What problem? - - PDF document

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• Theodore Feldman, MD,FACC,FACP

Medical Director, Center for Prevention and Wellness, Baptist Health Medical Director, South Miami Heart Center Heartwell LLP Clinical Associate Professor of Medicine FIU Wertheim College of Medicine

• Baptist Children’s Hospital

Baptist Hospital Doctors Hospital Baptist Cardiac & Vascular Institute Homestead Hospital Mariners Hospital West Kendall Baptist Hospital Baptist Outpatient Services South Miami Hospital

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What problem?

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Increased caloric intake + refined carb consumption & physical inactivity

• explosion in incidence of abdominal obesity & epidemic of insulin

resistance.

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• Obesity is one of the greatest health

threats currently facing the United States BMI > 30 highly prevalent in U.S. 36% (>78 million) US adults are

• bese

Definitions of Obesity

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2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society

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American College of Physicians for Medical Management of Obese Patients

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/.! ,0 Dietary therapy Physical activity Behavior therapy "Combined" therapy Pharmacotherapy Weight8loss surgery

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Top Weight Loss Apps: New York Daily News and Forbes

Topping both lists – and the recipient of the United States Surgeon General’s Healthy Apps Challenge – is an app called "Lose It."

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Do they really help you lose weight?

Recent pilot randomized control trial has looked into compliance with smartphone apps for weight loss compared tcompared to website or paper diary8based tools Results 8 better adherence for smartphone apps compared to other conventional weight8loss tools Participants using smartphone apps lost a mean weight of 10.2 pounds over the course of the 68month trial

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Components of Successful Web Based Weight Loss Tools

According to a recent study in Telemedicine Journal and e8Health Must allow for self monitoring Have social support Have an integrated counselor feedback and communication tool Incorporate the use of a structured program Allow for the tailoring of the program to the individual.

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Baptist Employee Healthy Heart Study

• Identify those with Metabolic syndrome (MetS)/Type II DM (T2DM) and

screen them for subclinical CVD

• Diagnosis of three or more of the following:

Waist circumference >=40 inches in and male and >= 35 inches in a female,

• Fasting triglyceride level > 150 mg/dl*

HDL8C < 40 mg/dl in men or < 50 mg/dl in women* BP > 130/85 mm Hg* Fasting blood glucose > 110 mg/dl *Or currently on medication to treat the abnormal condition

• Develop a web based treatment program which is effective at reducing the

risks associated with MetS

• Delivering the treatment to a large, diverse population in a cost effective

manner

• ): Web8based “South Beach” intervention vs WebMD

will result in a significant difference in BMI and markers of subclinical CVD (Berkeley panel, Imaging studies, CAC) at 1 year F/up.

Medications

• Short8term obesity management
• Sympathomimetics (, Diethylpropion,

Benzphetamine)

• Long8term obesity management
• Lipase inhibitors ()
• Recently approved obesity medications
• Serotonin agonists (07
• Combination agents (-)

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Phentermine (Suprenza)

Type: sympathomimetic Mechanism of action: stimulates the hypothalamus to suppress appetite Year of approval: 1959 FDA approved indication: short8term (< 12 weeks) adjunct to exercise and caloric restriction for BMI ≥ 30 or ≥ 27 in the presence of other risk factors such as hypertension, diabetes or hyperlipidemia Efficacy: 3.6 kg mean weight loss beyond that achieved by placebo at 2824 weeks (meta8analysis of six placebo8controlled trials; 2002;26:262873) Adverse effects: risk of dependence and abuse, hypertension, dry mouth, insomnia, tremor, GI disturbance, primary pulmonary hypertension (rare, associated with combined use of fenfluramine in “fen8phen”), valvular heart disease (rare), psychosis (rare) Contraindications: history of CV disease, MAOIs, hyperthyroidism, glaucoma, history of drug abuse, pregnancy, breastfeeding

Orlistat (Xenical, Alli)

Type: lipase inhibitor Mechanism of action: inhibits the breakdown of triglycerides into absorbable free fatty acids by lipase enzymes in the stomach and pancreas, resulting in less fat being absorbed Year of approval: 1999 (Xenical – prescription 120 mg TID), 2007 (Alli – OTC 60 mg) FDA approved indication: as an adjunct to a reduced8calorie and low8fat diet for weight loss or to lower the risk of regaining weight after prior weight loss Efficacy: 2.9 kg mean weight loss (Xenical) beyond that achieved by placebo at one year (meta8analysis of 15 trials; 2005;142:532846) Adverse effects: significant diarrhea, fecal incontinence, oily spotting, flatulence, bloating, dyspepsia (all can be reduced with avoidance of fat8rich foods), reduced absorption of fat8soluble vitamins, serious liver injury (rare) Contraindications: malabsorption, cholestasis, impaired liver function, pancreatic disease, pregnancy (added in 2012)

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Lorcaserin (Belviq)

Type: serotonin agonist Mechanism of action: activates 58HT2C receptors in the hypothalamus, resulting in increased proopiomelanocortin (POMC) production, which promotes satiety Year of approval: 2012 FDA approved indication: treatment of obesity for adults with BMI ≥ 30 or ≥ 27 in the presence of other risk factors such as hypertension, diabetes or hyperlipidemia Efficacy: 3.6 kg mean weight loss beyond that achieved by placebo (5.8 kg

• vs. 2.2 kg) at one year (Phase 3 RCT; !" 2010; 363:2458256)

Adverse effects: headache, nasopharyngitis Contraindications: pregnancy, MAOIs, SSRIs (caution)

Phentermine8topiramate (Qsymia)

Year of approval: 2012 FDA approved indication: chronic weight management, as an adjunct to a reduced8calorie diet and exercise, for BMI ≥ 30 or ≥ 27, in the presence of

• ther risk factors such as hypertension, diabetes or hyperlipidemia

Efficacy: 10.7 kg mean weight loss beyond that achieved by placebo (12.6 kg

• vs. 1.9 kg) at one year (Phase 3 RCT; (2012); 20 2, 330–342)

Adverse effects: tachycardia, insomnia, paresthesias, dizziness, distorted taste sensation, constipation, dry mouth, anxiety, suicidality (rare), acute angle closure glaucoma (rare), metabolic acidosis (rare), increased serum creatinine (rare) Contraindications: pregnancy, glaucoma, hyperthyroidism, MAOIs, history of suicide attempt

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Findings

Obesity medications approved for long8term use, when prescribed with lifestyle interventions:

Produce additional weight loss relative to placebo ranging from approximately 3% of initial weight for orlistat and lorcaserin to 9% for top8dose (15/92 mg) phentermine plus topiramate– extended release at 1 year . The proportion of patients achieving clinically meaningful (at least 5%) weight loss ranges from 37% to 47% for lorcaserin, 35% to 73% for orlistat, and 67% to 70% for top8dose phentermine plus topiramate–extended release. All 3 medications produce greater improvements in many cardiometabolic risk factors than placebo No obesity medication has been shown to reduce cardiovascular morbidity or mortality Most prescriptions are for noradrenergic medications, despite their approval only for short8term use and limited data for their long8term safety and efficacy.

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Conclusions

Medications approved for long8term

• besity treatment:

When used as adjunct to lifestyle intervention, lead to greater mean weight loss and an increased likelihood of achieving clinically meaningful 18year weight loss relative to placebo. By discontinuing medication in patients who do not respond with weight loss of at least 5%, clinicians can decrease their patients’ exposure to the risks and costs of drug treatment when there is little prospect

• f long8term benefit.

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Bariatric Surgery

+9A

• BMI > 40 or > 35 with hypertension, heart disease, diabetes or

severe sleep apnea

• Documentation that other significant attempts at weight loss have

been ineffective

• Highly motivated increase activity and established healthier eating

habits

• Smoke8free for at least six months
• Able to tolerate general anesthesia

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• Alcoholic or drug abuse issues
• Active liver disease
• Untreated psychiatric condition
• Correctable cause of obesity (e.g. thyroid disease)
• Unable to comply program guidelines
• Unstable eating pattern related to medications
• Uncontrolled eating disorder

Three Major Procedures

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