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Clinical Studies and Practice

LAP-BAND for BMI 30–40: 5-year health outcomes from the multicenter pivotal study

Abstract

Background:

We performed a 5-year multicenter study to evaluate the safety and effectiveness of the LAP-BAND System surgery (LBS) in patients with obesity with a body mass index (BMI) of 30–39.9 kg m2. This pivotal study was designed to support LBS application to the US Food and Drug Administration for broadening the indications for surgery and the lower BMI indication was approved with 1-year data in 2011, with the intention to complete the 5-year evaluation.

Objectives:

To present broad health outcome data including weight change, patient reported outcomes, comorbidity change and complications during the 5-year study.

Setting:

The study was conducted at seven US private practice clinical trial sites.

Methods:

We enrolled 149 BMI 30–39.9 subjects into a 5-year, multicenter, longitudinal, prospective post-approval study. Data for those completing each time point are presented.

Results:

The predefined target of at least 30% excess weight loss was achieved by more than 76% of subjects by 1-year and at every year thereafter during the 5-year study. Mean percentage weight loss at 5 years was 15.9±12.4%. Sustained weight loss was accompanied by sustained improvement in generic and weight-specific quality of life, symptoms of depression and the prevalence of binge-eating disorder. The number of subjects with normal fasting triglyceride, high-density lipoprotein cholesterol, plasma glucose and HbA1c increased significantly between baseline and 5 years. Fifty-four months after LBS implantation, the rate of device explants without replacement was 5.4%; however, the rate of explants increased to 12.1% by month 60 owing to no cost-elective band removals offered to subjects at study exit. No deaths or unanticipated adverse device effects were reported.

Conclusions:

The LBS is safe and effective for people with BMI 30–39.9 with demonstrated improvements in weight loss, comorbidities and quality of life, and with a low explant rate through 5 years following treatment.

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Acknowledgements

The LAP-BAND Lower BMI Study Group Investigators included Thomas Chua, MD (Wisconsin), Kevin Montgomery, MD (Washington), Terry Simpson, MD (Arizona), Timothy Ehrlich, MD (Connecticut), George Woodman, MD (Tennessee), Brad Watkins, MD (Ohio), and Hans Joseph Schmidt (New Jersey).

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Correspondence to J B Dixon.

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Competing interests

Allergan Medical (Goleta, CA, USA) designed and funded the study before it was transferred to Apollo Endosurgery (Austin, TX, USA). LLE, VV and JBD are consultants for Apollo Endosurgery. LLE and JBD were also consultants for Allergan Medical while the study was being conducted. VV was an employee of Allergan, Inc. and a shareholder while the study was being conducted. RM was an investigator in the study and a consultant to Allergan Medical (Goleta, CA, USA).

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Dixon, J., Eaton, L., Vincent, V. et al. LAP-BAND for BMI 30–40: 5-year health outcomes from the multicenter pivotal study. Int J Obes 40, 291–298 (2016). https://doi.org/10.1038/ijo.2015.156

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