Enteryx implantation for GERD: expanded multicenter trial results and interim postapproval follow-up to 24 months - 18/08/11
Reprint requests: Lawrence B. Cohen, MD, 311 East 79th St, New York, NY 10021.New York, New York; Norfolk, Virginia; Minneapolis, Minnesota, USA; Brussels, Belgium; Lancaster, Pennsylvania, USA; Toronto, Ontario, Canada; Los Angeles, California; Indianapolis, Indiana, USA
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.
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| See CME section; p. 729. Results were presented, in part, at the annual meeting of the American Gastroenterological Association Digestive Diseases Week, May 15-20, 2004, New Orleans, Louisiana (Am J Gastroenterol 2003;98:A71). |
Vol 61 - N° 6
P. 650-658 - mai 2005 Retour au numéro
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