Prevalence of comorbidities and baseline characteristics of LAP-BAND AP® subjects in the Helping Evaluate Reduction in Obesity (HERO) study.

Prevalence of Comorbidities and Baseline Characteristics of LAP-BAND APH Subjects in the Helping Evaluate Reduction in Obesity (HERO) Study Nancy Dreyer 1 *, John B. Dixon 2 , Ted Okerson 3,4 , Eric A. Finkelstein 5 , Denise Globe 6 1 Quintiles Outcome, Cambridge, Massachusetts, United States of America, 2 Monash University and the Baker Heart and Diabetes Institute, Melbourne, Australia, 3 Medical Affairs, Allergan, Inc., Irvine, California, United States of America, 4 University of California Irvine, Irvine, California, United States of America, 5 Duke-NUS Graduate Medical School, Singapore, Singapore, 6 Global Health Outcomes Strategy & Research, Allergan, Inc., Irvine, California, United States of America Abstract Objective: To describe the baseline characteristics in patients who chose placement of a LAP-BAND APH System (LBAP) and participated in the Helping Evaluate Reduction in Obesity (HERO) Study across regions. Patients and Methods: HERO is a five- year, prospective, multicenter, international study of patients with LBAP placement between July 22, 2009 and January 31, 2011. In addition to baseline and peri-surgery clinical data, seven follow up visits are scheduled at 3, 6 and 12 months, and annually through year five. Data collection included family and medical history, clinical outcomes, laboratory data, health-related quality of life (HRQoL), productivity, healthcare resource utilization, and adverse events. Results: LBAP were placed in 1106 enrolled patients; 56.6% from the US, 26.3% from Europe, 7.1% from Canada, and 10.0% from Australia. The majority were female (n = 877 (79.3%)) with a mean age of 43 years (s.d. = 11.4) and mean body mass index of 45.1 kg/m 2 (s.d. = 6.9). The most common comorbidities were hypertension (HTN) (overall = 42.9%) and diabetes (overall 22.2%, with 27% from the US and 14% from Europe). Overall, less than 5% had a history of cardiovascular disease. The prevalence rates of HTN, diabetes and cardiovascular disease were significantly (p,0.001) higher in men than in women across all regions. Overall HRQoL also worsened with increasing BMI. Conclusions: The HERO study is the first large, multinational and long-term registry with the LBAP. This study will provide real-world outcomes data on LAGB that will help inform patient choice, clinician treatment strategies, and payer reimbursement decisions. Citation: Dreyer N, Dixon JB, Okerson T, Finkelstein EA, Globe D (2013) Prevalence of Comorbidities and Baseline Characteristics of LAP-BAND APH Subjects in the Helping Evaluate Reduction in Obesity (HERO) Study. PLoS ONE 8(11): e78971. doi:10.1371/journal.pone.0078971 Editor: Franco Folli, University of Texas Health Science Center at San Antonio, United States of America Received March 8, 2013; Accepted September 18, 2013; Published November 15, 2013 Copyright: s 2013 Dreyer et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Funding: The authors have no support or funding to report. Competing Interests: The authors have the following interests: co-author Nancy Dreyer is employed by Quintiles Outcome. Co-authors Ted Okerson and Denise Globe are employed by Allergan, Inc. There are no patents, products in development or marketed products to declare. This does not alter the authors’ adherence to all the PLoS ONE policies on sharing data and materials. * E-mail: Nancy.dreyer@quintiles.com geography, safety and reimbursement. Bariatric surgery typically results in greater and more sustainable weight loss compared to non-surgical approaches [9]. In addition, a growing body of evidence suggests that modest sustained weight loss achieved through bariatric surgery can improve health outcomes, including improving co-morbid conditions, in surgery-eligible obese indi- viduals more successfully than diet, exercise, and/or medications [10]. As a result, multiple professional organizations including the American Diabetes Association, the American Association of Clinical Endocrinologists and governmental health agencies such as the National Institute for Clinical Excellence (NICE) recom- mend bariatric surgery as an option for adults with Body Mass Index (BMI) $40 kg/m 2 or (BMI) .35 kg/m 2 with one or more comorbid conditions [11,12,13,14] and for any patient with a BMI $40 kg/m 2 [12,13]. Bariatric procedures are now mostly done laparoscopically and have widely-acceptable safety profiles, with Introduction Obesity is a global public health problem of epidemic proportions, affecting 205 million men and 297 million women over the age of 20 worldwide in 2008 [1]. Obesity has a profound impact on increased risk for developing comorbid chronic diseases and premature mortality [2,3]. Excess weight also imposes an economic burden on individuals and health care systems, including direct costs from health resource utilization and indirect societal costs from absenteeism and workplace injuries, disability payments, and decreased productivity [4–8]. Due to the notable clinical, economic and humanistic impact of obesity, weight reduction is a critical goal for both patients and clinicians. Bariatric surgery is one such weight reduction option for a subset of obese individuals. The choice by patients and their physicians to use a surgical option for weight loss is influenced by various factors including weight, comorbidity, gender, age, PLOS ONE | www.plosone.org November 2013 | Volume 8 | Issue 11 | e78971