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 A. Lehman

Research output: Contribution to journalArticle

55 Scopus citations

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

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

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    Cohen, L. B., Johnson, D. A., Ganz, R. A., Aisenberg, J., Devière, J., Foley, T. R., Haber, G. B., Peters, J. H., & Lehman, G. A. (2005). Enteryx implantation for GERD: Expanded multicenter trial results and interim postapproval follow-up to 24 months. Gastrointestinal endoscopy, 61(6), 650-658. https://doi.org/10.1016/S0016-5107(04)02835-4