• Curr Med Res Opin · May 2014

    Multicenter Study Clinical Trial Observational Study

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

    • Mark Fusco, Steven James, Christopher Cornell, and Ted Okerson.
    • Health First Medical Group , Melbourne, FL , USA.
    • Curr Med Res Opin. 2014 May 1;30(5):849-55.

    ObjectiveObesity 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 MethodsThe 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 RegistrationNCT00501085.ResultsAt 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/m(2)/-21.7%, -8.3 kg/m(2)/-18.7%, and -5.7 kg/m(2)/-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%).ConclusionsThese 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.

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