FDA Committee Approves New LAP-BAND Criteria

Last month, the Gastroenterology and Urology Devices Panel of the Food and Drug Administration (FDA) approved a request by Allergan, manufacturers of the LAP-BAND^® System, to expand the eligibility criteria for approved use.

Voting 8-to-2 in favor of increasing the candidate pool, the FDA advisory panel agreed to Allergan’s application to lower the minimum standards from “morbidly” obese to a lesser degree of obesity. In terms of body mass index (BMI), the new inclusion standards lower the minimum BMI without comorbid conditions from ≥40 to ≥35 and for those with at least one major comorbid condition from ≥35-39 down to ≥30-34. The National Institutes of Health (NIH) defines obesity as a BMI ≥30 and morbid obesity as ≥40.

For a 5-foot-6-inch patient, the new qualifying standard for someone without other underlying risk factors would be 217 pounds as opposed to 248 pounds previously. With a comorbid condition such as diabetes or cardiovascular disease, the weight requirement could be as low as 186 pounds.

Douglas Olsen, MD, FACS, FASMBS, medical director for the Centennial Center for the Treatment of Obesity and president of the Tennessee Chapter of the Society of Metabolic & Bariatric Surgeons, said the FDA does not give a green light to surgical procedures. However, he continued, “Since the Lap-Band is an actual medical device, the FDA has the right to regulate its use.”

Lap-Band, one of two approved adjustable gastric banding systems in the United States, won original FDA approval in 2001. To receive the required endorsement, Olsen explained, Allergan had to submit evidence for the indications of use, safety and efficacy. At that time, the company used NIH criteria based on pre-1991 data. In fact, he continued, the benefit/risk data was generated from the much more complex procedures of gastric bypass and vertical banded gastroplasty. “The Lap-Band’s morbidity and mortality profile is about one-tenth of what it is for the other major bariatric operations,” Olsen said. “Even these procedures are less risky now as compared to then. Everything has gotten safer today,” he pointed out of advances made in bariatric procedures over the past two decades.

For any bariatric intervention, Olsen said the procedure is only a tool to help a patient with weight management rather than the actual cause of weight loss. “It’s ultimately the diet they live by for the rest of their life that makes them lose weight,” he noted. With that caveat in mind, he added the available surgical “tools” could be categorized in tiered levels of efficacy with the Lap-Band being on the bottom level. “It has the lowest operative risk, the lowest rate of complications, the lowest cost ... but also the lowest weight loss. For most people, once you get a BMI over 45, the band really drops off in its ability to help you lose weight.”

Because the adjustable band is on the lower end of the management tools, Olsen said it made sense that it would be helpful to those on the lower end of the obesity spectrum. The population base included in the expanded criteria, he noted, have had some measure of success in keeping their BMI from escalating to a morbidly obese level but still cannot seem to get their weight into a normal category.

 “This patient population we’re talking about probably would be the group that would have the best results with the band,” he said. “From a psycho/social standpoint, it’s a tremendous addition. You’re going to give them a tool to make that day-to-day struggle much easier.”

Dawn Gibson, manager of the Metabolic Surgery Center at Baptist Hospital, said her facility has followed the NIH guidelines for weight loss surgery and has therefore turned away patients interested in the Lap-Band surgery. “Many of these patients would likely meet the newly proposed guidelines so we definitely believe there will be some demand,” she said.

In approving the expanded use, the FDA advisory committee considered three questions:

• Is there a reasonable assurance the device would be safe in the new patient population?
• Is there a reasonable assurance the device would be effective in assisting with weight reduction in the new patient population?
• Do the benefits for use in the new patient population outweigh the risks?

By lowering the baseline BMI from ≥40 to ≥35, Gibson said, “When the new guidelines are in place, these patients who have about 50-75 excess pounds will now qualify for surgery without having the comorbidity, allowing them to reduce significant obesity-related medical conditions before they get to a certain degree of severity.”

She added, “Studies show weight loss is a huge factor in improving or even curing health conditions such as hypertension, sleep apnea and type 2 diabetes.”

As for effectiveness and risks, Gibson pointed out the Lap-Band is adjustable so surgeons have the ability to monitor and fine-tune the band if a patient is losing too rapidly. Olsen added complications from the surgery are comparable to the risk of any surgery where general anesthesia is used. Most of the complications with adjustable gastric banding, he continued, are associated with the patient’s ability to tolerate a foreign object implanted in the body. In which case, he pointed out, the procedure is reversible.

Although the new criteria must still have full FDA consent, Olsen said it would be unusual not to receive approval after the advisory panel has passed a measure.

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TAGS: LAP-Band, Allergan, Weight Loss, Bariatric Surgery, Obesity, Dr. Douglas Olsen, Dawn Gibson, Centennial Center for the Treatment of Obesity, Metabolic Surgery Center at Baptist Hospital

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Heading: And a New Diet Pill, Too

While in the approval mood, another FDA committee has given the green light to a sustained release diet pill designed to boost metabolism and decrease food cravings. On Dec. 7, the Endocrinologic and Metabolic Drugs Advisory Committee voted 13-to-7 to make the drug marketed under the brand name Contrave^® (naltrexone HCI/bupropion HCI) available for the treatment of obesity. Indications for use are in patients with an initial BMI ≥30 or those with a BMI ≥27 with one or more comorbid condition.

Of concern to the panel, however, is the increase in blood pressure associated with Contrave usage. The committee voted 11-to-8 on a post-approval requirement to order a dedicated study to examine the drug’s effect on risk for major adverse cardiac events.

Manufactured by Orexigen Therapeutics, Inc., the drug combines the antidepressant bupropion (brand name Wellbutrin^®) with naltrexone, which is used in cases of narcotic addiction and alcoholism. In four clinical studies (56 weeks, randomized, multicenter, double-blind, placebo-controlled), 44 percent or more of the patients who took Contrave lost ≥5 percent of their baseline body weight, which was roughly double the percentage of those with the same results in the placebo control group. An interesting proposed label note is that most patients who were going to respond to the drug did so by four months of treatment. Patients with no statistically significant weight loss at the 16-week mark should probably discontinue use.

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