance

Side effects


Dose Frequency

Efficacy Side Effects Contraindications

60 mg OTC

120 mg TID within 1 h of fat-containing meal

§ Mean weight loss ranged from 3.9%-10.2% at year 1 in 17 RCTs (120mg TID)

§ ↓ BP, TC, LDL-C, fasting glucose at 1 year

§ Slows risk of progression to T2DM

Oily spotting, cramps, flatus with discharge, fecal urgency, fatty oily stool, increased defecation, fecalincontinence

Chronic malabsorption syndrome, pregnancy,breastfeeding, cholestasis, some medications (ex. warfarin, antiepileptic agents, levothyroxine, cyclosporine)

Practical Considerations

§ Consider fat-soluble mult ivitamin§ Limit fat intake to 30% of calories§ Counsel on risk of GI adverse events

Le xico mp

Bra gg R, e t a l . J Am Asso c Nurse Pra ct 2016;28:107-15; Ka h a n S. Am J Ma na g Ca re . 2016;22:S186-S196

Dose Frequency Efficacy Contraindications Side Effects

§ Init iate treatment at 3.75 mg/23 mg for 2 weeks

§ Increase to 7.5 mg/46 mg

§ Escalate to 11.25mg/69mg for 2 weeks then to max 15 mg/92 mg

§ 10% weight loss with treatment vs 2% placebo

§ Improved cardiometabolicmarkers

§ Reducedprogression to T2DM

Pregnancy and breastfeeding, hyperthyroidism, glaucoma, use of monoamine oxidase inhibitors

Paresthesiasdizziness, taste alterat ions,insomnia, constipation,dry mouth, elevation in heart rate, memory or cognit ive changes

Practical Considerations§ Titrate dose at initiation and discontinuation § Drug Enforcement Agency Schedule IV drug § Risk Evaluation and Mitigation Strategy § Counsel about risk for mood disorders, suicidal thoughts§ Taper highest dose every other day for 1 week if discontinuation is

necessaryLe xico mp



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§ Weekly titration by 0.6mg over 5 weeks to target dose of3.0mg

§ Mean weight loss 9% at 1 year

§ Reduced progression to T2DM in patients with prediabetes

§ Reduced risk of weight regain at 1 year

Medullary thyroid cancer history, multiple endocrine neoplasia type 2 history, history of pancreatitis,pregnancy, breastfeeding

Nausea, vomiting, diarrhea, constipation, hypoglycemia in patients with T2DM, increased lipase, increased heart rate, pancreatitis

Practical Considerations§ Injectable administration§ FDA approved for use in adults with BMI > 30kg/m2 or BMI > 27

kg/m2 with at least one complication.§ Risk Evaluation and Mitigation Strategy (medullary thyroid

carcinoma, acute pancreatitis)

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10 mg twice daily

ER 20mg daily

§ Average weight loss 8%-10%

§ Improvedcardiovascular risk factors

§ Improved HbA1c in patients with T2DM

§ Reduced risk of developing T2Dm in patients with prediabetes

Pregnancy, breastfeeding

Caution withserotoninergic agents (due to risk of serotonin syndrome)

Avoid in patients w/severe hepatic or renal insufficiency, valvular heart disease

Headache, dizziness, fat igue, nausea, dry mouth, cough, and constipation

Patients w/T2DM, back pain, cough, hypoglycemia

Practical Considerations§ Schedule IV Drug§ ER is slowly absorbed and lasts throughout the day§ Independent effect on lowering HgbA1c

Le xico mp



§ Initiate8mg/90mg x 1 week

§ Weekly escalation to target dose of 32mg/360 mg (2 tablets BID)

§ Weight loss of 8.2% vs 1.4% (placebo)

§ Improvedcardiometabolicparameters

§ Fewer cravings§ Lowered HbA1c

in patients with T2DM

Uncontrolled hypertension, seizure disorder, anorexia or bulimia, drug or alcohol withdrawal, chronic opioid use, monamine oxidase inhibitors

Nausea, constipation, headache, dizziness, vomiting, insomnia, dry mouth

Transient increase in blood pressurePractical Considerations

§ Titrate dose on initiation§ Monitor blood pressure § Monitor closely for depression

Le xico mp


At week 16 (includes titration period) Pamela has lost 2% of her baseline weight and her HbA1c remains 5.8%.

What would be your next management step?

•Initiate 8mg/90mg x 1 week•Escalate to target dose of 32mg/360 mg•Weekly follow up monitoring

Begin therapy with naltrexone-bupropion

•≥5% of baseline body weight at 3 monthsEffective response to therapy

•5%-10% overall reduction of risk for T2DM, HTN, CVD

Improvement in cardiovascular risk

markers

If no clinical improvement after 12 weeks with one anti-obesity medication, consider:

Increasing anti-obesity medication dose, if

applicable

Alternative anti-obesity medicationOR

Bra y GA , e t a l . La nce t 2016;387:1947-56. A p o via n CM, e t a l . J Cl in End o crino l Me ta b 2015;100:342-62.


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LORCASERIN? •No history of CVD but

borderline high LDL/TC•Caution w/SSRI•Monitor for depression

LIRAGLUTIDE?•HbA1c remains elevated•No family history of thyroid or

pancreatitis

1. A p o via n CM, e t a l . J Cl in End o crino l Me ta b 2015;100:342-62.2. Th o ma s JG, e t a l . Am J Pre v Me d . 2014;46(1):17-23

Weight regain typically occurs when medication is stopped1

•Self-monitoring•Weight loss of >2kg in 4 weeks•Frequent/regular attendance at weight loss program•Self-belief that weight can be controlled

Successful weight maintenance includes:2

Maintaining weight loss is made difficult by the reduction in energy expenditure that weight loss induces

Weight loss <5% at 3 months with approved medication

Safety or tolerability issues

Patient-centered concerns

A p o via n CM, e t a l . J Cl in End o crino l Me ta b 2015;100:342-62. Je nse n MD, e t a l . Circu la tio n 2014;129:S102-S138.

A p o via n CM, e t a l . J Cl in End o crino l Me ta b 2015;100:342-62 Rub ino F , e t a l . Dia b Ca re 2016;39:861-877

BMI ≥40 kg/m2 if surgical risk is acceptable

BMI ≥35 kg/m2 if >1 obesity-related disease

BMI 30-34.9 kg/m2 for T2DM and/or metabolic syndrome

Inability to achieve + sustain healthy weight loss with prior weight loss efforts

She has visited 10 times in 6 months for intensive behavioral

therapy and monitoring.


ü Lost 8% baseline weightü HbA1c = 5.4%ü Sleep apnea is minimalü No longer requires ibuprofen for osteoarthritisü Walking 10,000 steps/day, 5 days/weekü Hiking with friends on weekendsü Signed up for a charity 5K

Provider F/Uü Close follow-upü Continue to prescribe medication with lifestyleü Pregnancy prevention planü Close follow-up


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A d a p te d fro m h ttp ://www.o b e si tyne two rk .ca /5A s

Obesity is a chronic and often progressive condition

Obesity management is not about simply reducing numbers on the scale

Early intervention means addressing root causes and removing roadblocks

Success is different for every individual

A patient’s ‘best’ weight may never be an ‘ ideal’ weight

NO SHAME, NO BLAME

Diabetes Prevention Program1 LOOK AHEAD3

1. Kno wle r WC, e t a l . N Engl J Me d . 2002;346(6):393.

2. Dia b e te s Pre ve n tio n Pro gra m Re se a rch Gro up . L a nce t Dia b e te s End o crino l . 2015 3(11):866-75. 3. Lo o k A HEA D Re se a rch Gro up . Ob e si ty. 2014;22:5-13

§ Multi-center trial in patients with impaired glucose tolerance

§ Weight loss of 7% reduced the rate of progression from impaired glucose tolerance to diabetes by 5%

§ Reduced risk factors for CVD over 15 years2

§ 5145 ethically diverse overweight/obese adults w/T2DM

§ Year 1 : 5% weight loss in 68% who received intensive lifestyle counseling vs 13.3% who received usual care

§ Year 8 : 5% weight loss in 50.5% who received intensive lifestyle counseling vs 35.7% who received usual care

Self-monitoring e.g., food diaries

Controlling or modifying the stimuli that activate eatingSlowing down the eating processGoal-setting

Behavioral contracting and reinforcementNutrition education and meal planningModification of physical activitySocial supportCognitive restructuringProblem-solving

Je nse n MD, e t a l . Circu la tio n 2014;129:S102-S138.


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38 behavioral treatment trials

Average baseline BMI: 31.9 kg/m2

Overweight adults with 12-26 intervention sessions in year 1 lost 6% baseline weightControl groups lost little or no weight

Le Bla nc E , e t a l . Ann In te rn Me d 2011;155:434.

Patient education sessions:

§ Healthy diet choices§ Physical activity§ Weight loss goals§ Barriers to weight loss

Regular weight checks

Peer support

AntihistaminesSteroidsHypoglycemic agentsEstrogensBeta blockersCalcium channel blockers

Some antidepressantsAnticonvulsants/mood stabilizersMigraine medicationsAtypical antipsychoticsHIV medicationsChemotherapy

Do me cq JP, e t a l . J Cl in End o crino l Me ta b . 2015;100:363-70. h ttp ://d x.d o i .o rg/10.1210/jc.2014-3421#sth a sh .sT2 TK9 LY .d p u f

Indications Contraindications Side Effects Monitoring/Administration

Short-term adjunct to comprehensive regimen in management of exogenous obesity with initial BMI ≥30 kg/m2 or ≥27 kg/m2 in the presence of other risk factors (eg, diabetes, hyperlipidemia, controlled hypertension).

H istory of CVD, uncontrolled hypertension, during or within 14 days of using MAO inhibitors, glaucoma, agitated states, pregnancy,breastfeeding, drug abusehistory, known hypersensitivity, or idiosyncrasy to the sympathomimetic amines.

Not recommended for use in pediatric patients ≤16 years.

Cardiac: Pulmonaryhypertension and/or regurgitant cardiac valvulardisease, palpitation, tachycardia, elevated blood pressure, ischemic events, CNS: overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosisGI: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbancesOther: urticaria, impotence, libido changes

Dosage should be individualized to obtain an adequate response with the lowest effective dose.

The usual adult dose is 1 tablet TID ½ hour before meals.

Tablet is scored to facilitate administering one half of the usual dosage for patients not requiring the full dose.

Caution patients about potential to impair ability to operate machinery or drive a vehicle.

h ttp s://d a i lyme d .n lm.n ih .go v


Obesity management, including weight loss and weight maintenance, when used in conjunction with a reduced-calorie diet; to reduce the risk for weight regain after prior weight loss.



BMI, calorie/fat intake; serum glucose in patients with diabetes; thyroid function in patient with thyroid disease; liver function tests in patients exhibiting symptoms of hepatic impairment; renal function in patients at risk for renal impairment.

Le xico mp

Bra gg R, e t a l . J Am Asso c Nurse Pra ct 2016;28:107-15


Adjunct to comprehensive regimen in management of exogenous obesity with init ial BMI ≥30 kg/m2 or ≥27 kg/m2 in the presence of at least weight-related comorbidity.

Pregnancy and breastfeeding, hyperthyroidism, glaucoma, during/within 14 days of taking monoamine oxidase inhibitors

Paresthesias dizziness, taste alterat ions,insomnia, constipation,dry mouth, elevation in heart rate, memory or cognit ive changes

Seizure frequency, hydration status, electrolytes, serum creatinine, symptoms of acute acidosis, ammonia level in patients with unexplained lethargy, vomit ing, or mental status changes; intraocular pressure, suicidality, weight + eating behaviors in patients with eating disorder symptoms/risk factors

h ttp s://d a i lyme d .n lm.n ih .go v. Bra gg R, e t a l . J Am Asso c Nurse Pra ct 2016;28:107-15

Risk Evaluation and Mitigation Strategy


Adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of ≥30 kg/m2 or ≥27 kg/m2 in the presence of at least one weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, and/or dyslipidemia)



Transient increase in blood pressure

Blood pressure and heart rate; blood glucose; weight; BMI; renal and liver function; mental status for depression, suicidal ideation, anxiety, social functioning, mania, and panic attacks.



12


Chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity, in adults with either an initial body mass index (BMI) of ≥30 kg/m2 or an initial BMI of ≥27 kg/m2 and at least one weight-related comorbid condition (eg, hypertension, dyslipidemia, type 2 diabetes).




Headache, dizziness, fatigue, nausea, dry mouth, cough, and constipation


Weight, waist circumference; CBC; blood glucose (if diabetes); prolactin; depression and/or suicidal thoughts/behavior; signs/symptoms of SS/NMS-like reaction; signs/symptoms of valvular heart disease (dyspnea, dependent edema)

h ttp s://d a i lyme d .n lm.n ih .go v Bra gg R, e t a l . J Am Asso c Nurse Pra ct 2016;28:107-15


As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial BMI of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least 1 weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, dyslipidemia)



Plasma glucose, HbA1c, renal function; signs/symptoms of pancreatitis; emergence of worsening depression, suicidal thoughts/behavior, changes in behavior; heart rate; body weight (at week 16 when used for chronic weight management)

h ttp s://d a i lyme d .n lm.n ih .go v. Bra gg R, e t a l . J Am Asso c Nurse Pra ct 2016;28:107-15; Ka h a n S. Am J Ma na g Ca re . 2016;22:S186-S196


Drug Advantages DisadvantagesPhentermine → Inexpensive

→Weight loss >3-5%→Side effect profile→No long-term data

Toperimate/phentermine →Weight loss >5%→ Long-term data

→ Expensive→ Teratogen

Lorcaserin →Side effect profile→ Long-term data

→ Expensive→Weight loss 3-5%

Orlistat

Orlistat OTC

→Nonsystemic→ Long-term data→ Inexpensive

→Weight loss 2-3%→Side effect profile

Natrexone/bupropion →Weight loss 3-5%→ Food addiction→ Long-term data

→Side effect profile→Mid-level price range

Liraglutide →Side effect profile→ Long-term data

→ Expensive→ Injectable


Apovian CM, Aronne LJ, Bessesen DH, et al. Pharmacological management of obesity: an endocrine Society clinical pract ice guideline. J Clin Endocrinol Metab. 2015;100(2):342-362.Bays HE, Seger JC, Primack C, McCarthy W, Long J, Schmidt SL, Daniel S, Wendt J, Horn DB, Westman EC: Obesity Algorithm, presented by the Obesity Medicine Associat ion. www.obesityalgorithm.org. 2016-2017.Bragg R, Crannage E. Review of pharmacotherapy options for the management of obesity. J Am Assoc Nurse Pract. 2016;28(2):107-115.Bray GA, Fruhbeck G, Ryan DH, Wilding JP. Management of obesity. Lancet. 2016;387(10031):1947-1956.Bray GA, Ryan DH. Medical therapy for the patient with obesity. Circulat ion. 2012;125(13):1695-1703.Chou W-yS, Prest in A, Kunath S. Obesity in social media: a mixed methods analysis. Translat ional Behavioral Medicine. 2014;4(3):314-323.Dietrich MO, Horvath TL. Limitat ions in anti-obesity drug development: the crit ical role of hunger-promoting neurons. Nat Rev Drug Discov. 2012;11(9):675-691.Dobkin BH. Wearable motion sensors to continuously measure real-world physical act ivit ies. Current Opinion in Neurology. 2013;26(6):602-608.Flegal KM, Kruszon-Moran D, Carroll MD, et al. Trends in Obesity Among Adults in the United States, 2005 to 2014. JAMA. 2016;315(21):2284-2291.Garvey WT, Mechanick JI, Brett EM, et al. American Associat ion of Clinical Endocrinologists and American College of Endocrinology Comprehensive Clinical Pract ice Guidelines for Medical Care of Patients with Obesity. Endocr Pract. 2016;22 Suppl 3:1-203.

Golden A. Obesity. In A. Hollier (Ed.), Clinical Guidelines in Primary Care . pp. 281-285, 2016.Jakicic J, Davis KK, Rogers RJ et al. Effect of wearable technology combined with a lifestyle intervention on long-term weight loss: The IDEA randomized controlled trial. JAMA. 2016;316(11):1161-1171.Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults. Circulat ion. 2014;129(25 suppl 2):S102-S138.Kahan SK. Overweight and Obesity Management Strategies. Am J Manag Care 2016;22:S186-S196.LeBlanc E, O’Connor E, Whit lock EP, et al. Effect iveness of primary care-relevant treatments for obesity in adults: A systemic evidence review for the US Preventive Services Task Force. Ann Intern Med. 2011;155(7):434Locke AE, Kahali B, Berndt SI, et al. Genetic studies of body mass index yield new insights for obesity biology. Nature. 2015;518(7538):197-206.Mozaffarian D. Dietary and Policy Priorit ies for Cardiovascular Disease, Diabetes, and Obesity: A Comprehensive Review. Circulat ion. 2016;133(2):187-225.Murray S, Tulloch A, Gold MS, Avena NM. Hormonal and neural mechanisms of food reward, eating behaviour and obesity. Nat Rev Endocrinol. 2014;10(9):540-552.

Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014;311(8):806-814.Rubino F, Nathan D, Eckel RH, et al. Metabolic Surgery in the Treatment Algorithm for Type 2 Diabetes: A Joint Statement by International Diabetes Organizations. Diab Care. 2016;39(6):861-877.Sumithran P, Prendergast LA, Delbridge E, et al. Long-Term Persistence of Hormonal Adaptations to Weight Loss. New England Journal of Medicine. 2011;365(17):1597-1604.Suzuki K, Jayasena CN, Bloom SR. Obesity and Appetite Control. Experimental Diabetes Research. 2012;2012:824305Vallis M, Piccinini–Vallis H, Sharma AM, FreedhoffY. Modified 5 As: Minimal intervention for obesity counseling in primary care. Canadian Family Physician. 2013;59(1):27-31.Vilsboll T, Christensen M, Junker AE, et al. Effects of glucagon-like peptide-1 receptor agonists on weight loss: systematic review and meta-analyses of randomised controlled trials. BMJ. 2012;344:d7771.Yanovski SZ, Yanovski JA. Long-term drug treatment for obesity: a systematic and clinical review. JAMA. 2014;311(1):74-86.


13

Without Background

Diabetes Prevention Program1 LOOK AHEAD3

1. Kno wle r WC, e t a l . N Engl J Me d . 2002;346(6):393.

2. Dia b e te s Pre ve n tio n Pro gra m Re se a rch Gro up . L a nce t Dia b e te s End o crino l . 2015 3(11):866-75. 3. Lo o k A HEA D Re se a rch Gro up . Ob e si ty. 2014;22:5-13

§ Multi-center trial in patients with impaired glucose tolerance

§ Weight loss of 7% reduced the rate of progression from impaired glucose tolerance to diabetes by 5%

§ Reduced risk factors for CVD over 15 years2

§ 5145 ethically diverse overweight/obese adults w/T2DM

§ Year 1 : 5% weight loss in 68% who received intensive lifestyle counseling vs 13.3% who received usual care

§ Year 8 : 5% weight loss in 50.5% who received intensive lifestyle counseling vs 35.7% who received usual care

Self-monitoring e.g., food diaries

Controlling or modifying the stimuli that activate eatingSlowing down the eating processGoal-setting

Behavioral contracting and reinforcementNutrition education and meal planningModification of physical activitySocial supportCognitive restructuringProblem-solving

Je nse n MD, e t a l . Circu la tio n 2014;129:S102-S138.

38 behavioral treatment trials

Average baseline BMI: 31.9 kg/m2

Overweight adults with 12-26 intervention sessions in year 1 lost 6% baseline weightControl groups lost little or no weight

Le Bla nc E , e t a l . Ann In te rn Me d 2011;155:434.

Patient education sessions:

§ Healthy diet choices§ Physical activity§ Weight loss goals§ Barriers to weight loss

Regular weight checks

Peer support

AntihistaminesSteroidsHypoglycemic agentsEstrogensBeta blockersCalcium channel blockers

Some antidepressantsAnticonvulsants/mood stabilizersMigraine medicationsAtypical antipsychoticsHIV medicationsChemotherapy

Do me cq JP, e t a l . J Cl in End o crino l Me ta b . 2015;100:363-70. h ttp ://d x.d o i .o rg/10.1210/jc.2014-3421#sth a sh .sT2 TK9 LY .d p u f


Short-term adjunct to comprehensive regimen in management of exogenous obesity with initial BMI ≥30 kg/m2 or ≥27 kg/m2 in the presence of other risk factors (eg, diabetes, hyperlipidemia, controlled hypertension).

H istory of CVD, uncontrolled hypertension, during or within 14 days of using MAO inhibitors, glaucoma, agitated states, pregnancy,breastfeeding, drug abusehistory, known hypersensitivity, or idiosyncrasy to the sympathomimetic amines.

Not recommended for use in pediatric patients ≤16 years.

Cardiac: Pulmonaryhypertension and/or regurgitant cardiac valvulardisease, palpitation, tachycardia, elevated blood pressure, ischemic events, CNS: overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosisGI: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbancesOther: urticaria, impotence, libido changes

Dosage should be individualized to obtain an adequate response with the lowest effective dose.

The usual adult dose is 1 tablet TID ½ hour before meals.

Tablet is scored to facilitate administering one half of the usual dosage for patients not requiring the full dose.

Caution patients about potential to impair ability to operate machinery or drive a vehicle.

h ttp s://d a i lyme d .n lm.n ih .go v


14


Obesity management, including weight loss and weight maintenance, when used in conjunction with a reduced-calorie diet; to reduce the risk for weight regain after prior weight loss.



BMI, calorie/fat intake; serum glucose in patients with diabetes; thyroid function in patient with thyroid disease; liver function tests in patients exhibiting symptoms of hepatic impairment; renal function in patients at risk for renal impairment.

Le xico mp

Bra gg R, e t a l . J Am Asso c Nurse Pra ct 2016;28:107-15


Adjunct to comprehensive regimen in management of exogenous obesity with init ial BMI ≥30 kg/m2 or ≥27 kg/m2 in the presence of at least weight-related comorbidity.

Pregnancy and breastfeeding, hyperthyroidism, glaucoma, during/within 14 days of taking monoamine oxidase inhibitors

Paresthesias dizziness, taste alterat ions,insomnia, constipation,dry mouth, elevation in heart rate, memory or cognit ive changes

Seizure frequency, hydration status, electrolytes, serum creatinine, symptoms of acute acidosis, ammonia level in patients with unexplained lethargy, vomit ing, or mental status changes; intraocular pressure, suicidality, weight + eating behaviors in patients with eating disorder symptoms/risk factors




Adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of ≥30 kg/m2 or ≥27 kg/m2 in the presence of at least one weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, and/or dyslipidemia)



Transient increase in blood pressure

Blood pressure and heart rate; blood glucose; weight; BMI; renal and liver function; mental status for depression, suicidal ideation, anxiety, social functioning, mania, and panic attacks.



Chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity, in adults with either an initial body mass index (BMI) of ≥30 kg/m2 or an initial BMI of ≥27 kg/m2 and at least one weight-related comorbid condition (eg, hypertension, dyslipidemia, type 2 diabetes).




Headache, dizziness, fatigue, nausea, dry mouth, cough, and constipation


Weight, waist circumference; CBC; blood glucose (if diabetes); prolactin; depression and/or suicidal thoughts/behavior; signs/symptoms of SS/NMS-like reaction; signs/symptoms of valvular heart disease (dyspnea, dependent edema)

h ttp s://d a i lyme d .n lm.n ih .go v Bra gg R, e t a l . J Am Asso c Nurse Pra ct 2016;28:107-15


As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial BMI of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least 1 weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, dyslipidemia)



Plasma glucose, HbA1c, renal function; signs/symptoms of pancreatitis; emergence of worsening depression, suicidal thoughts/behavior, changes in behavior; heart rate; body weight (at week 16 when used for chronic weight management)

h ttp s://d a i lyme d .n lm.n ih .go v. Bra gg R, e t a l . J Am Asso c Nurse Pra ct 2016;28:107-15; Ka h a n S. Am J Ma na g Ca re . 2016;22:S186-S196


Drug Advantages DisadvantagesPhentermine → Inexpensive

→Weight loss >3-5%→Side effect profile→No long-term data

Toperimate/phentermine →Weight loss >5%→ Long-term data

→ Expensive→ Teratogen

Lorcaserin →Side effect profile→ Long-term data

→ Expensive→Weight loss 3-5%

Orlistat

Orlistat OTC

→Nonsystemic→ Long-term data→ Inexpensive

→Weight loss 2-3%→Side effect profile

Natrexone/bupropion →Weight loss 3-5%→ Food addiction→ Long-term data

→Side effect profile→Mid-level price range

Liraglutide →Side effect profile→ Long-term data

→ Expensive→ Injectable


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