Enteryx implantation for GERD

Expanded multicenter trial results and interim postapproval follow-up to 24 months

Lawrence B. Cohen, David A. Johnson, Robert A. Ganz, James Aisenberg, Jacques Devière, T. Raymond Foley, Gregory B. Haber, Jeffrey H. Peters, Glen Lehman

Research output: Contribution to journalArticle

54 Citations (Scopus)

Abstract

Background: Enteryx implantation in the esophagus is an alternative therapy for patients with proton pump inhibitor (PPI) dependent GERD. Although this treatment resulted in highly significant improvement at 6 and 12 months, longer follow-up is needed to more fully assess the durability of these positive effects. Methods: An open-label, international clinical trial was conducted in 144 PPI-dependent patients with GERD with follow-up at 6 and 12 months. In addition, the durability and the safety of the treatment were assessed for 24 months in 64 patients enrolled in a postapproval study. The primary study outcome measure was usage of PPI. Secondary outcomes in the multicenter trial were GERD health-related quality of life (GERD-HRQL) symptom score and esophageal acid exposure. Results: At 12 months, PPI use was reduced ≥50% in 84%: 95% confidence interval (CI) [76%, 90%] and was eliminated in 73%: 95% CI[64%, 81%] of evaluable patients (intent-to-treat analysis 78%: 95% CI[70%, 84%] and 68%: 95% CI[60%, 76%], respectively). A GERD-HRQL ≤11 was attained in 78%: 95% CI[69%, 85%] of evaluable patients. Esophageal acid exposure (total time pH <4) was reduced by 31%: 95% CI[17%, 43%]. At 24 months, a ≥50% or greater reduction in PPI use was achieved in 72%: 95% CI[59%, 82%] and PPI use was eliminated in 67%: 95% CI[54%, 78%] of patients. Conclusions: This investigation provides evidence for sustained effectiveness and safety of implantation of Enteryx in the esophagus in PPI-dependent patients with GERD.

Original languageEnglish
Pages (from-to)650-658
Number of pages9
JournalGastrointestinal Endoscopy
Volume61
Issue number6
DOIs
StatePublished - Jun 2005
Externally publishedYes

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Gastroesophageal Reflux
Proton Pump Inhibitors
Multicenter Studies
Confidence Intervals
Esophagus
Quality of Life
Safety
Acids
ethylene-vinyl alcohol copolymer
Complementary Therapies
Outcome Assessment (Health Care)
Clinical Trials
Therapeutics

ASJC Scopus subject areas

  • Gastroenterology

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Enteryx implantation for GERD : Expanded multicenter trial results and interim postapproval follow-up to 24 months. / Cohen, Lawrence B.; Johnson, David A.; Ganz, Robert A.; Aisenberg, James; Devière, Jacques; Foley, T. Raymond; Haber, Gregory B.; Peters, Jeffrey H.; Lehman, Glen.

In: Gastrointestinal Endoscopy, Vol. 61, No. 6, 06.2005, p. 650-658.

Research output: Contribution to journalArticle

Cohen, LB, Johnson, DA, Ganz, RA, Aisenberg, J, Devière, J, Foley, TR, Haber, GB, Peters, JH & Lehman, G 2005, 'Enteryx implantation for GERD: Expanded multicenter trial results and interim postapproval follow-up to 24 months', Gastrointestinal Endoscopy, vol. 61, no. 6, pp. 650-658. https://doi.org/10.1016/S0016-5107(04)02835-4
Cohen, Lawrence B. ; Johnson, David A. ; Ganz, Robert A. ; Aisenberg, James ; Devière, Jacques ; Foley, T. Raymond ; Haber, Gregory B. ; Peters, Jeffrey H. ; Lehman, Glen. / Enteryx implantation for GERD : Expanded multicenter trial results and interim postapproval follow-up to 24 months. In: Gastrointestinal Endoscopy. 2005 ; Vol. 61, No. 6. pp. 650-658.
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T2 - Expanded multicenter trial results and interim postapproval follow-up to 24 months

AU - Cohen, Lawrence B.

AU - Johnson, David A.

AU - Ganz, Robert A.

AU - Aisenberg, James

AU - Devière, Jacques

AU - Foley, T. Raymond

AU - Haber, Gregory B.

AU - Peters, Jeffrey H.

AU - Lehman, Glen

PY - 2005/6

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N2 - Background: Enteryx implantation in the esophagus is an alternative therapy for patients with proton pump inhibitor (PPI) dependent GERD. Although this treatment resulted in highly significant improvement at 6 and 12 months, longer follow-up is needed to more fully assess the durability of these positive effects. Methods: An open-label, international clinical trial was conducted in 144 PPI-dependent patients with GERD with follow-up at 6 and 12 months. In addition, the durability and the safety of the treatment were assessed for 24 months in 64 patients enrolled in a postapproval study. The primary study outcome measure was usage of PPI. Secondary outcomes in the multicenter trial were GERD health-related quality of life (GERD-HRQL) symptom score and esophageal acid exposure. Results: At 12 months, PPI use was reduced ≥50% in 84%: 95% confidence interval (CI) [76%, 90%] and was eliminated in 73%: 95% CI[64%, 81%] of evaluable patients (intent-to-treat analysis 78%: 95% CI[70%, 84%] and 68%: 95% CI[60%, 76%], respectively). A GERD-HRQL ≤11 was attained in 78%: 95% CI[69%, 85%] of evaluable patients. Esophageal acid exposure (total time pH <4) was reduced by 31%: 95% CI[17%, 43%]. At 24 months, a ≥50% or greater reduction in PPI use was achieved in 72%: 95% CI[59%, 82%] and PPI use was eliminated in 67%: 95% CI[54%, 78%] of patients. Conclusions: This investigation provides evidence for sustained effectiveness and safety of implantation of Enteryx in the esophagus in PPI-dependent patients with GERD.

AB - Background: Enteryx implantation in the esophagus is an alternative therapy for patients with proton pump inhibitor (PPI) dependent GERD. Although this treatment resulted in highly significant improvement at 6 and 12 months, longer follow-up is needed to more fully assess the durability of these positive effects. Methods: An open-label, international clinical trial was conducted in 144 PPI-dependent patients with GERD with follow-up at 6 and 12 months. In addition, the durability and the safety of the treatment were assessed for 24 months in 64 patients enrolled in a postapproval study. The primary study outcome measure was usage of PPI. Secondary outcomes in the multicenter trial were GERD health-related quality of life (GERD-HRQL) symptom score and esophageal acid exposure. Results: At 12 months, PPI use was reduced ≥50% in 84%: 95% confidence interval (CI) [76%, 90%] and was eliminated in 73%: 95% CI[64%, 81%] of evaluable patients (intent-to-treat analysis 78%: 95% CI[70%, 84%] and 68%: 95% CI[60%, 76%], respectively). A GERD-HRQL ≤11 was attained in 78%: 95% CI[69%, 85%] of evaluable patients. Esophageal acid exposure (total time pH <4) was reduced by 31%: 95% CI[17%, 43%]. At 24 months, a ≥50% or greater reduction in PPI use was achieved in 72%: 95% CI[59%, 82%] and PPI use was eliminated in 67%: 95% CI[54%, 78%] of patients. Conclusions: This investigation provides evidence for sustained effectiveness and safety of implantation of Enteryx in the esophagus in PPI-dependent patients with GERD.

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