Efficacy and safety of the adjustable gastric band-pooled interim analysis of the APEX and HERO studies at 48 weeks

Jaime Ponce, Shahrad Taheri, Vincent Lusco, Christopher Cornell, Daisy S. Ng-Mak, Rui Shi, Ted Okerson

Research output: Contribution to journalArticle

Abstract

Objective: 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. Methods: 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. Results: 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 ≤45kg/m2: 17.7% [8.4] vs. >45kg/m2: 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. Conclusions: 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.

Original languageEnglish
Pages (from-to)841-848
Number of pages8
JournalCurrent Medical Research and Opinion
Volume30
Issue number5
DOIs
Publication statusPublished - 2014
Externally publishedYes

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Stomach
Safety
Weight Loss
European Union
Canada
Practice Management
Reoperation
Type 2 Diabetes Mellitus
Equipment and Supplies

Keywords

  • Adjustable gastric band
  • Obesity
  • Prospective observational study
  • Weight loss

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Efficacy and safety of the adjustable gastric band-pooled interim analysis of the APEX and HERO studies at 48 weeks. / Ponce, Jaime; Taheri, Shahrad; Lusco, Vincent; Cornell, Christopher; Ng-Mak, Daisy S.; Shi, Rui; Okerson, Ted.

In: Current Medical Research and Opinion, Vol. 30, No. 5, 2014, p. 841-848.

Research output: Contribution to journalArticle

Ponce, Jaime ; Taheri, Shahrad ; Lusco, Vincent ; Cornell, Christopher ; Ng-Mak, Daisy S. ; Shi, Rui ; Okerson, Ted. / Efficacy and safety of the adjustable gastric band-pooled interim analysis of the APEX and HERO studies at 48 weeks. In: Current Medical Research and Opinion. 2014 ; Vol. 30, No. 5. pp. 841-848.
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abstract = "Objective: 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. Methods: 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. Results: 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 ≤45kg/m2: 17.7{\%} [8.4] vs. >45kg/m2: 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. Conclusions: 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.",
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author = "Jaime Ponce and Shahrad Taheri and Vincent Lusco and Christopher Cornell and Ng-Mak, {Daisy S.} and Rui Shi and Ted Okerson",
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T1 - Efficacy and safety of the adjustable gastric band-pooled interim analysis of the APEX and HERO studies at 48 weeks

AU - Ponce, Jaime

AU - Taheri, Shahrad

AU - Lusco, Vincent

AU - Cornell, Christopher

AU - Ng-Mak, Daisy S.

AU - Shi, Rui

AU - Okerson, Ted

PY - 2014

Y1 - 2014

N2 - Objective: 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. Methods: 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. Results: 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 ≤45kg/m2: 17.7% [8.4] vs. >45kg/m2: 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. Conclusions: 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.

AB - Objective: 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. Methods: 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. Results: 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 ≤45kg/m2: 17.7% [8.4] vs. >45kg/m2: 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. Conclusions: 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.

KW - Adjustable gastric band

KW - Obesity

KW - Prospective observational study

KW - Weight loss

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