title: LAP-BAND for lower BMI: 2-year results from the multicenter pivotal study.
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.
  
  
  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.
  
  
  CONCLUSIONS
  LAGB is safe and effective for people with 30-39.9 BMI, with weight loss and comorbidity improvement through at least 2 years.
authors: Northwest Weight Loss Surgery, Everett, Washington, USA.
authors: Robert
authors: R
authors: Michaelson
authors: Diane K
authors: DK
authors: Murphy
authors: Todd M
authors: TM
authors: Gross
authors: Scott M
authors: SM
authors: Whitcup
mesh_terms: D000293:Adolescent; D000328:Adult; D001786:Blood Glucose / Q000378:metabolism; D001794:Blood Pressure; D015992:Body Mass Index; D002784:Cholesterol / Q000097:blood; D015897:Comorbidity; D003920:Diabetes Mellitus / Q000453:epidemiology*; D050171:Dyslipidemias / Q000453:epidemiology*; D023381:Endpoint Determination; D005260:Female; D015391:Gastroplasty / Q000379:methods*; D006801:Humans; D006973:Hypertension / Q000453:epidemiology*; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000453:epidemiology / Q000601:surgery*; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood; D015431:Weight Loss; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D014280:Triglycerides; D002784:Cholesterol