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The Efficacy of Pharmaceutical Approaches to Weight Loss

The Efficacy of Pharmaceutical Approaches to Weight Loss. Joseph Martinez, RPh, PDE, PPC former New Jersey State Medicaid Pharmacy Director Medicaid 2004: 900,000 beneficiary lives covered Annual drug spend of $1.4 billion. 1998. 2000. 2002. 2004.

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The Efficacy of Pharmaceutical Approaches to Weight Loss

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  1. The Efficacy of Pharmaceutical Approaches to Weight Loss • Joseph Martinez, RPh, PDE, PPC • former New Jersey State Medicaid Pharmacy Director • Medicaid 2004: • 900,000 beneficiary lives covered • Annual drug spend of $1.4 billion

  2. 1998 2000 2002 2004 No Data <10% 10%–14% 15%–19% ≥20 No Data <10% 10%–14% 15%–19% ≥20 No Data <10% 10%–14% 15%–19% 20%–24% ≥25% No Data <10% 10%–14% 15%–19% 20%–24% ≥25% Obesity Trends Among US Adults: Obesity: BMI ≥30 kg/m2, or ~ ≥14 kg overweight for 163 cm person Data from CDC. Behavioral Risk Factor Surveillance System.

  3. Hypertension Obesity Insulin Resistance Diabetes High LDL Low HDL Metabolic Syndrome Obesity Related Metabolic Disease

  4. Health Risks of Obesity Obesity is associated with an increased risk of: • Morbidity • Hypertension • Dyslipidemia (high total cholesterol, high TG levels or low HDL • Coronary heart disease • Type 2 diabetes • Stroke • Cancer (endometrial, breast and colon) • Impairments in health-related quality of life and psychosocial well-being • Mortality NIH-NHLBI. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. 1998.

  5. Overweight and Obesity Rates for Adults by Race/Ethnicity, 2005

  6. Impact of Weight Loss on CV Risk Factors 1 1 2 2 3 3 3 3 4 1. Wing RR et al. Arch Intern Med. 1987;147:1749-1753. 2. Mertens IL, Van Gaal LF. Obes Res. 2000;8:270-278. 3. Blackburn G. Obes Res. 1995;3 (Suppl 2):211S-216S. 4. Ditschunheit HH et al. Eur J Clin Nutr. 2002;56:264-270.

  7. Surgery Pharmacotherapy Lifestyle Modification Diet Physical Activity Obesity Treatment Pyramid

  8. Guide for Selecting Obesity Treatment BMI Category (kg/m2) The Practical Guide: Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. October 2000, NIH Pub. No.00-4084

  9. Current Obesity Treatments • Non-pharmacological treatment (behavioral therapy including diet and exercise) • Effective short-term (average weight loss <5%) • Poor long-term compliance • Weight loss is generally not sustained • Pharmacological treatment • Only two drugs, sibutramine and orlistat, presently approved for long-term use • Modestly effective (average weight loss 5-10% compared to placebo) • Side effects include increased heart rate and blood pressure, abdominal pain, incontinence, and flatulence Yanovsky SZ, et al. New England J Med 2002; 346(8):591-602. Moyers SV. J Am Diet Assoc 2005; 105:948-959

  10. Drugs Approved by FDA for Treating Obesity

  11. Other Therapeutic Agent Comparison Sources: 1.) Padwal R et al. Cochrane Database Syst Rev. 2004;(3):CD004094; 2.) Package inserts 3.) Decision Resources

  12. Selected Medications That Can Cause Weight Gain • Diabetes medications • Insulin • Sulfonylureas • Thiazolidinediones • Highly active antiretroviral therapy • Tamoxifen • Steroid hormones • Glucocorticoids • Progestational steroids • Psychotropic medications • Tricyclic antidepressants • Monoamine oxidase inhibitors • Specific SSRIs • Atypical antipsychotics • Lithium • Specific anticonvulsants • -adrenergic receptor blockers SSRI=selective serotonin reuptake inhibitor

  13. Obesity in the US: Disease Burden • Enormous disease burden: • Public health: • 65% (~127M) US adults are overweight (BMI  25 kg/m2) • 31% (~60M) are obese (BMI  30 kg/m2) • 5% (~9M) are severely obese (BMI  40 kg/m2) • Medical impact: considerable increase in morbidity, disability, and mortality • 2nd-ranked preventable cause of death (~365,000/y) • Economic impact: ~$127 billion/y (~5% of every health care $) • Increasingly acknowledged as a serious, treatment-requiring condition • Medical profession • Public policy makers • Managed care • Federal regulators • Pharmaceutical industry

  14. Vagal afferents Hypothalamus GI tract Adipose tissue Ghrelin Hindbrain CCK Leptin PYY3-36 Insulin GLP-1 Amylin Resistin Visfatin OXM Adiponectin GIP Pancreatic islets PP Amylin Multi-Hormonal Control of Body Weight:Role Of Fat-, Gut-, And Islet-derived Signals Adapted from Badman M.K. and Flier J.S. Science 2005; 307: 1909-1914.

  15. Future Pharmacotherapy Obesity: Unmet Medical Needin Metabolic Disease Space 100- 80- Pills Surgery 50- % of Patients 0- 25 15 30 20 10 5 0 Weight loss (%) Current goal

  16. Obesity Treatment Guidelines The Practical Guidecan be found at: NHLBI web site:www.nhlbi.nih.gov NAASO web site:www.naaso.org

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