LAP-BAND ® for Lower BMI: 2-Year Results from the Multicenter Pivotal Study
2013; Wiley; Volume: 21; Issue: 6 Linguagem: Inglês
10.1002/oby.20477
ISSN1930-739X
AutoresRobert Michaelson, Diane K. Murphy, Todd M. Gross, Scott M. Whitcup,
Tópico(s)Diet and metabolism studies
ResumoThe 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.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.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.LAGB is safe and effective for people with 30-39.9 BMI, with weight loss and comorbidity improvement through at least 2 years.
Referência(s)