摘要
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.
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.
