Document Detail


LAP-BAND for lower BMI: 2-year results from the multicenter pivotal study.
MedLine Citation:
PMID:  23637029     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Robert Michaelson; Diane K Murphy; Todd M Gross; Scott M Whitcup;
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Publication Detail:
Type:  Journal Article; Multicenter Study    
Journal Detail:
Title:  Obesity (Silver Spring, Md.)     Volume:  21     ISSN:  1930-739X     ISO Abbreviation:  Obesity (Silver Spring)     Publication Date:  2013 Jun 
Date Detail:
Created Date:  2013-08-05     Completed Date:  2014-02-28     Revised Date:  2014-04-14    
Medline Journal Info:
Nlm Unique ID:  101264860     Medline TA:  Obesity (Silver Spring)     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1148-58     Citation Subset:  IM    
Copyright Information:
Copyright © 2013 The Obesity Society.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00570505
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MeSH Terms
Descriptor/Qualifier:
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*
Intervention Studies
Linear Models
Male
Middle Aged
Obesity / epidemiology,  surgery*
Prospective Studies
Quality of Life
Treatment Outcome
Triglycerides / blood
Weight Loss
Young Adult
Chemical
Reg. No./Substance:
0/Blood Glucose; 0/Triglycerides; 97C5T2UQ7J/Cholesterol
Investigator
Investigator/Affiliation:
Nicholas Bertha / ; Thomas Chua / ; Timothy Ehrlich / ; Kevin Montgomery / ; Peter Rantis / ; Terry Simpson / ; George Woodman /
Comments/Corrections
Comment In:
Obesity (Silver Spring). 2013 Nov;21(11):2204   [PMID:  23637015 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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