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Weight Loss Pharmacotherapy

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Randy Rostock

on 29 January 2013

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Transcript of Weight Loss Pharmacotherapy

Lorcaserin - 5HT Receptor Antagonist Weight-Loss Pharmacotherapy
Options Randy Rostock
PharmD candidate, 2013
Idaho State University
College of Pharmacy Diet
Exercise
Behavior modification
Drug therapy in combination with the above
Concerns:
Efficacy
Safety
Weight-loss often plateaus with continued treatment, and most patients regain their weight when their weight-loss drugs are stopped. Strategies Weight Loss
treatment-eligible BMI
>30 (Obese)
>27-30 (Overweight) w/ co-morbid conditions
Waist circumference (enlarged = higher risk)
Assessment of co-morbid diseases:
Diabetes mellitus
Dyslipidemia
Hypertension
Heart disease
Obstructive Sleep Apnea Initiating weight loss drug therapy
“Effective” therapy
>2 kg weight loss during the first month
one pound per week
>5% below baseline by 3-6 months, and remain there
In trials (generally)
10-15% weight loss = very good response
>15% weight loss = excellent response Goals of therapy Considerations to be made prior to drug therapy initiation: Goals for drug therapy should be realistic, attainable Benefits of weight loss psychological one three two physiological lower blood pressure
improving serum lipid concentrations
increasing insulin sensitivity
reducing hyperglycemia increased
self-confidence
motivation
self-control Counsel patient Initiating weight loss therapy
Diet
Exercise
Goals for weight loss currently available FDA approved drugs for the treatment of Obesity: Short-term use: (noradrenergics)
Diethylpropion
Phentermine
Benzphetamine
Phendimetrazine
Long-term use:
Orlistat - Pancreatic Lipase inhibitor Belviq

Qsymia The new drugs on the block Pharmacotherapy Orlistat Dose: 120mg po TID with fat-containing meals
Only currently available long-term obesity treatment
MOA: Alters fat digestion by inhibiting pancreatic lipases
Fecal fat excretion is increased (up to 30% of ingested fat is not digested) 60mg capsules available OTC as Alli (Xenical) 2C Approved
June 2012 Lorcaserin Not yet available
MOA: antagonist at 5HT receptor expressed in brain, including hypothalamus, which is involved in the control of appetite and metabolism
Thought to promote weight-loss through satiety
Dosing: 10mg twice daily (Belviq, Lorqess) Novel 5HT Receptor Antagonist
FDA approved June 2012 for the treatment of obesity Investigational products Bupropion SR / Naltrexone SR (Contrave) Pramlintide/metreleptin
Tauro/UrsoDeoxy-Chloic Acid (TUDCA) On the Horizon Tip is
growing Obesity One of the most important public health problems in the United States
Rates have more than doubled in adults and children since the 1970’s
As prevalence has increased, so have co-morbidities: almost 1/3 of children and adolescents are overweight or obese Environmental factors contributing toward obesity:
increasing glycemic index of foods
sugar-containing beverages
larger portion sizes for prepared foods
fast food service
diminishing family presence at meals
decreasing structured physical activity
shortened sleep duration
television viewing Environmental factors Prevalence Need for weight management options In 2008
est. $147 billion in obesity-associated medical costs
Obese patients cost an average of $1,429 more than those of normal weight heart disease
stroke
type 2 diabetes
cancer Costs Currently >35.7% of U.S. adults are obese Why are so many becoming obese? Increased caloric intake
Decreased physical activity Gall stones
oily spotting
fecal incontinence, urgency or frequency Common or Serious Side effects Contraindications Chronic malabsorption syndrome
Cholestasis
hypersensitivity
pregnancy Clinical Pearls Recommend a vitamin A,D,E,K, and beta carotene containing Multivitamin taken >2 hours apart from orlistat
Monitor drug-drug and absorption interactions
warfarin - increased INR
decreased effects of amiodarone, contraceptives, antiepileptics, etc. Noradrenergic anorexiants All sympathomimetic anorexiants
Approved as SHORT term adjunct therapies
MOA: decreased appetite, increased hypothalamic norepinephrine release Diethylpropion (Tenuate)
Phentermine (Adipex-P, generics)
Benzphetamine (Didrex)
Phendimetrazine (Bontril)
methamphetamine (Desoxyn) pulmonary hypertension
valvular heart disease
ischemic events
dependence, withdrawal
psychosis
tachycardia, HTN, CNS stimulation
increased blood pressure
euphoria, dysphoria
HA, GI complaints
Bone marrow suppression (DEP) Common or Serious Side effects Clinical Pearls Contraindicated in pulmonary HTN, severe atherosclorosis or HTN, hyperthyroidism, glaucoma, PMH drug abuse
Avoid use within 14 days of MAOI
Consider baseline cardiac eval/echo
discontinue if ineffective at 4 weeks
caution w/ seizure, CNS drugs, DM, arrythmias Efficacy pooled analysis of 2-24 week studies:
mean weight loss of 6.6-7.9lbs more than placebo in a
Varies by agent
Combined with exercise and/or diet Phentermine/topiramate Efficacy Common or serious adverse effects 2-year RCT:
mean weight loss of 7 lbs over placebo
Combined with lifestyle changes and/or diet oily or fatty stool
abdominal or rectal pain
nausea
hepatitis, pancreatitis Efficacy 1 year study:
7.6 lbs more than placebo
over half of pts lost 5% of baseline body weight
when combined with lifestyle changes and/or diet Nausea
Headache
Dizziness
Fatigue
Constipation
Euphoria Cognitive impairment
Hallucinations
Dissociation
Bradycardia
Pancytopenia Clinical Pearls Contraindications
Pregnancy
Monitor for serotonin syndrome and neuroleptic malignant syndrome
Caution in valvular heart disease, hyperprolactinemia, pulmonary HTN, and CHF
Monitor: CBC periodically, suicidality, priapism Approved
June 2012 Approved
July 2012 Phentermine/topiramate Topiramate can cause birth defects (Qsymia) Combined low dose sympathomimetic anorexiant and extended-release anticonvulsant
FDA approved July 2012 for the treatment of obesity
Risk Evaluation and Mitigation Strategy (REMS) to help prevent use during pregnancy Efficacy Common or serious adverse effects mean weight loss of 20 lbs over placebo (with max dose)
When combined with lifestyle changes and/or diet Paraesthesia
Dizziness
Dysgeusia
Insomnia
Hypokalemia
Metabolic acidosis
Constipation
Dry mouth Decreased sweating
Tachycardia
Anxiety
Fatigue
Cognitive impairment
Kidney stones
Elevated sCr
Hypotension Clinical Pearls Contraindications
Pregnancy
glaucoma
hyperthyroidism
MAOI use within 14 days
Ensure adequate fluid intake
Watch for increased body temp, decreased sweating
Monitor: pregnancy monthly, electrolytes, glucose, suicidality periodically
Avoid in severe liver disease or ESRD, or concomitant alcohol use
Taper to avoid withdrawal seizure (with antihypertensives) prescriber training
MedGuides for patients
initial availability at specialty pharmacies only What to expect "but it's just phentermine & topiramate..." Qsymia (Phentermine/Topiramate) prescribers may be tempted to prescribe phentermine and topiramate separately
note that dosing is different
topiramate is extended-release Will be a controlled substance due to small incidence of euphoria Other agents used for weight loss Bupropion (Wellbutrin SR, generics) patients with co-morbid depression
AEs: seizure, CNS stimulation, dry mouth, nausea, increased BP, suicidality Exenatide (Byetta, Bydureon) Patients with co-morbid diabetes
AE's: hypoglycemia, nausea, vomiting, pancreatitis (exenatide, liraglutide) Human Chorionic Gonadotropin (HCG)

Thyroid replacement


Ephedra-and-similar-substance-containing dietary supplements Topiramate (Topamax)
Zonisamide (Zonegran) 17 lbs (32 weeks) 14.5 lbs (1 year) 3.7 lbs (6 months) 17 lbs (2 years) 6.1 lbs (weight loss over placebo at 6-12 mo) 5-7 lbs (24 weeks) Liraglutide (Victoza)
Pramlintide (Symlin) MOA: Combines sympathomimetic anorexiant with weight loss effects seen with topiramate
Dosing: 3.75/23mg once daily, titrated to 15/92mg if needed Avoid in pregnancy
AE's: (zonisamide) skin and hematologic rxns, mood disorders, psychosis, cognitive impairment, somnolence, memory/concentration problems, dizziness, ataxia, HA, fatigue, muscle damage, renal impairment, pancreatitis, metabolic acidosis Not currently recommended lipase blocker, similar to orlistat
possibly better tolerated rejected by FDA February 2011
CV effects studies are incomplete metabolite of ursodiol that increases leptin sensitivity, suppressing appetite Bupropion SR / Zonisamide SR (Empatic)
Cetilistat Tesofensine Promising Investigational Agents References Questions? Approved
July 2012 some of the leading preventable causes of death dopamine, noradrenaline and serotonin reuptake inhibitor Bray GA, Mulder JE, Overview of therapy for obesity in adults. UpToDate, Waltham, MA, 2012. Accessed August 24, 2012.
Flegal KM, Carroll MD, Kit BK, et al. Prevalence of Obesity and Trends in the Distribution of Body Mass Index Among US Adults, 1999-2010. JAMA. February 2012;307(5):491-497.
United States Health and Nutrition Examination Surveys (NHANES).
Centers for Disease Control and Prevention. CDC Grand Rounds: Childhood obesity in the United States. MMWR Morb Mortal Wkly Rep 2011; 60:42.
PL Detail-Document, Drugs for Weight Loss. Pharmacist’s Letter/Prescriber’s Letter. April 2012.
“FDA approves weight-management drug Qsymia” U.S. Food and Drug Administration News Release http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm312468.htm/ Accessed August 24, 2012.
Lexi-Comp Online. Lexi-Drugs Online. Hudson, OH: Lexi-Comp, Inc.; 2012. http://online.lexi.com/. Accessed August 23, 2012.
Micromedex Healthcare Series. DRUGDEX System. Greenwood Village, CO: Thomson Healthcare; 2012. http://www.thomsonhc.com/. Accessed August 24, 2012.
Gadde KM, Franciscy DM, Wagner HR, Krishnan KR. Zonisamide for weight loss in obese adults: a randomized controlled trial. JAMA 2003;289:1820-5. 2C 2C No reliable data Product labels specifically warn against use for obesity Not FDA approved or regulated
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