News and Trends—February 2015

| February 1, 2015

Obesity Experts Recommend Weight Loss Drugs, Surgery as Supplement to Lifestyle Interventions
Endocrine Society publishes Clinical Practice Guideline on medications for treating obesity
WASHINGTON, District of Columbia—The Endocrine Society issued a Clinical Practice Guideline (CPG) on strategies for prescribing drugs to manage obesity and promote weight loss.
The CPG, entitled “Pharmacological Management of Obesity: An Endocrine Society Clinical Practice Guideline,” was published online and will appear in the February 2015 print issue of the Journal of Clinical Endocrinology and Metabolism (JCEM), a publication of the Endocrine Society.

Obesity is a worsening public health problem. According to the 2012 National Health and Nutrition Examination Survey, about 33.9 percent of adults ages 19–79 were overweight, 35.1 percent were obese and 6.4 were extremely obese.

The Food and Drug Administration has approved four new anti-obesity drugs – lorcaserin, phentermine/topiramate, naltrexone/bupropion and liraglutide—in the past two years. Medications like these can be used in combination with diet and exercise to help people lose weight.

“Lifestyle changes should always be a central part of any weight loss strategy,” said Caroline M. Apovian, MD, of Boston University School of Medicine and Boston Medical Center, and chair of the task force that authored the guideline. “Medications do not work by themselves, but they can help people maintain a healthy diet by reducing the appetite. Adding a medication to a lifestyle modification program is likely to result in greater weight loss.”

In the CPG, the Endocrine Society recommends that diet, exercise and behavioral modifications be part of all obesity management approaches. Other tools such as weight loss medications and bariatric surgery can be combined with behavioral changes to reduce food intake and increase physical activity. Patients who have been unable to successfully lose weight and maintain a goal weight may be candidates for prescription medication if they meet the criteria on the drug’s label.
Other recommendations from the CPG include:

•    If a patient responds well to a weight loss medication and loses 5 percent or more of their body weight after three months, the medication should be continued. If the medication is ineffective or the patient experiences side effects, the prescription should be stopped and an alternative medication or approach considered.
•    Since some diabetes medications are associated with weight gain, people with diabetes who are obese or overweight should be given medications that promote weight loss or have no effect on weight as first- and second-line treatments. Doctors should discuss medications’ potential effects on weight with patients.
•    Certain types of medication – angiotensin converting enzyme inhibitors, angiotensin receptor blockers and calcium channel blockers – should be used as a first-line treatment for high blood pressure in obese people with Type 2 diabetes. These are effective blood pressure treatments that are less likely to contribute to weight gain than the alternative medication, beta-adrenergic blockers.
•    When patients need medications that can have an impact on weight such as antidepressants, antipsychotic drugs and medications for treating epilepsy, they should be fully informed and provided with estimates of each option’s anticipated effect on weight. Doctors and patients should engage in a shared-decision making process to evaluate the options.
•    In patients with uncontrolled high blood pressure or a history of heart disease, the medications phentermine and diethylpropion should not be used.

The Hormone Health Network offers resources on weight and health at http://www.hormone.org/diseases-and-conditions/weight-and-health.

Other members of the Endocrine Society task force that developed this CPG include: Louis J. Aronne of Weill-Cornell Medical College in New York, NY; Daniel H. Bessesen of Denver Health Medical Center in Denver, CO; Marie E. McDonnell of Brigham and Women’s Hospital in Boston, MA; Mohammad Hassan Murad of the Mayo Clinic in Rochester, MN; Uberto Pagotto of Alma Mater University of Bologna in Bologna, Italy; Donna H. Ryan of Pennington Biomedical Research Center in Baton Rouge, LA; and Christopher D. Still of Geisinger Health Care System in Danville, PA.

The Society established the CPG Program to provide endocrinologists and other clinicians with evidence-based recommendations in the diagnosis and treatment of endocrine-related conditions. Each CPG is created by a task force of topic-related experts in the field. Task forces rely on scientific reviews of the literature in the development of CPG recommendations. The Endocrine Society does not solicit or accept corporate support for its CPGs. All CPGs are supported entirely by Society funds.

The CPG was co-sponsored by the European Society of Endocrinology and The Obesity Society.
About the Endocrine Society. Founded in 1916, the Endocrine Society is the world’s oldest, largest and most active organization devoted to research on hormones and the clinical practice of endocrinology.  Today, the Endocrine Society’s membership consists of over 18,000 scientists, physicians, educators, nurses and students in 122 countries. Society members represent all basic, applied and clinical interests in endocrinology. The Endocrine Society is based in Washington, DC. To learn more about the Society and the field of endocrinology, visit www.endocrine.org.

New Guidelines Address Bariatric Surgery in Children
ROME, Italy (Medscape Medical News)—Bariatric surgery should be considered as an option in carefully selected obese children and adolescents, according to a new position statement from the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition.

The position statement was published online in the Journal of Pediatric Gastroenterology and Nutrition[1] by a 12-member pediatric hepatologist panel chaired by Valerio Nobili, MD, professor and chief of the Hepatometabolic Unit and head of the Laboratory of Liver Diseases at the Bambino Gesù Hospital in Rome, Italy.

The group advised consideration of bariatric surgery in “carefully selected” patients with body mass indexes of greater than 40kg/m2 who have severe comorbidities such as nonalcoholic fatty liver disease (NAFLD), or in those with a body mass index of greater than 50kg/m2 who have milder comorbidities.

This is the first guideline on the use of bariatric surgery in youth since the 2012 joint document from the National Association of Children’s Hospitals and Related Institutions and the North American Society of Pediatric Gastroenterology, Hepatology, and Nutrition addressed the nutritional needs of adolescents undergoing the procedure.[2]

“The aim of this position paper is to outline current indications and limitations in this controversial field of therapy and to define a standardized approach for extremely affected adolescents with complications such as NAFLD. Despite only limited evidence for bariatric interventions, the authors aim to provide guidance for clinical scenarios of complicated obesity in the presence of advanced NAFLD and other comorbidities when all established therapy has failed,” the authors wrote.

The authors pointed out that although lifestyle intervention and diet are the mainstays of current medical management of obesity and its medical complications, long-term results are “often disappointing,” and recent evidence suggests that “in carefully selected patients an early intervention by bariatric surgery can strongly reduce the risk of adulthood obesity and obesity-related conditions,” including NAFLD, type 2 diabetes, and sleep apnea.

Additional factors to consider in deciding whether a child or adolescent should undergo bariatric surgery include physical and psychological maturity, personal desire to undergo the procedure, previous attempts at weight loss, and ability to adhere to follow-up care.

The position statement also includes recommendations for preoperative evaluation and for obtaining informed consent from families.

The Roux-en-Y gastric bypass, laparoscopic adjustable gastric band, and sleeve gastrectomy are the most widely used procedures in pediatric obesity, but their use is associated with subsequent nutritional deficiencies. Temporary intragastric devices could represent a better option for initial treatment in pediatric populations, Dr. Nobili and colleagues wrote.

The position statement gives no age threshold. Dr. Nobili told Medscape Medical News that he personally believes children aged 10 years and older could benefit, and even rare exceptions could be made for younger children with extremes of body mass index or comorbidities.

Dr. Nobili said the European panel intended the recommendations to be helpful to physicians in the United States, where “despite the relative effectiveness of bariatric surgery for the treatment of severe obesity and its associated comorbidities, too few patients are eligible owing to lack of insurance coverage and relatively stringent eligibility criteria….We tried to write ‘eligibility criteria’ which could be used by all pediatricians who care for these patients.”

Because of rapid evolution in the field, the panel intends to revise the guidelines in two years, Dr. Nobili told Medscape Medical News.

References
1.    Fullmer MA, Abrams SH, Hrovat K, et al. Nutritional strategy for adolescents undergoing bariatric surgery: report of a working group of the Nutrition Committee of NASPGHAN/NACHRI. J Pediatr Gastroenterol Nutr. 2012;54:125–135.
2.    Nobili V, Vajro P, Dezsofi A, et al. Indications and Limitations of Bariatric Intervention in Severely Obese Children and Adolescents With and Without Non-alcoholic Steatohepatitis: the ESPGHAN Hepatology Committee Position Statement. J Pediatr Gastroenterol Nutr. 2015 Feb 2. [Epub ahead of print]

Bariatric surgery associated with improved long-term survival
CHICAGO, Illinois—Among obese patients receiving care in the Veterans Affairs health system, those who underwent bariatric surgery, compared with obese patients who did not have this surgery, had a lower all-cause rate of death at five years and up to 10 years following the procedure, according to a study in The Journal of the American Medical Association (JAMA).

Bariatric surgery is associated with improvement in weight, obesity-related conditions, and quality of life among severely obese adults. Accumulating evidence suggests that bariatric surgery improves survival among patients with severe obesity, but these studies have examined lower-risk, predominantly female patients. The long-term outcomes of bariatric surgery on patients with substantial co-existing illnesses are not known, according to background information in the article.

David E. Arterburn, MD, MPH, of the Group Health Research Institute, Seattle, and colleagues examined long-term survival among 2,500 patients (74 percent men) who underwent bariatric surgery in Veterans Affairs (VA) bariatric centers from 2000–2011 and matched them to 7,462 control patients who did not undergo bariatric surgery. Bariatric procedures included gastric bypass (74 percent), sleeve gastrectomy (15 percent), adjustable gastric banding (10 percent), and other (1 percent). Surgical patients had an average age of 52 years and an average body mass index (BMI) of 47kg/m2; control patients had an average age of 53 years and an average BMI of 46.

At the end of the 14-year study period, there were a total of 263 deaths in the surgical group and 1,277 deaths in the control group. Estimated mortality rates for surgical patients were 2.4 percent at one year, 6.4 percent at five years, and 13.8 percent at 10 years; for control patients, estimated mortality rates were 1.7 percent at 1 year, 10.4 percent at five years, and 23.9 percent at 10 years. Bariatric surgery was not associated with all-cause mortality in the first year of follow-up, but associated with significantly lower mortality after 1 to 5 years and 5 to 14 years.

The researchers found no significant difference in the association of bariatric surgery on mortality across groups defined by sex, diabetes diagnosis, and super obesity (BMI greater than 50kg/m2); “however, future studies with larger samples and longer-term follow-up should seek to confirm these findings.”
The authors write that the results of this study “provide further evidence for the beneficial relationship between surgery and survival that has been demonstrated in younger, predominantly female populations.”

Web surfing to weigh up bariatric surgery options
Obese Claim No. 2 spot Among e-Health Information Seekers
New York, New York and Heidelberg, Germany—Obese people considering weight-reducing bariatric surgery are only topped by pregnant women when it comes to how often they turn to the Internet for health advice. While most use it to read up on relevant procedures and experiences, one in every four patients actually chooses a surgeon based solely on what he or she has gleaned from, in particular, websites hosted by public hospitals and former patients. This is according to a study in the journal Obesity Surgery, led by Luca Paolino of the Joseph Ducuing Hospital in Toulouse, France.

In a questionnaire completed by 212 candidates for bariatric surgery, Paolino and his colleagues assessed if the participants had access to the Internet and what role the e-health information they read ultimately played in their decision whether or not to undergo surgery. The researchers also assessed how useful and trustworthy the participants found the Internet information, and how they verified the facts they read.
It was found that the vast majority (77.8 percent) of participants used the Internet, in particular, to seek information about different surgical procedures and to learn from the experiences of patients with similar conditions. According to Paolino, only one previous study on pregnant women noted a higher rate (95 percent) of Internet e-health use among a specific group of patients.

Just over half of the patients found relevant e-information on the topics quite easily. Participants generally preferred the advice provided by public hospitals or patients’ associations to that of popular media websites or the pharmaceutical industry. However, the majority of patients (92.6 percent) still verified the e-information they read with other sources such as their general medical practitioners, family and friends. Only a minority of patients (16.2 percent) did not trust what they read about the topic on the web as a whole.
A little more than three-quarters of the bariatric surgery patients also largely take their lead from their general practitioners about which hospital or surgeon to choose. However, Paolino and his colleagues found that one in every four patients relies only on Internet information to choose their surgeon – indicative of the popularity of using the web to read up on the matter.

“The Internet has already become an important source of knowledge in patients’ decision-making processes. Therefore it is important to create or promote independent high-quality healthcare websites and to integrate them into discussions with patients,” is Paolino’s advice to health professionals.

References
1.    Paolino, L. et al. (2015). The web-surfing bariatric patient: the role of the Internet in the decision-making process, Obesity Surgery.

Federal Trade Commission Continues Crackdown on Fad Weight-Loss Products
WASHINGTON, District of Columbia—Marketers who pitched homeopathic HCG drops as a quick and easy way to lose substantial weight have agreed to pay $1 million to settle Federal Trade Commission charges that their weight-loss claims were deceptive and not supported by scientific evidence. The defendants have stopped selling HCG Platinum drops, and under the settlement, Kevin Wright and his Utah-based companies, HCG Platinum, LLC and Right Way Nutrition, LLC, are banned from making similar weight-loss claims in the future.

The settlement marks the second time in 2014 the FTC has taken legal action against marketers of HCG weight-loss products. In January 2014, a company called HCG Diet Direct settled similar charges brought by the FTC.

“Fad weight-loss products like HCG drops come and go, but consumers shouldn’t be fooled by their empty promises,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “The foundation of successful weight loss is to eat a healthy diet and to increase physical activity.”

HCG, or human chorionic gonadotropin, is a hormone produced by the human placenta that for decades has been falsely promoted for weight loss. In November 2011, Wright and six other HCG marketers received warning letters issued jointly by FDA and FTC staff, advising them that their products are mislabeled drugs under the Federal Food, Drug, and Cosmetic Act, and warning that it is illegal to make weight-loss claims that are not supported by competent and reliable scientific evidence.

Selling the products at GNC, Rite Aid, Walgreens, and on their own websites, Wright and his companies promised consumers that HCG Platinum drops would cause rapid and substantial weight loss, and that consumers likely would lose as much as 43 and even 50 pounds, as claimed in product testimonials.
The defendants, who also made claims on Facebook, on product packaging, and in Internet pop-up ads and magazines, directed consumers to place the HCG drops under their tongues before meals and stick to a very low calorie diet. The defendants marketed two of their three formulations as “homeopathic,” meaning the listed ingredients were diluted to the point they were undetectable. They typically charged between $60 and $85 for a 30-day supply of all three formulations, and sold approximately $10 million of the products from 2010 to earlier this year, when they were sued.

The settlement bans the defendants from making a number of specific weight-loss claims about any over-the-counter drug, patch, cream, wrap, or any other product. It also requires the defendants to substantiate any future claims that using a product causes weight loss, rapid weight loss, or a specific amount of weight loss or that consumers can expect to lose as much weight as the product’s endorser, unless they have at least two adequate and well-controlled human clinical studies. Claims regarding the health benefits, safety, performance, or efficacy cannot be made unless they are not misleading and are substantiated by competent and reliable scientific evidence. The defendants also are barred from misrepresenting the results of any scientific study.

The order also imposes a $10 million judgment, representing all net sales of HCG Platinum drops, which will be suspended, provided the defendants pay the FTC $1 million. If it is determined that the financial information the defendants gave the FTC was untruthful, the full amount of the judgment will become due.

Finding Solutions to Major Health Concerns Across the Americas
Renowned Medical Association Assembles Endocrinology Experts for Scientific Symposium
in Latin America
JACKSONVILLE, Florida—The American Association of Clinical Endocrinologists (AACE) will convene the first-ever, Pan-American Scientific Symposium: Clinical Endocrinology in Latin America, February 26–28 in San Jose, Costa Rica.

Endocrinologists from throughout South and Central America, the Caribbean Basin, as well as members of current AACE Chapters in the region—Colombia, Costa Rica, Peru and Puerto Rico, will attend the three-day conference to be held at the Intercontinental Hotel and hosted in cooperation with the Asociacion Nacional Pro Estudio de la Diabetes, Endocrinologia y Metabolismo.

“This is AACE’s first educational conference in Latin America that will address the endocrine pandemics widely affecting emerging economies throughout the region,” said AACE President R. Mack Harrell, MD, FACP, FACE, ECNU. “It’s a transcultural opportunity for us to share and adapt our AACE guidelines and educational programs with the help of our colleagues throughout Latin America.”

With the implementation of the Pan-American Scientific Symposium: Clinical Endocrinology in Latin America, AACE continues to demonstrate a leadership role providing dynamic educational opportunities to clinical endocrinologists around the globe. This conference will focus on endocrine diseases such as diabetes, obesity, thyroid disease and thyroid cancer as they pertain to Latin America. Also, a special workshop on neck ultrasound will be offered to participants.

Interested participants can learn more and register via email: endocrinocr@medicos.cr or by calling
011-506-2487-4318.

About AACE. The American Association of Clinical Endocrinologists (AACE) represents more than 6,900 endocrinologists in the United States and abroad. AACE is the largest association of clinical endocrinologists in the world with 13 international chapters. The majority of AACE members are certified in Endocrinology and Metabolism and concentrate on the treatment of patients with endocrine and metabolic disorders including diabetes, thyroid disorders, osteoporosis, growth hormone deficiency, cholesterol disorders, hypertension and obesity. For more information, visit the AACE website at www.aace.com, become a fan on Facebook at www.facebook.com/theaace or follow AACE on Twitter at www.twitter.com/theaace.

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