PHARM - Obesity Treatment.pdf

MPAP 517: Obesity Treatment Allison Presnell, PharmD, BCACP, BC-ADM, CPP Clinical Assistant Professor, CPHS Clinical Pharmacist Practitioner, Duke Family Medicine [email protected] February 14, 2024 Objectives Discuss the mechanism of action, indications, therapeutic course, contraindication...

MPAP 517: Obesity Treatment Allison Presnell, PharmD, BCACP, BC-ADM, CPP Clinical Assistant Professor, CPHS Clinical Pharmacist Practitioner, Duke Family Medicine [email protected] February 14, 2024 Objectives Discuss the mechanism of action, indications, therapeutic course, contraindications, drug interactions, side effects, and monitoring parameters of pharmacotherapeutic agents commonly used for weight loss Develop an evidence-based pharmacologic treatment plan for an obese patient based on patient specific factors Develop a monitoring plan to assess the efficacy and safety of pharmacologic therapy initiated Obesity in the US (Adults) What percentage of adults in the US are living with obesity? a) 28 b) 32 c) 38 d) 42 Adult Obesity Facts | Overweight & Obesity | CDC. Classification Classification BMI (kg/ m2) Underweight < 18.5 Normal weight 18.5-24.9 Overweight 25-29.9 Class I Obesity 30-34.9 Class II Obesity 35-39.9 Class III Obesity (morbid) ≥40 Waist Circumference and Comorbidity risk Men ≤ 40 in Women ≤ 35 in Men > 40 in Women > 35 in Increased High Very High Extremely High High Very High Very High Extremely High Garvey WT, et al. Endocr Pract. 2016;22(3):1-203. Risk Factors/Causes Eating/Physical Activity Patterns Insufficient Sleep Social Determinants of Health (SDOH) Genetics Illnesses Medications Causes of Obesity | Overweight & Obesity | CDC Physiology of Weight Loss Physiology of Weight Loss | Rethink Obesity® Hormones and Metabolic Adaptation in Weight Loss Ghrelin Hunger hormones increase Satiety hormones decrease Amylin Insulin Leptin GLP-1 PYY CCK N Engl J Med. 2011;365(17):1597-1604. Weight Management Guidance Gastroenterology 2022;163:1198–1225 Who qualifies for weight loss medication? The AGA 2022 panel strongly recommended the use of pharmacotherapy in addition to lifestyle intervention (diet and exercise) in adults with: kg/m2 1) BMI ≥30 OR 2) BMI ≥27 kg/m2 and ≥1 weight-associated comorbidity (HTN, dyslipidemia) 1) Lifestyle modifications 2) Medication 3) Follow-up Patient specific factors If patient loses ≥ 5% body weight after 3 months, continue the medication If not, discontinue and try alternative medication/ approach Comorbidities Patient preference Associated adverse effects Cost Am J Manag Care. 2022;28(suppl 15):S288-S296 Diet and Lifestyle Modifications Diet and Lifestyle Modifications Meal Plan Calorie deficit Eating patterns: Mediterranean, DASH low-carb low-fat intermittent fasting keto Whole 30 intuitive eating volumetric high protein vegetarian Physical Activity Aerobic activity: goal > 150 mins/week Resistance exercise Decrease sedentary behavior Behavior Goal setting Education Stress reduction Motivational interviewing Self-monitoring Stimulus control Cognitive restructuring Psych evaluation, counseling, treatment if needed Endocr Pract. 2016;22(3):1-203. Formalized Non-Pharmacologic Approaches Do-itYourself Overeaters Anonymous Take off Pounds Sensibly (TOPS) Nonclinical Diet Center Jenny Craig Nutri/System Weight Watchers Noom MyFitnessPal Clinical Health Management Resources (HMR) Medifast, Optifast New Direction Medical-based Programs Polling Question Have you ever tried one of the meal plans mentioned on the previous slide? a) Yes b) No 71 Bariatric Surgery Bariatric Surgery Eligibility BMI 30-34.9 AND diabetes or metabolic syndrome BMI ≥ 35 AND at least one obesity-related complication (i.e. T2DM, HTN, OSA, GERD, etc) BMI ≥ 40 without coexisting medical problems Type Mechanism Biliopancreatic diversion +/- duodenal switch Gastric banding Sleeve gastrectomy Roux-en-Y gastric bypass Vertical banded gastroplasty Malabsorptive/Restrictive Restrictive Restrictive (Most common) Restrictive/Malabsorptive Restrictive (Rarely performed) 72 Garvey WT, et al. Endocr Pract. 2016;22(3):1-203. Bariatric Surgery and Medication Use (therapeuticresearch.com). Pharmacotherapy for Weight Loss Goals of Weight Loss Associated Risk Weight Loss Goal* Clinical Goal No Comorbidity At least 5% Metabolic Syndrome Pre-Diabetes Type 2 Diabetes Mellitus 10% 10% 5-15% Dyslipidemia 5-15% Hypertension 5-15% Asthma/Reactive Airway Disease 7-8% Disease prevention Improved sense of wellbeing Improved physical function Prevent T2DM Prevent T2DM Reduce A1C Reduce medication use Diabetes remission Lower TG and non-HDL-c Increase HDL Lower systolic and diastolic BP Reduce medication use Improves FEV1 Improves symptoms *3-6 months Pharmacologic Treatment Strategies ✓Appetite altering drugs Appetite suppressant ↑ satiety ↓ hunger ✓Absorption altering drugs Decreased absorption of nutrients/calories X Thermogenesis increasing drugs Increase energy expenditure, metabolic rate Phentermine (Adipex-P®) Sympathomimetic, stimulant (C IV) Sympathomimetic, stimulant (C IV) Adjunct to diet and exercise for short-term use (max 12 weeks), but commonly used longer Decreases appetite by stimulating hypothalamus to release norepinephrine (and dopamine) Dosing (Ages 17 years and up) Dosing (Ages 17 years and up) 15-37.5mg daily 1-2 times daily (first dose before breakfast or 1-2 hours after) Contraindications/warnings, DDI Contraindications/warnings, DDI Cardiovascular disease (i.e., uncontrolled hypertension), hyperthyroidism, glaucoma, drug abuse, seizure disorder, Tourette’s, MAO inhibitors within the past 14 days DDI: sympathomimetics, EtOH, serotonergic agents, TCA, opioids Side effects Side effects Increased heart rate, increased blood pressure (BP), headache, tremor, anxiety MAO inhibitors: monoamine oxidase inhibitors 75 Adipex-P (phentermine) [prescribing information]. Parsippany, NJ: Teva Pharmaceuticals USA Inc; September 2020. Phentermine/Topiramate ER (Qsymia®) Sympathomimetic/antiepileptic extended release combination Sympathomimetic/antiepileptic extended release combination (C IV) (C IV) Suppresses appetite and increases satiety Risk Evaluation and Mitigation Strategy (REMS) Risk Evaluation and Mitigation Strategy (REMS) Pregnancy Category X: teratogenic risk Dosing (Ages 12 years and up) Dosing (Ages 12 years and up) Dose: 3.75 mg/23 mg x 14 days -> 15 mg/92 mg PO QAM x 12 weeks If 18 years Week 1-4: 2.5 mg/week Week 5-8: 5 mg/week Week 9-12: 7.5 mg/week Week 13-16: 10 mg/week Week 17-20: 12.5 mg/week Week 21+: 15 mg/week 82 Saxenda (liraglutide) [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc; April 2023. Wegovy (semaglutide) [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc; July 2023. Cellulose + Citric Acid (Plenity®) FDA-cleared medical device, BMI 25-40 FDA-cleared medicalkg/m device, BMI 25-40 kg/m2 Gel matrix fills stomach/small intestine and create a sensation of fullness to increase satiety Dosing years and up) Dosing (Ages 18 (Ages years18and up) 2.25 g (3 capsules) twice daily before two largest meals Side effects Side effects Abdominal pain/distension, bloating, irregular bowel movements 86 Plenity (cellulose/citric acid) [prescribing information]. Boston, MA: Gelesis Inc; September 2021. Mean Weight Loss for Medications Medication Clinical Trial Weight Loss Plenity (cellulose/citric acid) Xenical (orlistat) Phentermine Contrave (naloxone/bupropion) Saxenda (liraglutide) Qsymia (phentermine + topiramate) Wegovy (semaglutide) Zepbound (tirzepatide) ~2 kg over 24 weeks 3.45 kg over 52 weeks ~3.6 kg over 24 weeks ~4.1 kg over 56 weeks 3.7-5.2 kg over 56 weeks ~9 kg over 52 weeks 10.6-12.7 kg over 56 weeks 18.65 kg over 72 weeks 83 Pharmacist’s Letter. Weight Loss Products. August 2021. N Engl J Med 2022;387(3):205-16. Special Population Considerations GLP, GLP/GIP Agonists Phentermine Orlistat Phentermine/ Naltrexone/ Topiramate Bupropion CVD Monitor HR Avoid Safe Avoid Avoid Hypertension Safe Caution Safe Caution Caution Depression Safe Safe Safe Safe Avoid Type 2 DM Safe Safe Safe Safe Safe Hx of Seizures Safe Caution Safe Caution Avoid Opioids Safe Safe Safe Safe Avoid Pregnancy Avoid Avoid Avoid Avoid Avoid 30-49 ml/min Avoid dehydration Safe Safe Max Max 7.5/46 mg QD 8/90 mg BID