Safety and efficacy of the LAP-BAND AP® adjustable gastric band in the treatment of obesity: results at 2 years.

BACKGROUND

The objective of this analysis is to report interim, 2-year results for morbidly obese patients who have undergone laparoscopic adjustable gastric banding in the LAP-BAND AP® EXperience (APEX) trial.

METHODS

The APEX trial is an ongoing, multicenter, prospective, open-label, 5-year study of the LAP-BAND AP® System (LBAP) in 517 morbidly obese patients at 50 clinical centers in the United States. Last observation carried forward was used in the analyses of change in body weight and comorbid conditions, and observed data were analyzed for the Obesity and Weight-Loss Quality of Life (OWLQOL) questionnaire. Changes in body weight, percent weight loss, percent excess weight loss, body mass index (BMI), OWLQOL score, remission or improvement in obesity-related comorbid conditions, and adverse events were reported.

RESULTS

At baseline, 81.5% of patients were female, and 85.8% were white. The mean age was 42.5 years, and the mean BMI was 44.0 kg/m(2). More than 85% of patients had ≥ 1 obesity-related comorbidity. At 2 years, the mean BMI change was -8.5 kg/m(2), and the mean percent weight loss was -19.3%. Responses to all questions on the OWLQOL questionnaire had a mean improvement of 54% (range, 26%-67%) at 2 years. Obesity-related comorbid conditions were remitted or improved in the majority of patients at 2 years, including type 2 diabetes mellitus (96%), hypertension (91%), gastroesophageal reflux disease (91%), hyperlipidemia (77%), obstructive sleep apnea (86%), depression (75%), and osteoarthritis (93%). The LBAP and its implantation were well tolerated, with 19.1% and 6.0% of patients reporting device-related adverse events or serious device-related adverse events, respectively.

CONCLUSION

The LBAP safely and effectively facilitated weight loss in morbidly obese patients, with clinically meaningful improvements in quality of life and obesity-related comorbidities. The durability of these results will be further described with additional follow-up through 5 years.

TRIAL REGISTRATION

www.ClinicalTrials.gov identifier NCT00501085.