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Nutritional Dilemmas

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Nutritional Dilemmas Welcome to CMHC WEST Ken Fujioka, M.D. Director of Nutrition and Metabolic Research Wireless Weight loss Dept. of Scripps Clinic Dept. of Diabetes and Endocrine Sharp Liberty Station Obesity Symposium May 31, 2019 Recently Approved Weight Loss Medications Medication Target Lorcaserin Serotonin 5HT-2c agonist (non- stimulant) Phentermine/topiramate Sympathomimetic / anti-seizure medication that enhances the inhibitory effect of GABA Naltrexone/bupropion opioid receptor antagonist /catecholamine reuptake inhibitor Liraglutide GLP-1 receptor agonist Fujioka K. Current and emerging medications for overweight or obesity in people with comorbidities. Diabetes Obes Metab. 2015 Jun 4 Eat (Hunger) Stop Eating Hypothalamus NYP POMC Fat Gastrointestinal Cells Track Pancreas Leptin GLP-1, GLP-2, PYY, and Amylin, Insulin many more Eat (Hunger) Stop Eating Hypothalamus Dorsal Vagal Complex NYP POMC Hind Brain Stop Eating Fat Gastrointestinal Pancreas Vagal Afferent fibers Cells Track Lorcaserin 5HT2c agonist Eat (Hunger) Stop Eating Lorcaserin Hypothalamus 5HT2c Dorsal Vagal satiety Complex NYP Hind Brain POMC Stop Eating Fat Gastrointestinal Pancreas Vagal Afferent fibers Cells Track Bupropion/Naltrexone Dopamine Phentermine/Topiramate Nor-epinephrine Opioid Motivated reward eating Eat (Hunger) Stop Eating Mesolimbic system Reward centers Nucleus accumbens Hypothalamus Prefrontal cortex Dorsal Vagal NYP POMC Complex Hind Brain Stop Eating Fat Gastrointestinal Pancreas Vagal Afferent fibers Cells Track Liraglutide GLP-1 Hormone Dopamine Nor-epinephrine Motivated reward eating Increase eating Stop Eating Mesolimbic system Hypothalamus Dorsal Vagal NPY POMC Complex Hind Brain Stop Eating GLP-1 Gastrointestinal Track Vagal Afferent fibers ITT Weight loss at one year without intensive behavior modification Percent Weight Loss 12 10 8 6 4 2 0 Naltrexone/Bupropion Lorcaserin Liraglutide Phentermine/Topiramate Percent Weight Loss Fujioka K. Current and emerging medications for overweight or obesity in people with comorbidities. Diabetes Obesity Met. 2015 doi:10.1111/dom.12502 3 Effect of Phentermine/Topiramate ER on Weight Loss in Obese Adults Over 2 Years SEQUEL Study Placebo -1.8% Phentermine/topiramate CR 7.5/46-9.3% -10.5% Phentermine/topiramate CR 15/92 Data are shown with least squares mean (95% CI). Garvey WT, et al. Am J Clin Nutr. 2012;95:297-308. 9 Phentermine/Topiramate ER: EQUIP and CONQUER Most Commonly Reported Treatment Emergent Adverse Events Adverse Event (%) PHEN/TPM ER PHEN/TPM ER PHEN/TPM ER Placebo (N=3749) 3.75/23 7.5/46 15/92 Paresthesia 1.9 4.2 13.7 19.9 Dry mouth 2.8 6.7 13.5 19.1 Constipation 6.1 7.9 15.1 16.1 Upper respiratory 12.8 15.8 12.2 13.5 tract infection Headache 9.3 10.4 7.0 10.6 Dysgeusia 1.1 1.3 7.4 9.4 Nasopharyngitis 8.0 12.5 10.6 9.4 Insomnia 4.7 5.0 5.8 9.4 Dizziness 3.4 2.9 7.2 8.6 Sinusitis 6.3 7.5 6.8 7.8 Nausea 4.4 5.8 3.6 7.2 Back pain 5.1 5.4 5.6 6.6 Fatigue 4.3 5.0 4.4 5.9 Blurred vision 3.5 6.3 4.0 5.4 Diarrhea 4.9 5.0 6.4 5.6 Phentermine and topiramate extended-release [package insert]. Mountain View, CA: Vivus; 2012. 10 Phentermine/Topiramate • Very potent weight loss agent • Positive studies in Binge Eating (topiramate) • Significant number of potential Adverse Events (two drugs two sets of potential AEs) • REMS program: potential for teratogenicity, cleft lip and cleft palate • Suicide, mood, and sleep disorders (topiramate) • Acute myopia and glaucoma (topiramate) • Cognitive impairment (topiramate) • Phentermine: sympathomimetic that can increase heart rate and blood pressure Phentermine and topiramate extended-release [package insert]. Mountain View, CA: Vivus; 2012. Clinical Pearls and Phentermine/Topiramate ER • Balance significant weight loss with potential for adverse events • In the pivotal trials they did allow pts on SSRIs to be in the study • Despite the fact that this medication contains a sympathomimetic it did not typically increase blood pressure but does increase pulse • Recommend the middle 7.5/46mgs dose • Weight loss at 2 years very similar to highest dose • If the patient needs to stop they do not have to taper down Buproprion – Naltrexone Placebo 0 Naltrexone 16 mg plus bupropion Naltrexone 32 mg plus bupropion -2 -4 -6 -8 Weight changefrom baselineWeight (%) -10 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 Greenway, FL, Fujioka, K et al. Lancet. Weeks 2010;376(9741):595-605 Change in Selected Items from the Control of Eating Questionnaire at Week 56 Placebo (n=511) How hungry have you felt? Naltrexone 16 mg plus * bupropion (n=471) Naltrexone 32 mg plus * How full have you felt? bupropion (n=471) * How difficult has it been * to control your eating? * How difficult has it been * to resist any food cravings? How often have you eaten * in response to food cravings How often have you had * food cravings for starchy foods? -20 -15 -10 -5 0 -5 Less Change from baseline (mm) More *P <.05 vs placebo. Greenway FL, Fujioka, K, et al. Lancet. 2010;376, 595-605. 14 MacMillan M, Cummins K, Fujioka K What weight loss treatment options do geriatric patients with overweight and obesity want to Prevalence of Cravings consider? Obes Sci Pract. 2016 Dec;2(4):477-482 Chart 3: Perceptions 0.9 0.8 0.762 0.7 0.739 0.719 0.6 0.648 0.594 0.573 0.5680.554 0.5 0.543 0.545 0.523 0.512 0.475 0.467 0.473 0.4 0.446 0.416 0.398 0.406 0.376 0.3 0.315 0.273 0.267 0.261 0.2 0.25 0.218 0.228 0.178 0.1 0 A B C D E F G Cravings 1 (<50) 2 (50-65) 3 (>65) Total Adverse Events Naltrexone ER • Nausea /Bupropion SR 32mg/360 mg • (Forced Titration in studies) N=2545 • Constipation % • Headache • Vomiting • Dizziness • Insomnia • Take second dose late afternoon not late evening • Dry mouth Clinical Pearls Bupropion/Naltrexone • May have added benefit in the depressed obese patient • Be cautious with combining with other depression meds (potential for interaction) • Has potential to work on “Cravings” and food reward type eating • Recommend slow titration due to nausea • May not need to go to the highest dose, in clinical practice many patients lose weight on lower doses Drug-Drug and other interactions • Ticlopidine and Clopidogrel (Plavix) • Decrease dose to 1 BID • Seizure risk with bupropion thus do not give to patients with a seizure history • Bulimics • One to two mmHg rise in blood pressure and pulse (check BP the first 12 weeks) • Do not give to patient on chronic opioids • Do not give with high fat meal Lorcaserin—BLOOM Study: Body Weight Over Years 1 and 2* BLOOM = Behavioral Modification and Lorcaserin for Overweight and Obesity Management. *Only included patients who continued the study past year 1. Smith SR et al. N Engl J Med. 2010;363(3):245–256. Lorcaserin: Those Who Lost ≥ 4.5% Total Body Weight by Week 12 Were Week 52 Responders Studies 009 and 011, MITT 0 Non-responder: Lorcaserin BID STOP -2.46% -5 % Change -10 -10.22% Responder: Lorcaserin BID -15 0 4 8 12 16 20 24 28 32 36 40 44 48 52 Week MITT Lorcaserin BID WeekResponder: 12 Completed WeekNon-Responder: 12 Completed Week 52 N = 3097 ≥4.5%Lorcaserin wt loss BID 1369/3097 (44.2%)Lorcaserin BID1083/1369 (79.1%) <4.5% wt loss 1168/3097 (37.7%) 680/1168 (58.2%) Slide courtesy Dr. Steve Smith; May 10, 2012 FDA Advisory Committee Meeting 20 Lorcaserin for Weight Loss in Type 2 DM O’Neil PM, et al. Obesity (Silver Spring). 2012 Jul;20(7):1426-36. New Studies in Obesity medicine: CardioVascular Outcome Trials (CVOT) Enroll 10,000 or more patients with known cardiovascular disease or diabetes with multiple risk factors for impending cardiovascular disease Randomize to placebo or study drug and followed for 3-5 years This has to be completed for most weight loss medications as well as diabetic medications Sibutramine 1997-2010 Sibutramine: % of major adverse norepinephrine, serotonin, and cardiovascular events dopamine reuptake inhibition 12 11.5 Approved as a weight loss medication in 1997 11 Published their CardioVascular 10.5 Outcomes Trial in 2010 Subjects with preexisting cardiovascular 10 conditions receiving sibutramine had an increased risk of nonfatal myocardial 9.5 infarction and nonfatal stroke 9 Removed from the market in Placebo Sibutramine 2010 % of major adverse cardiovascular events Status of Cardiovascular Outcome Trials (CVOT) Weight loss medication Status of CVOT Lorcaserin Completed (2018) Phentermine/Topiramate Not completed Naltrexone/Bupropion 2015 CVOT trial stopped prematurely* Liraglutide 3.0 mg FDA allowed use of Liraglutide 1.8 mg data Liraglutide felt to be CVOT safe and a CVOT not required “Orexigen shared the CVOT data with over 100 individuals both within and outside the company (data leaked) When the FDA found out the company was told to continue the trial but must do a second CVOT trial. The CVOT interim data was released by the company to the public in a patent application and the executive committee of the study felt the study was unblinded And it was completely terminated. Medpage Today in collaboration with AACE April 13,2016 Cardiovascular Safety of Lorcaserin in Obesity Randomize 12,000 patients with Cardiovascular disease (75%) and/or Diabetes (57%) with multiple cardiovascular risk factors Randomized half the patients to lorcaserin and half to placebo Primary outcome: cardiovascular event • (example stroke, myocardial infarction, heart failure, angina etc.) NEJM E.A.
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