MEDICAL MANAGEMENT 101

Transcription

1 MEDICAL MANAGEMENT 101 Christopher Still, DO, FACN, FACP Medical Director, Center for Nutrition & Weight Management Director, Geisinger Obesity Research Institute Geisinger Health Care System Your Weight Matters National Convention October 26, 2012 Effective Obesity Management Program Components Behavior Modification Diet Medications or Surgery Physical Activity Wadden TA, Foster GD. Behavioral treatment of obesity. Med Clin North Am. 2000;84: Stumbo, PH, et. al. Dietary and medical therapy of obesity. Surg Clin N Am 85(2005)

2 Algorithmic Treatment Plan Standardized meal plan based on body habitus Kcal, 25% - 30% fat Kcal, 25% - 30% fat CHO Modified Meal Plan Daily food logs journal Weekly weigh-in outside of the house Occurrence exercise program Water intake (cold vs. hot beverages) Behavior modification lessons Pharmacotherapy if weight loss plateaus Bariatric surgery after comprehensive process 3 Algorithmic Treatment Plan Standardized meal plan based on body habitus Kcal, 25% - 30% fat Kcal, 25% - 30% fat CHO Modified Meal Plan 4 2

3 5 INDIVIDUAL INFLUENCES Genetic/Epigenetic Intake Expenditure ETOH Fat Stable Activity TEF Carb Protein Basal Metabolic Rate 6 3

4 Algorithmic Treatment Plan Standardized meal plan based on body habitus Kcal, 25% - 30% fat Kcal, 25% - 30% fat CHO Modified Meal Plan Daily food logs journal 7 Energy Intake Total Consumption USDA/ERS Food Review 2002;25:

5 Estimates of Increased Energy Intake Since the 1970 s Agency Calories per Day Men Women CDC USDA CSFII Author Hill et al, 2000 Wang et al, 2006 Swinburn et al, 2009 Calories per Day 100 kcal/d kcal/d 350 kcal/d MMWR (CDC) 2009:52:80-82; Hill JO et al Science 2003;299: ; Wang YC et al Pediatrics 2006;118: ; Swinburn et al AJCN 2009; 89: Increased Portion Sizes King Size (3.7 oz) 541 Calories 27.8 gms fat Regular (2 oz) 273 Calories 14 gms fat

6 Increased Soda Consumption 11 Lunch Special $

7 Label Reading Serving Size = ½ cup Servings Per Container = 4 Calories Per Serving = Calories Count One pound of body fat = 3500 calories Energy Expenditure To lose 1 pound per week: Decrease intake by 500 calories per day Calorie Intake To lose 2 pounds per week: Decrease intake by 1000 calories per day 14 7

8 Algorithmic Treatment Plan Standardized meal plan based on body habitus Kcal, 25% - 30% fat Kcal, 25% - 30% fat CHO Modified Meal Plan Daily food logs journal Weekly weigh-in outside of the house 15 Algorithmic Treatment Plan Standardized meal plan based on body habitus Kcal, 25% - 30% fat Kcal, 25% - 30% fat CHO Modified Meal Plan Daily food logs journal Weekly weigh-in outside of the house Water intake (cold vs. hot beverages) 16 8

9 Algorithmic Treatment Plan Standardized meal plan based on body habitus Kcal, 25% - 30% fat Kcal, 25% - 30% fat CHO Modified Meal Plan Daily food logs journal Weekly weigh-in outside of the house Water intake (cold vs. hot beverages) Occurrence exercise program Structured Classes Pedometers 17 INDIVIDUAL INFLUENCES Genetic/Epigenetic Intake Expenditure ETOH Fat Stable Activity TEF Carb Protein Basal Metabolic Rate Lean Body Mass 18 9

10 Energy Savers Personal Computers Cellular Phones Shopping by Phone Phone Extensions Escalators/Elevators Drive-thru Windows Intercoms Remote Controls Tele-commuting /Internet Food Delivery Services Dishwashers Cable Movies Computer Games Moving Sidewalks Garage Door Openers 19 Television Remote Control 20 10

11 Diet and Physical Activity 0-2- Weight loss/gain (kg) 4- Non-exercise Exercise Treatment (wk) Follow-up (mo) Balanced caloric deficit diet Protein-sparing modified fast Pavlou KN, et al. Am J Clin Nutr. 1989;49: Algorithmic Treatment Plan Standardized meal plan based on body habitus Kcal, 25% - 30% fat Kcal, 25% - 30% fat CHO Modified Meal Plan Daily food logs journal Weekly weigh-in outside of the house Occurrence exercise program Water intake (cold vs. hot beverages) Behavior modification lessons Depression Screening 22 11

12 Algorithmic Treatment Plan Standardized meal plan based on body habitus Kcal, 25% - 30% fat Kcal, 25% - 30% fat CHO Modified Meal Plan Daily food logs journal Weekly weigh-in outside of the house Occurrence exercise program Water intake (cold vs. hot beverages) Behavior modification lessons Pharmacotherapy if weight loss plateaus Screen for medication that can cause weight GAIN 23 Prescription Medications May Promote Weight Gain Antidiabetics Antipsychotics Antidepressants Antiepileptics Steroids Antihistamines 24 12

13 Weight Loss Pharmacotherapy

14 The FDA has not approved a new prescription weight loss drug in? 13 years Anti-obesity Medications Rationale and Indications Non-drug interventions should be attempted before considering pharmacotherapy 1 For patients with BMI > 30 For patients with BMI > 27 or above with concomitant risk factors or diseases (hypertension, dyslipidemia, CHD, type 2 diabetes, sleep apnea) 1 1. NIH Clinical Guidelines Evidence Report, Sept

15 Obesity Medications Status At-a-Glance Belviq Qsymia Contrave Arena Pharmaceuticals Vivus, Inc. Orexigen Therapuetics Lorcaserin October 23, 2010 Denied FDA Advisory Board May 10, 2012 Approved FDA Advisory Board June 27, 2012 FDA APPROVAL Phentermine and topiramate February 22, 2012 Approved FDA Advisory Board July 17, 2012 FDA APPROVAL Bupropion and naltrexone February 1, 2011 Denied FDA Advisory Board 2014 PDUFA 29 Antiobesity Drugs Recently FDA Reviewed, Rejected, or Approved: Qsymia Powell AG, Apovian CM, Aronne LJ. Clin Pharmacol Ther Jul;90(1):

16 Lorcaserin Belviq Lorcaserin: Mechanism of Action Selective serotonin 2C receptor agonist Serotonin 2C receptor is expressed in the brain, including hypothalamus, which is an area involved in the control of appetite and metabolism In in vitro studies, lorcaserin demonstrated greater affinity and activity at the serotonin 2C receptor than at the serotonin 2A and 2B receptors Activation of the latter two receptors has been associated with undesirable effects: Activation of the 2A receptor has been associated with central nervous system, or CNS, effects, including altered perception, mood and abuse potential Activation of the 2B receptor has been associated with cardiac valvulopathy 32 16

17 Lorcaserin Side Effects The most frequent adverse events were headache, nausea, dizziness, fatigue and dry mouth Headache the only adverse event increased over placebo by > 5% 33 Qsymia 17

18 Qsymia : Mechanism of Action Phentermine is an appetite suppressant and stimulant Topiramate is classified as an anticonvulsant, but has been found to have weight loss as a common side effect Qsymia combines low doses both agents for weight loss and control Designed to decrease appetite and increase satiety Phentermine (Adipex-P), approved in 1959 as an appetite suppressant, is available in strengths ranging from 15 mg to 37.5 mg Topiramate (Topamax) was approved in 1996 for the treatment of seizures at doses up to 400 mg/day in adults and in 2004 for the prevention of migraine headaches at doses up to 100 mg/day 35 Qsymia CONQUER: Weight Loss Over Time (Completer Population) Placebo -2.4%, 6 lbs Mean % Weight Loss Qnexa Mid -10.5%, 24 lbs Qnexa Full -13.2%, 30 lbs Weeks Patients Placebo Mid Full Completers (% of randomized) % % 1 64% 1 1. Statistically greater number of patients completing study on Qnexa vs. placebo, p< * Data from patients that completed 56 weeks on treatment 36 18

19 Qsymia : Dosages Low 3.75 mg phentermine/23 mg topiramate CR (controlled release) Full 15 mg phentermine/ 92 mg topiramate Final, marketed strength(s) will not be known until FDA makes its final determination. If approved, Qnexa will be available as an extended-release capsule and a controlled substance Schedule IV drug due to the phentermine component. 1. Smith SR, et al. N Engl J Med 2010;363: Fidler MC, et al. J Clin Endocrinol Metab, October 2011, 96(10): O Neil PM, et al. Obesity (16 March 2012) doi: /oby Qsymia : Side Effects FDA saw increases in heart rate among patients taking the drug, but the clinical significance was not conclusive Other side effects included: Increased anxiety Sleep disturbances Dry mouth Tingling Constipation Altered taste Depression Infections in the sinus and respiratory tracts

20 Contrave Contrave: Mechanism of Action Sustained-release combination of the dopamine and norepinephrine reuptake antagonist bupropion and the opioid antagonist naltrexone Proposed dual mechanism of action involves complementary stimulation of central melanocortin pathways, resulting in increased energy expenditure and reduced appetite Padwal R. Curr Opin Investig Drugs Oct;10(10):

21 Expected Weight Loss with Currently Approved and Investigational Drugs Qsymia Contrave Belviq Powell AG, Apovian CM, Aronne LJ. Clin Pharmacol Ther Jul;90(1): What Is Realistic Weight Loss? COMMON ACCEPTABLE??? IDEAL Time 42 21

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