Download Guidelines Update: Obesity - South Carolina Society of Health

3/3/2014
SCSHP 2014 Annual Meeting
Guidelines Update: Obesity
Disclosure
• I do not have a vested interest in or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation.
Jennifer N. Clements, Pharm.D., BCPS, CDE, BCACP
Associate Professor of Pharmacy Practice
Presbyterian College School of Pharmacy
Learning Objectives for Pharmacists
Learning Objectives for Pharmacists
• Describe the epidemiology and health complications of obesity.
• Review the new FDA‐approved agents, including efficacy and safety, for the treatment of obesity.
• Discuss the recognition of obesity as a disease state.
• Outline the role of non‐pharmacologic and pharmacologic interventions in the treatment of obesity.
• Recognize current evidence‐based recommendations for the treatment of obesity.
Learning Objectives for Pharmacy Technicians
Learning Objectives for Pharmacy Technicians
• Describe the epidemiology and health complications of obesity.
• Review non‐pharmacologic interventions for the treatment of obesity.
• Discuss the recognition of obesity as a disease state.
• Recall the new FDA‐approved agents in the treatment of obesity.
• Define and distinguish healthy weight, overweight, and obesity.
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Epidemiology – United States
Obesity Trends* Among U.S. Adults
Behavioral Risk Factors Surveillance Systems, CDC (1990)
(*BMI ≥30, or ~ 30 lbs. overweight for 5’ 4” person)
• 35.7% of American adults are obese
• 2nd leading cause of preventable death
• $147B towards medical spending and $1,429 in additional medical costs, if obese (2008) • Rates differ among ethnic groups
• Non‐Hispanic blacks (49.5%) > Mexican Americans (40.4%) > Hispanics (39.1%) > Non‐
Hispanic whites (34.3%)
No Data
<10%
10%–14%
Overweight and Obesity Statistics. CDC Website. Available at: http://www.cdc.gov/obesity/data/facts.html. Obesity Trends* Among U.S. Adults
Behavioral Risk Factors Surveillance Systems, CDC (2000)
Obesity Trends* Among U.S. Adults
Behavioral Risk Factors Surveillance Systems, CDC (2010)
(*BMI ≥30, or ~ 30 lbs. overweight for 5’ 4” person)
No Data
<10%
10%–14%
15%–19%
≥20%
Epidemiology – South Carolina
(*BMI ≥30, or ~ 30 lbs. overweight for 5’ 4” person)
No Data
<10%
10%–14%
15%–19%
20%–24%
25%–29%
≥30%
Percent of Overweight and Obese Adults in South Carolina (2003)
• 8th worst overweight or obesity rate in the nation
•
No state met the Healthy People 2010 goal of lowering the obesity prevalence to 15%.
• 65.9% of adults are overweight or obese
• $1B in medical expenditures (2003)
• $256 per South Carolinian
• 50% of the cost financed by Medicare and Medicaid
•
For information on gender, race, and obesity rates by county, check out: https://www.scdhec.gov/health/chcdp/obesity/data.htm.
South Carolina Department of Health and Environmental Control. Division of Nutrition, Physical Activity, and Obesity, Surveillance and Data. February 2011. Available at: https://www.scdhec.gov/health/chcdp/obesity/data.htm.; Overweight and Obesity Statistics. CDC Website. Available at: http://www.cdc.gov/obesity/data/facts.html. Data Source: SC Behavioral Risk Surveillance System. Division of Nutrition, Physical Activity and Obesity, Bureau of Community Health and Chronic Disease Prevention.
Updated: 12/11
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Percent of Overweight and Obese Adults in South Carolina (2006)
Data Source: SC Behavioral Risk Surveillance System. Division of Nutrition, Physical Activity and Obesity, Bureau of Community Health and Chronic Disease Prevention.
Percent of Overweight and Obese Adults in South Carolina (2009)
Updated: 12/11
Health Complications of Obesity
 BMI =  risk of diabetes, hypertension, hyperlipidemia, stroke, heart disease, respiratory problems, osteoarthritis, and certain cancers
Data Source: SC Behavioral Risk Surveillance System. Division of Nutrition, Physical Activity and Obesity, Bureau of Community Health and Chronic Disease Prevention.
Metabolic Syndrome
Measurement
Waist Circumference
Hypertriglyceridemia
Low HDL cholesterol
Hypertension
Impaired fasting glucose
JAMA 2010;303:235‐41.; Obes Res 1998;6(suppl 2):51S‐209S.; JAMA 2004;291:1238‐45. Updated: 12/11
Criteria
> 40 inches (males)
> 35 inches (females)
≥ 150 mg/dL
< 40 mg/dL (males)
< 50 mg/dL (females)
≥ 130 mm Hg (systolic)
≥ 85 mm Hg (diastolic)
≥ 100 mg/dL
Circulation 2009;120:1640‐45.
American Medical Association
2013 Annual Meeting
South Carolina News Release
February 2014
• Voted to label obesity as a disease
• NEW PROPOSAL
• Obesity requires a variety of interventions for treatment and prevention.
• Medicaid program pay doctors and dietitians to treat obesity in the state.
• What could be the impact?
• Provider reimbursement
• Public policy
• Patient stigma
• ICD coding
• Coverage would include:
Frellick M. AMA declares obesity a disease. Medscape Medical News. June 19, 2013. http://www.medscape.com/viewarticle/806566. • Up to 6 visits per year with a physician
• Up to 6 visits with licensed dietitian
• If 60% of state Medicaid recipients participate, then additional $10.5M is needed (estimated: $7.5M from federal government and $3M from South Carolina taxpayers).
Beam A. State to pay doctors, dietitian to treat poor, obese South Carolinians. Available at: http://www.thestate.com/2014/02/06/3249709/state‐wants‐to‐pay‐doctors‐dietitians.html. 3
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Guidelines
Definitions (Adults)
• Body Mass Index
Classification
BMI (kg/m2)
Underweight
< 18.5
Healthy
18.5‐24.9
Overweight
25.0‐29.9
Obesity I
30.0‐34.9
Obesity II
35.0‐39.9
Obesity III
≥ 40.0
• Waist circumference*
• > 40 inches (men)
• > 35 inches (women)
Guidelines
Month / Year of Publication
American Heart Association/American College of Cardiology/The Obesity Society
American Society of Bariatric Physicians
• Waist‐to‐hip ratio^
• ≥ 1.0 (men)
• ≥ 0.8 (women)
American Association of Clinical Endocrinologists
Academy of Nutrition and Dietetics
American Medical Association
*Best way to evaluate central adiposity and risk of obesity
^Best predictor of death for individuals > 75 years National Heart, Lung, and Blood Institute
November 2013
October 2013
April 2013
February 2009
February 2004
September 1998
JAMA 2010;303:235‐41.; Obes Res 1998;6(suppl 2):51S‐209S.; JAMA 2004;291:1238‐45.; Overweight and Obesity Statistics. CDC Website. Available at: http://www.cdc.gov/obesity/data/facts.html. Desired Goals
Non‐Pharmacologic Interventions
• Reduce obesity‐related morbidity
• Dietary approaches (expenditure > intake)
• Prevent further weight gain
• Reduce body weight
• Reduce weight by 5 to 10% from baseline
• Obese: Lose 1 to 2 lb per week in first 6 months
• Overweight: Lose 0.5 lb per week in first 6 months
1. Reduce by 500‐1000 kcal per day to lose 1‐2 lbs per week.
2. Set a goal for daily caloric intake.
3. Eliminate a specific type of food. 4. Keep a food journal.
5. Specific diets only have short‐term benefits (i.e., 6‐12 months). • Maintain lower body weight (long‐term goal)
Obes Res 1998;6(suppl 2):51S‐209S.; Obes Res 2001;9:354S‐358S.; Circulation 2013. [Epub ahead of print November 12, 2013]. Obes Res 1998;6(suppl 2):51S‐209S.; Obes Res 2001;9:354S‐358S.; The Obesity Algorithm, American Society of Bariatric Physicians, 2013.; Circulation 2013. [Epub ahead of print November 12, 2013].
Non‐Pharmacologic Interventions
Non‐Pharmacologic Interventions
• Exercise (expenditure > intake) • Behavioral modifications
1. Engage in 30 minutes per day of aerobic activity for at least 5 days per week (weight loss).
2. Engage in 45 to 60 minutes per day of aerobic activity for at least 5 days per week (weight maintenance).
3. Evaluate intensity of activity.
4. Use a pedometer.
5. Limit television and computer use.
Obes Res 1998;6(suppl 2):51S‐209S.; Obes Res 2001;9:354S‐358S.; The Obesity Algorithm, American Society of Bariatric Physicians, 2013.; Circulation 2013. [Epub ahead of print November 12, 2013].
1. Emphasize self‐monitoring of dietary intake, physical activity, and weight.
2. Engage in individual or group session of moderate to high intensity for at least 6 months (weight loss).
3. Follow‐up at a minimum with monthly face‐to‐face visits or telephone encounters (weight maintenance).
4. Identify self‐sabotage.
5. Manage stress and optimize sleep.
Obes Res 1998;6(suppl 2):51S‐209S.; Obes Res 2001;9:354S‐358S.; The Obesity Algorithm, American Society of Bariatric Physicians, 2013.; Circulation 2013. [Epub ahead of print November 12, 2013].
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Established Pharmacotherapy
KEY TO SUCCESS
• Noradrenergic appetite suppressants
Physical activity
Healthy food choices
Behavioral modifications
Successful
weight loss
program
•
•
•
•
•
Phentermine (Adipex‐P)
Diethylpropion (Tenuate)
Benzphetamine (Didrex)
Phendimetrazine (Bontril)
Methamphetamine (Desoxyn)
Sibutramine: Voluntarily withdrawn in October 2010 (risk of myocardial infarction, stroke, resuscitated cardiac arrest, or death)
• Lipase Inhibitor
• Orlistat (Xenical / Alli)
Obes Res 1998;6(suppl 2):51S‐209S.; Obes Res 2001;9:354S‐358S.; The Obesity Algorithm, American Society of Bariatric Physicians, 2013.; Circulation 2013. [Epub ahead of print November 12, 2013].
Established Pharmacotherapy
Drug
Dose
Adverse Events
Weight Loss
(Compared to Placebo)
Phentermine
ADIPEX
15 to 36.5 mg PO QD in 1 or 2 divided doses
Palpitations, tachycardia, hypertension, dry mouth, constipation, insomnia, asthenia, pulmonary hypertension, valvular heart disease 2.16 to 3.6 kg for short‐term use (i.e., 12 weeks)
Orlistat
ALLI
XENICAL
OTC: 60 mg PO TID with fatty meals
Oily spotting, flatus with discharge, fecal urgency, fecal incontinence, bloating, cramping
3.45 kg for long‐term use (i.e., 1 year)
Rx: 120 mg PO TID with fatty meals
Obes Res 1998;6:51S‐209S; N Engl J Med 2010;363:905‐17.; Endo Pract 2013;19:327‐36.
NEW FDA‐Approved Drug:
BELVIQ® (Lorcaserin)
Mechanism of Action
Dose
Adverse Events
Activates serotonin 2C receptor in the hypothalamus, resulting in increased satiety and decreased food consumption 10 mg PO BID with or without meals; no renal or hepatic adjustments
Headache
Backache
Nasopharyngitis
Nausea
Fatigue N Engl J Med 2010;363:245‐56.; J Clin Endocrinol Metab 2011;96:3067‐77.; Obesity 2012;20:1426‐36.; BELVIQ (lorcaserin) [package insert]. Zofingen, Switzerland: Arena Pharmaceuticals; 2012.
Obes Res 1998;6:51S‐209S.; Ann Intern Med 2005;142:532‐46.
NEW FDA‐Approved Drug:
BELVIQ® (Lorcaserin)
Drug‐Drug Interactions
Contraindications
Comments
CYP2D6 substrates Serotonergic drugs
Pregnancy
•Discontinue if failure of 5% weight loss is not achieved at 12 weeks
•Expensive ($4 per day; $265 per 1‐kg weight loss)
BELVIQ® (10 mg BID) and the 1‐year Evidence
Study #
Mean % Change in Body Weight Proportion of Patients (%) with ≥ 5% Body Weight Loss
Lorcaserin
Placebo
Lorcaserin
Placebo
1 – BLOOM
5.8
2.16
47.5
20.3
2 – BLOOM‐DM
4.5
1.5
37.5
16.1
3 – BLOSSOM 5.8
2.8
47.2
25.0
•Schedule IV
N Engl J Med 2010;363:245‐56.; J Clin Endocrinol Metab 2011;96:3067‐77.; Obesity 2012;20:1426‐36.; BELVIQ (lorcaserin) [package insert]. Zofingen, Switzerland: Arena Pharmaceuticals; 2012.
N Engl J Med 2010;363:245‐56.; J Clin Endocrinol Metab 2011;96:3067‐77.; Obesity 2012;20:1426‐36.; BELVIQ (lorcaserin) [package insert]. Zofingen, Switzerland: Arena Pharmaceuticals; 2012.
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NEW FDA‐Approved Drug:
QSYMIA® (Phentermine/Topiramate)
Mechanism of Action
Dose (Phen/Top)
P – sympathomimetic
3.75 mg/23 mg PO QAM Paresthesias
Dry mouth
x 14 days; then, 7.5mg/46 mg x 12 weeks Constipation
Insomnia
Dysgeusia
Discontinue if patient has not lost at least 3% Potential increases in HR and BP of baseline body weight OR increase to 11.25/69 mg PO QAM x 14 days, followed by a daily dose of 15 mg/92 mg x 12 weeks
T – suppresses appetite and enhances satiety induced by a combination of effects on neurotransmitters and ion channels Adverse Events
Lancet 2011;377:1341‐52.; Obesity 2012;20:330‐42.; Am J Clin Nutr 2012;95:297‐308.; QSYMIA (phentermine/topiramate) [package insert]. Mountain View, CA: Vivus, Inc; 2013.
QSYMIA® [15 mg/92 mg] and the 1‐year Evidence
NEW FDA‐Approved Drug:
QSYMIA® (Phentermine/Topiramate)
Drug‐Drug Interactions
Contraindications
Comments
Carbonic anhydrase inhibitors
MAOIs
CNS depressants
Non‐potassium‐
sparing diuretics
MAOI use within 14 days
Pregnancy Glaucoma
Hyperthyroidism
Severe depression
Recent stroke or CV events • Discontinue if loss of 3% from baseline body weight is not achieved with 7.5/46 mg after 12 weeks
• Discontinue/taper if loss of 5% from baseline body weight is not achieved with 15/92 mg after 12 weeks • Expensive ($4.80 per day)
• Schedule IV
• REMS program
Lancet 2011;377:1341‐52.; Obesity 2012;20:330‐42.; Am J Clin Nutr 2012;95:297‐308.; QSYMIA (phentermine/topiramate) [package insert]. Mountain View, CA: Vivus, Inc; 2013.
“Off‐Label” Pharmacotherapy Options
Mean % Change in Body Weight Proportion of Patients (%) with ≥ 5% Body Weight Loss
Drug
Dose
Bupropion
300 to 400 mg per day
2.77 Phen/Top Placebo
Phen/Top
Placebo
Exenatide
10 mcg subcutaneously twice daily
3‐4
1 – CONQUER
10.9
2.6
66.7
17.3
Exenatide extended‐
release
2 mg subcutaneously once weekly
2.3
2 – EQUIP
9.8
1.2
70
20.8
Study #
In an extension study of 2‐year weight loss [Study 3 – SEQUEL], reduction of 10.5% from baseline was observed as 79.3% of participants achieved 5% weight loss from baseline with maximum dose of phentermine / topiramate. Lancet 2011;377:1341‐52.; Obesity 2012;20:330‐42.; Am J Clin Nutr 2012;95:297‐308.; QSYMIA (phentermine/topiramate) [package insert]. Mountain View, CA: Vivus, Inc; 2013.
Weight Reduction (kg)
Liraglutide
1.2 to 3 mg subcutaneously once daily 2‐7.8 Pramlinitide
60 to 120 mcg subcutaneously before 1.7
meals
Topiramate
100 to 200 mg per day
5.9‐6.6
Zonisamide
100 to 600 mg per day
5‐7.7
Selected pipeline agents: Bupropion / naltrexone, bupropion / zonisamide, pramlinitide / metreleptin
Recent Patents on Endocrine, Metabolic, and Immune Drug Discovery 2012;1‐12.; Pharmacotherapy 2013;33(12):1308‐12.
American Association of Clinical Endocrinologists (2013)
American Association of Clinical Endocrinologists (2013)
• If BMI is 25 to 26.9 or ≥ 27.0, then severity of complications should be assessed.
• Medical therapy includes:
BMI
Severity of Complications
25‐26.9
‐‐‐
1.
Lifestyle modifications
Low
1.
2.
Lifestyle modifications
Medical therapy
Medium
1.
Lifestyle modifications PLUS medical therapy
High
1.
Lifestyle modifications PLUS medical therapy
Surgical therapy, if BMI ≥ 35
≥ 27.0
Options
2.
Endo Pract 2013;19:327‐36.
•
•
•
•
Phentermine
Orlistat
Lorcaserin
Phentermine / topiramate
• If therapeutic goals are not achieved, intensify lifestyle, medical therapy, and/or surgical interventions for greater weight loss.
Endo Pract 2013;19:327‐36.
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American Society of Bariatric
Physicians (2013)
• Individuals with BMI ≥ 30 or ≥ 27 with weight‐
related comorbidities
•
•
•
Use pharmacotherapy as part of a comprehensive program of nutritional strategies, physical activity, and behavioral therapies.
If there is no clinical improvement after 12 weeks, then consider another pharmacologic option or increase dose (if possible).
If treatment is ineffective, refer to Obesity Medicine Specialist.
The Obesity Algorithm, American Society of Bariatric Physicians, 2013.
American College of Cardiology/American Heart Association/The Obesity Society (2013)
• Pharmacotherapy is indicated for patients who do not achieve goals after the first 6 months.
• Weigh the risks versus benefits of each pharmacologic option.
• If therapeutic goal is achieved with the pharmacologic option, then continue treatment.
Circulation 2013. [Epub ahead of print November 12, 2013]
Surgical Interventions
Surgical Interventions
• Indications
• Individuals with BMI ≥ 40
• Individuals with BMI ≥ 40
• Individuals with BMI ≥ 35 with comorbidities • Individuals who tried but did not respond to nonsurgical therapy
• Roux‐en‐Y gastric bypass
• Biliopancreatic diversion with or without duodenal switch
• Exclusions
• Current substance abuse
• Severe or uncontrolled psychiatric illness
• Poor ability to maintain lifestyle habits after surgery
Circulation 2013;127:945‐59.
• Individuals with BMI < 40
• Laparoscopic gastric sleeve
• Laparoscopic adjustable gastric banding
Circulation 2013;127:945‐59.
Conclusions
•
The key to success should include:
• Dietary approaches, • Physical activity, and
• Behavioral modifications.
•
If lifestyle modifications do not achieve desired weight loss, then a risk‐versus‐benefit assessment should be completed prior to the initiation of phentermine + topiramate, lorcaserin, or orlistat for long‐term use.
•
Consult a obesity specialist if bariatric surgery is considered for a patient.
QUESTIONS?
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