WHAT S THE SKINNY ON WEIGHT LOSS MEDICATION SAFETY? January 25, 2019 Pennsylvania Pharmacists Association

WHAT S THE SKINNY ON WEIGHT LOSS MEDICATION SAFETY? January 25, 2019 Pennsylvania Pharmacists Association

MEGAN N DUNLOP, PHARMD, CTTS CLINICAL PHARMACIST, UPMC COMMUNITY PROVIDER SERVICES

LEARNING OBJECTIVES Identify some commonly used weight loss medications and supplements Recall side effects associated with weight loss medications Recommend safe weight-loss strategies to patients using patient cases Apply safe weight-loss strategies to your own patient populations through group discussion

BACKGROUND Almost 70% of the US adult population is overweight (BMI 25-29.9) or obese (BMI 30+) 32% of US children are overweight or obese A diet high in carbohydrates and fats will Impair the hormone leptin (appetite suppressor) Increase the hormone ghrelin (which increases appetite) Most effective diets based on calorie deficit (3500 kcal= 1 pound) 2013 Guidelines for Management of Overweight and Obesity

COMMON MEDICATIONS THAT CAUSE WEIGHT GAIN Insulins Prednisone and other corticosteroids Pregabalin, gabapentin Tricyclic antidepressants SSRIs Antipsychotics Lithium Dronabinol 2013 Guidelines for Management of Overweight and Obesity

WEIGHT LOSS MEDICATIONS

Indication: Short term (a few weeks) adjunct for weight loss along with diet and exercise for adults with BMI > 30 kg/m 2 BMI > 27 kg/m 2 with presence of risk factors (diabetes, hypertension) Dose: 37.5 mg daily for most patients, but use smallest amount needed for patient Class: Structurally related to amphetamines, anorexitic Teva. Adipex-P Package insert.

ADIPEX-P Contraindications History of CVD Hypothyroidism Glaucoma Agitated states History of drug abuse Pregnancy/ nursing Warnings and Precautions Primary Pulmonary Hypertension Valvular Heart Disease Tolerance (must discontinue, not increase dose) Risk of abuse and dependence Risk of reactions when used with alcohol (increased CVD risk, increased effect alcohol) Caution in HTN Caution in Diabetes with use of insulin/ hypoglycemic agents Teva. Adipex-P Package insert.

SO IS IT WORTH IT? The magnitude of increased weight-loss in drug-treated patients over placebo-treated patients is only a fraction of a pound per week Anorexitic effect lasts only weeks Too many patient-specific factors to standardize studies Not a substitute to diet and exercise Teva. Adipex-P Package insert

Mechanism: naltrexone decreases food cravings while bupropion decreases appetite Dose: Week 1: 1 tablet every morning Week 2: 1 tablet BID Week 3: 2 tablets every morning and 1 every evening Week 4 and beyond: 2 tablets BID Patient Counseling: Swallow whole, do not take with high fat meal Side effects: NV, constipation, headache, dizziness, dry mouth, sleep disorder, increased BP and HR risk highest in 1 st 3 months Pharm Management of Obesity. J Clin Endocrinol Metab.

CONTRAVE Contraindications Chronic opioid use naltrexone will block opioids and their analgesic effect. Must discontinue 7-10 days before starting Contrave Seizure disorder Abrupt discontinuation of alcohol Uncontrolled hypertention Use of other bupropion-containing products Eating disorders Use of MAO inhibitors, linezolid or methylene blue Pregnancy Warnings and Precautions Boxed Warning: Suicidal ideation in children and young adults (due to the bupropion component) Seizure risk Hepatotoxicity Pregnancy Category X Pharm Management of Obesity. J Clin Endocrinol Metab.

SO IS IT WORTH IT? ~ 11 pounds average weight loss If patient has not lost 5% or more of body weight in 12 weeks, discontinue medication Pharm Management of Obesity. J Clin Endocrinol Metab.

REMS Program: Monthly pregnancy test due to teratogenicity Mechanism: blocking glutamate receptors and weak inhibition of carbonic anhydraseleads to decreased appetite Dose: Start with 3.75/23 mg tablet po qam for 14 days, then titrate up based on weight loss Max dose 15/92 mg daily If Crcl < 50 ml/min, max dose is 7.5/46 mg daily Side effects: Dizziness, tachycardia, headache, cognitive impairment, constipation, dry mouth, insomnia Vivus, Inc. Qsymia.

QSYMIA Contraindications Hypothyroidism Glaucoma MAO inhibitor use in last 14 days Pregnancy/ lactation Warnings and Precautions Pregnancy Category X Do not abruptly discontinue seizure risk Pharm Management of Obesity. J Clin Endocrinol Metab.

SO IS IT WORTH IT? ~19 pound average weight loss If patient has not lost 5% or more of body weight in 12 weeks, discontinue medication Pharm Management of Obesity. J Clin Endocrinol Metab.

Mechanism: Serotonin 5-HT receptor agonist, increases satiety resulting in weight loss Dose: 10 mg po BID Side effects: Headache, dizziness, fatigue, nausea, dry mouth, constipation, hypoglycemia Note: FDA requires manufacture to monitor cardiovascular outcomes Easai, Inc. Belviq.

BELVIQ Contraindications Pregnancy Category X Warnings and Precautions Valvular heart disease Serotonin syndrome CNS effects Decreased WBC, RBC Psychiatric disorders Priapism Pharm Management of Obesity. J Clin Endocrinol Metab.

SO IS IT WORTH IT? ~8 pound average weight loss If patient has not lost 5% or more of body weight in 12 weeks, discontinue medication Pharm Management of Obesity. J Clin Endocrinol Metab.

Mechanism: Long-term lipase inhibitor that decreases the absorption of dietary fat by ~30% Dose: Rx 120 mg po with each meal containing fat OTC 60 mg with each meal containing fat Rx Orlistat only weight loss medication approved in children (ages 12+) Must take multivitamin to replace fat soluble vitamins lost (A,D,E,K) separate medications Side effects: GI upset, flatulence with discharge, fecal urgency, fatty stool H2 Pharma. Xenical.

ORLISTAT Contraindications Pregnancy Malabsorption syndromes Cholestasis Warnings and Precautions Liver damage Kidney stones Hypoglycemia Pharm Management of Obesity. J Clin Endocrinol Metab.

SO IS IT WORTH IT? Efficacy depends on diet Most cannot tolerate GI effects If patient has not lost 5% or more of body weight in 12 weeks, discontinue medication Pharm Management of Obesity. J Clin Endocrinol Metab.

WHICH OF THE FOLLOWING IS A SERIOUS ADVERSE DRUG REACTION ASSOCIATED WITH ADIPEX-P (PHENTERMINE HCL)? A. Red Man Syndrome B. Valvular Heart Disease C. Liver Failure D. Muscular atrophy

WHICH HORMONE NATURALLY SUPPRESSES APPETITE? A. Leptin B. Ghrelin C. Aldosterone D. Testosterone

WHICH WEIGHT LOSS MEDICATION MENTIONED IS THE ONLY WITH A REMS PROGRAM? A. Adipex B. Contrave C. Qsymia D. Alli

WHAT METHODS CAN WE TEACH?

ADA WEIGHT LOSS METHODS Mediterranean Diet DASH Diet Low carb/ low fat diets Plate Method Nutrition labels and calorie counting

PLATE METHOD Create Your Plate. American Diabetes Association.

NUTRITION LABELS US Food and Drug. Nutrition Facts.

PATIENT CASE AP is a 31 yo female who is 195 lbs and 5 4 tall. She has major depressive disorder, for which she takes Wellbutrin XL 150 mg po qd. She also takes a multivitamin. She has no other medications and otherwise lives a healthy lifestyle. AP lives with her husband and two dogs, and is interested in becoming pregnant within the next year. AP has tried diet and exercise, and has even consulted a nutritionist, but is not having any luck loosing weight. She asks you if there is any kind of pill she could take that would help? Which, if any, weight loss medication would you suggest? What would you tell her about it?

PATIENT CASE PK is a 68 yo male with Type II Diabetes (controlled with metformin and glipizide) that comes to your pharmacy for Diabetes Self Management Education. PK is 5 11 and weighs 237 lbs. He was recently told by his doctor that if he doesn t loose weight, he may have to go on insulin some day, and he really does not want that to happen. In addition to diabetes, PK also has high blood pressure, for which he takes lisinopril, and hypercholesterolemia, for which he takes atorvastatin. You learned at DSME class that he is a widower and often eats fast food or a TV dinner for every meal. Which, if any, weight loss medication would you suggest for him? What other weight loss advice might you give him?

DISCUSSION How can you incorporate this information into your own practices?

THANK YOU! Questions? dunlomn@gmail.com

RESOURCES 2013 AHA/ACC/TOS Guideline for the management of Overweight and Obesity in Adults: A Report of thr American College of Cardiology/AHA Task Force on Practice Guidelines and the Obesity Society. J Am Coll Cardiol. 2014; 63:2985-3023. Pharmacological Management of Obesity: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015; 100(2):342-62. Teva. Adipex. 2018. http://www.adipex.com/. Teva Pharmaceuticals USA. Adipex-P Package Insert. 2012. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/085128s065lbl.pdf. Nalpropion Pharmaceuticals, Inc. Contrave. 2018. https://contrave.com/?gclid=cjwkcaia9qhhbrb2eiwa7poaepbxeig4nxlzgwppi1rhdevx6dp_sxrs1zyexr45fghajnwju5zhbxocxasqav D_BwE. Vivus, Inc. Qsymia. 2018. https://qsymia.com/. Easai, Inc. Belviq. 2018. https://www.belviq.com/patient/discover-belviq/proven-results. H2 Pharma, LLC. Xenical. 2018. https://www.xenical.com/. American Diabetes Association. Create Your Plate. 2018. http://www.diabetes.org/food-and-fitness/food/planning-meals/create-your-plate/. US Food and Drug Administration. How to Understand and Use the Nutrition Facts Label. 2018. https://www.fda.gov/food/labelingnutrition/ucm274593.htm.