Download - Obesity Guidelines (3)

AACE/ACE Clinical Practice Guidelines for Comprehensive Medical Care of Patients with

Obesity

By: Erin JohnsonMidpoint PresentationURI PharmD Candidate

Apothecare Elective Rotation

Outline• Intro/Rationale• Medical Diagnosis of Obesity• Weight-Related Complications• Lifestyle Therapy• When to Start Pharmacological Therapy• Treatment Goals• Preferred Weight-Loss Medications• Medical Management of Obesity• Conclusions

Intro/Rationale• Obesity rates have significantly increased

over past 30 years - global public health crisis

• National Health and Nutrition Examination Surveys: 2 out of every 3 adults in the US are overweight or obese

• Obesity adds $3,559 annually to medical expenditures per patient

Intro/Rationale• Recent advances in lifestyle intervention,

pharmacotherapy and weight-loss procedures (i.e. bariatric surgery)

• Pathophysiology understanding has grown• Obesity = complex, chronic disease• Involving: genetics, environment and behavioral

determinants

Anthropometric Component of Medical Dx of Obesity

If BMI > 25 kg/m2

Diagnosis(Antropometric

Component)

Significant Measures to Consider:1. Clinical interpretation of BMI

2. Waist Circumference 3. Consider body composition technologies

Screening

Annual BMI

Clinical Diagnostic Measures(Anthropometric Component)

• Evidence-based screening and diagnosis for excess adiposity in clinical settings

• Clinical interpretation of BMI:• Ensure elevated BMI demonstrates actual

excess adiposity• Waist Circumference if BMI < 35• Body composition technologies

Clinical Component of Medical Dx of Obesity

Patients present with Overweight or Obesity(BMI > 25 kg/m2)

Candidate for Weight Loss Therapy(Evaluate for weight-related complications OR Evaluate for

overweight/obesity)

Patient Presents with Weight- Related Disease or Complication (Clinical Component)

Weight-Related Diseases or Complications

Weight-Related Complication

Key Screenings for Diagnosis

Prediabetes Fasting glucose; A1cMetabolic Syndrome Waist circumference; blood

pressure; fasting glucose; TGsType 2 Diabetes Fasting glucose; A1cDyslipidemia Lipid panelHypertension Sitting blood pressureCardiovascular disease Physical exam; ROS; historyNonalcoholic Fatty Liver Disease

Physical exam; LFTs

Polycystic Ovarian Syndrome and Female Infertility

Physical exam; ROS; menstrual/reproductive history

Weight-Related Disease and Complications

Weight-Related Complication

Key Screenings for Diagnosis

Male hypogonadism Physical exam; ROSObstructive Sleep Apnea Physical exam; neck

circumference; ROS; sleep study

Asthma/Respiratory Disease Physical exam; ROSOsteoarthritis Physical exam; ROSUrinary Stress Incontinence Physical exam; ROSGERD Physical exam; ROSDepression, anxiety, Binge Eating Disorder

History; ROS

Diagnosis and Medical Management

DIAGNOSIS COMPLICATION-SPECIFIC STAGING AND TREATMENT

Anthropometric Component

Clinical Component Suggested Therapy

< 25 kg/m2 No complications Healthy lifestyle25 – 29.9 kg/m2

(overweight)No complications Lifestyle therapy

> 30 kg/m2 (obese) No complications •Lifestyle therapy•Weight-loss medications

> 25 kg/m2 1+ mild- moderate complication

•Lifestyle therapy•Weight-loss medications

> 25 kg/m2 At least 1 severe complication

•Lifestyle therapy•Add weight-loss medications•Consider bariatric surgery

Lifestyle Therapy• Meal Plan:• Reduced calories (~500 – 750 kcal daily

deficit)• Individualize based on personal & cultural

preference• Can include:• Mediterranean, DASH, low-carb, low-fat,

high protein, vegetarian• Meal replacements (shakes, nutrition bars)

Lifestyle Therapy

• Physical Activity:• Aerobic physical activity for > 150min/week• Resistance exercise• Reduction in sedentary behavior• Individualize based on preference and

physical limitations

Lifestyle Therapy• Behavior:• Self-monitoring & goal setting• Education & problem-solving skills• Stimulus control• Stress reduction• Psychological evaluation• Motivational interviewing• Mobilization of social support structures

When do we start Pharmacological Options?

Initiate Lifestyle Interventions

1. No Complications

2. Mild to Moderate Complications

Initiate Weight Loss Medication as Adjunct to Lifestyle

Therapy1. Failure on Lifestyle

Therapy2. Weight Regain on

Lifestyle Therapy

3. Presence of Weight-Related Complication

Treatment GoalsDIAGNOSIS TREATMENT GOALS

Anthropometric + Clinical Component

Intervention/Weight-Loss Goal

Clinical Goals

PRIMARY PREVENTIONPrimordial Prevention

BMI < 25 kg/m2

(environmental RFs)• Public education•Access to healthy foods

Decreased incidence of overweight/obesity in populations

Primary Prevention

BMI < 25 kg/m2

(high risk)•Annual BMI screening•Healthy meal plan•Increased physical activity

Decreased incidence of overweight/obesity in high-risk patients

SECONDARY PREVENTIONOverweight BMI = 25 – 29.9 kg/m2

(no weight-related issues)

•Prevent progressive weight gain•Weight loss

Prevent progression to obesity & development of weight-related issues

Obesity BMI = > 30 kg/m2

(no weight-related issues)

•Weight loss•Prevent progressive weight gain

Prevent development of weight-related issues



Clinical Component Intervention/Weight-Loss Goal

Clinical Goals

TERTIARY PREVENTIONOverweight or Obesity

BMI > 25 kg/m2

Metabolic syndrome, Prediabetes

10% Prevention of T2DM

Type 2 Diabetes Mellitus

5% to >15%

•Reduce A1c•Reduce amount of glucose lowering medications

Dyslipidemia 5% to >15%

•Lower TGs•Raise HDL-c

Hypertension 5% to >15%

•Lower SBP and DBP•Reduce amount of antihypertensive meds

Nonalcoholic fatty liver disease

Steatosis 5% or more Reduce lipid profileSteatohepatitis

10% to 40% Reduce inflammation and fibrosis



Clinical Component Intervention/Weight-Loss Goal

Clinical Goals

TERTIARY PREVENTIONOverweight or Obesity

BMI > 25 kg/m2

Polycystic ovary syndrome

5% to 15% or more

•Ovulation•Regularization of menses•Enhanced insulin sensitivity

Female infertility 10% or more

•Ovulation•Pregnancy and live birth

Male hypogonadism 5% to 10% or more

Increase in serum testosterone

Obstructive sleep apnea

7% to 11% or more

•Improved symptoms•Decrease hypopnea index

Asthma/reactive airway disease

7% to 8% •Improve in expiratory volume•Improved symptoms

Osteoarthritis >10% •Improvement in symptoms•Increased function

Weight-Loss Medications Approved by FDA for long-term Treatment of

Obesity

• Orlistat (Xenical™, Alli ™ -OTC)• Lorcaserin (Belviq®)• Phentermine/Topiramate ER (Qsymia®)• Naltrexone ER/Bupropion ER (Contrave®)• Liraglutide (Saxenda®)

Orlistat (Xenical ™ , Alli ™ )

• FDA approved – 1999• Approved for children > 12 years old

• Dose: 120mg PO TID (before meals)• OTC (Alli ™ ): 60mg PO TID (before meals)

• Mechanism of Action: lipase inhibitor• Landmark trial: XENDOS• % total body weight loss from baseline:• 1 yr: 4.0%• 4 yr: 2.6%

Orlistat (Xenical ™ , Alli ™ ) • Contraindications:

• Pregnancy and breastfeeding• Chronic malabsorption

sydrome• Cholestasis• Oxalate nephrolithiasis

• Warning/Safety Concerns:• Rare severe liver injury• Cholelithiasis• Malabsorption of fat-soluble

vitamins

• Common Side Effects:• Steatorrhea• Fecal urgency &

incontinence• Flatulence

Orlistat (Xenical ™ , Alli ™ ) • Effects on Other Medications:• Warfarin (enhances)• Antiepileptics (decreases)• Levothyroxine (decreases)• Cyclosporine (decreases)

• Monitoring:• Cholelithiasis• Nephrolithiasis

• Special Recommendations:• Recommend standard vitamin• Eating >30% kcal from fat Increased GI side effects• Administer levothyroxine at least 4 hours apart• Drug of choice for B.E.D.

Lorcaserin (Belviq®)• FDA approved – 2012• Dose: 10mg PO twice daily• Mechanism of Action: serotonin (5HT2c)

receptor agonist• Landmark trial: BLOSSOM, BLOOM• % total body weight loss from baseline:• 1 yr: 3.0% - 3.6%• 2 yr: 3.1%

Lorcaserin (Belviq®)• Contraindications:

• Pregnancy and breastfeeding• Serotonin syndrome • Neuroleptic malignant syndrome

• Warning/Safety Concerns:• Poor safety data in patients with

depression• Serotonin syndrome risk increased with: • SSRIs, SNRIs, MAOIs, bupropion, St. John’s

Wort• Uncontrolled mood disorders• Cognitive impairment• Caution in patients with:• Severe liver injury, renal insufficiency,

leukopenia, bradycardia or heart failure

• Common Side Effects:• Nausea• Dizziness• Anticholinergic effects• Back pain

Lorcaserin (Belviq®)• Effects on Other Medications:• Increased risk of serotonin syndrome with:

• Dextromethorphan, Linezolid, Tramadol, Lithium

• Monitoring:• Blood pressure, HR, cardiac valve disease• Serotonin syndrome symptoms• Neuroleptic malignant syndrome symptoms• Blood sugar levels• Priaprism

• Special Recommendations:• Can be administered without regards to food• No testing in patients under 18 years old

Phentermine/Topiramate ER (Qsymia®)

• FDA approved – 2012• Dose:• Starting dose: 3.75/23mg PO daily for 2 weeks• Recommended maintenance dose: 7.5/46mg PO daily• Escalation dose: 11.25/69mg PO daily• Maximum dose: 15/92mg PO daily

• Mechanism of Action: NE-releasing agent (phentermine) & GABA receptor modulation (topiramate)

• Landmark trial: EQUIP, CONQUER, SEQUEL• % total body weight loss from baseline:• 1 yr: 6.6% - 9.3%• 2 yr: 7.5% - 8.7%


• Contraindications:• Pregnancy and breastfeeding• Hyperthyroidism• Acute-angle closure glaucoma• Concomitant MAOI use

• Warning/Safety Concerns:• Decrease cognition• Seizure disorders• Anxiety and panic attacks• Hyperchloremic metabolic acidosis• Concern for abuse potential• Combined with alcohol or depressant

drugs worsens cognitive impairment

• Common Side Effects:• Parethesia• Insomnia• Anxiety, Depression• Constipation


• Effects on Other Medications:• Increased cardiovascular adverse events with:

• Amphetamines, ephedra, MAOIs, selegiline

• Monitoring:• Blood pressure, HR• Worsening depression• Potassium levels• Ocular pain

• Special Recommendations:• Dose adjustment with hepatic and renal impairment• Increased potential for lactic acidosis with metformin• Taper patient off if on max dosing• Discontinue medication if no loss of 3% of BLBW – 12 weeks; 5% - 24

weeks

• Kidney stone formation• Blood sugar levels• Electrolytes and

creatinine

Naltrexone ER/Bupropion ER (Contrave®)

• FDA approved – 2014• Dose: (titration)• Week 1: 1 tab (8/90mg) PO every morning• Week 2: 1 tab (8/90mg) PO BID• Week 3: 2 tabs (16/180mg) PO every morning & 1 tab (8/90mg) PO at

bedtime• Week 4: 2 tabs (16/180mg) PO at bedtime

• Mechanism of Action: opiate antanogist (naltrexone) & reuptake inhibitor of DA and NE (bupropion)

• Landmark trial: COR-I, COR-II, COR-BMOD• % total body weight loss from baseline:• 1 yr: 4.2% - 5.2%


• Contraindications:• Pregnancy and breastfeeding• Uncontrolled hypertension• Seizure disorder• Eating disorders• Drug or alcohol withdrawal• Chronic opioid use

• Warning/Safety Concerns:• Cardiac arrhythmias• Narrow-angle glaucoma• Uncontrolled migraines• GAD, bipolar disorder, seizure disorder• Poor safety data in patients with

depression

• Common Side Effects:• Insomnia• Vomiting• Constipation• Anxiety


• Effects on Other Medications:• Increased cardiovascular adverse events with:

• MAOIs, methylene blue

• Monitoring:• Blood pressure, HR• Worsening depression• Worsening migraines• Liver Injury

• Special Recommendations:• Dose adjustment with hepatic and renal impairment• Avoid taking with high-fat meals• Causes false positive urine test for amphetamines• Discontinue medication if no loss of 5% of BLBW – 12 months

• Blood sugar levels• Monitor seizures

Liraglutide (Saxenda®)• FDA approved – 2014• Dose: 0.6mg SC daily• Titrate dose weekly by 0.6mg based on patient

tolerance• Max/Target dose: 3mg SC daily

• Mechanism of Action: GLP-1 analog• Landmark trial: SCALE Obesity & Prediabetes• % total body weight loss from baseline:• 1 yr: 5.6%

Liraglutide (Saxenda®)• Contraindications:

• Pregnancy and breastfeeding• Personal of family history of

meduallary thyroid cancer• Pancreatitis, Acute gallbladder

disease

• Warning/Safety Concerns:• Caution in patients with:• Gastroparesis, history of

pancreatitis, cholelithiasis• Dehydration & vomiting can lead

to renal impairment

• Common Side Effects:• Vomiting• Dyspepsia• Increased heart rate

Liraglutide (Saxenda®)• Effects on Other Medications:• Increased risk of hypoglycemia:

• Insulin detemir (Levemir), beta-blockers, alcohol

• Monitoring:• Blood pressure, HR• Pancreatitis• Cholelithiasis & Cholecystitis• Blood sugar levels

• Special Recommendations:• Discontinue medication if no loss of 4% of BLBW – 16 weeks• No testing in patients under 18 years old• Drug of choice for post-bariatric surgery patients

• Suicidal thoughts• Injection site

reactions• Dehydration

Conclusions• For the “perfect obese patient” & for prevention – recommend Orlistat

• Preventing weight gain/fat absorption• Least amount of disease state interactions

• Patients with CKD – recommend Orlistat or Liraglutide

• Patients with hepatic impairment – caution using any weight-loss medications

• Patients with CVD (except CHF) - recommend Orlistat or Lorcaserin

• Post-Bariatric Surgery patients – recommend Phntermine/topiramate ER or Liraglutide

• Patients with depression – recommend Orlistat, Phentermine/topiramate ER or Liraglutide

Conclusions• Helpful information to have as pharmacists to assist in

the care for our patients who have obesity or overweight• Lifestyle therapy is always the first step for all stages• There are limits to how long you can take certain

medications – if not seeing results• Obesity can cause other disease states, while certain

disease states can cause obesity• Be sure to closely monitor and educate all patients at risk

• Medication is not what is going to keep a person at a healthy weight – play your part as another resource!

References• Garvey WT, Mechanick JI, et al. AACE/ACE comprehensive obesity

management algorithm for medical care. Endocr Pract. 2016: 1-68.• Centers for Disease Control and Prevention (CDC). Healthy weight − it's not a

diet, it's a lifestyle! Available at: http://www.cdc.gov.uri.idm.oclc.org/healthyweight/index.html. Accessed June 8, 2016.

• Lexicomp Online® , Patient Education – Disease and Procedure. ® Metabolic Syndrome. Hudson, Ohio: Lexi-Comp, Inc.; Accessed June 8, 2016.

• Lexicomp Online® , Lexi-Drugs.® Obesity Treatment Guidelines. Hudson, Ohio: Lexi-Comp, Inc.; Accessed June 8, 2016.

• The Rudd Center for Food Policy and Obesity. Motivational interviewing for diet, exercise and weight. Available at: http://www.uconnruddcenter.org/resources/upload/docs/what/bias/healthcareproviders/MotivationalInterviewing.pdf. Accessed June 9, 2016.

http://www.cdc.gov.uri.idm.oclc.org/healthyweight/index.html.%20Accessed%20June%208

http://www.uconnruddcenter.org/resources/upload/docs/what/bias/healthcareproviders/MotivationalInterviewing.pdf

http://www.uconnruddcenter.org/resources/upload/docs/what/bias/healthcareproviders/MotivationalInterviewing.pdf