Effect of adjustable gastric banding on quality of life and weight loss in the Helping Evaluate Reduction in Obesity (HERO) registry study: 2 year analysis

Abstract

Objective:

This report from the Helping Evaluate Reduction in Obesity (HERO) Study investigated weight loss, health-related quality of life (HRQOL), and factors predictive of HRQOL improvement during a 2 year period following Lap-Band AP implantation (post-LBAP).

Research design and methods:

This prospective, observational study included patients with 1 and 2 year follow-up data post-LBAP (N = 585). Changes in body mass index (BMI), percentage of weight loss (%WL), excess weight loss (%EWL) and HRQOL (Impact of Weight on Quality of Life [IWQOL]–Lite measure), and differences between <30% EWL and ≥30% EWL subgroups were assessed at 1 and 2 years post-LBAP. Multiple linear regression examined association of %EWL groups with IWQOL-Lite scores controlling for age, gender, region (US vs outside US), household income, employment status, and comorbidities.

Results:

Most patients were female (80.2%) and from the US (64.8%); overall mean (SD) age was 43.6 (11.28) years and 65.8% of patients had ≥30% EWL at year 2. At 2 years post-LBAP, mean %EWL was 43.5%; %EWL was 12.4% in the <30% EWL group and 59.6% in ≥30% EWL group (P ≤ 0.0001). Changes in IWQOL total and subscores were significantly greater in ≥30% EWL versus <30% EWL patients (all P < 0.0005) at years 1 and 2; Self-Esteem and Physical subscores had the largest changes. Multiple regression analysis showed that patients with ≥30% EWL had clinically meaningful improvements in HRQOL compared with patients having <30% EWL (P ≤ 0.001). Similarly, US patients and females had a clinically significant change in IWQOL score versus their counterparts (P ≤ 0.001). Conversely, income, comorbidities and employment status were not significant predictors of change in IWQOL scores at year 2.

Conclusions:

These results support and extend findings regarding the effectiveness of LBAP for weight loss and illustrate the importance of ≥30% EWL as a significant factor in predicting clinically significant improvement in HRQOL 1 and 2 years post-LBAP.

Clinical trial registration:

NCT00953173.

Keywords: :

• Bariatric surgery
• Gastric banding
• Gender
• Geographic region
• Prospective registry
• Quality of life
• Weight loss

Transparency

Declaration of funding

This study was funded by Allergan Inc., Irvine, CA, USA.

All authors were involved in all stages of the manuscript development, with final content decisions being exclusively retained by the authors. Allergan Inc. was involved in the study design and study conduct and provided logistical support to trial sites. Allergan Inc. employees worked with the investigators to develop the statistical analysis plan, and the analyses were performed by Allergan Inc.

Declaration of financial/other relationships

W.-L.L. and J.J. have disclosed that they were employees of Allergan Inc. at the time of the study. D.C.M., E.P.A., and S.S. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article. D.V. has disclosed that he participated as an investigator for this study and received funding from Allergan, Inc. N.D. has disclosed that she is employed by Quintiles Outcome, a company that specializes in patient registries and which received funding from Allergan Inc. to facilitate data collection for the study. D.G. has disclosed that she is employed by Allergan Inc.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

The authors thank Caroline Burk PharmD MS, Daisy Ng-Mak PhD, and Arnold Degboe MBChB PhD for their contributions with the study design, study implementation, and statistical analysis plan. In addition, the authors thank Laura Spurchise and Deborah Micklos MPH for their collaborative efforts with the study design and implementation.

Under the direction and supervision of the authors and funded by Allergan Inc., assistance with manuscript preparation, including writing assistance and copyediting provided by William R. Perlman PhD and Susan M. Kaup PhD of Evidence Scientific Solutions.

Previous presentation: Presented at the 31st Annual Scientific Meeting of The Obesity Society, Atlanta, Georgia, 11–16 November 2013.

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, USA