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Obesity and Weight Management The Role of Phentermine/Topiramate Extended-release in the Treatment of Obesity and Obesity-related Adverse Health Consequences James R Gavin III, MD, PhD Clinical Professor of Medicine, Emory University School of Medicine, Atlanta, Georgia, US Abstract Long-term pharmacologic strategies that may be used in conjunction with lifestyle changes to combat the obesity epidemic have, until recently, been an unmet clinical need. In 2012, the US Food and Drug Administration (FDA) approved two new drugs for chronic weight management in obese adults in conjunction with a reduced-calorie diet and increased physical activity: phentermine/topiramate extended-release (PHEN/TPM ER) and lorcaserin. The efficacy and safety of PHEN/TPM ER has been studied in clinical trials. PHEN/TPM ER had a substantial impact on weight loss with the National Institutes of Health (NIH) National Heart, Lung, and Blood Institute (NHLBI) target of 10 % weight loss from baseline being achieved in almost half of patients receiving PHEN/TPM ER 15/92. Furthermore, PHEN/TPM ER was associated with improvement in obesity- related adverse health consequences, including hyperglycemia, dyslipidemia, and hypertension, and a reduction in the rate of progression to type 2 diabetes. This clinical evidence supports PHEN/TPM ER as an efficacious, well-tolerated anti-obesity agent that may also have a significant impact on obesity-related adverse health consequences. Keywords Obesity, phentermine, topiramate, weight loss Disclosure: James R Gavin III, MD, PhD, has served as a speaker for Vivus Pharmaceuticals and has received speaker’s fees for this activity. Acknowledgments: Editorial assistance was provided by Katrina Mountfort, PhD, at Touch Medical Media. Received: September 5, 2013 Accepted: November 8, 2013 Citation: US Endocrinology, 2013;9(2):139–45 Correspondence: James R Gavin III, MD, PhD, Healing Our Village, Inc., 4751 Best Road, Suite 420, Atlanta, GA 30337, US. E: Support: The publication of this article was supported by VIVUS, Inc. The views and opinions expressed are those of the author and not necessarily those of VIVUS, Inc. Obesity has traditionally been defined as a body mass index (BMI) of 30  kg/m 2 or more. However, BMI has limitations, and obesity is now defined by a number of factors, including waist circumference. 1 The growing prevalence of obesity is a global health concern. In 2008, 10  % of men and 14  % of women aged 20+ were obese compared with 5 % in men and 8 % in women in 1980. 2 Obesity rates in the US are among the highest in the world: in 2009–10, more than 37  % of US adults and almost 17 % of youth were obese. 3 These trends have affected all ethnic groups, all regions of the country, and all socioeconomic groups, with the largest increases in obesity occurring among children. 4 In recognition of its underlying vasculopathic physiology, and its association with significant morbidity and mortality, the nation’s largest physician group has recently categorized obesity as a disease itself rather than simply a risk factor for other metabolic diseases. The prevailing thought among many is that metabolic diseases are pathologic consequences of adiposity. 1,5 This article will discuss the health and economic burdens of obesity as well as strategies for treating the condition, with a focus on a recently approved pharmacologic agent: phentermine/topiramate extended-release (PHEN/ TPM ER). © TO U CH MEDICAL MED IA 2013 The Health and Economic Burdens of Obesity Obesity contributes to adverse metabolic consequences. 1 As BMI increases, views of both current health decline and of future health become more pessimistic. Although the intention or desire to lose or maintain weight and to exercise regularly is stronger among obese individuals, the proportion who currently exercise or actually maintain desired weight is low. 6 Obesity has a substantial negative effect on longevity, reducing the life expectancy of people who are severely obese by an estimated 5 to 20 years. 7 Obesity contributes to additional health risks such as hypertension, 8 cardiovascular disease, 9 diabetes, 10,11 stroke, 12 and cancer: every additional 5  kg/m 2 in BMI increases a man’s risk for esophageal cancer by 52  % and for colon cancer by 24  %. In women: endometrial cancer by 59  %, gall bladder cancer by 59  %, and postmenopausal breast cancer by 12  %. 13 Prediabetes, which involves impaired glucose tolerance as well as an elevation of fasting plasma glucose above the normal range but below that of clinical diabetes, and the metabolic syndrome can also be consequences of obesity. 14 The latter is widespread among adults in the US, with an estimated prevalence of 34.3–38.5 % (dependent on waist circumference criteria used). 15 139