An Individualized Approach to Optimize Obesity Treatment Louis Aronne, MD
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1 An Individualized Approach to Optimize Obesity Treatment Louis Aronne, MD Sanford I. Weill Professor of Metabolic Research Director of the Comprehensive Weight Control Program Weill Cornell Medical College New York City, NY
2 FDA-Approved Obesity Pharmacotherapy Options Phentermine (and other noradrenergic agents) Orlistat Lorcaserin Phentermine/topiramate ER Naltrexone SR/bupropion SR Liraglutide 3.0 mg Indications: Adjunct to behavioral modification in BMI >30 kg/m 2 or kg/m 2 with comorbidities. All obesity medications contraindicated in pregnancy
3 Phentermine Sympathomimetic amine; NE release Blunts appetite Approved 1959; short-term use Schedule IV Dosing: mg qam Contraindications: Pregnancy, nursing, MAOIs, glaucoma, drug abuse history, hyperthyroidism, uncontrolled HTN, tachycardia, history of CAD, CHF, stroke Phentermine [package insert]. Cranford, NJ: Alpex Pharma SA : Munro JF, et al. Br Med J. 1968;1(5588):
4 Orlistat Lipase inhibitor, decreases fat absorption Approved 1999; long-term use Not scheduled 120 mg TID with meals (Rx) or 60 mg TID (OTC) Use MVI with fat-soluble vitamins at bedtime Contraindications: pregnancy, chronic malabsorption syndrome, cholestasis Possible GI AEs Torgerson JS, et al. Diabetes Care. 2004;27: Orlistat [package insert]. South San Francisco, CA : Genentech: 2012; Orlistat [package insert]. Moon Township, PA: GlaxoSmithKline: 2011.
5 Orlistat and Prevention of Diabetes Torgerson JS, et al. Diabetes Care. 2004;27:
6 Lorcaserin Selective 5HT-2c receptor agonist Increases satiety Approved in 2012 for long-term use Schedule IV Single dose: 10 mg BID; discontinue if <5% BWL after 12 weeks Contraindications: pregnancy Warnings: coadministration with serotonergic agents; valvular heart disease; psychiatric disorders, priapism BELVIQ [Prescribing Information]. Woodcliff Lake, NJ: Eisai Inc; 2012; Fidler MC, et al. J Clin Endocrinol Metab. 2011;96:3067; Smith SR, et al. N Engl J Med. 2010;363(3):245.
7 Key Secondary Endpoints Endpoint Lorcaserin Placebo P Waist circumference (cm) <0.001 SBP/DBP (mm Hg) 1.4/ / /0.01 Cholesterol (% ) Total LDL HDL Triglycerides (%) <0.001 A1c <0.001 Heart rate (bpm) Beck depression II Smith SR, et al. N Engl J Med. 2010;363(3):245. O Neil PM, et al. Obesity. 2012;20:
8 Outcomes By Responder Status BELVIQ [Prescribing Information]. Woodcliff Lake, NJ: Eisai Inc; Smith SR, et al. Obesity. 2014; Jul 18. doi: /oby
9 Lorcaserin: Weight Change in 2 nd Year of Treatment versus Placebo Smith SR, et al. N Engl J Med. 2010;363:
10 Lorcaserin: Adverse Events and Discontinuation N (%) Lorcaserin (N = 3195) Placebo (N = 3185) Discontinuation Lorcaserin Discontinuation Placebo Headache 537 (16.8) 321 (10.1) 1.3% 0.8% Dizziness 270 (8.5) 122 (3.8) 0.7% 0.2% Nausea 264 (8.3) 170 (5.3) Constipation 186 (5.8) 125 (3.9) Fatigue 229 (7.2) 114 (3.6) Dry mouth 169 (5.3) 74 (2.3) Hypoglycemia in T2DM 75 (29.3) 53 (21.0) % % Overall 8.6% 6.7% Smith SR, et al. N Engl J Med. 2010;363: ; O Neil PM, et al. Obesity. 2012;20: ; Lorcaserin (Prescribing Information) Woodcliff Lake, NJ Eisai Inc
11 Phentermine/Topiramate ER Phentermine: blunts appetite Topiramate: prolongs satiety Approved in 2012 for long-term use Schedule IV Four fixed-dose options in 3.75 mg/23 mg increments Titrate or discontinue if <3% weight loss at 12 weeks Contraindications: pregnancy, glaucoma, MAOIs, hyperthyroidism Phentermine and topiramate extended-release [package insert]. Mountain View, CA : Vivus; 2012.
12 Garvey WT, et al. Am J Clin Nutr. 2012;95(2): Phentermine/Topiramate ER
13 Patients With Extreme Obesity (BMI >45) Kahan S, et al. The Obesity Society Annual Meeting, Poster T P 3143.
14 Phentermine/Topiramate ER Prevents Progression to Type 2 Diabetes Mellitus % Annualized Incidence of T2DM Progressors per year (%) % 1.7% P= % 0.9% P= Placebo Phen/TPM CR 7.5/46 mg Phen/TPM CR 15/92 mg Garvey WT, et al. Am J Clin Nutr. 2012;95:
15 Most Common Adverse Events Phentermine and topiramate extended-release [package insert]. Mountain View, CA: Vivus; 2012.
16 Adverse Reactions Leading to Treatment Discontinuation Placebo (n=1561), % Phentermine/ Topiramate ER 3.75 mg/23 mg (n=240), % Phentermine/ Topiramate ER 7.5 mg/46 mg (n=498), % Phentermine/ Topiramate ER 15 mg/92 mg (n=1580), % Vision blurred Headache Irritability Dizziness Paresthesia Insomnia Depression Anxiety Qsymia (phentermine and topiramate) capsules [package insert]. Mountain View, CA: Vivus; 2014.
17 Naltrexone SR/Bupropion SR Bupropion: Dopamine/norepinephrine reuptake inhibitor Naltrexone: opioid receptor antagonist Approved 2014 Long-term use; not controlled Dosing (8 mg/90 mg tabs): titrate weekly to 2 BID Consider discontinuation if <5% weight loss after 12 weeks Contraindications: pregnancy, seizures, uncontrolled HTN, chronic opioid use, MAOI use Contrave prescribing information. Takeda Pharmaceuticals. Greenway FL, et al. Obesity. 2009;17: Billes SK, et al. Pharmacol Res. 2014;84;1-11.
18 Naltrexone SR/Bupropion SR: Mechanism of Action α-msh - β-endorphin + MC4 receptor μ-opioid receptor Billes SK, et al. Pharmacol Res. 2014;84:1-11.
19 Naltrexone SR/Bupropion SR: Patients Completing 1 Year of Treatment Wadden TA, et al. Obesity. 2011;19: Hollander P, et al. Diabetes Care. 2013;36(12): Greenway FL, et al. Obesity. 2009;17: Apovian CM, et al. Obesity. 2013;21(5): Billes SK, et al. Pharmacol Res. 2014;84;1-11.
20 Naltrexone SR/Bupropion SR Naltrexone SR/bupropion SR 32/360 mg Placebo Nausea 32.5% 6.7% Constipation 19.2% 7.2% Headache 17.6% 10.4% Vomiting 10.7% 2.9% Dizziness 9.9% 3.4% Insomnia 9.2% 5.9% Dry mouth 8.1% 2.3% Subjects discontinuing due to AE: Overall 24% 12% Nausea 6.3% Headache 1.7% Vomiting 1.1% Contrave (naltrexone HCL and bupropion HCL) extended-release tablets [package insert]. Deerfield, IL and La Jolla, CA: Takeda / Orexigen; 2014.
21 Liraglutide 3.0 mg GLP-1 receptor agonist Multiple actions; effect on weight is primarily via POMC neurons Liraglutide 1.8 mg: type 2 diabetes Liraglutide 3.0 mg: obesity treatment Long-term use; not controlled Dosing: SC; titrate weekly by 0.6 mg Discontinue if <4% loss at 16 weeks REMS: medullary thyroid carcinoma, acute pancreatitis Pi-Sunyer X, et al. N Eng J Med. 2015;373(1): Saxenda (liraglutide) injection [package insert]. Plainsboro, NJ: Novo Nordisk, 2014
22 Liraglutide 3.0 mg Prediabetes status Patients receiving a diagnosis of diabetes Pi-Sunyer X, et al. N Engl J Med. 2015;373:11-22.
23 Percentage of Patients Achieving >5% Weight Loss With Liraglutide 3.0 mg Phase 2 (Dose-finding) n=564 Phase 3 (Weight loss) n=3731 Phase 3 (Maintenance) n=422 Phase 3 (DM2) n=846 Phase 3 (OSA) n=359 Data submitted to FDA Endocrinologic and Metabolic Drug Advisory Committee, NDA , September 11, 2014.
24 Liraglutide and Weight Maintenance Data submitted to FDA Endocrinologic and Metabolic Drug Advisory Committee, NDA , September 11, 2014.
25 Liraglutide 3.0 mg Delayed Time to Onset of Type 2 Diabetes Mellitus le Roux C, et al. The Obesity Society Annual Meeting, Poster T P LB 3843.
26 Liraglutide 3.0 mg % Liraglutide 3.0 mg Placebo Discontinuation Nausea Diarrhea Vomiting Constipation 19 8 Dyspepsia 9 3 Abdominal pain 5 3 Hypoglycemia in T2DM Headache Dizziness 7 5 Fatigue 7 4 Increased lipase 5 2 Overall discontinuation: 9.8% vs 4.3% Saxenda (liraglutide) injection [package insert]. Plainsboro, NJ: Novo Nordisk; 2014.
27 Contraindications and Cautions Clinical Scenario Elevated seizure risk History of recurrent kidney stones History of glaucoma Uncontrolled hypertension Coronary artery disease Moderate-severe renal impairment Moderate-severe hepatic impairment SSRI use Avoid/Caution Naltrexone SR / bupropion SR Phentermine / topiramate ER, orlistat Phentermine / topiramate ER Naltrexone SR / bupropion SR Phentermine Do not exceed half-dose: Phentermine / topiramate ER, naltrexone SR / bupropion SR Caution: liraglutide 3.0 mg, lorcaserin Do not exceed half-dose: Phentermine / topiramate ER Do not exceed ¼ dose: naltrexone SR / bupropion SR Caution: liraglutide 3.0 mg, lorcaserin Caution: lorcaserin
28 Dual Benefits Obesity and Smoking Depression Migraines Diabetes Chronic constipation Elevated LDL Consider, but not explicitly approved Naltrexone SR / bupropion SR Naltrexone SR / bupropion SR Phentermine / topiramate ER Liraglutide 3.0 mg Orlistat Orlistat
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