Weight loss drugs

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Project ECHO - Nevada
Karmella Thomas, RD, CDE
Brenda Mortara, DTR, dietetic intern
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Weight loss drug history
Recent FDA approvals & common
weight loss drugs
Non-FDA approved drugs being used for
weight loss
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Have you used them with patients in the
past?
What success did patients have?
What was the most challenging for you
when prescribing them?
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1947- FDA approved the first prescription obesity medication
 Desoxyephedrine or methamphetamine
1973- FDA limited all weight loss drugs to short-term use
 concerns with epidemic of amphetamine use
1997- Fenfluramine and Dexfenfluarmine removed
 Concerns with damage to heart valves
1999- First long-term weight loss drug approved
 Orlistat- marketed as Xenical
2010- Meridia removed
 Concerns with  risk of heart attacks and stroke
2012- First long term weight loss drugs approved in 13 years
 Qsymia and Belviq
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Indications:
 BMI >30 OR
 BMI >27 with weight related condition
Use along with reduced calorie diet and
increased physical activity
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Phentermine/Topiramate (Qysmia) and
Lorcaserin (Belviq)
Both approved for long-term weight loss
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3 randomized, placebo controlled studies
Treated for 1 year with extension study for
another year (SEQUEL Trial)
 Reduced calorie diet (500/day), increased water
intake, and increased PA
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Results:
 5.1% weight loss for low dose (3.75/23mg/d)
 7.8 – 9.3% weight loss for medium dose
(7.5/46mg/d)
 9.8 - 10.9 % weight loss for high dose (15/92
mg/d)
Mechanism of Action
Possible Side effects
Contra-indications
Common Side effects
and dosing
Phentermine:
Sympathomimetic
agent
May suppress
appetite and
increase
metabolism
Topiramate:
Antiepileptic drug
Neurotransmittermediated appetite
suppression and
enhancement of
satiety.
Birth defects
Dose related
cognitive impairment
heart rate
Suicidality
Serious eye problems
Mood changes,
trouble sleeping
Memory &
concentration
difficulty
Speech difficulty
Metabolic acidosis
Hypoglycemia
Kidney stones
Elevated Serum
Creatinine
Pregnancy
Plan to or become
pregnant
Glaucoma
Hyperthyroidism
Use of MAO
inhibitors in last 14
days
sympathomimetic
amines or
Topiramate allergy
Dry mouth*
Constipation*
Parasthesia*
Dizziness*
Nephrolithiasis*
Parethesia*
Back pain
Blurred vision
Dygeusia
Insomnia
*Symptoms noted most
often in clinical trials
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3 randomized placebo controlled studies
 1-2 years; included Type 2 diabetics;
habitual diet and exercise until phase 3
 10 mg/day, 15 mg/day, or 10 mg BID
>5% weight loss:
 w/o Diabetes Mellitus Type 2:
 47% drug group (vs 23%)
 With Diabetes Mellitus Type 2:
 38% drug group (vs 16%)
http://health-dietsolution.blogspot.com/2012/10/belviq-vsqsymia-ingredients.html
Mechanism of
Action
Possible Side effects
Main
Contraindications
Acts at the
serotonin 2C
(5-HT2C)
receptors in
the CNS,
particularly
the
hypothalamus
to reduce
appetite
Serotonin syndrome &
Pregneuroleptic malignant
nancy
syndrome type reactions
Nursing
(when combined with
serotinergic drugs)
Valvular heart disease
Cognitive impairement
Psychiatric disorders
Hypoglycemia
Priapism
Bradycardia
Hematological problems
Prolactin elevation
Pulmonary HTN
Common Side
effects
Headaches*
Dizziness*
Upper respiratory
infections*
Nausea*
Nasopharyngitis
Fatigue
Dry mouth
Constipation
DM:
Hypoglycemia
Headache
Back pain
Cough
Fatigue
*Symptoms noted
most often in clinical
trials
http://www.mydietpill.ca/phentermine-in-canada
http://www.treatdiscreet.co.uk/products/189-alli-capsules-120-pack
COMMON WEIGHT LOSS
MEDICATIONS
http://drugline.org/drug/medicament/17220/
Mechanism of
Action
Possible Side
effects
ContraIndications
Common Side
effects
FDA
Lipase
inhibitorreduces
absorption of
fat by ~30%
Severe liver
problems and
risk of liver
failure
Kidney
stones
Possible fat
soluble
vitamin
deficiency
w/o
adequate
supplementat
ion
Gallbladder
problems
Gallbladder
problems
Chronic
malabsorptio
n syndrome
Pregnancy
Nursing
Steatorrhea
Bloating
Oily
spotting
Fecal
urgency
Fecal
incontinence
Gas with
oily
discharge
 # of stools
n/v/d/abd
pain
Approved in
1999.
First drug
for long-term
weight loss
drug
approved.
Mechanism of
Action
Over the
counter
Possible Side
effects
Severe liver
problems and
risk of liver
Lower dose failure
of Xenical
Kidney
stones
Lipase
Possible fat
inhibitorsoluble
reduces
vitamin
absorption of deficiency
fat by ~30%
w/o
adequate
supplementat
ion
Gallbladder
problems
Indication
Common Side
effects
FDA
Contraindications:
Gallbladder
problems
Chronic
malabsorptio
n syndrome
Steatorrhea Approved in
1999
Oily
spotting
Gas with
oily
discharge
 # of stools
n/v/d/abd
pain
Mechanism of
Action
Possible Side
effects
Contraindications
Common Side
effects
FDA
Acts as a
sympathomim
etic agent
Risk of abuse
and
dependency
Primary
pulmonary
HTN
Ischemic
events
Valvular
heart disease
-Tachycardia
HTN
Effect on
ability to
engage in
potentially
hazardous
tasks
Pregnancy
Nursing
Hx of
CVD,CAD,
stroke,
arrhythmias,
uncontrolled
HTN
Hyperthyroidi
sm
Glaucoma
Epilepsy
Hx of drug
abuse
Headaches
Dizziness
Fatigue
Nausea
Vomiting
Irritability
Dry mouth
Diarrhea or
Constipation
Approved in
1959
May suppress
appetite,
increase
metabolism
Meant for
short term
weight loss
adults who are
exercising
reduce kcal
diet.
Originally
marketed with
fenfluramine
as a combo
appetite
suppressant
and fat
burning agentFen-Phen
1997fenfluramine
taken off the
market
voluntary at
request of FDA
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Human Chorionic Gonadotropin (HCG)
Over the counter weight loss drugs
 Ephedra, chromium, hoodia, diuretics, herbal
laxatives
 Common components
 sibutramine,fenproporex,fluoxetine,
bumetanide, furosemide, phenytoin,
rimonabant, cetilistat, phenolphthalein
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Polypeptide hormone produced by the human
placenta.
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Approved by FDA as RX for infertility or pituitary
gland disorder in young boys
First introduced as a weight loss drug by Dr. Albert T. W.
Simeon in the 1950’s
 1954-Published a book—Pounds and Inches
Popularized by Kevin Trudeau
 2007-Published a book
 The weight loss cure “they”
don’t want you to know about
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Causes a more attractive or “normal”
distribution of fat
Decreases hunger and discomfort
associated with calorie restricted diets
http://www.alivamax.com/hcg-diet-label.php
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Low fat diet of 500kcal/day
Breakfast:
 Tea or coffee with 1T milk
Lunch:
 100g protein- boiled or grilled and weighed
raw
 Higher fat fish not allowed
 One vegetable from approved list
 One fruit from approved list
Dinner
 Same four choices as lunch
http://hcgdietinfo.co
m/Diet-HCG.htm
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Pulmonary embolisms, depression, heart attack, death
Effect of very low calorie diet: heart arrhythmias,
electrolyte imbalances, gallstone formation
Men:
 Breast enlargement
 Decreased sperm production
 Infertility
Women:
 Irregular periods & vaginal bleeding
 Ovarian cysts
 Headaches
 Increased long term risk of breast cancer
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“HCG has not been demonstrated to be
effective adjunctive therapy in the treatment
of obesity. There is no substantial evidence
that it increases weight loss beyond that
resulting from caloric restriction, that it
causes a more attractive or “normal”
distribution of fat, or that it decreases the
hunger and discomfort associated with
calorie-restricted diets.”
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“We conclude that the scientific evidence does
not support the use of HCG for the treatment
of obesity. This position is in agreement with
the U.S. FDA. The Obesity Society is
committed to advocating the use of therapies
for the treatment of obesity that are evidencebased and rejects those that have been shown
to be ineffective.”
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Many different options for treatment
Evidence-based treatment
Weighing the benefits with the risks
Keeping treatment individualized
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To name a few..
 Counseling for behavior change
 Medically supervised diets
 Weight loss drugs
 Bariatric surgery
FDA approves Belviq to treat some overweight or obese adults. US Food and Drug Administration. Accessed August 1, 2014.
Available at:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm309993.htm
Belviq. Belviq.com. Accessed July 29, 2014. Available at: http://www.belviq.com/
Belviq. Drugs.com. Accessed July 29, 2014. Available at: http://www.drugs.com/belviq.html
Locaserin (Belviq). British Journal of Clinical Pharmocology. Accessed August 6, 2014.. Available at:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3828930/
FDA approves weight-management drug Qsymia. US Food and Drug Administration. Accessed July 31, 2014. Available at:
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm312468.htm
Qsymia. Drugs.com. Accessed: July 29, 2014. Available at: http://www.drugs.com/pro/qsymia.html
Phentermine/Topiramate Extended-Release Capsules (Qsymia) for Weight Loss. Pharmacy and Therapeutics. Accessed
August 6, 2014. Available at:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3814438/
Pharmacotherapy for obesity. British Journal of Clinical Pharmocology. Accessed August 6, 2014. Available at:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2810792/
Medications Target Long-Term Weight Control. US Food and Drug Administration. Accessed July 30, 2014. Available at:
http://www.fda.gov/forconsumers/consumerupdates/ucm312380.htm
Phentermine. Drugs.com. Accessed July 28, 2014. Available at: http://www.drugs.com/phentermine.html
Drugs and medications: Phentermine. WebMD. Accessed July 30, 2014. Available at:
http://www.webmd.com/drugs/drug-4151-Phentermine.aspx?drugid=4151&drugname=Phentermine
Phentermine, Adipex-P, Fastin (Discontinued), Obenix, Oby-Trim (Discontinued), Suprenza. Medicinenet.com. Accessed July 29,
2014. Available at: http://www.medicinenet.com/phentermine/article.htm
Human chorionic gonadotropin(HCG)-an ineffective approach to treating obesity. Obesity society. Accessed August 6, 2014.
Available at:
http://www.obesity.org/images/TOSpositionPaperlHCGrxObesityRevised12-12_-_Final_Approved_1-23-13.pdf
HCG diet products are illegal. US Food and Drug Administration. Accessed: August 4, 2014. Available at:
http://www.fda.gov/forconsumers/consumerupdates/ucm281333.htm
Does the HCG diet work — and is it safe? Mayo Clinic. Accessed July 30, 2014. Available at:
http://www.mayoclinic.org/healthy-living/weight-loss/expert-answers/hcg-diet/faq-20058164
hCG for Weight Loss. WebMD. Accessed July 29, 2014. Available at: http://www.webmd.com/diet/hcg-for-weight-loss
HCG. Drugs. Com. Accessed July 30, 2014. Available at: http://www.drugs.com/hcg.html
Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Products. US Food and Drug Administration.
Accessed August 6, 2014. Available at:
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm136187.htm
Orlistat. Drugs.com. Accessed July 28,. 2014. Available at: http://www.drugs.com/orlistat.html
Orlistat, Xenical, Alli. Medicinenet.com. Accessed July 28, 2014. Available at: http://www.medicinenet.com/orlistat/article.htm
Xenical Orlistat. Xenical.com. Accessed July 28,2014. Available at: http://www.xenical.com/xenical/
Alli: everything you need to know. WebMD. Accessed July 28, 2014. Available at: http://www.webmd.com/diet/alli-orlistatfor-weight-loss