Weight loss through adjustable gastric banding and improvement in daytime sleepiness: 2 year interim results of APEX study

Abstract

Objective:

Obesity is one factor associated with an increased risk of obstructive sleep apnea (OSA). This study reports the investigator-reported resolution or improvement of OSA and improvements in sleep-related quality of life (QOL) 2 years after surgical placement of the LAP-BAND AP (LBAP) system.

Research design and methods:

The LBAP Experience (APEX) study is an ongoing 5 year, prospective, observational study assessing change in weight, comorbidities, and QOL after LBAP implantation. This is an interim analysis of patients with evaluable data at 24 months who had OSA at baseline.

Clinical trial registration:

NCT00501085.

Results:

At baseline, 117 of 395 patients (29.6%; mean body mass index [BMI], 45.0 kg/m2) reported OSA; of these, 57 had evaluable patient-reported outcome data at 2 years. Investigator-reported resolution or improvement of OSA was 69% and 86% at post-operative years 1 and 2, respectively. Patients reporting resolution, improvement, or no change in OSA experienced mean changes in BMI and percentage of weight loss of −9.7 kg/m²/−21.7%, −8.3 kg/m²/−18.7%, and −5.7 kg/m²/−13.2%, respectively (n = 54). Mean 2 year BMI was not statistically different between the groups (p = not significant). Mean scores for all Epworth Sleepiness Scale responses for the OSA population improved by −0.43 from baseline (p < 0.0001; n = 78) compared with −0.29 for patients without OSA at baseline (n = 177; p = 0.037 between groups). In addition, the overall study population experienced resolution and/or improvement in other obesity-related comorbidities, such as type 2 diabetes (96%) and hypertension (91%).

Conclusions:

These data support that surgically facilitated weight loss can improve sleep-related QOL and may result in resolution or improvement of OSA; the degree of weight loss may be related to these changes.

Keywords::

• Bariatric surgery
• Epworth Sleepiness Scale
• Obesity
• Sleep apnea
• Sleepiness

Transparency

Declaration of funding

This study was funded by Allergan Inc.

Author contributorship: Allergan Inc. employees worked with the investigators to develop the statistical analysis plan, and the analyses were performed by Allergan Inc. Manuscript content development decisions and final manuscript approval were exclusively retained by the authors.

Declaration of financial/other relationships

S.J., C.C., and T.O. were employees and stockholders of Allergan Inc. at the time of writing. M.F. is a clinical investigator in the APEX study.

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

Under the direction of the authors and funded by Allergan Inc., Melissa Earl provided medical writing assistance on the manuscript.

Previous presentation: Presentation at SLEEP 2012, the Associated Professional Sleep Societies (APSS) 26th Annual Meeting, 9–13 June 2012, Boston, MA, USA.

Notes

*LAP-BAND AP is a registered trade name of Allergan Inc., Irvine, CA, USA

*LAP-BAND AP is a registered trade name of Allergan, Inc., Irvine, CA, US