LAP-BAND for lower BMI: 2-year results from the multicenter pivotal study

Obesity (Silver Spring). 2013 Jun;21(6):1148-58. doi: 10.1002/oby.20477.

Abstract

Objective: The goal of this study was to examine the safety and effectiveness of the LAP-BAND System for patients with 30-39.9 BMI and associated comorbidities.

Design and methods: In this prospective, multicenter, interventional cohort study, subjects with a BMI between 30 and 39.9 who had failed prior weight loss attempts were recruited from 7 surgical centers. The primary effectiveness endpoint required that >40% of subjects achieve ≥30% excess weight loss (EWL) at 1 year. Secondary endpoints included assessment of comorbidities and quality-of-life.

Results: Of 149 subjects, 90.6% were female, with mean BMI of 35.3 kg/m2 . At 1 year, 84.6% of subjects achieved ≥30% EWL (P < 0.0001), with 65.0% mean EWL; 66.4% of subjects were no longer obese (BMI < 30). Baseline comorbidities improved at 1 year for 64.4% with dyslipidemia, 59.6% with hypertension, and 85.7% with diabetes. Quality-of-life (IWQOL-Lite) also improved (P < 0.0001). The Year 1 results were maintained or improved at 2 years. Regression analysis indicates that each additional 10% weight loss at Year 2 was associated with an increase in IWQOL-Lite by 7.1 points and a decrease in triglycerides by 13.7 mg/dL, fasting glucose by 3.5 mg/dL, and systolic blood pressure by 3.3 mmHg. Most adverse events were mild to moderate and resolved without sequelae within 1 month. Five subjects (3.4%) had explantations.

Conclusion: LAGB is safe and effective for people with 30-39.9 BMI, with weight loss and comorbidity improvement through at least 2 years.

Trial registration: ClinicalTrials.gov NCT00570505.

Publication types

  • Multicenter Study

MeSH terms

  • Adolescent
  • Adult
  • Blood Glucose / metabolism
  • Blood Pressure
  • Body Mass Index*
  • Cholesterol / blood
  • Comorbidity
  • Diabetes Mellitus / epidemiology*
  • Dyslipidemias / epidemiology*
  • Endpoint Determination
  • Female
  • Gastroplasty / methods*
  • Humans
  • Hypertension / epidemiology*
  • Linear Models
  • Male
  • Middle Aged
  • Obesity / epidemiology
  • Obesity / surgery*
  • Prospective Studies
  • Quality of Life
  • Treatment Outcome
  • Triglycerides / blood
  • Weight Loss
  • Young Adult

Substances

  • Blood Glucose
  • Triglycerides
  • Cholesterol

Associated data

  • ClinicalTrials.gov/NCT00570505