WEIGHT MANAGEMENT: A TEAM APPROACHCrystal Whitman, PharmD, BCACPAleda E. Lutz VA Medical CenterSaginaw, MI

OBJECTIVES1. Evaluate the current guidelines for the

management of overweight and obesity in adults.

2. Identify the components of a high-intensity, comprehensive-lifestyle intervention program.

3. Review treatment options that may aid patients in their weight loss goals.

CASE 1 MK is a 32 y.o. hispanic female with body mass

index (BMI) of 32. She has a diagnosis of hypertension (HTN) and hypothyroidism. She discusses her and her spouse’s desire to become pregnant within the next year and her frustrations with her current weight. She reports ‘trying really hard at home’ without success. What is your recommendation?

A. phenteramine/topiramate (Qsymia)B. diethylpropionC. a comprehensive lifestyle intervention

programD. bariatric surgery

WHAT DO WE KNOW?

Obesity and overweight

increase the risk of morbidity from

HTN

Dyslipidemia

Type 2 diabetes (T2DM)

Coronary heart

disease (CHD)

StrokeGallbladder disease

Osteoarthritis

Sleep apnea & respiratory

problems

Cancer: endometrial,

breast, prostate, and colon

Obesity Trends* Among U.S. AdultsBRFSS, 1990, 2000, 2010

(*BMI 30, or about 30 lbs. overweight for 5’4” person)

No Data <10% 10%–14% 15%–19% 20%–24% 25%–29% ≥30%

www.cdc.gov/obesity/downloads/obesity_trends_2010.pptBRFSS: Behavioral Risk Factor Source Surveillance System

STATISTICS More than one-third of

U.S. adults (35.7%) are obese Overweight (BMI>25)= 69%

The estimated annual medical cost of obesity in the U.S. was $147 billion in 2008 U.S. dollars $99.2 billion in 1995

The medical costs for people who are obese were $1,429 higher than those of normal weighthttp://www.cdc.gov/obesity/data/adult.html

NIH, NHLBI. Clinical Guidelines on the identification, evaluation, and treatment of overweight and obesity in Adults. The evidence report. NIH Publication No. 98-4083, 1998.

31.0%

33.3%

35.7% NormalOverweightObese

WHO RESPONDED? National Heart, Lung, Blood Institute

(NHLBI) in cooperation with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identification, Evaluation, and Treatment of

Overweight and Obesity In Adults (1998) Examined the evidence of benefits Assessment/classification: BMI, waist circumference Goals of weight loss and management (1-2 lbs/week) Strategies for weight loss and management

Pharmacotherapy Bariatric Surgery Diet therapy (500 to 1000 kcal/d deficit) Physical Activity (30 min moderate intensity most days)

TIME FOR AN UPDATE 2013 American Heart Association

(AHA)/American College of Cardiology (ACC)/The Obese Society (TOS) Guideline for the Management of Overweight and Obesity in Adults 2008 NHLBI initiated June 2013 began collaboration with ACC/AHA Other ACC/AHA 2013 guidelines

Assessment of cardiovascular (CV) risk Lifestyle modifications to reduce CV risk Blood cholesterol

2013 OVERWEIGHT/OBESITY GUIDELINES Differ from other ACC/AHA guidelines

More limited in scope Focus on select critical questions (CQ)

based on the highest quality evidence available

Recommendations derivedRandomized trialsMeta-analysesObservational studies evaluated for quality

Evidence not considered beyond 2011

2013 OVERWEIGHT/OBESITY GUIDELINES Panel began with 23 possible CQ Excluded CQ

Examples: genetics, binge, pharmacotherapy, cost effectiveness

Panel’s ultimate goalDevelop evidence statements (ES) and

recommendations for 5 CQs to assist clinicians in primary care

Our goal todayDiscuss summary of recommendationsDiscuss 4 CQ and selected ES

2013 OVERWEIGHT/OBESITY GUIDELINES: CQ

CQ1: address the expected health benefits of weight loss

CQ2: (i) address the health risk of overweight and obesity (ii) determine if

waist circumference/BMI cutpoints appropriate across all subgroups

CQ3: which dietary intervention strategies are effective for weight loss

effortsCQ4: determine the efficacy and effectiveness of a comprehensive

lifestyle approach on weight loss and maintenance

CRITICAL QUESTION 1 (CQ1) Among overweight and obese (O/O) adults,

does achievement of reduction in body weight with lifestyle and pharmacological interventions affect cardiovascular disease (CVD) risk factors, CVD events, morbidity and mortality? Weight loss and risk of diabetes Weight loss and impact on cholesterol/lipid

profile Weight loss and hypertension risk

CQ1 (DM) Weight loss and risk of diabetes (DM)ES: O/O adults at risk for T2DM

2.5 to 5.5kg weight loss at > 2 years achieved w/ lifestyle intervention (+/- orlistat) reduced risk of developing T2DM by 30-60%

ES: O/O adults with T2DM 2 to 5% weight loss in 1-4 years (lifestyle +/-

orlistat) lowered HgbA1c by 0.2-0.3% 5-10% weight loss at 1 year (lifestyle +/-

orlistat) associated with HgbA1c reductions of 0.6-1% and ↓ DM medications

Strength of Evidence: High

CQ1(DM)-MORTALITYES: O/O adults with T2DM

Intentional weight loss of 9 to13 kg had a 25% decrease in mortality rate vs. weight stable controls

Observational cohort studies

Strength of Evidence: Low

CQ1(LIPID) Weight loss and impact on lipid profilesES: O/O adults +/- elevated CVD risk

Dose-response relationship between amount of weight loss (lifestyle) and the improvement in lipid profile Weight loss

<3 kg: more modest/variable improvements in triglycerides (TG) , high-density lipoprotein (HDL) cholesterol, and low-density lipoprotein (LDL) cholesterol

3kg: decrease TG at least 15 mg/dL 5 kg to 8 kg

Decrease LDL by ~5 mg/dL Increase HDL by 2 to 3 mg/dL

Strength of evidence: High

CQ1(HTN) Weight loss and hypertension (HTN)

riskES: O/O adults with +CVD risk (including T2DM/HTN)

Dose-response relationship between the amount of weight loss achieved at up to 3 years (lifestyle +/- orlistat) and the lowering of blood pressure (BP) 5% weight loss: mean reduction observed

3 mm Hg systolic BP 2 mm Hg diastolic BP

<5% weight loss: more modest/variable BP reductionsStrength of evidence: High

SUMMARY-CQ1 Counsel O/O adults with CV risk

factors that lifestyle changes that produce even modest, sustained weight loss of 3%-5% produce clinically meaningful health benefits Greater weight losses = greater benefits

NHLBI grade: A (strong) ACC/AHA: IA

CRITICAL QUESTION 2 (CQ2)

**Not enough evidence to answer

• Are the current BMI cutpoint values for O/O vs. normal associated with ↑ CVD risk?

• Are the current waist circumference cutpoints associated with ↑ CVD risk? How do they compare**

• Are differences across population subgroups (in relation to BMI/waist circumference and ↑ CVD risk/mortality) sufficiently large to warrant different cutpoints? **

• What are the associations between maintaining weight and weight gain with ↑ CVD risk in normal weight, overweight, and obese adults?**

CLASSIFICATION OF OVERWEIGHT AND OBESITY BY BMI, WAIST CIRCUMFERENCE AND ASSOCIATED

DISEASE RISK*Disease Risk* Relative to Normal Weight and Waist Circumference

BMI (kg/m2) Obesity Class

Men: < 102 cm (< 40 in)Women: < 88 cm (< 35 in)

> 102 cm (> 40 in)> 88 cm (> 35 in)

Underweight

<18.5 — —

Normal 18.5 –24.9

— —

Overweight

25.0 – 29.9

Increased High

Obesity 30.0 – 34.9

I High Very High

35.0 – 39.9

II Very High Very High

Extreme Obesity

> 40 III Extremely High Extremely High

* Disease risk for T2DM, HTN, and CVD

NIH, NHLBI. Clinical Guidelines on the identification, evaluation, and treatment of overweight and obesity in Adults. The evidence report. NIH Publication No. 98-4083, 1998.

CRITICAL QUESTION 2 (CQ2)

Associated with ↑ risk of combined fatal and nonfatal coronary heart disease (CHD)

Associated with ↑ risk of fatal CHD in both sexes

The current category for overweight NOT associated with ↑ risk of all-cause mortality

BMI at or above the current cutpoint for obesity IS associated with an ↑ risk of all-cause mortality vs.

normal weightStrength of Evidence: Moderate

ES: All-cause mortality

ES: Current BMI cutpoint - O/O vs. normal

SUMMARY-CQ2(IDENTIFY PATIENTS WHO NEED TO LOSE WEIGHT) Calculate BMI at least annually

NHLBI grade: expert opinion ACC/AHA: IC

Use current cutpoints: For O/O to identify adults who may be at ↑risk of

CVD Obesity to identify adults who may be at ↑ risk

of mortality from all causes NHLBI grade: A (strong) ACC/AHA: IB

SUMMARY CQ2(IDENTIFY PATIENTS WHO NEED TO LOSE WEIGHT) Advise O/O adults that greater BMI= greater

risk of CVD, T2DM, and all-cause mortality NHLBI grade: A (strong) ACC/AHA: IB

Measure waist circumference at annual visits or more frequently in O/O adults Greater waist circumference= greater risk of

CVD, T2DM, and all-cause mortality NHLBI grade: expert opinion ACC/AHA: IIB

CRITICAL QUESTION 3 (CQ3)• During weight loss or weight

maintenance after weight loss, what are the comparative health benefits or harms of the above diets and other dietary weight loss strategies?

• In O/O adults, what is the comparative efficacy/effectiveness of diets of differing forms and structures OR other dietary weight loss strategies in achieving or maintaining weight loss?

SUMMARY: CQ3(DIETS FOR WEIGHT LOSS) Prescribe a diet to achieve reduced

calorie intake for O/O individuals who would benefit from weight loss, as part of a comprehensive lifestyle intervention. Prescribing options:

NHLBI grade: A (strong)ACC/AHA: IB

1,200–1,500 kcal/d for women &

1,500–1,800 kcal/d for

men

500 kcal/day or

750 kcal/day energy deficit

Evidence-based diet

that restricts certain food

types

SUMMARY: CQ3(DIETS FOR WEIGHT LOSS) Prescribe a calorie-restricted diet, for O/O

individuals based on the patient’s preferences and health status and preferably refer to a nutrition professional for counseling Variety of dietary approaches = weight loss

NHLBI grade: A (strong) ACC/AHA: IB

CRITICAL QUESTION 4 (CQ4)• Among O/O adults, what is the

efficacy/effectiveness of a comprehensive lifestyle intervention program (CLIP) in facilitating weight loss or maintenance of lost weight?

• What characteristics of delivering comprehensive lifestyle interventions are associated with greater weight loss or weight loss maintenance?• Frequency and duration of treatment• Individual vs. group sessions• Onsite vs. telephone/email contact

CRITICAL QUESTION 4 (CQ4) ES: The principal components of an effective

high-intensity, on-site CLIP include

Behavioral therapy

•Food intake•Physical activity•Weight

Increased

physical activity

•Physical activity >150 min/week

•200-300 min/week to maintain/minimize gain

Strength of evidence: High

SUMMARY CQ4(LIFESTYLE INTERVENTION AND COUNSELING)

† Trained internationalist (reviewed studies) included mostly health professionals (ie. RN, psychologist, exercise specialists, or health counselors).

Advise O/O individuals to participate for ≥6 months in a CLIP that assists participants in adhering to the principal components

NHLBI grade: A (strong)

ACC/AHA: IA

Prescribe on site, high-intensity CLIP in individual or group sessions by a trained interventionist (TI)†

NHLBI grade: A (strong)

ACC/AHA: IB

SUMMARY CQ4(LIFESTYLE INTERVENTION AND COUNSELING) Electronically

delivered weight loss programs (+ telephone) that include personalized feedback from TI can be prescribed but may result in smaller weight loss vs. face-to-face

NHLBI grade: B (moderate)

ACC/AHA: IIaA

Some commercial-based programs that provide a CLIP can be prescribed, provided there is peer-reviewed published evidence of safety and efficacy

NHLBI grade: B (moderate)

ACC/AHA: IIaA

SUMMARY CQ4(LIFESTYLE INTERVENTION AND COUNSELING) Use a very low calorie diet (defined as <800

kcal/day) ONLY in limited circumstances ONLY when provided by trained practitioners in a

medical care setting Medical supervision required (more discussion

ahead) NHLBI grade: A (strong) ACC/AHA: IIA

Advise O/O individuals who have lost weight to participate long-term (≥1 year) in a CLIP

NHLBI grade: A (strong) ACC/AHA: IA

SUMMARY CQ4(LIFESTYLE INTERVENTION AND COUNSELING)

For weight loss MAINTENANCE Prescribe face-to-face or programs that provide

regular contact (> monthly) With a trained interventionist who

Engage in high levels of physical activity 200-300 minutes/week

Monitor body weight regularly Weekly or more frequent

Consume a reduced-calorie diet (maintain lower body wt)

NHLBI grade: A (strong) ACC/AHA: IA

COMPREHENSIVE LIFESTYLE + MEDICALLY SUPERVISED PROGRAMS Veteran’s Administration

MOVE!(Managing Overweight and/or Obesity for Veterans Everywhere). Evidence-based weight management program Largest/most comprehensive weight management

program Individual, group, and activity sessions

MOVE! Intensive Designed extreme obesity who have NOT been

successful in MOVE!

MOVE! INTENSIVE 12 day on-site program focus: diet, exercise

and behavior Criteria

BMI >35 w/ comorbid conditions or BMI >40 Failure to achieve/maintain a 5-10% weight loss with

standard MOVE! Must be

Independent with all ADL’s Able to walk 100 feet unassisted Willing to complete health appraisal and sign

behavioral agreement

MOVE! INTENSIVE Team

Dietician Nurse practitioner Pharmacist Physical therapist Behavioral

psychologist Recreational

therapist Chaplain

Clearance by primary care provider (PCP) +/- Mental health Cardiac Pulmonary Hematology GI/liver Nephrology, etc

MOVE! INTENSIVE

Medication adjustments

Diabetes• Discontinue• Short acting insulin• Orals causing

hypoglycemia• Cut in half• Intermediate, long-

acting insulin• Continue/adjust• Metformin/DPP-4

• Case-by-case• GLP-1/TZDs

Blood Pressure• ACE/ARB• Discontinue

• Diuretics• Discontinued• Reduced in HF or

excess fluid

Additions• Multi-vitamin• Constipation• Non-rx

MOVE! INTENSIVE

Behavior

• Journaling (sleep, emotions, etc.)

• Food Records• Blood pressure/blood

sugar records• Group & individual

therapy• Health assessment• Goal setting

Exercise

• Two 1-hour gym sessions daily

• Walking• Tai Chi• Wii fitness

Diet

• 800 calorie diet• Cooking• Shopping

MOVE! INTENSIVEWEEK 1 MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY SUNDAY6:00 AM Weigh In Weigh In Weigh In Weigh In Weigh In Weigh In 6:30 AM Walk/Wheel Walk/Wheel Walk/Wheel Walk/Wheel Walk/Wheel Walk/Wheel

7:00 AM Breakfast Breakfast Breakfast Breakfast Breakfast Breakfast Breakfast7:30 AM Journaling Journaling Journaling Journaling Journaling Journaling

8:00 AM Orientation CLC Fitness Center Fitness Center Fitness Center Fitness Center Wii Games Wii Games

8:30 AM

9:00 AM Behavior Change Wii Games Behavior Change Nutrition Class:

Behavior Change Fitness Center Fitness Center

9:30 AM Counseling CLC1 DR

Counseling CLC1 DR

Grocery Shopping

Counseling CLC1 DR

10:00 AMPhysical Therapy

Educational DVD

Educational DVD Tour Wii Games Free Time Free Time

10:30 AM (room)Supersize Me Healthy Shopping

11:00 AM Diet Preview (room) Health Class

MOVE Support

Free Time Educational DVD Educational DVD

11:30 AM Pharmacy Review

Free TimeCLC1 DR

Group ( rm 2315)

Enjoy Nutrition (1) Food Matters

12:00 PM Lunch Lunch Lunch Lunch Lunch Lunch Lunch 12:30 PM 1:00 PM Nutrition Class-

PortionEducational

DVD ChaplainFree Time Menu Planning Wii Games Wii Games

1:30 PM Control/Label Reading CLC1 DR

Overweight & Obesity Chapel

2:00 PM Fitness Center Fitness Center Fitness Center Fitness Center Fitness Center Fitness Center Free Time

2:30 PM Orientation CLC2

3:00 PM Dexascan Free TimeMyHealtheVet

Educational DVD

Free Time Educational DVDTai Chi CLC2

3:30 PM 4th floor Molly Class (CLC 1)

Forks over Knives

Enjoy Nutrition (2)dining room

4:00 PM

Home Exercise Tai Chi (rm 2315)

Tai Chi (rm 2315)

Home Exercise Free Time Free Time

4:30 PM Video /Walk Video /Walk

5:00 PM Supper Supper Supper Supper Supper Supper Supper

6:00 PM Walking Walking Walking Walking Walking Walking Walking8:00 PM Journaling Journaling Journaling Journaling Journaling Journaling Journaling

9:00 PM Snack Snack Snack Snack Snack Snack Snack

MOVE! INTENSIVE Discharge

1200 calorie diet Group or individual classes (dietician) With most current medication adjustments

Follow-up within 2 weeks clinical pharmacist/PCP

MOVE! INTENSIVE Data (8/2012-4/2014)

Average BMI: 42.41

Post-IOP (n=104)

1 month (n=94) 3 month (n=83) 6 month (n=81) 9 month (n=55) 12 month (n=65) 18 month (n=15)012345678

4.94 5.766.94 6.38 5.56 5.53 4.82

Average MOVE! IOP % Body Weight Lost

Time

% B

ody

Wei

ght L

ost

PHARMACOLOGY

Fenfluramine (Pondimin,1973) Dexfenfluramine (Redux, 1996)

Provider-initiated reports of valvular heart disease

Withdrawn September 1997 Off-label use of “Fen-phen”

Sibutramine (Meridia,1997) SCOUT trial: 16% ↑ in risk of

major adverse CV events Withdrawn: October 2010

Diethylpropion HCL and ER (Tenuate, 1960) Indication (C-IV)

Short-term adjunct (diet) for weight loss

Contraindications (CI) Pulmonary HTN Advanced arteriosclerosis Hyperthyroidism Glaucoma Severe HTN Agitated states History drug abuse MAOI within 14 days

Withdrawn… Still hanging on…

PHARMACOLOGY

Orlistat (Alli, Xenical, 1999) Indication

Weight loss AND maintenance with diet

Reduce the risk for weight regain after prior weight loss

CI Pregnancy Chronic malabsorption

syndrome Cholestasis

MVI indicated +/- 2hrs of dose

DI: levothyroxine (+/- 4hrs) cyclosporine (3hrs after)

Phentermine (Adipex-P, 1959) Indication (C-IV)

Short-term adjunct (exercise/diet/behavior) for weight loss

CI CVD (uncontrolled HTN, CVA,

arrhythmias, CHF) Hyperthyroidism Glaucoma Agitated states History of drug abuse MAOI within 14 days Pregnancy/lactation

Drug interaction (DI) SSRI: coadministration NOT

recommended

Still hanging on… Still hanging on…

PHARMACOLOGY:THE NEW KIDS ON THE BLOCKPhentermine/Topiramate (Qsymia) Locaserin (Belviq)

PHENTERMINE/TOPIRAMATE (QSYMIA)THE HISTORY... 2008 reports: providers writing phentermine

in am + topiramate bedtime New Drug Application (NDA) 12/2009

phentermine/topiramate (Qnexa) July 2010 reviewed by FDA committee

No efficacy issues cited 2 safety concerns

Teratogenic potential Detailed plan/strategy to evaluate and mitigate risk

Provide evidence that ↑heart rate (hr), 0.6 to 1.6 beats/min (bpm), does not increase the risk for major adverse cardiovascular events (MACE) Results from SEQUEL

PHENTERMINE/TOPIRAMATE (QSYMIA)THE HISTORY... SEQUEL

1-year extension study to look at a second year of exposure of obese subjects with obesity-related comorbidities

676 subjects enrolled Mean exposure: 728.5 days

Results 1.6 bpm ↑hr (high dose) + 5.2 mmHg decrease in

systolic BP (SBP) Clinical relevance unknown (1−2 bpm increase in HR)

NO increase in MACE composite hazard ratios vs. placebo Approved July 2012

10 postmarketing studies mandated Potential name confusion

PHENTERMINE/TOPIRAMATE (QSYMIA) Indication (C-IV)

Adjunct (diet/exercise) for chronic weight management with BMI >30 or 27+ comorbidity

Dose titration < 3% not achieved: ↑

dose < 5% not achieved: d/c

CI Pregnancy MAOI within 14 days Glaucoma Hyperthyroidism

Caution/Consideration Cardiac/CV disease

Not studied in HF Excluded

stroke/MI/unstable CV disease in previous 6 mo.

Elderly: >65 y.o. only 7% of subjects

On topiramate Oral carbonic

anhydrase inhibitor (avoid use)

CNS effects Renal/hepatic

impairment

PHENTERMINE/TOPIRAMATE (QSYMIA) Safety

The FDA-approved REMS program Purpose

Increase awareness of congenital malformations Prescriber Requirements

Encouraged to undergo the training Counsel women of childbearing potential Fax/mail universal form + prescription to certified pharmacy

Pharmacy Requirements Certified to dispense Staff must receive training Medication guide + risk of birth defects brochure Maintain a list of prescribers

Monitoring BP, glucose, blood chemistry, mood

LOCASERIN (BELVIQ)THE HISTORY… NDA December 2009

2 completed Phase III trials in non-diabetic (>7000 pts)

Phase III trial (BLOOM-DM) was ongoing

October 2010 FDA responded siting 4 main issues + updated safety (particularly valvulopathy)

Mammary tumor findings in female rats Astrocytoma in male rats A request to include data from BLOOM-DM Assessment of abuse potential (2 rodent experiments)

LOCASERIN (BELVIQ)THE HISTORY… April 2012 briefing document submitted to FDA

Mammary tumor Pathology work group established tumor related to high

dose (24x human exposure) Astrocytoma

Extrapolated data: exposure in rat brain at dose level revealing NO astrocytoma was ~70x estimated level that 10mg bid would produce

Abuse potential Repeated animal studies Package insert

Human abuse potential study in recreational drug abusers, doses of lorcaserin (40 and 60 mg) 2- to 6-fold increases on measures of “High”, “Good Drug

Effects”, “Hallucinations” and “Sedation” vs. placebo Similar to those produced by zolpidem and ketamine

LOCASERIN (BELVIQ)THE HISTORY… Briefing (continued)

Safety update (valvulopathy)

Approved June 2012 6 postmarketing studies mandated

  BLOOM BLOSSOM BLOOM-DMLorcaserinn=1278

Placebon=1191

Lorcaserinn=1208

Placebon=1153

Lorcaserinn=210

Placebon=209

Valvulopathy, n (%) 34 (2.7) 28 (2.4) 24 (2.0) 23 (2.0) 6 (2.9) 1 (0.5)

Rel. Risk (95% CI) 1.13 (0.69, 1.85) 1.00 (0.57, 1.75) 5.97 (0.73, 49.17)

Pooled Rel. Risk 1.16 (0.81, 1.67)

LOCASERIN (BELVIQ) Mechanism of action: serotonin 2C receptor

agonist Believed to decrease food consumption and

promote satiety Indication (C-IV)

Adjunct (diet/exercise) for chronic weight management with BMI >30 or 27+ comorbidity

Dose: 10 mg twice daily (max) 5% of baseline body weight not lost by week 12

= discontinue

LOCASERIN (BELVIQ) CI

Pregnancy DI

SSRI/SNRI excluded 2D6 substrate

caution Safety

No REMS Monitoring

BP, glucose, mood

Caution/Consideration Serotonin syndrome

or neuroleptic malignant syndrome

Valvular heart disease Not studied CHF

Cognitive impairment; psychiatric disorders

Priapism Elderly (2.5% >65 y.o.

studied)

HOW DO THEY STACK UP?

kg weight loss more than placebo 0123456789

10

diethylpropionphentermineorlistatlorcaserinlorcaserin2Qsymia 7.5/46Qsymia 15/92

CASE 1 MK is a 32 y.o. hispanic female with body mass

index (BMI) of 33. She has a diagnosis of hypertension (HTN) and hypothyroidism. She discusses her and her spouse’s desire to become pregnant within the next year and her frustrations with her current weight. She reports trying really hard at home without success. What is your recommendation?

A. phenteramine/topiramate (Qsymia)B. diethylpropionC. a comprehensive lifestyle intervention

programD. bariatric surgery

QUESTIONS?

REFERENCES1. Smith SR, Weissman NJ, Anderson CM, et al. Multicenter, placebo-controlled trial of lorcaserin for weight

management. N Engl J Med 2010;363:245-56.2. O’Neil PM, Smith SR, Weissman NJ, et al. Randomized placebo-controlled clinical trial of lorcaserin for weight loss in

type 2 diabetes mellitus: The BLOOM-DM study. Obesity 2012;20:1426-36.3. Fidler MC, Sanchez M, Raether B, et al. A one-year randomized trial of lorcaserin for weight loss in obese and

overweight adults: The BLOSSOM trial. J Clin Endocrinol Metab 2011;96:3067-77.4. BELVIQ (lorcaserin hydrochloride) package insert. June 2012.5. Li Z, Maglione M, Tu W, et al. Meta-analysis: pharmacologic treatment of obesity. Ann Intern Med 2005; 142: 532-46.6. Allison DB, Gadde KM, Garvey WT, et al. Controlled-release phentermine/topiramate in severely obese adults: a

randomized control trial (EQUIP). Obesity 2011;20:330-42.7. Gadde KM, Allison DB, Ryan DH, et al. Effects of low-dose, controlled-release, phentermine plus topiramate

combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomized, placebo-controlled, phase 3 trial. Lancet 2011;377:1341-52.

8. Garvey WT, Ryan DH, Look M, et al. Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study. Am J Clin Nutr 2012;95:297-308.

9. Jensen MD, Ryan DH, Apovian CM, et. al. Circulation. 2013 Nov 12. 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society.

10. FDA. FDA Briefing Document http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm179871.htm (Accessed 30 Apr 2014)

11. FDA. FDA Briefing Document http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm293908.pdf (Accessed 30 Apr 2014)

12. Micromedex. [Internet]. Greenwood Village: Truven Health Analytics. [cited 2014 Apr 30]. Available from: http://www.micromedexsolutions.com/micromedex2/librarian/ND_T/evidencexpert/ND_PR/evidencexpert/CS/81F8F6/ND_AppProduct/evidencexpert/DUPLICATIONSHIELDSYNC/0E5775/ND_PG/evidencexpert/ND_B/evidencexpert/ND_P/evidencexpert/PFActionId/pf.HomePage