Efficacy and safety of the adjustable gastric band – pooled interim analysis of the APEX and HERO studies at 48 weeks

Abstract

Objective:

This 48 week combined analysis reports safety and clinical effectiveness of the LAP-BAND AP laparoscopic adjustable gastric band (LAGB) in severely obese patients enrolled in the 5 year, prospective, observational, open-label APEX (NCT00501085) and HERO (NCT00953173) studies.

Methods:

The studies enrolled 1620 patients (APEX: N = 514; HERO: N = 1106), 1140 patients in the US (including all APEX patients), and 480 patients in the European Union (EU), Canada or Australia. APEX and HERO are non-randomized, non-comparator, open-label studies with differences in study management practices and follow-up. Notably, laboratory data were not collected during the APEX study.

Results:

After 48 weeks, mean (SD) percentage weight loss (%WL) was for APEX: 18.7% (7.9); HERO-US: 17.9% (8.5); HERO-EU: 16.5% (10.3); HERO-Canada: 13.4% (8.9); and HERO-Australia: 12.3% (6.9). After 48 weeks, there were no significant differences in %WL for APEX vs. HERO-US. After 48 weeks in the combined analysis (APEX + HERO): (1) patients without vs. with type 2 diabetes at baseline had greater %WL (18% [8.7] vs. 16% [8.5], p = 0.002); (2) female patients had greater %WL vs. male patients (17.9% [8.5] vs. 15.9% [9.3], p = 0.003); (3) younger patients had greater %WL vs. older patients (<50 years: 17.8% [8.7] vs. ≥50 years: 16.7% [8.6], p = 0.035); (4) baseline BMI did not affect %WL (≤35 to ≤45 kg/m²: 17.7% [8.4] vs. >45 kg/m²: 17.1% [9.1], p = 0.272). Device-related serious adverse events and adverse events were reported in 1.9% and 17.7% of patients, respectively. Revision and explantation surgeries were carried out on 3.4% and 2.3% of patients, respectively during the 48 weeks of follow-up.

Conclusions:

This analysis demonstrates the effective weight loss and safety profile of the current LAGB system, with US patients achieving better weight loss than patients from outside the US.

Keywords::

• Adjustable gastric band
• Obesity
• Prospective observational study
• Weight loss

Transparency

Declaration of funding

The APEX and HERO studies and the development of this manuscript were funded by Allergan Inc. All authors contributed equally to the preparation of this manuscript.

Declaration of financial/other relationships

J.P. is an investigator in the APEX clinical study, is a consultant for Reshape Medical and Allergan Inc., and is a speaker for W.L. Gore & Associates Inc. S.T. is involved in the Allergan European Center for Excellence Program. V.L. is an investigator in the APEX and HERO clinical studies, and is a consultant for Allergan Inc. R.S., C.C., D.S.N.-M., and T.O. are employees and stock holders of Allergan Inc. This study was funded by 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 authors thank the APEX study group, including: Layton Alldredge, Jeff Allen, Michael Baptista, Nicholas Bertha, Sunil Bhoyrul, Helmuth Billy, Matthew Brengman, Tom Chua, Trace Curry, Robert Cywes, Timothy Eldridge, David Elliott, Timothy Erlich, George Fortier, Mark Fusco, Alan Geiss, Lee Grossbard, Darrin Hansen, Isaias Irgau, Daniel Jones, Peter Kwon, Carson Liu, Vincent Lusco, Steve Malley, Robert Michaelson, Kevin Montgomery, William Neal, John Olsofka, Pavlos Papasavas, Jaime Ponce, Peter Rantis, Kent Sasse, Gregory Schroder, Vafa Shayani, Michael Snyder, Adam Smith, David Voellinger, Van Wagner, Brad Watkins, and George Woodman.

The authors also thank the HERO study group, including: David Ashton, Justin Bessell, Zubin Bhesania, Sunil Bhoyrul, Chris Cobourn, Trace Curry, Robert Cywes, Franco Favretti, Pietro Forestieri, George Fortier, Francesco Furbetta, Mark Fusco, Dominick Gadaleta, Richard Gilhome, Lee Grossbard, Jeff Holloway, Ivo Jacobs, Paul Leeder, Vincent Lusco, Kevin Montgomery, Joseph Moran, John Olsofka, Hans Schmidt, Adam Smith, Shaw Somers, Paul Super, David Voellinger, Kristel De Vogeleare, and Derek Weiss.

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