Understanding Obesity: The Causes, Effects, and Treatment Options

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1 Understanding Obesity: The Causes, Effects, and Treatment Options Jeffrey Sicat, MD, FACE Virginia Association of Clinical Nurse Specialists September 29, 2017 Objectives By the end of this discussion, you should be able to: Understand and appreciate multiple factors contribute to weight gain Discuss the physiology of weight regulation Understand the role of weight loss medications Outline Background and Epidemiology of Obesity Defining Obesity as a Chronic Complex Disease Treatment Options Pharmacology of Obesity Management 1

2 The causes of weight gain are multifactorial Strategies for Weight Loss What is more effective for weight loss? a) Diet b) Exercise The majority of diets do not cause significant sustained weight loss 2

3 Most people who lose regain The body s hormone system adapts to weight loss and tries to regain Multiple Complex Interactions Among Hormonal & Neural Pathways Regulate Food Intake 3

4 Treating obesity requires control of hunger NIH Guidelines for Weight Management BMI Range Treatment Diet and Nutrition Exercise & Activity Behavior Therapy Overweight Overweight Obesity (Class 1) Obesity (Class 2) Obesity (Class 3) 40 or higher Pharmacotherapy (Comorbidities) Surgery (Lap Band with Comorbidities) (With Comorbidities) Newer Anti-Obesity Drugs--- Drug Name (Generic Name) Drug (Brand Name) Approved Lorcaserin Belviq June 2012 Phentermine/topiramate XR Qsymia July 2012 Bupropion/Naltrexone Contrave October 2014 Liraglutide (high dose 3.0 mg) Saxenda December

5 --- 4 Newer Anti-Obesity Drugs--- FDA Approved Indications and Usage Indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial BMI of: 30 kg/m 2 or greater (obese) or 27 kg/m 2 or greater (overweight) in the presence of at least one weightrelated comorbid condition (e.g. hypertension, type 2 diabetes mellitus, or dyslipidemia) Limitations of Use: Effects on cardiovascular morbidity and mortality have not been established The safety and effectiveness in combination with other products intended for weight loss, including prescription, OTC, and herbal supplements has not been established Pregnancy Category X Qsymia (phentermine and topiramate extended release) Qsymia (phentermine/topiramate XR) XR Phentermine: Reduces Hunger Lasting 6-12 hrs Can be stimulating Topiramate XR: Hunger / Satiety / Other Mechanisms? Long Acting / Extended Release Non-stimulating Allison et al. EQUIP Study. Obesity 2011;20:

6 Qsymia (phentermine/topiramate XR) Qsymia (phentermine/topiramate XR) Allison et al. EQUIP Study. Obesity 2011;20: Qsymia (phentermine/topiramate XR) Completers were 84%, 67%, 48% compared to the above which were ITT Allison et al. EQUIP Study. Obesity 2011;20:

7 Qsymia (phentermine/topiramate XR) Garvey et al. SEQUEL Study. Am J Clin Nutrition 2012; 95: Qsymia (phentermine/topiramate XR) XR Side Effects that were significantly more than placebo: Phentermine: Dry Mouth (19%) Constipation (16%) Insomnia (9%) Topiramate XR: Paresthesias (20%) Dizziness (9%) Dysgeusia (9%) Allison et al. EQUIP Study. Obesity 2011;20: Qsymia (phentermine/topiramate XR) Factors to consider: Qsymia is the most potent medication option for weight loss but Qsymia is Pregnancy Category X and can cause birth defects REMS (Risk Evaluation and Mitigation Strategy) Program Counsel women on the risk of orofacial clefts in infants exposed to Qsymia during the first trimester of pregnancy Topiramate can cause cleft palate (1-4%) if taken in 1 st trimester Women of childbearing years MUST be counseled on effect birth control if using this medication Recommend having a pregnancy before starting and monthly while on Qsymia 7

8 Belviq (lorcaresin) Belviq (lorcaserin) FDA Approved June 2012 Appetite suppressant non stimulating Selectively binds to serotonin (5-HT2c) receptors to reduce appetite Does not bind to serotonin (5-HT2b) receptors which could potentially cause valvulopathy (i.e. fenfluramine) Smith et al. BLOOM Study Group. NEJM 2010;363: Belviq (lorcaserin) 5-HT-2c receptors present in the hypothalamus Stimulation reduces hunger BELVIQ SELECTIVELY BINDS 5-HT-2b receptors present in the heart Stimulation can cause valvulopathy FENFLURAMINE MILDLY BOUND Smith et al. BLOOM Study Group. NEJM 2010;363:

9 Belviq (lorcaserin) Average 5.8% weight reduction Smith et al. BLOOM Study Group. NEJM 2010;363: Belviq (lorcaserin) Attained medically significant weight loss Smith et al. BLOOM Study Group. NEJM 2010;363: Belviq (lorcaserin) Factors to consider: Belviq selectively binds to the 5-HT2c receptor to reduce appetite Valvulopathy was not seen greater than placebo up to 2 years It is the only non-stimulating appetite suppressant Side effects noted were: URIs, headaches, dizziness, nausea Exluded from the trials (i.e. not studied) included: Patients with moderate to severe mitral valve regurgitation or in patients with any aortic regurgitation Patients with depression or psychiatric disease requiring psychiatric medications in the last 2 years Belviq Package Insert accessed 4/15/16. 9

10 Belviq (lorcaserin) Warnings and Precautions: Belviq is a serotonergic drug. The development of potentially life threatening serotonin syndrome or neuroleptic malignant syndrome-like reactions have been reported with serotonin agents especially in combination (hyperthermia, muscle rigidity, autonomic instability, AMS) Triptans and dextromethorphan can increase levels of Belviq Belviq can inhibits CYP 2D6-mediated drug metabolism thus increasing levels of medications metabolized by cytochrome P450 2D6 can increase levels of fluoxetine, paroxetine, sertraline, duloxetine In patients with type 2 diabetes, risk of hypoglycemia reduced A1c by 0.9% Rare priapism (avoid in conditions that might predispose including sickle cell, multiple myeloma, peyronies ) Belviq Package Insert accessed 4/15/16. Contrave (bupropion / naltrexone) 10

11 Contrave Warning SUICIDALITY AND ANTIDEPRESSANT DRUGS CONTRAVE is not approved for use in the treatment of major depressive disorder or other psychiatric disorders. CONTRAVE contains bupropion, the same active ingredient as some other antidepressant medications (including, but not limited to, WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL and APLENZIN). Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older. In patients of all ages who are started on CONTRAVE, monitor closely for worsening, and for the emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. CONTRAVE is not approved for use in pediatric patients Contrave 1 year weight loss was 8% in completers Contrave 1 yr weight loss was 12% in completers + aggressive BMOD 11

12 Contrave Saxenda (liraglutide 3.0 mg) 12

13 GLP-1 Mechanism of Action 1. Glucose dependent insulin secretion Restoration of 1 st phase insulin response 2. Reduced hepatic gluconeogenesis 3. Delayed gastric emptying 4. Central reduction of hunger / Weight loss Victoza (liraglutide) (high dose) Astrup et al. International Journal of Obesity. 2012;36: Saxenda 3.0 mg GLP-1 Therapy 1 yr weight loss was 9% in completers Pi-Sunyer et al. SCALE Obesity and Pre-Diabetes Trial. NEJM. 2015;373:

14 Saxenda 3.0 mg GLP-1 Therapy Pi-Sunyer et al. SCALE Obesity and Pre-Diabetes Trial. NEJM. 2015;373: How to start and adjust Saxenda Saxenda Warning WARNING: RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Saxenda causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined Saxenda is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the risk of MTC with use of Saxenda and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Saxenda Saxenda Package Insert accessed 4/15/16. 14

15 Saxenda Risks and Precautions Adverse Symptoms: Nausea Constipation / diarrhea Diarrhea Vomiting Dyspepsia Hypoglycemia (in T2DM pts on sulfonylureas) Dizziness 9.8% Discontinuation Rate due to Adverse Symptoms Saxenda Package Insert accessed 4/15/16. Saxenda REMS Program 1) Potential risk of Medullary Thyroid Cancer Liraglutide causes dose dependent and treatment duration dependent thyroid C-cell tumors in at clinically relevant doses in both genders of rats and mice It is unknown whether Saxenda causes thyroid C-cell tumors, including medullary thyroid cancer in humans as the human relevance has not been determined 2) Risk of Acute Pancreatitis: Based on spontaneous postmarketing reports acute pancreatitis has been observed in people treated with liraglutide In clinical trials there were more cases of pancreatitis in patients treated with Saxenda than placebo Saxenda Package Insert accessed 4/15/16. Conclusions Obesity is a chronic, relapsing, progressive disease Weight gain and obesity have a tremendous affect on our physical and mental health and on our healthcare system Diet is more effective than exercise for weight loss Weight gain is caused by multiple factors Many common medications can cause weight gain The majority of people attempting to lose weight do not succeed with diet and exercise alone Multiple factors beyond a patients control increase hunger and cravings and the desire to eat 15

16 Conclusions Successful long term weight loss requires control of hunger Hunger control can be achieved: Nutritionally, Behaviorally, Pharmacologically, or Surgically Medications enhance the amount of weight lost If diet and exercise fail patients may benefit from a complete medical evaluation to evaluate and treat potential other causes of weight gain Four new medications have been approved since 2012 for chronic weight management Due to its complexity, the treatment of obesity requires a chronic, long-term, multimodal approach QUESTIONS? Jeffrey Sicat, MD, FACE jeffsicat@gmail.com 16

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