Bariatric Times

JUN 2017

A peer-reviewed, evidence-based journal that promotes clinical development and metabolic insights in total bariatric patient care for the healthcare professional

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26 News and Trends Bariatric Times • June 2017 WEIGHT-LOSS SURGERY PUTS PATIENTS AT HIGH RISK FOR ALCOHOL PROBLEMS, EVEN YEARS AFTER PROCEDURE PITTSBURGH, Pennsylvania—One in five patients who undergo one of the most popular weight-loss surgical p rocedures is likely to develop problems with alcohol, with symptoms sometimes not appearing until years after their surgery, according to one of the largest, longest-running studies of adults who got weight-loss surgery. The finding—reported online in Surgery for Obesity and Related Diseases, the journal of the American Society for Metabolic and Bariatric Surgery—indicates that bariatric surgery patients should receive long- term clinical follow-up to monitor for and treat alcohol use disorder, which includes alcohol abuse and dependence. "We knew there was an increase in the number of people experiencing problems with alcohol within the first two years of surgery, but we didn't expect the number of affected patients to continue to grow throughout seven years of follow-up," said lead author Wendy C. King, Ph.D., associate professor of epidemiology at the University of Pittsburgh Graduate School of Public Health. She and her team discovered that 20.8 percent of participants developed symptoms of alcohol use disorder within five years of Roux-en-Y gastric bypass (RYGB). In contrast, only 11.3 percent of patients who underwent gastric banding reported problem alcohol use. Starting in 2006, King and her colleagues followed more than 2,000 patients participating in the National Institutes of Health-funded Longitudinal Assessment of Bariatric Surgery-2 (LABS-2), a prospective observational study of patients undergoing weight- loss surgery at one of 10 hospitals across the United States. RYGB, a surgical procedure that significantly reduces the size of the stomach and changes connections with the small intestine, was the most popular procedure, with 1,481 participants receiving it. The majority of the remaining participants, 522 people, had a less invasive procedure— laparoscopic adjustable gastric banding—where the surgeon inserts an adjustable band around the patient's stomach, lessening the amount of food t he stomach can hold. That procedure has become less popular in recent years because it doesn't result in as much weight loss as RYGB. Both groups of patients increased t heir alcohol consumption over the seven years of the study; however, there was only an increase in the prevalence of alcohol use disorder symptoms, as measured by the Alcohol Use Disorders Identification Test, following RYGB. Among patients without alcohol problems in the year prior to surgery, RYGB patients had more than double the risk of developing alcohol problems over seven years compared to those who had gastric banding. "Because alcohol problems may not appear for several years, it is important that doctors routinely ask patients with a history of bariatric surgery about their alcohol consumption and whether they are experiencing symptoms of alcohol use disorder, and are prepared to refer them to treatment," said King. The American Society for Metabolic and Bariatric Surgery currently recommends that patients be screened for alcohol use disorder before surgery and be made aware of the risk of developing the disorder after surgery. Additionally, the society recommends that high-risk groups be advised to eliminate alcohol consumption following RYGB. However, given the data, King suggests that those who undergo RYGB are a high-risk group, due to the surgery alone. The LABS-2 study was not designed to determine the reason for the difference in risk of alcohol use disorder between surgical procedures, but previous studies indicate that, compared with banding, RYGB is associated with higher and quicker elevation of alcohol in the blood. Additionally, some animal studies suggest that RYGB may increases alcohol reward sensitivity via changes in genetic expression and the hormone system affecting the areas of the brain associated with reward. In addition to RYGB, the LABS-2 study identified several personal characteristics that put patients at increased risk for developing problems with alcohol, including being male and younger, and having less of a social support system. Getting divorced, a w orsening in mental health post- surgery and increasing alcohol consumption to at least twice a week also were associated with a higher risk of alcohol use disorder symptoms. K ing and her team found that although RYGB patients were nearly four times as likely to report having received substance use disorder treatment compared with banding patients, relatively few study participants reported such treatment. Overall, 3.5 percent of RYGB patients reported getting substance use disorder treatment, far less than the 21 percent of patients reporting alcohol problems. "This indicates that treatment programs are underutilized by bariatric surgery patients with alcohol problems," said King. "That's particularly troubling given the availability of effective treatments." Additional authors on this study are Jia-Yuh Chen, Ph.D., and Gretchen E. White, M.P.H., both of Pitt Public Health; Anita P. Courcoulas, M.D., M.P.H., of UPMC; Gregory F. Dakin, M.D., and Alfons Pomp, M.D., both of Weill Cornell Medical College; Scott G. Engel, Ph.D., and James E. Mitchell, M.D., both of the Neuropsychiatric Research Institute in Fargo, N.D.; David R. Flum, M.D., and Marcelo W. Hinojosa, M.D., both of the University of Washington; Melissa A. Kalarchian, Ph.D., of Pitt and Duquesne University; Samer G. Mattar, M.D., and Bruce M. Wolfe, M.D., both of the Oregon Health Sciences University; Walter J. Pories, M.D., of East Carolina University; Kristine J. Steffen, Pharm.D., Ph.D., of the Neuropsychiatric Research Institute and North Dakota State University; and Susan Z. Yanovski, M.D., of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). To access the full press release, visit http://www.upmc.com/media/NewsRele ases/2017/Pages/king-aud-long- soard.aspx ENTEROMEDICS ANNOUNCES THE ACQUISITION OF THE GASTRIC VEST SYSTEM ST. PAUL, Minnesota (PRNewswire)—EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices treating obesity, m etabolic diseases and other gastrointestinal disorders, announced today that it has acquired the Gastric Vest System ™ (the "Gastric Vest" or "Vest"), through its acquisition of BarioSurg, Inc. The Gastric Vest is an investigational, minimally-invasive, laparoscopically implanted medical device being studied for weight loss in morbidly obese patients. The device, which wraps around the stomach and emulates the effect of conventional weight loss surgery, enables gastric volume reduction without permanently changing patient anatomy. In a pilot study conducted outside the U.S., at 12 months, Vest patients demonstrated a mean percent excess weight loss (%EWL) of 85%, an average drop in HbA1c (Hemoglobin A1c) of 2.1 points, and an average waist circumference reduction of 38 centimeters, or approximately 15 inches. "We are excited to both incorporate BarioSurg's Gastric Vest into our now further differentiated portfolio of medical devices for fighting obesity and related comorbidities, and to explore potential clinical opportunities to combine the Vest and vBloc Therapy ® ," said Dan Gladney, EnteroMedics President, Chief Executive Officer and Chairman of the Board. "As we move toward building a comprehensive bariatric and metabolic continuum of care platform to effectively address unmet needs within these areas, we believe that the strong foundation we've built at EnteroMedics will maximize the potential for a successful approval and the subsequent commercialization of this device. " "Based on early results, when comparing short-term %EWL, the Gastric Vest appears to perform as well as, and possibly even better than, gastric bypass and sleeve gastrectomy procedures," stated Scott Shikora, MD, Director, Center for Metabolic and Bariatric Surgery, Brigham and Women's Hospital, Former President of the American Society for Metabolic and News and Trends JUNE 2017

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