Obesity Treatment News: Benefits of obesity treatment depend on individual
Benefits of obesity treatment depend on individual
Recent research has suggested that different groups of people stand to gain in different ways from obesity treatment.
Published in the JAMA journal, the study looked at 850 veterans who underwent obesity treatment between 2000 and 2006.
A control group were also monitored, who had an average age of 54.7 and an average Body Mass Index (BMI) or 42.
The veterans, meanwhile, had an average age of 49.5 years and a BMI of 47.4.
A total of 1.29 per cent of the surgical cases died within 30 days of surgery, but once six years had passed, a mortality rate of 6.8 per cent was recorded in this group.
Meanwhile, the control group had a mortality rate of 15.2 per cent after this time.
However, further analysis concluded that the surgery was not significantly associated with reduced mortality when propensity-match patients were looked at.
The study’s authors noted: “Our results highlight the importance of statistical adjustment and careful selection of surgical and nonsurgical cohorts, particularly during evaluation of bariatric surgery according to administrative data.”
Obesity Groups See Evidence FDA Decisions Will Discourage Obesity Research
The Obesity Care Continuum (OCC), represented by The Obesity Society (TOS), the Obesity Action Coalition (OAC), the American Society for Metabolic and Bariatric Surgery (ASMBS) and the American Dietetic Association (ADA), expresses a deep concern for the recent decision by the FDA, Division of Metabolic and Endocrinologic Products (DMEP), to require Orexigen to conduct a pre-approval cardiovascular outcomes trial for Contrave, even after the FDA Advisory Panel voted for approval of Contrave with a post-approval cardiovascular trial. Furthermore, the OCC believes that the requested pre-approval outcomes trial is unprecedented for any disease and would generate more information than is necessary or feasible.
This verdict has far broader consequences than simply impacting one company and one drug. The decision falls on the heels of two other decisions to disallow additional drugs for obesity treatment made over the last 12 months by the FDA, Center for Drug Evaluation and Research (CDER). The FDA/CDER’s charge is “to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.” The agency has not approved an obesity drug since 1999, and, last year, also removed from the market a drug it approved in 1997. The OCC feels this track record shows a trend of the FDA being “benefit-blind” causing an overly risk averse position. “We believe that in order to comprehensively treat the disease of obesity, healthcare professionals must have access to a variety of treatment options. We are extremely disappointed in the short-sightedness of the FDA to objectively and fairly evaluate benefits as well as risks of potential obesity medications,” said Jennifer Lovejoy, TOS President.
If the Agency’s approach to this class of drugs continues, it will likely further discourage any research and development in the area of obesity ever again. We have already witnessed the withdrawal of the major pharmaceutical companies from this market given the lack of clear predictability surrounding FDA’s approval process. We are now seeing the same result in the small biotech market and truly wonder who will fill this void in the absence of any firm drug approval guidance from the FDA.
The greatest consequence however is the impact that lack of treatment options has on the American people. More than a third of US adults are obese, and vulnerable to obesity’s damaging consequences and a growing number are severely affected and left without treatment options. Obesity is responsible for the deaths of more than 100,000 Americans each year. Costs attributable to obesity and overweight have been estimated at $270 billion annually, including direct medical costs and indirect costs, such as absenteeism and productivity losses. “The result of limiting treatment options for healthcare professionals will be catastrophic to the health of millions of Americans and our healthcare system,” said Joe Nadglowski, OAC President and CEO.
With the obesity epidemic driving risk for type 2 diabetes, sleep apnea, fatty liver disease and many other co-morbidities, we cannot afford to wait any longer to fairly weigh the risks against the benefits and the benefits lost to find a way toward drug approval.
About OCC
All of our organizations work together representing patients, registered dietitians, scientists, clinicians, and surgeons to elevate the recognition of both the prevention and treatment of obesity.
About TOS
The Obesity Society is the leading scientific society dedicated to the study of obesity. Since 1982, The Obesity Society has been committed to encouraging research on the causes and treatment of obesity, and to keeping the medical community and public informed of new advances. Visit TOS at obesity.org.
About OAC
The OAC is a national nonprofit charity dedicated to helping individuals affected by obesity. The OAC was formed to bring together individuals struggling with weight issues and provide educational resources and advocacy tools. In 2011, the OAC launched a national Membership Drive to recruit 50,000 members to strengthen its advocacy efforts and raise awareness of the disease of obesity. For more information on OAC Membership, please visit www.obesityaction.org.
About the ASMBS
The mission of the ASMBS is to advance the art and science of bariatric surgery by continued encouragement of its members to: improve the care and treatment of people with obesity and related diseases; advance the science and understanding of metabolic surgery; foster communication between health professionals on obesity and related conditions; and advocate for health care policy that ensures patient access to high-quality prevention and treatment of obesity. Visit ASMBS at asmbs.org.
About ADA
The American Dietetic Association is the world’s largest organization of food and nutrition professionals. ADA is committed to improving the nation’s health and advancing the profession of dietetics through research, education and advocacy. Visit ADA at eatright.org.
Genetic factor controls obesity-induced inflammation
ISLAMABAD: Scientists have discovered a genetic factor that can regulate obesity-induced inflammation that contributes to chronic health problems.
Researchers at Case Western Reserve University School of Medicine feel if they learn to control levels of the factor in defense cells called macrophages, they would find a new treatment for health-harming obesity.
“We have a shot at a novel treatment for obesity and its complications, such as diabetes, heart disease and cancer,” Mukesh K. Jain, MD, Ellery Sedgwick Jr. Chair, director of the Case Cardiovascular Research Institute, and senior author of the new study, said.
Macrophages contain low levels of KLF4 and are more easily irritated by cytokines, which are cell-signalling proteins, and fatty acids released by fat cells, and they respond by producing a low level of inflammation, Jain explained.
“A low level of inflammation over time is deleterious,” he said.
In people, long-lasting inflammation is connected to diabetes, increased risk of cardiovascular disease, cancer and other chronic illnesses.
In experiments using mouse models, Jain’s team found that when KLF4 was removed from macrophages, they all assumed the inflammatory state.
Furthermore, when the KLF4-deficient mice were fed a high-fat diet for 10 weeks, they gained 15 percent more weight than control animals fed the same diet, and developed severe diabetes as evidenced by glucose tolerance tests.
The researchers are now designing experiments to determine if they can prevent or reverse the shift from anti-inflammatory to inflammatory by increasing KLF4 levels in macrophages as cytokines or fats bombard them.
The findings have been published online in the Journal of Clinical Investigation
New Study Identifies Key Risk Factors for Bariatric Surgery
Newswise — ORLANDO, FL – June 15, 2011 – University of California at Irvine (UC Irvine) researchers reviewed data from more than 100,000 bariatric surgery patients and discovered the top six risk factors that could help doctors and patients predict, evaluate, reduce or avoid in-hospital mortality after weight loss surgery. The findings* were presented here at the 28th Annual Meeting of the American Society for Metabolic & Bariatric Surgery (ASMBS).
The risk factors include the type of weight loss operation (gastric bypass or gastric band), surgical technique (open or laparoscopic), patient gender, type of insurance (private or Medicare), age and the presence of Type 2 diabetes. Researchers say one or more of these risk factors may increase the risk of death before discharge from the hospital.
“Bariatric surgery is safer than it has ever been, but there may be more we can do to make it even safer and improve the odds of survival for high risk patients,” said Ninh T. Nguyen, MD, the study’s primary author and Chief of the Division of Gastrointestinal Surgery at UC Irvine Medical Center. “Doctors can use these risk factors to help in pre-operative planning and to help patients better understand his or her individual risk.”
Researchers analyzed hospital discharge data from the University HealthSystem Consortium (UHC) database where they identified 105,287 patients who underwent bariatric surgery between 2002 and 2009 at academic medical centers in the United States. More than 80 percent of the patients were female and nearly three-quarters were Caucasian. The type of operations included laparoscopic gastric bypass (45%), open gastric bypass (41%) and laparoscopic adjustable gastric banding (14%). The overall in-hospital mortality rate was 0.17 percent, which was the primary outcome examined in the study.
For each top risk factor an adjusted odds ratio (AOR) was calculated using statistical analyses to determine its individual and relative impact on in-patient mortality. The higher the AOR, the greater the odds of it having an impact on patients.
The study showed a person who had an open, rather than a laparoscopic, weight loss operation faced nearly five times (AOR 4.8) the risk of in-hospital mortality. The AOR was 5.8 if the patient had a gastric bypass versus non-bypass patients, 3.2 if the patient was male, 3.0 if the patient had Medicare coverage rather than private insurance, 1.9 if the patient was age 60 or over and 1.6 if Type 2 diabetes was present.
“It’s important to remember that despite these risk factors, we are still talking about highly effective and safe operations that result in significant weight loss and improvement or resolution of obesity-related diseases. Morbid obesity itself is a major risk factor for premature death, and in fact may be riskier without intervention than the surgery itself,” added Dr. Nguyen. “The data shows laparoscopic bariatric surgery has become no riskier than gallbladder or hip replacement surgery.”
Previous studies have shown that the risks of living with morbid obesity outweigh the risks of bariatric surgery ,(1) and that patients may improve life expectancy by 89 percent(2) and reduce their risk of premature death by 30 to 40 percent ,(3,4) after bariatric surgery.
Dr. Nguyen and his colleagues also identified a simple risk classification system that aims to enable clinicians to predict individual patient risk of mortality that they can use to strategize a preoperative plan that may reduce surgical risk. In this bariatric mortality risk classification, patients can be grouped according to a score that is calculated based on the number of points assigned to their individual risk factors (I, II, III, or IV). The lowest risk group (class I) has an in-hospital mortality of 0.10 percent while the highest risk group (class IV) has a mortality of 0.70 percent.
Bariatric surgery has been shown to be the most effective and long lasting treatment for morbid obesity and many related conditions.(5) People with morbid obesity have BMI of 40 or more, or BMI of 35 or more with an obesity-related disease such as Type 2 diabetes, heart disease or sleep apnea. Recently the FDA approved the use of an adjustable gastric band for BMI 30 and above, recognizing that there is an increase in mortality and medical complications of obesity at even this level of obesity.
According to the ASMBS, more than 15 million Americans have morbid obesity. Studies have shown patients may lose 30 to 50 percent of their excess weight 6 months after surgery and 77 percent of their excess weight as early as one year after surgery.(6)
The most common methods of bariatric surgery are laparoscopic gastric bypass and laparoscopic adjustable gastric banding (LAGB). Bariatric surgery limits the amount of food the stomach can hold, and/or limits the amount of calories absorbed, by surgically reducing the stomach’s capacity to a few ounces.
The federal government estimated that in 2008, annual obesity-related health spending reached $147 billion,(7) double what it was a decade ago, and projects spending to rise to $344 billion each year by 2018.(8) The Agency for Healthcare Research and Quality (AHRQ) reported significant improvements in the safety of bariatric surgery due in large part to improved laparoscopic techniques and the advent of bariatric surgical centers of excellence. The overall risk of death from bariatric surgery is about 0.1 percent(9) and the risk of major complications is about 4 percent.(10)
In addition to Dr. Nguyen, study authors include Brian Nguyen BS, Brian Smith MD, Xuan-Mai T. Nguyen PhD, Christian Elliott BS, Kevin Reavis MD, and Samuel Hohmann PhD.
About the ASMBS
The ASMBS is the largest organization for bariatric surgeons in the world. It is a non-profit organization that works to advance the art and science of bariatric surgery and is committed to educating medical professionals and the lay public about bariatric surgery as an option for the treatment of morbid obesity, as well as the associated risks and benefits. It encourages its members to investigate and discover new advances in bariatric surgery, while maintaining a steady exchange of experiences and ideas that may lead to improved surgical outcomes for morbidly obese patients.