George Woodman, MD, Robert Cywes, MD, Helmuth T Billy, MD, Michael Oefelein, MD FACS, Ted Okerson, MD FACP. Midsouth Bariatrics; Jacksonville Weight Loss Center; Ventura Advanced Surgical Associates; Allergan Pharmaceuticals, Inc
Introduction: Bariatric surgery has been established as an effective treatment to reduce weight in severely obese patients (> 40 kg/m² OR > 35 kg/m² with > one co-morbidities) refractory to behavioral and medical therapies. Numerous co-morbid illnesses (e.g. GERD, etc.) have been associated with obesity. This study reports the 1 year resolution and/or improvement of GERD after surgical placement of the adjustable gastric band(AGB) (AP Band, Allergan, Irvine, CA) as documented by patient-reported outcomes and/or GERD medication reduction/discontinuation and the accompanying percent excess weight loss (EWL), and co-morbidity benefits.
Methods: The APEX study is an ongoing 5-year, prospective, multi-center, open-label, observational study which will assess weight reduction, co-morbidities and QOL after implantation of the gastric band (NCT00501085). All patients provided informed consent. This is an interim analysis of 112 subjects who reported daily medical therapy for GERD before AGB and who have completed the 1 year post-operative scheduled visit.
Results: At baseline, 165 out of 436 subjects (38%) reported GERD requiring daily medical therapy, with data from 112 containing sufficient information to assess outcome at 48 weeks. Complete resolution of GERD was reported in 77 patients (69%), with improvement in 27 patients (24%), no change in 7 patients (6%) and worsening in 1 patient (1%). Overall, 93% had resolution and/or improvement in GERD. Baseline BMI was not significantly different among the 4 responder groups. Mean BMI change and the %EWL was -9.1/47.6%, -8.7/48.4%, -6.7/41.7% and -9.2/45.2% in the four groups respectively. %EWL and reductions in BMI were similar among groups. As occurred in patients with GERD, resolution or improvement also occurred in other pre-existing co-morbidities measured: depression (71%), hyperlipidemia (57%), hypertension (78%), obstructive sleep apnea (69%) and type 2 diabetes (88%). Quality of life as measured by the Obesity and Weight Loss Quality of Life instrument also improved.
Conclusion: GERD PRO symptoms and medication requirements were reduced in severely obese patients after surgical intervention with the LAP-BAND AP® system. These improvements tended to be greater in those with a greater %EWL, but this was not statistically different. Other obesity-related co-morbidities also improved, along with quality of life. These data suggest that the LAP-BAND AP® offers an important therapeutic approach to severe obesity which may also lead to clinically meaningful reductions in multiple obesity-related co-morbidities.
Program Number: S062