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Clinical Studies and Practice

Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial

Abstract

Background/objectives:

This trial evaluated the safety and effectiveness of the Orbera Intragastric Balloon as an adjunct to lifestyle intervention.

Subjects/methods:

In this multicenter, randomized, open-label clinical trial, 255 adults with a body mass index of 30–40 kg m2 were treated and outcomes were assessed up to 12 months. Participants were randomized to endoscopic placement of an intragastric balloon plus lifestyle or lifestyle intervention alone. Balloons were removed at 6 months and lifestyle intervention continued for both groups through 12 months. At 9 months, coprimary end points were two measures of weight loss.

Results:

At 6 months, weight loss was −3.3% of total body weight (−3.2 kg) in the lifestyle arm vs −10.2% (−9.9 kg) in the balloon plus lifestyle arm (P<0.001); at 9 months (3 months postballoon removal), weight loss was −3.4% (−3.2 kg) vs −9.1% (−8.8 kg, P0.001); and at 12 months, −3.1% (−2.9 kg) vs −7.6% (−7.4 kg, P0.001). For the primary end points, at 9 months, mean percent loss of weight in excess of ideal body weight (s.d.) at 9 months was 26.5% (20.7) (P=0.32) and 9.7% (15.1) in the balloon and control groups, respectively. Also, 45.6% (36.7, 54.8) of the subjects randomized to the balloon achieved at least 15% loss of weight in excess of ideal body weight greater than the control group (P<0.001). The majority of balloon subjects experienced adverse events; 86.9% nausea, 75.6% vomiting, 57.5% abdominal pain and 18.8% had their device removed before 6 months because of an adverse event or subject request. Five subjects (3.1%) in the balloon group had a gastric abnormality at the time of device removal, and no ulcers were found.

Conclusions and relevance:

Intragastric balloon achieved greater short-term weight loss at 3 and 6 months postballoon removal than lifestyle intervention alone. Adverse gastrointestinal events were common.

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Acknowledgements

The IB-005 Study Investigators included Nicholas Berth, MD (New Jersey), Helmuth Billy, MD (California), Anita Courcoulas, MD (Pennsylvania), Timothy Ehrlich, MD (Connecticut), Mark Fusco, MD (Florida), Daniel Pambianco, MD (Virginia), Michael Snyder, MD (Colorado), George Woodman, MD (Tennessee), Colin Powers, MD (New York), Hans Joseph Schmidt, MD (New Jersey), Vafa Shayani, MD (Illinois), Peter Billing, MD (Washington), Thomas Chua, MD (Wisconsin), Lee Grossbard, MD (Florida) and Adam Smith, DO (Texas). The study was designed, funded and conducted by Allergan Medical, which was acquired by Apollo Endosurgery—the sponsor. The specific role of the sponsor for each of the following was: design and conduct of the study—sponsor initiated and led; data collection—study sites collected data that was then transmitted to sponsor; data management and study monitoring—sponsor led; statistical analysis—sponsor led, statistical analysis was provided by SimulStat Inc. and North American Science Associates (NAMSA), investigator and writing group input to analyses; interpretation of the data—study investigators and writing group members; preparation of manuscript—writing group; review of manuscript—writing group; approval of the manuscript—writing group; decision to submit the manuscript for publication—writing group.

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Correspondence to A Courcoulas.

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Competing interests

AC has received research grants from the NIH-NIDDK, Nutrisystem, Ethicon J & J Healthcare, Covidien, is a consultant for Apollo Endosurgery for this project and was a project consultant for Ethicon J & J Healthcare. BAD is a consultant for Apollo Endosurgery and Xlumina. He has research agreements with Aspire Bariatrics and GI Dynamics. LE was a consultant to Allergan Medical while the study was being conducted. She currently serves as a consultant to Apollo Endosurgery and is the principal consultant for UltaMed Corporation. JR was an employee of Allergan Medical during the close of the study but did not work on the trial, and currently serves as a consultant to Apollo Endosurgery. He currently is an employee of Simulstat. GW is a clinical trial investigator with USGI, ReShape and Obalon. MF is a former Allergan consultant and proctor. VS is a consultant for Apollo Endosurgery. He has research agreements with Apollo Endosurgery and Obalon as well as a clinical trial investigator for Obalon. HB is a consultant for Transenterix and speaker for Ethicon and Apollo Endosurgery. DP has nothing to disclose. CG is a consultant for Apollo Endosurgery and Olympus Corporation. He has performed sponsored research for Olympus Corporation and GI Supply. AC and JR had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

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Courcoulas, A., Abu Dayyeh, B., Eaton, L. et al. Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial. Int J Obes 41, 427–433 (2017). https://doi.org/10.1038/ijo.2016.229

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