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2 Diabetes Prevention Program 1 LOOK AHEAD 3 Multi-center trial in patients with impaired glucose tolerance Weight loss of 7% reduced the rate of progression from impaired glucose tolerance to diabetes by 5% Reduced risk factors for CVD over 15 years ethically diverse overweight/obese adults w/t2dm Year 1: 5% weight loss in 68% who received intensive lifestyle counseling vs 13.3% who received usual care Year 8: 5% weight loss in 50.5% who received intensive lifestyle counseling vs 35.7% who received usual care 1. Knowler WC, et al. N Engl J Med. 2002;346(6): Diabetes Prevention Program Research Group. Lancet Diabetes Endocrinol (11): Look AHEAD Research Group. Obesity. 2014;22:5-13

3 Self-monitoring e.g., food diaries Controlling or modifying the stimuli that activate eating Slowing down the eating process Goal-setting Behavioral contracting and reinforcement Nutrition education and meal planning Modification of physical activity Social support Cognitive restructuring Problem-solving Jensen MD, et al. Circulation 2014;129:S102-S138.

4 38 behavioral treatment trials Average baseline BMI: 31.9 kg/m 2 Overweight adults with intervention sessions in year 1 lost 6% baseline weight Control groups lost little or no weight Patient education sessions: Healthy diet choices Physical activity Weight loss goals Barriers to weight loss Regular weight checks Peer support LeBlanc E, et al. Ann Intern Med 2011;155:434.

5 Antihistamines Steroids Hypoglycemic agents Estrogens Beta blockers Calcium channel blockers Some antidepressants Anticonvulsants/mood stabilizers Migraine medications Atypical antipsychotics HIV medications Chemotherapy Domecq JP, et al. J Clin Endocrinol Metab. 2015;100:

6 Indications Contraindications Side Effects Monitoring/ Administration Short-term adjunct to comprehensive regimen in management of exogenous obesity with initial BMI 30 kg/m 2 or 27 kg/m 2 in the presence of other risk factors (eg, diabetes, hyperlipidemia, controlled hypertension). History of CVD, uncontrolled hypertension, during or within 14 days of using MAO inhibitors, glaucoma, agitated states, pregnancy, breastfeeding, drug abuse history, known hypersensitivity, or idiosyncrasy to the sympathomimetic amines. Not recommended for use in pediatric patients 16 years. Cardiac: Pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevated blood pressure, ischemic events, CNS: overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis GI: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances Other: urticaria, impotence, libido changes Dosage should be individualized to obtain an adequate response with the lowest effective dose. The usual adult dose is 1 tablet TID ½ hour before meals. Tablet is scored to facilitate administering one half of the usual dosage for patients not requiring the full dose. Caution patients about potential to impair ability to operate machinery or drive a vehicle.

7 Indications Contraindications Side Effects Monitoring/ Administration Obesity management, including weight loss and weight maintenance, when used in conjunction with a reduced-calorie diet; to reduce the risk for weight regain after prior weight loss. Chronic malabsorption syndrome, pregnancy, breastfeeding, cholestasis, some medications (ex. warfarin, antiepileptic agents, levothyroxine, cyclosporine) Oily spotting, cramps, flatus with discharge, fecal urgency, fatty oily stool, increased defecation, fecal incontinence BMI, calorie/fat intake; serum glucose in patients with diabetes; thyroid function in patient with thyroid disease; liver function tests in patients exhibiting symptoms of hepatic impairment; renal function in patients at risk for renal impairment. Lexicomp Bragg R, et al. J Am Assoc Nurse Pract 2016;28:107-15

8 Indications Contraindications Side Effects Monitoring/ Administration Adjunct to comprehensive regimen in management of exogenous obesity with initial BMI 30 kg/m 2 or 27 kg/m 2 in the presence of at least weightrelated comorbidity. Pregnancy and breastfeeding, hyperthyroidism, glaucoma, during/within 14 days of taking monoamine oxidase inhibitors Risk Evaluation and Mitigation Strategy Paresthesias dizziness, taste alterations, insomnia, constipation, dry mouth, elevation in heart rate, memory or cognitive changes Seizure frequency, hydration status, electrolytes, serum creatinine, symptoms of acute acidosis, ammonia level in patients with unexplained lethargy, vomiting, or mental status changes; intraocular pressure, suicidality, weight + eating behaviors in patients with eating disorder symptoms/risk factors Bragg R, et al. J Am Assoc Nurse Pract 2016;28:107-15

9 Indications Contraindications Side Effects Monitoring/ Administration Adjunct to a reducedcalorie diet and increased physical activity for chronic weight management in adults with an initial BMI of 30 kg/m 2 or 27 kg/m 2 in the presence of at least one weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, and/or dyslipidemia) Uncontrolled hypertension, seizure disorder, anorexia or bulimia, drug or alcohol withdrawal, chronic opioid use, monamine oxidase inhibitors Nausea, constipation, headache, dizziness, vomiting, insomnia, dry mouth Transient increase in blood pressure Blood pressure and heart rate; blood glucose; weight; BMI; renal and liver function; mental status for depression, suicidal ideation, anxiety, social functioning, mania, and panic attacks. Bragg R, et al. J Am Assoc Nurse Pract 2016;28:107-15

10 Indications Contraindications Side Effects Monitoring/ Administration Chronic weight management, as an adjunct to a reducedcalorie diet and increased physical activity, in adults with either an initial body mass index (BMI) of 30 kg/m 2 or an initial BMI of 27 kg/m 2 and at least one weight-related comorbid condition (eg, hypertension, dyslipidemia, type 2 diabetes). Pregnancy, breastfeeding Caution with serotoninergic agents (due to risk of serotonin syndrome) Avoid in patients w/severe hepatic or renal insufficiency, valvular heart disease Headache, dizziness, fatigue, nausea, dry mouth, cough, and constipation Patients w/t2dm, back pain, cough, hypoglycemia Weight, waist circumference; CBC; blood glucose (if diabetes); prolactin; depression and/or suicidal thoughts/behavior; signs/symptoms of SS/NMS-like reaction; signs/symptoms of valvular heart disease (dyspnea, dependent edema) Bragg R, et al. J Am Assoc Nurse Pract 2016;28:107-15

11 Indications Contraindications Side Effects Monitoring/ Administration As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial BMI of 30 kg/m 2 or greater (obese) or 27 kg/m 2 or greater (overweight) in the presence of at least 1 weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, dyslipidemia) Medullary thyroid cancer history, multiple endocrine neoplasia type 2 history, history of pancreatitis, pregnancy, breastfeeding Risk Evaluation and Mitigation Strategy Nausea, vomiting, diarrhea, constipation, hypoglycemia in patients with T2DM, increased lipase, increased heart rate, pancreatitis Plasma glucose, HbA1c, renal function; signs/symptoms of pancreatitis; emergence of worsening depression, suicidal thoughts/behavior, changes in behavior; heart rate; body weight (at week 16 when used for chronic weight management) Bragg R, et al. J Am Assoc Nurse Pract 2016;28:107-15; Kahan S. Am J Manag Care. 2016;22:S186-S196

12 Drug Advantages Disadvantages Phentermine Inexpensive Weight loss >3-5% Toperimate/phentermine Weight loss >5% Long-term data Lorcaserin Side effect profile Long-term data Orlistat Nonsystemic Long-term data Orlistat OTC Inexpensive Natrexone/bupropion Weight loss 3-5% Food addiction Long-term data Liraglutide Side effect profile Long-term data Side effect profile No long-term data Expensive Teratogen Expensive Weight loss 3-5% Weight loss 2-3% Side effect profile Side effect profile Mid-level price range Expensive Injectable Apovian CM, et al. J Clin Endocrinol Metab 2015;100:

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