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Lap-Band study

Lap-Band effective in long-term obese patients

At one year 66.4% of subjects were no longer obese

Researchers from the Northwest Weight Loss Surgery in Everett, Washington, have revealed that the Lap-Band can induce weight loss in long-term obese patients.

Dr Robert Michaelson

"Patients in our study had been obese for an average of 17 years," said Dr Robert Michaelson of Northwest. "They tried numerous other weight loss methods and finally reached out for surgical treatment when they were weary of the repetitive failures at maintaining weight loss."

The study’s findings, published in the journal Obesity, indicate that the procedure may help to intervene before obesity becomes life threatening to patients.

To assess the safety and effectiveness of Lap-Band in an expanded group of patients, and included 149 individuals from seven surgical centres with a BMI 35 to 39.9 without an additional condition, or a BMI o30 to 34.9 with at least one obesity-related condition. All patients had failed prior weight loss attempts.

The primary effectiveness endpoint required that >40% of subjects achieve ≥30% EWL at one year. Secondary endpoints included assessment of comorbidities and quality-of-life.

Results

The majority of the patients were female (90.6% were female) and presented with a mean BMI 35.3. At one year, 84.6% of subjects achieved ≥30% EWL (p<0.0001), with 65.0% mean EWL and 66.4% of subjects were no longer obese (BMI<30).

Baseline comorbidities improved at one year for 64.4% with dyslipidemia, 59.6% with hypertension, and 85.7% with diabetes. Quality-of-life also improved (p<0.0001). Most side effects were mild to moderate and resolved within one month.

The researchers also found that the one year results were maintained or improved at two years, and that each additional 10% weight loss at year two was linked with a decrease in triglycerides by 13.7mg/dL, blood sugar levels by 3.5mg/dL and systolic blood pressure by 3.3mmHg. Five subjects (3.4%) had explantations.

“LAGB is safe and effective for people with 30-39.9 BMI, with weight loss and comorbidity improvement through at least two years,” the authors concluded.

"The results of this study convinced the FDA that early intervention in the continuum of obesity is the right thing to do: treat before people go on to develop serious comorbid conditions of obesity," he said.

He added that this and similar studies prompted the American Society for Metabolic and Bariatric Surgery to issue a position statement endorsing weight loss surgery for patients with moderate obesity who have failed non- surgical methods of weight loss.

"The next step is to get the private insurers and Medicare, who continue to rely on guidelines established in 1991, to review the incontrovertible literature, take down the barriers to the necessary treatment for this disease, and offer the hope of a cure to 27 million Americans," said Michaelson.

However, in an accompanying editorial, Drs David Arterburn, Group Health Research Institute in Seattle, and Melinda Maggard, University of California Los Angeles, cautioned that the long-term benefits and risks of banding in lower weight individuals still need to be determined, and that studies in higher weight individuals show weight regain starting at two years.

"There are also concerns that serious adverse events are common; including reports of removal rates as high as 5%. As the prevalence of severe comorbidities is less in this patient population, the benefits of preventing comorbidities is not known, which will require larger sample sizes to determine," they note. "Until longer-term data on the benefits and harms are available, the use of LAGB in patients with BMI o30 to 35 should be primarily reserved for clinical research studies."

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