When Diet and Exercise Aren’t Enough - FOMA …...When Diet and Exercise Aren’t Enough:...
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Transcript of When Diet and Exercise Aren’t Enough - FOMA …...When Diet and Exercise Aren’t Enough:...
When Diet and Exercise Aren’t Enough:
Pharmacologic Management of Obesity
Casey Bonaquist, DO
Saturday, April 30th, 2016
17th Annual Primary Care & Cardiovascular
Symposium
Learning Objectives
After participating in this lecture, healthcare providers will be
able to:
Select appropriate patients for anti-obesity
pharmacotherapy
Understand the metabolic effects of therapy
Compare the profiles of anti-obesity agents
Utilize shared decision making with patients
Obesity Recognized as a
Disease
“Obesity is a chronic disease, and both the
patient and practitioner need to understand that
successful treatment requires a life-long effort.”
National Institutes of Health (1998)
Obesity as a Disease
• Recognized By:
– Food and Drug Administration
– American Medical Association (2013)
– Internal Revenue Service
Goals of Medical Weight Loss
5 to 10% Weight Loss
- Reduces Cardiovascular Disease Risk
Factors
- Prevents/Delays Progression of diseases
such as Type II Diabetes
- Improves Obesity Related Conditions
NIH
Guidelines for Medication Use
o ADJUNCT TO OTHER THERAPIES o NUTRITIONAL, PHYSICAL ACTIVITY AND BEHAVIORAL
o BMI ≥ 30 kg/m2
o If comorbidities, BMI 27 ≥ kg/m2
o Reassessment after 12 weeks
o Not pregnant
US Department of Health and Human Services (2013)
Anti-Obesity Pharmacotherapy Approved by the FDA
Agents Action Approval
Phentermine Noradrenergic Sympathomimetic 1959
Orlistat Pancreatic Lipase Inhibitor 1997
Lorcaserin Serotonin-2C Receptor Agonist 2012
Phentermine -Topiramate ER Sympathomimetic/Anticonvulsant 2012
Naltrexone SR-Bupropion
SR
Opioid Receptor Antagonist/
Dopamine and Norepinephrine
Reuptake Inhibitor
2014
Liraglutide GLP-1 Agonist 2014
FDA Criteria
1. 5% or more decrease in body weight
compared to placebo
2. 35% or more study participants lost at
least 5% of body weight
3. Benefits outweigh harms
Short-Term Use (3 Months)
Sympathomimetic Amines: Phentermine
Mechanism of Action: Increases satiety
Stimulation of Hypothalamus
Release norepinephrine
Phentermine
o Side Effects
o Palpitations, tachycardia, increased blood
pressure, insomnia, dysphoria
o Precautions
o CAD, Arrhythmias, Uncontrolled HTN,
hyperthyroidism and substance abuse hx
o Schedule IV
Phentermine
• Frequently prescribed off
label for longer
• Most widely prescribed
• Meta Analysis of 6 studies
– Timeframe: 2 to 24 weeks
– Total weight loss 6.3 Kg
• Similar weight loss in
continuous vs. intermittent
Long-Term Use
Orlistat
Lorcaserin
Phentermine -Topiramate ER
Naltrexone - Buproprion ER
Liraglutide
Orlistat
Mechanism of Action
o Inhibits 1/3 of fat absorption
Side Effects
oCommon: Gastrointestinal
oImproved with Metamucil
oRare: Severe liver disease
Precautions
oMulti-vitamin
Roche Laboratories 2009
Torgerson J S et al. Dia Care 2004;27:155-161
Copyright © 2014 American Diabetes Association, Inc.
~4 kg
1 year
Does Orlistat Meet the FDA
Standards?
1. 5% or more loss of body weight?
No, average 3%
2. 35% or more participants lost at least 5%?
Almost 13 - 34%
3. Benefits outweigh harm?
Likely
(Yanovski 2013)
Locaserin
Mechanism of Action: Selective
Serotonin 2C Receptor Agonist
Eisai Inc. 2013
Locaserin
o Side Effects: Headache, dizziness, fatigue,
nausea
o Potential drug interactions: Serotonergic
or antidopaminergic agents
o Warnings- Valvular heart disease,
psychiatric disorders, cognitive impairment
o Schedule IV
Locaserin
• How to evaluate patient response?
– After 3 months, is weight loss more than 5%
body?
Smith et al.
2010
Does Locaserin Meet the FDA
Standards
1. 5% or more loss of body weight? No,
average is 3%
2. 35% or more participants lost at least
5%? No, 25% of participants
3. Benefits outweigh harm? Unsure, post –
marketing studies
Phentermine - Topiramate ER
o Mechanism of Action: Appetite Suppression
o Side Effects: Paresthesia, dizziness, insomnia, taste
alterations
o Precautions- Alcohol use, non-potassium sparing diuretics
o Contraindication- Glaucoma, Hyperthyroidism, MAOIs
o Pregnancy Category X:
–Cleft Palate
o Monthly Pregnancy testing
o Schedule IV
o Monitoring
o CO2, K+ , Glucose
SEQUEL Study: Weight Loss
Percentage Per BMI
Garvey WT, et al. Am J Clin Nutr. 2012;95:297-308
Does Phentermine – Topiramate
ER Meet the FDA Standards?
1. 5% or more loss of body weight? Yes,
average of 7% weight loss
2. 35% or more participants lost at least 5%?
Yes, 43% lost 5% or more
3. Benefits outweigh harm? Unsure, Post-
marketing studies required
Naltrexone SR - Bupropion SR
Mechanism of Action:
Naltrexone: Opioid Antagonist
Bupropion: Dopamine and Norepinephrine uptake inhibitor
Regulation of food intake
Hypothalamus
Mesolimbic
Dopaminergic
Contraindications: Uncontrolled HTN, Seizure disorders,
Chronic opioid use,
Side effects: Nausea, constipation, headache, vomiting
Naltrexone SR – Buproprion SR
Efficacy (COR-1 Change in Body Weight)
Greenway F et al, Lancet. 2010:376 (9741): 595-605
Naltrexone SR – Buproprion SR
1. 5% or more loss of body weight?
2. 35% or more participants lost at least
5%?
3. Benefits outweigh harm? Unsure
Liraglutide
• Mechanism of Action: Insulin sensitizer,
GLP-1 Receptor Agonist
• Originally marketed for diabetes
• Increased risk of pancreatitis
Liraglutide Efficacy with Low
Calorie Diet (SCALE Study)
Wadden T et al 2013
Non- FDA Regulated
Supplements
Unknown Safety and Efficacy
• Green Coffee Bean Extract
• Garcinia Cambogia
• Raspberry Ketones
• Unicorn hair, ect…
