FDA approves Lap-Band for less obese adults
The FDA has approved expanded use of Allergan’s Lap-Band adjustable gastric banding system for adults who have a BMI between 30 and 40 and at least one obesity-related comorbid condition, according to a press release from the company.
The system was first approved by the FDA in 2001 for severely obese adults: those with a BMI of 35 with at least one severe comorbid condition; a BMI of 40; or those who are at least 100 lb overweight. Allergan estimates that more than 300,000 people worldwide have the Lap-Band. The surgery can cost $12,000 to $20,000.
“The Lap-Band system meets an unmet clinical need, as it provides an effective treatment option, which is used in combination with diet and exercise to enable sustained weight loss,” Robert Michaelson, MD, PhD, of Northwest Surgical Weight Loss Surgery in Washington, and clinical trial investigator, said in a press release.
In January, an FDA Gastroenterology and Urology Devices Advisory Panel voted 8-2 that the Lap-Band is safe for reducing weight in less obese adults, and it voted 8-1, with one abstention, that the device is effective in this patient population.
Data for approval
The approval to expand the use of the Lap-Band adjustable gastric banding system is based on a review of 12-month data and available 24-month data from a prospective, single-arm, non-randomized, multicenter, 5-year study and the more than 17-year safety and effectiveness record of the system. The study, initiated by Allergan, is being conducted under an FDA-approved Investigational Device Exemption. The study began in 2007 and included 149 patients with a mean excess weight of 62.8 lb who had been obese, on average, for 17 years and who underwent the Lap-Band procedure.
After approval, trial follow-up will continue for 5 years. In addition, researchers will analyze the outcomes of patients with BMI of 30 to 40 recorded in the Bariatric Outcomes Longitudinal Database (BOLD). BOLD was established in 2007 by the Surgical Review Corporation and is now the world's largest and most comprehensive repository of clinical bariatric surgery patient information, according to the release. The database currently contains information on more than 300,000 patients, and 12,000 new patients are added monthly. Using data from BOLD, the researchers will examine the explant rates, adverse events, weight loss and changes in the status of obesity-related comorbidities observed in lap-band patients during the course of 10 years.
Study results show benefit
The criterion for success of the study was at least 40% of patients achieving clinically meaningful weight loss, defined as at least 30% excess weight loss, at the 12-month time point. Results from the 12-month dataset demonstrate that 83.9% of the patients lost at least 30% of their excess weight at the 1-year time point, more than twice the percentage required for success. More than 65% of patients were no longer obese after 1 year. Weight loss was maintained in the second year of the study.
The secondary endpoints for the trial were improvement in obesity-related comorbidities of dyslipidemia, type 2 diabetes and hypertension, and improvement in quality of life. Eighty-five percent of patients had at least one comorbid condition. After 1 year, 22% to 33% of patients with comorbidities saw their conditions resolved. In addition, approximately 60% of patients who had a comorbidity at baseline had improvement of at least one comorbidity by month 12. Also, there was a statistically significant improvement in quality of life at months 6 and 12.
During the 12-month study period, adverse events included vomiting, dysphagia and gastroesophageal reflux. Most adverse events were mild to moderate in severity and resolved in less than 4 weeks.
“As a surgeon, I see patients every day who have been obese for years and have tried several diet and exercise programs without success,” Michaelson said in the release. “These patients frequently feel judged by their weight, as obesity is often viewed as a lack of will power, which it is not. Obesity is a disease, which requires medical treatment, but unfortunately, diet and exercise alone do not work for everyone.”
|Follow EndocrineToday.com on Twitter.|