Hamilton Medical Center , Dalton, GA , USA.
Curr Med Res Opin. 2014 May;30(5):841-8. doi: 10.1185/03007995.2013.874992. Epub 2014 Jan 16.
This 48 week combined analysis reports safety and clinical effectiveness of the LAP-BAND AP * laparoscopic adjustable gastric band (LAGB) in severely obese patients enrolled in the 5 year, prospective, observational, open-label APEX (NCT00501085) and HERO (NCT00953173) studies.
The studies enrolled 1620 patients (APEX: N = 514; HERO: N = 1106), 1140 patients in the US (including all APEX patients), and 480 patients in the European Union (EU), Canada or Australia. APEX and HERO are non-randomized, non-comparator, open-label studies with differences in study management practices and follow-up. Notably, laboratory data were not collected during the APEX study.
After 48 weeks, mean (SD) percentage weight loss (%WL) was for APEX: 18.7% (7.9); HERO-US: 17.9% (8.5); HERO-EU: 16.5% (10.3); HERO-Canada: 13.4% (8.9); and HERO-Australia: 12.3% (6.9). After 48 weeks, there were no significant differences in %WL for APEX vs. HERO-US. After 48 weeks in the combined analysis (APEX + HERO): (1) patients without vs. with type 2 diabetes at baseline had greater %WL (18% [8.7] vs. 16% [8.5], p = 0.002); (2) female patients had greater %WL vs. male patients (17.9% [8.5] vs. 15.9% [9.3], p = 0.003); (3) younger patients had greater %WL vs. older patients (<50 years: 17.8% [8.7] vs. ≥50 years: 16.7% [8.6], p = 0.035); (4) baseline BMI did not affect %WL (≤35 to ≤45 kg/m(2): 17.7% [8.4] vs. >45 kg/m(2): 17.1% [9.1], p = 0.272). Device-related serious adverse events and adverse events were reported in 1.9% and 17.7% of patients, respectively. Revision and explantation surgeries were carried out on 3.4% and 2.3% of patients, respectively during the 48 weeks of follow-up.
This analysis demonstrates the effective weight loss and safety profile of the current LAGB system, with US patients achieving better weight loss than patients from outside the US.
本 48 周联合分析报告了严重肥胖患者中使用 LAP-BAND AP*腹腔镜可调胃带（LAGB）的安全性和临床疗效，这些患者参加了为期 5 年的前瞻性、观察性、开放性 APEX（NCT00501085）和 HERO（NCT00953173）研究。
研究纳入了 1620 名患者（APEX：N=514；HERO：N=1106），其中 1140 名患者来自美国（包括所有 APEX 患者），480 名患者来自欧盟、加拿大或澳大利亚。APEX 和 HERO 是非随机、非对照、开放性研究，研究管理实践和随访存在差异。值得注意的是，APEX 研究期间未收集实验室数据。
48 周后，APEX 的平均（标准差）体重减轻百分比（%WL）为 18.7%（7.9）；HERO-US：17.9%（8.5）；HERO-EU：16.5%（10.3）；HERO-Canada：13.4%（8.9）；HERO-Australia：12.3%（6.9）。48 周后，APEX 与 HERO-US 之间的%WL 无显著差异。在联合分析（APEX+HERO）的 48 周后：（1）与基线时患有 2 型糖尿病的患者相比，无糖尿病患者的%WL 更高（18%[8.7] vs. 16%[8.5]，p=0.002）；（2）女性患者的%WL 高于男性患者（17.9%[8.5] vs. 15.9%[9.3]，p=0.003）；（3）年轻患者的%WL 高于老年患者（<50 岁：17.8%[8.7] vs. ≥50 岁：16.7%[8.6]，p=0.035）；（4）基线 BMI 不影响%WL（≤35 至≤45kg/m2：17.7%[8.4] vs. >45kg/m2：17.1%[9.1]，p=0.272）。分别有 1.9%和 17.7%的患者报告了与设备相关的严重不良事件和不良事件。在 48 周的随访期间，分别有 3.4%和 2.3%的患者接受了修订和取出手术。
本分析表明，当前 LAGB 系统具有有效的减重效果和安全性，美国患者的减重效果优于非美国患者。
