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Abstract
Objective:
Bariatric surgery is an effective treatment for the reduction of weight in obese patients (BMI ≥ 40 kg/m2 or 30 kg/m2 with ≥1 comorbidities), who are refractory to behavioral and medical therapies. This study examined the effect of the adjustable gastric band (AGB) system on changes in gastroesophageal reflux disease (GERD) and patient-reported outcomes, including measures of quality of life.
Methods:
Two-year interim analysis of patients (N = 171) in the 5 year, prospective APEX study who reported GERD prior to the AGB procedure. An unrecorded number of hiatal hernia repairs were conducted during the APEX study.
Results:
At baseline, 171 of 395 patients (43%) reported GERD requiring daily medical therapy. After 2 years, 122 patients had sufficient data to assess outcome (71%). Complete resolution of GERD was reported in 98 patients (80%), improvement in 13 (11%), no change in 9 (7%), and worsening in 2 (2%). Overall, 91% of GERD patients experienced resolution and/or improvement of GERD. Baseline BMI was not significantly different among the GERD response categories (resolved, improved, and stable/worse), p = 0.4581. Mean ΔBMI and percentage excess weight loss (%EWL) were: −8.8 kg/m2/−0.9%, −11.4 kg/m2/−53.9%, −6.4 kg/m2/−36.1%, and −7.1 kg/m2/−31.2%, respectively. There were no significant differences in reductions in BMI or %EWL between responder groups (resolved versus stable/worse ΔBMI p = 0.1031, %EWL p = 0.0667 OR resolved/improved versus stable/worse ΔBMI p = 0.0918, %EWL p = 0.0552). After 2 years, resolution or improvement occurred in pre-existing comorbidities: type 2 diabetes (96%), hypertension (91%), hyperlipidemia (77%), obstructive sleep apnea (86%), osteoarthritis (93%), and depression (75%). Patient satisfaction with AGB was assessed as: very satisfied/satisfied (87%), very satisfied (50%), dissatisfied (5.0%). Quality of life measured by the Obesity and Weight-Loss Quality of Life Instrument (GERD patients) significantly improved from baseline.
Conclusion:
Obese patients with GERD had meaningful improvement in patient-reported outcomes with the AGB system. In addition, other obesity-related comorbidities and measures of quality of life improved.
Transparency
Declaration of funding
The APEX study and the development of this manuscript were funded by Allergan, Inc. The LBAP system is manufactured by Allergan, Inc. All authors contributed equally to the preparation of this manuscript.
Declaration of financial/other relationships
G.W., R.C., H.B., and K.M. are investigators and advisors for Allergan, Inc. C.C. and T.O. are employees and stock option/stock holders of Allergan, Inc.
CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.
Acknowledgments
Dr. Anthony Stonehouse provided writing support during the development of this article. Dr. Stonehouse is an employee of Watson & Stonehouse Enterprises, LLC. Funding for the project was provided by Allergan, Inc.
The APEX study group includes: Gregory Schroder, Michael Baptista, Robert Cywes, Timothy Eldridge, Mark Fusco, Lee Grossbard, Jaime Ponce, David Voellinger, George Woodman, Layton Alldredge, Sunil Bhoyrul, Helmuth Billy, Darrin Hansen, Carson Liu, Robert Michaelson, Kevin Montgomery, William Neal, Kent Sasse, Adam Smith, Jeff Allen, Tom Chua, Trace Curry, George Fortier, Vince Lusco, Steve Malley, John Olsofka, Peter Rantis, Vafa Shayani, Michael Snyder, Van Wagner, Brad Watkins, Nicholas Bertha, Matthew Brengman, Timothy Erlich, David Elliott, Alan Geiss, Isaias Irgau, Daniel Jones, Peter Kwon, and Pavlos Papasavas.
Notes
*LAP-BAND AP is a registered trade name of Allergan, Inc., Irvine, California, USA.