Tuesday, December 20, 2011

Endoscopic Bariatric Therapies

Bariatric surgery is a very effective weight loss treatment. Non-surgical weight loss approaches, including pharmacotherapy, diet, exercise and lifestyle modification, are, many times, less effective than weight loss surgery. But weight loss surgery has more associated complications than non-surgical methods. Fortunately, experts are exploring treatment options that mimic bariatric surgery while reducing the associated complications. Some of these options could prove to be good weight loss approaches.
Many of the options can be classified as endoscopic bariatric therapies or EBTs. A task force was formed to investigate these options. Members comprising the taskforce are drawn from two well known organizations. These organizations are The American Society for Gastrointestinal Endoscopy (ASGE) and The American Society for Metabolic and Bariatric Surgery (ASMBS). EBTs are "performed entirely through the gastrointestinal (GI) tract using flexible endoscopes." Usually there is no surgical incision associated with EBTs. Many EBTs mimic the functions of bariatric surgery.
Bariatric surgical procedures can be put into two broad categories. The procedures are either restrictive or malabsorptive. For example, the adjustable lap band is restrictive since it restricts the amount of food that can pass through the band. And gastric bypass surgery is both restrictive and malabsorptive. It is restrictive since it shrinks the size of the stomach, reducing the amount of food one needs to eat to feel full. And bypass surgery is malabsorptive, since the surgery reroutes the small intestine in a way to cause food to bypass parts of the small intestine, allowing fewer calories (and other nutrients) to be digested.
EBTs may be put into three categories. They may be restrictive, malabsorptive , or neuro-hormonal. An example of an EBT that fits into the restrictive category is the gastric balloon. This device is first placed in the stomach, endoscopically, then filled with a liquid or air. When the gastric balloon is filled, an individual’s stomach feels full with less food. A complex version of this EBT is in research at ReShape Medical, Inc, headquartered in San Clemente, California.
An example of an EBT device that may be classified as malabsorptive is the Endobarrier. Produced by Lexington, MA based GI Dynamics, the Endobarrier is a liner for a segment of the small intestine. Similar to the gastric balloon, the Endobarrier is placed in the small intestine endoscopically. The device is engineered to create a barrier between the food one eats and the intestinal walls. After insertion, food digestion is delayed in a fashion similar to gastric bypass surgery.
And finally, an example of a potential EBT that can be classified as neuro-hormonal is VBLOC. VBLOC was developed by Minnesota based EnteroMedics Inc. VBLOC is a system placed in the digestive system, laparoscopically, to block signals sent from the digestive system, via the vagus nerve, to the brain. The signals include messages associated with hunger, satisfaction and fullness.
As EBTs are developed, tested, and proven effective, medical weight loss options might be enhanced. Both patients and weight loss service providers could benefit. Medical and surgical weight loss service providers should monitor the progress made in EBT research, so that the providers will know when they might offer the EBT as part of their services, or give advice regarding appropriate EBT application.
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Tuesday, December 6, 2011

Would FDA Approval of Obesity Drugs Help Reduce Health Care Costs?

There is renewed attention being given to three obesity drugs that recently received a thumbs-down by the FDA. The drugs are Qnexa, produced by Vivus, a California based company, Lorcaserin, manufactured by Arena Pharmaceuticals, Inc. , a California based company, and Contrave, produced by California based Orexigen Therapeutics, Inc. If either of the three drugs eventually receives FDA approval, given the health care cost of obesity, we might assume that the use of the drugs would likely reduce the cost of health care. However, at least one study indicates that weight loss drugs don't necessarily reduce health care costs.

The study was done in Australia. The researchers looked at the costs associated with treating ailments associated with body weight, including hypertension, Type ll diabetes, colon cancer, and heart disease. The two drugs used in the study were Sibutramine (Meridia) and Orlistat (Alli and Xenical).

The researchers concluded that the use of Sibutramine and Orlistat reduced "body weight related disease burden ... by 2% and 1% respectively." Therefore, the researchers concluded that for Australians, weight loss treatment using Sibutramine or Orlistat is not cost effective, because of the modest weight loss, likely weight regain, and a lack of adherence to the regimen.

Although the Australian study may show that some obesity drugs don't reduce health care costs, having one or more of the three drugs, Qnexa, Lorcaserin, or Contrave, available for use as an approved obesity drug will likely encourage medical weight loss providers to find ways to maximize the effectiveness of the drug or drugs. This effort may reduce health care costs.

The Australian results should motivate medical weight loss providers to determine the cost effectiveness of the obesity drugs currently in the FDA pipeline. And when appropriate, depending on which drugs are approved, a provider should of course choose the drug that gives maximum weight loss. The provider should also use proven long term behavior modification treatment approaches to minimize the risk of weight regain, and maximize adherence to the weight loss maintenance program.

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