News and Trends June 2017

| June 1, 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 procedures 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 the 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 their 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 worsening 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.

King 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/NewsReleases/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, metabolic 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 Bariatric Surgery, and Chief Medical Consultant, EnteroMedics. “If the Vest continues to yield similar results to those observed to date, it will be a game changer in the field of bariatrics.”

Raj Nihalani, MD, inventor of the Gastric Vest System, Founder and Former Chief Executive Officer of BarioSurg stated: “EnteroMedics is a leader in minimally-invasive, sustainable weight loss treatment with vBloc Therapy. I look forward to joining the company and navigating a path toward potential FDA approval and eventual commercialization, while at the same time exploring ways in which the Vest may be able to be combined with vBloc Therapy to enhance patient outcomes.”

The consideration paid by EnteroMedics for BarioSurg, Inc. consists of 1.38 million unregistered shares of EnteroMedics common stock, 1.0 million unregistered shares of conditional convertible preferred stock (which will be convertible into 5.0 million unregistered shares of common stock upon the receipt of the required approval of EnteroMedics’ stockholders under NASDAQ rules), and $2.0 million in cash. The shares of common stock issued in the acquisition represent 19.99% of EnteroMedics’ outstanding common stock immediately prior to the acquisition. EnteroMedics expects to hold a special meeting of its stockholders to seek the required approval of the conversion of the conditional convertible preferred stock in the summer of 2017.

In connection with the acquisition, EnteroMedics has appointed Dr. Nihalani as Chief Technology Officer, EnteroMedics.

To read the full press release, visit http://ir.enteromedics.com/releasedetail.cfm?ReleaseID=1027468

About EnteroMedics Inc. EnteroMedics is a medical device company focused on the development and commercialization of its neuroscience based technology to treat obesity and metabolic diseases. vBloc® Neurometabolic Therapy, delivered by a pacemaker-like device called the vBloc® System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. EnteroMedics’ vBloc® System has received U.S. Food and Drug Administration approval and CE Mark.

About BarioSurg Inc. BarioSurg, Inc. was founded in 2008 by Dr. Raj Nihalani. BarioSurg was a privately held medical device company that developed the proprietary, minimally invasive and reversible device, the Gastric Vest System™ to treat obesity and related comorbidities.

Anthony Comuzzie Named New Executive Director at The Obesity Society

SILVER SPRING, Maryland—Anthony Comuzzie, Ph.D., FTOS, a world-renowned obesity researcher, scientist and co-director of the TOPS Nutrition and Obesity Research Center at Texas Biomedical Research Institute, will serve as the new executive director of The Obesity Society (TOS).

“We are pleased to welcome Dr. Comuzzie to The Obesity Society,” said TOS President Allen Levine, Ph.D., FTOS. “He is an accomplished scientist, well respected among his peers and has the experience and dedication to successfully helm our professional society. We greatly look forward to his ideas and plans for TOS as it continues to be a leader in the field of obesity.”

Dr. Comuzzie has more than 25 years of research experience focused on the genetics of obesity. He is active in numerous scientific societies, served as a member of the NHLBI Expert Panel on Obesity and Overweight, and continues to serve on the Board of Trustees for the Scientists Center for Animal Welfare (SCAW). Dr. Comuzzie also sat on TOS’s Executive Committee as Secretary/Treasurer before accepting the position of executive director.

Additionally, Dr. Comuzzie serves as Editor of Frontiers in Applied Genetic Epidemiology, is an Associate Editor for BMC Medical Genetics, and is a member of the editorial board of the International Journal of Nutrigenetics and Nutrigenomics. He is a recognized expert and advisor on the genetics of obesity and has published more than 250 journal articles.

“The Obesity Society has a unique mission in its dedication to obesity research and treatment,” said Dr. Comuzzie.” Knowing firsthand just how special this organization is, I’m honored and excited to be a part of it.”

About The Obesity Society. The Obesity Society (TOS) is the leading professional society dedicated to better understanding, preventing and treating obesity. Through research, education and advocacy, TOS is committed to improving the lives of those affected by the disease. For more information visit: www.Obesity.org.

World Obesity Federation publishes position statement in Obesity Reviews defining obesity as a chronic, relapsing disease, alongside an accompanying commentary

In a statement published in Obesity Reviews, the World Obesity Federation confirmed its support for defining obesity as a chronic, relapsing disease. The statement was prepared by a scientific committee of the Federation, which concluded that obesity fits the epidemiological model of a disease process except that the toxic or pathological agent is diet-related rather than a microbe.

The question of whether obesity should be called a “disease” has sparked controversy for the most of the last century. In their Obesity Reviews position statement, Dr. George Bray and his colleagues examine how an abundance of food, low physical acivity, and several other environmental factors interact with genetic susceptibility. They draw parallels to chronic diseases, noting that the magnitude of obesity and its adverse effects in individuals may relate to the virulence or toxicity of the environment and its interaction with the host.

“Accepting the concept that obesity is a chronic disease process is important for several reasons,” said Bray. “First, it removes the feeling that patients alone are responsible for their excess weight. It also focuses attention on the way in which this disease process can be tackled. And finally, it shows that is we can successfully treat obesity, many of its associated disease will be eliminated.”

In an accompanying letter to the editor, the Federation’s policy experts suggest that declaring obesity to be a disease could benefit those people who are suffering with obesity and wish to have access to medical advice and support, “whilst also strengthening the call for dealing with the social determinants, obesogenic environments and system causes of individual weight gain.” They note that obesity is a normal response to an obesogenic environment, but is not in itself a biologically normal or healthy condition. They also note that recognizing obesity as a disease may reduce individuals’ internalized stigma, change the public discourse about blame for the condition, and have benefits in countries where health service costs are funded from insurance schemes that limit payments for non-disease conditions or risk factors. To access the article in Obesity Reviews titled, “Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation,” visit http://onlinelibrary.wiley.com/doi/10.1111/obr.12551/full. To access its accompanying commentary, “Comment: obesity as a disease – some implications for the World Obesity Federation’s advocacy and public health activities,” visit http://onlinelibrary.wiley.com/doi/10.1111/obr.12554/full

About the World Obesity Federation. The World Obesity Federation is an alliance of over 50 national and regional organizations dedicated to research into obesity, and treatment and prevention of the disease. It promotes better understanding of the problems faced by people with high levels of adiposity and urges stronger government action to reduct the obesogenicity of the modern environment. The Federation is a charity based in the United Kingdom, and is the host of World Obesity Day on October 11th each year. To learn more visit http://www.worldobesity.org.

New WHO study on health and well-being of Europe’s youth reveals that obesity continues to rise

Copenhagen, Denmark—A new WHO report, launched at the European Congress on Obesity in Portugal, reveals that the number of obese adolescents is continuing to rise in many countries across the WHO European Region.

“Despite sustained efforts to tackle childhood obesity, one in three adolescents is still estimated to be overweight or obese in Europe, with the highest rates found in southern European and Mediterranean countries. What is of particular concern is that the epidemic is on the rise in eastern European countries, where historically rates have been lower,” states Dr Zsuzsanna Jakab, WHO Regional Director for Europe. “Ambitious policy action is required to reach the Sustainable Development Goal to halt the increase in childhood obesity. Governments must target efforts and break this harmful cycle from childhood into adolescence and beyond.”

A major global health concern. Childhood obesity is considered one of the most serious public health challenges of the 21st century. Obese children are at greater risk of type 2 diabetes, asthma, sleep difficulties, musculoskeletal problems and future cardiovascular disease, as well as school absence, psychological problems and social isolation.

Dr Joao Breda, Programme Manager for Nutrition, Physical Activity and Obesity at the WHO Regional Office for Europe, stresses that this has severe consequences reaching far into the future: “Most young people will not outgrow obesity: about four in every five adolescents who become obese will continue to have weight problems as adults. As such, they carry forward the increased risk of ill health, stigma and discrimination. Furthermore, the chronic nature of obesity can limit social mobility and help sustain a damaging intergenerational cycle of poverty and ill health.”

The report highlights persisting inequalities in obesity among young people. In general, younger adolescents, boys and those living in families of lower socioeconomic position are more likely to be obese. These findings indicate that ongoing health promotion and disease prevention efforts aimed at reducing childhood obesity are failing to adequately reach these groups.

Preventive action to reverse negative trends. Policy initiatives and interventions need to target high-risk adolescents within the context of families, schools and wider communities, and prioritize policies that improve young people’s access to healthy diets. Efforts are also needed to improve built environments so that physical activity is re-established as an integral part of daily living.

To access the full press release, visit http://www.euro.who.int/en/media-centre/sections/press-releases/2017/new-who-study-on-health-and-well-being-of-europes-youth-reveals-that-obesity-continues-to-rise

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